{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-06-01", "results": { "skip": 0, "limit": 1, "total": 2 } }, "results": [ { "spl_product_data_elements": [ "Lunsumio Mosunetuzumab MOSUNETUZUMAB MOSUNETUZUMAB HISTIDINE ACETIC ACID METHIONINE SUCROSE POLYSORBATE 20 WATER Lunsumio Mosunetuzumab MOSUNETUZUMAB MOSUNETUZUMAB HISTIDINE ACETIC ACID METHIONINE SUCROSE POLYSORBATE 20 WATER" ], "boxed_warning": [ "WARNING: CYTOKINE RELEASE SYNDROME Cytokine release syndrome (CRS), including serious or life-threatening reactions, can occur in patients receiving LUNSUMIO. Initiate treatment with the LUNSUMIO step-up dosing schedule to reduce the risk of CRS. Withhold LUNSUMIO until CRS resolves or permanently discontinue based on severity [see Dosage and Administration (2.1 and 2.4) and Warnings and Precautions (5.1) ] . WARNING: CYTOKINE RELEASE SYNDROME See full prescribing information for complete boxed warning. Cytokine release syndrome (CRS), including serious or life-threatening reactions, can occur in patients receiving LUNSUMIO. Initiate treatment with the LUNSUMIO step-up dosing schedule to reduce the risk of CRS. Withhold LUNSUMIO until CRS resolves or permanently discontinue based on severity. ( 2.1 , 2.4 , 5.1 )" ], "recent_major_changes": [ "Dosage and Administration ( 2.1 , 2.3 , 2.5 ) 12/2025 Warnings and Precautions ( 5.1 , 5.5 , 5.7 ) 12/2025" ], "recent_major_changes_table": [ "
Dosage and Administration (2.1, 2.3, 2.5)12/2025
Warnings and Precautions (5.1, 5.5, 5.7)12/2025
" ], "indications_and_usage": [ "1 INDICATIONS AND USAGE LUNSUMIO is a bispecific CD20-directed CD3 T-cell engager indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). ( 1.1 ) 1.1 Follicular Lymphoma LUNSUMIO is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate [see Clinical Studies (14) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s)." ], "dosage_and_administration": [ "2 DOSAGE AND ADMINISTRATION LUNSUMIO and LUNSUMIO VELO have different dosage and administration instructions. Administer LUNSUMIO only as an intravenous infusion. ( 2.1 ) Premedicate to reduce risk of CRS and infusion-related reactions. ( 2.3 , 5.1 ) Recommended dosage for LUNSUMIO for intravenous infusion ( 2.2 ): Day of Treatment Cycle length = 21 days Intravenous Dose of LUNSUMIO Rate of Infusion Cycle 1 Day 1 1 mg Administer over a minimum of 4 hours. Day 8 2 mg Day 15 60 mg Cycle 2 Day 1 60 mg Administer over 2 hours if infusions from Cycle 1 were well-tolerated. Cycles 3+ Day 1 30 mg See Full Prescribing Information for instructions on preparation and administration. ( 2.5 ) 2.1 Important Dosing Information LUNSUMIO and LUNSUMIO VELO have different dosage and administration instructions [see Dosage and Administration (2.2) and Warnings and Precautions (5.7) ]. LUNSUMIO is for intravenous use only. Check the product label to ensure that the correct formulation (LUNSUMIO or LUNSUMIO VELO) is being prescribed and administered. Do not substitute LUNSUMIO for or with LUNSUMIO VELO. Administer LUNSUMIO to well-hydrated patients. Premedicate before each dose in Cycle 1 and Cycle 2 [see Dosage and Administration (2.3) ] . Administer only as an intravenous infusion through a dedicated infusion line. Do not use an in-line filter to administer LUNSUMIO . Drip chamber filters can be used to administer LUNSUMIO. LUNSUMIO should only be administered by a qualified healthcare professional with appropriate medical support to manage severe reactions such as CRS and neurologic toxicity, including ICANS [see Warnings and Precautions (5.1 and 5.2) ] . 2.2 Recommended Dosage The recommended dosage for LUNSUMIO intravenous infusion is presented in Table 1 . Administer for 8 cycles, unless patients experience unacceptable toxicity or disease progression. For patients who achieve a complete response, no further treatment beyond 8 cycles is required. For patients who achieve a partial response or have stable disease in response to treatment with LUNSUMIO after 8 cycles, an additional 9 cycles of treatment (17 cycles total) should be administered, unless a patient experiences unacceptable toxicity or disease progression. Table 1. Recommended Dose and Schedule of LUNSUMIO Intravenous Infusion (21-Day Treatment Cycles) Day of Treatment Intravenous Dose of LUNSUMIO Rate of Infusion Cycle 1 Day 1 1 mg Administer over a minimum of 4 hours. Day 8 2 mg Day 15 60 mg Cycle 2 Day 1 60 mg Administer over 2 hours if infusions from Cycle 1 were well-tolerated. Cycles 3+ Day 1 30 mg Table 2. Recommendations for Restarting Therapy with LUNSUMIO Intravenous Infusion After Dose Delay Last Intravenous Dose Administered Time Since Last Dose Administered Action for Next Intravenous Dose(s) 1 mg Cycle 1 Day 1 1week to 2 weeks Administer 2 mg (Cycle 1 Day 8), then resume the planned treatment schedule. Greater than 2 weeks Repeat 1 mg (Cycle 1 Day 1), then administer 2 mg (Cycle 1 Day 8) and resume the planned treatment schedule. 2 mg Cycle 1 Day 8 1 week to 2 weeks Administer 60 mg (Cycle 1 Day 15), then resume the planned treatment schedule. Greater than 2 weeks to less than 6 weeks Repeat 2 mg (Cycle 1 Day 8), then administer 60 mg (Cycle 1 Day 15) and resume the planned treatment schedule. Greater than or equal to 6 weeks Repeat 1 mg (Cycle 1 Day 1) and 2 mg (Cycle 1 Day 8), then administer 60 mg (Cycle 1 Day 15) and resume the planned treatment schedule. 60 mg Cycle 1 Day 15 1 week to less than 6 weeks Administer 60 mg (Cycle 2 Day 1), then resume the planned treatment schedule. Greater than or equal to 6 weeks Repeat 1 mg (Cycle 2 Day 1) and 2 mg (Cycle 2 Day 8), then administer 60 mg (Cycle 2 Day 15), followed by 30 mg (Cycle 3 Day 1) and then resume the planned treatment schedule. 60 mg Cycle 2 Day 1 3 weeks to less than 6 weeks Administer 30 mg (Cycle 3 Day 1), then resume the planned treatment schedule. Greater than or equal to 6 weeks Repeat 1 mg (Cycle 3 Day 1) and 2 mg (Cycle 3 Day 8), then administer 30 mg (Cycle 3 Day 15) For the Day 1, Day 8, and Day 15 doses in the next cycle, administer premedication as per Table 3 for all patients. , followed by 30 mg (Cycle 4 Day 1) and then resume the planned treatment schedule. 30 mg Cycle 3 onwards 3 weeks to less than 6 weeks Administer 30 mg, then resume the planned treatment schedule. Greater than or equal to 6 weeks Repeat 1 mg on Day 1 and 2 mg on Day 8 during the next cycle, then administer 30 mg on Day 15 , followed by 30 mg on Day 1 of subsequent cycles. 2.3 Recommended Premedication Premedication to reduce the risk of CRS and infusion-related reactions are outlined in Table 3 [see Warnings and Precautions (5.1) ] . Table 3. Premedication to be Administered to Patients Prior to LUNSUMIO Intravenous Infusion Treatment Cycle Patients Requiring Premedication Premedication Dosage Administration Cycle 1 and Cycle 2 All patients Corticosteroid Dexamethasone 20 mg (preferred) intravenous or methylprednisolone 80 mg intravenous Complete at least 1 hour prior to infusion Antihistamine Diphenhydramine hydrochloride 50 mg to 100 mg or equivalent oral or intravenous antihistamine At least 30 minutes prior to infusion Antipyretic Oral acetaminophen (500 mg to 1,000 mg) At least 30 minutes prior to infusion Cycles 3+ Patients who experienced any grade CRS with the previous dose Corticosteroid Dexamethasone 20 mg (preferred) intravenous or methylprednisolone 80 mg intravenous Complete at least 1 hour prior to infusion Antihistamine Diphenhydramine hydrochloride 50 mg to 100 mg or equivalent oral or intravenous antihistamine At least 30 minutes prior to infusion Antipyretic Oral acetaminophen (500 mg to 1,000 mg) At least 30 minutes prior to infusion 2.4 Dosage Modifications for Adverse Reactions See Tables 4 and 5 for the recommended dosage modifications for adverse reactions of CRS and neurologic toxicity, including immune effector cell-associated neurotoxicity (ICANS). See Table 6 for the recommended dosage modifications for other adverse reactions following administration of LUNSUMIO. Dosage Modifications for Cytokine Release Syndrome Identify CRS based on clinical presentation [see Warnings and Precautions (5.1) ] . Evaluate for and treat other causes of fever, hypoxia, and hypotension. If CRS is suspected, withhold LUNSUMIO until CRS resolves, manage according to the recommendations in Table 4 and per current practice guidelines. Administer supportive therapy for CRS, which may include intensive care for severe or life-threatening CRS. Table 4. Recommendations for Management of Cytokine Release Syndrome with LUNSUMIO Intravenous Infusion Grade Based on American Society for Transplantation and Cellular Therapy (ASTCT) 2019 grading for CRS. Presenting Symptoms Actions If CRS is refractory to management, consider other causes including hemophagocytic lymphohistiocytosis [see Warnings and Precautions (5.4) ] . Grade 1 Fever ≥ 100.4°F (38°C) Premedication may mask fever, therefore if clinical presentation is consistent with CRS, follow these management guidelines. Withhold current infusion of LUNSUMIO and manage per current practice guidelines. If symptoms resolve, restart infusion at the same rate. Ensure CRS symptoms are resolved for at least 72 hours prior to the next dose of LUNSUMIO. Refer to Table 2 for information on restarting LUNSUMIO after dose delays [see Dosage and Administration (2.2) ] . Administer premedication Refer to Table 3 for additional information on premedication. prior to next dose of LUNSUMIO and monitor patient more frequently. Grade 2 Fever ≥ 100.4°F (38°C) with: Hypotension not requiring vasopressors and/or hypoxia requiring low-flow oxygen Low-flow oxygen defined as oxygen delivered at < 6 L/minute; high-flow oxygen defined as oxygen delivered at ≥ 6 L/minute. by nasal cannula or blow-by. Withhold current infusion of LUNSUMIO and manage per current practice guidelines. If symptoms resolve, restart infusion at 50% rate. Ensure CRS symptoms are resolved for at least 72 hours prior to the next dose of LUNSUMIO. Administer premedication prior to next dose of LUNSUMIO and consider infusing the next dose at 50% rate. For the next dose of LUNSUMIO, monitor more frequently and consider hospitalization. Recurrent Grade 2 CRS Manage per Grade 3 CRS. Grade 3 Fever ≥ 100.4°F (38°C) with: Hypotension requiring a vasopressor (with or without vasopressin) and/or hypoxia requiring high flow oxygen by nasal cannula, face mask, non-rebreather mask, or Venturi mask. Withhold LUNSUMIO, manage per current practice guidelines and provide supportive therapy, which may include intensive care. Ensure CRS symptoms are resolved for at least 72 hours prior to the next dose of LUNSUMIO. Administer premedication prior to next dose of LUNSUMIO and infuse the next dose at 50% rate. Hospitalize for the next dose of LUNSUMIO. Recurrent Grade 3 CRS Permanently discontinue LUNSUMIO. Manage CRS per current practice guidelines and provide supportive therapy, which may include intensive care. Grade 4 Fever ≥ 100.4°F (38°C) with: Hypotension requiring multiple vasopressors (excluding vasopressin) and/or hypoxia requiring oxygen by positive pressure (e.g., CPAP, BiPAP, intubation and mechanical ventilation). Permanently discontinue LUNSUMIO. Manage CRS per current practice guidelines and provide supportive therapy, which may include intensive care. Dosage Modifications for Neurologic Toxicity, including ICANS Management recommendations for neurologic toxicity, including ICANS, are summarized in Table 5 . At the first sign of neurologic toxicity, including ICANS, consider neurology evaluation and withholding of LUNSUMIO based on the type and severity of neurotoxicity. Rule out other causes of neurologic symptoms. Provide supportive therapy, which may include intensive care. Table 5. Recommendations for Management of Neurologic Toxicity (including ICANS) Adverse Reaction Severity Based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0. , Based on American Society for Transplantation and Cellular Therapy (ASTCT) 2019 grading for ICANS. Actions Neurologic Toxicity (including ICANS ) Grade 1 Continue LUNSUMIO and monitor neurologic toxicity symptoms. If ICANS, manage per current practice guidelines. Grade 2 Withhold LUNSUMIO until neurologic toxicity symptoms improve to Grade 1 or baseline for at least 72 hours. See Table 2 for recommendations on restarting LUNSUMIO after dose delays [see Dosage and Administration (2.2) ] . Provide supportive therapy, and consider neurologic evaluation. If ICANS, manage per current practice guidelines. Grade 3 Withhold LUNSUMIO until neurologic toxicity symptoms improve to Grade 1 or baseline for at least 72 hours. Provide supportive therapy, which may include intensive care, and consider neurology evaluation. If ICANS, manage per current practice guidelines. If recurrence of ICANS, permanently discontinue LUNSUMIO. Grade 4 Permanently discontinue LUNSUMIO. Provide supportive therapy, which may include intensive care, and consider neurology evaluation. If ICANS, manage per current practice guidelines. Other Adverse Reactions Table 6. Recommended Dosage Modification for Other Adverse Reactions Adverse Reactions Based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0. Severity Actions Infections [see Warnings and Precautions (5.3) ] Grades 1 – 4 Withhold LUNSUMIO in patients with active infection until the infection resolves. See Table 2 for recommendations on restarting LUNSUMIO after dose delays [see Dosage and Administration (2.2) ] . For Grade 4, consider permanent discontinuation of LUNSUMIO. Neutropenia [see Warnings and Precautions (5.4) ] Absolute neutrophil count less than 0.5 × 10 9 /L Withhold LUNSUMIO until absolute neutrophil count is 0.5 × 10 9 /L or higher. Other Adverse Reactions [see Warnings and Precautions (5.5) and Adverse Reactions (6.1) ] Grade 3 or higher Withhold LUNSUMIO until the toxicity resolves to Grade 1 or baseline. 2.5 Preparation and Administration To prevent medication errors, check the vial labels to ensure that the drug being prepared and administered is LUNSUMIO for intravenous infusion. A peel-off label is provided on the LUNSUMIO Prescribing Information that should be attached to the final prepared solution. Remove the peel-off label from the Prescribing Information in the LUNSUMIO carton before discarding the carton. Affix the peel-off label to the diluted LUNSUMIO infusion bag. Preparation Use aseptic technique to prepare LUNSUMIO. Inspect the vial visually for any particulate matter, prior to administration. Do not use if the solution is discolored, or cloudy, or if foreign particles are present. Determine the dose, the total volume of LUNSUMIO solution required, and the number of LUNSUMIO vials needed. Dilution 1. Withdraw the volume from an infusion bag of 0.9% Sodium Chloride Injection, USP or 0.45% Sodium Chloride Injection, USP equal to the volume of the LUNSUMIO required for the patient's dose and discard. Only use infusion bags made of polyvinyl chloride (PVC) or polyolefin (PO) such as polyethylene (PE) and polypropylene (PP). 2. Withdraw the required volume of LUNSUMIO from the vial using a sterile needle and syringe and dilute into the infusion bag of 0.9% Sodium Chloride Injection, USP or 0.45% Sodium Chloride Injection, USP according to Table 7 . Discard any unused portion left in the vial. Table 7. Dilution of LUNSUMIO Dose of LUNSUMIO Volume of LUNSUMIO Size of 0.9% or 0.45% Sodium Chloride Injection Infusion Bag 1 mg 1 mL 50 mL or 100 mL 2 mg 2 mL 50 mL or 100 mL 60 mg 60 mL 100 mL or 250 mL 30 mg 30 mL 50 mL, 100 mL, or 250 mL 3. Gently mix the intravenous bag by slowly inverting the bag. Do not shake. 4. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if visibly opaque particles, discoloration, or foreign particles are observed. 5. Apply the peel-off label from the Prescribing Information to the infusion bag. 6. Immediately use diluted LUNSUMIO infusion solution. If not used immediately, the diluted solution can be stored refrigerated at 2°C to 8°C (36°F to 46°F) for up to 24 hours and at ambient temperature 9°C to 30°C (48°F to 86°F) for up to 16 hours. Prior to administration, ensure the infusion solution comes to reach room temperature. Administration Administer LUNSUMIO as an intravenous infusion only. Do not use an in-line filter to administer LUNSUMIO . Do not mix LUNSUMIO with, or administer through the same infusion line, as other medicinal products. No incompatibilities have been observed with infusion sets or infusion aids with product contacting materials of PVC, PE, polyurethane (PUR), polybutadiene (PBD), silicone, acrylonitrile butadiene styrene (ABS), polycarbonate (PC), polyetherurethane (PEU), fluorinated ethylene propylene (FEP), or polytetrafluorethylene (PTFE), or with drip chamber filter membrane composed of polyamide (PA)." ], "dosage_and_administration_table": [ "
Day of Treatment Cycle length = 21 daysIntravenous Dose of LUNSUMIORate of Infusion
Cycle 1Day 11 mgAdminister over a minimum of 4 hours.
Day 82 mg
Day 1560 mg
Cycle 2Day 160 mgAdminister over 2 hours if infusions from Cycle 1 were well-tolerated.
Cycles 3+Day 130 mg
", "
Table 1. Recommended Dose and Schedule of LUNSUMIO Intravenous Infusion (21-Day Treatment Cycles)
Day of TreatmentIntravenous Dose of LUNSUMIORate of Infusion
Cycle 1Day 11 mgAdminister over a minimum of 4 hours.
Day 82 mg
Day 1560 mg
Cycle 2Day 160 mgAdminister over 2 hours if infusions from Cycle 1 were well-tolerated.
Cycles 3+Day 130 mg
", "
Table 2. Recommendations for Restarting Therapy with LUNSUMIO Intravenous Infusion After Dose Delay
Last Intravenous Dose AdministeredTime Since Last Dose AdministeredAction for Next Intravenous Dose(s)
1 mg Cycle 1 Day 11week to 2 weeksAdminister 2 mg (Cycle 1 Day 8), then resume the planned treatment schedule.
Greater than 2 weeksRepeat 1 mg (Cycle 1 Day 1), then administer 2 mg (Cycle 1 Day 8) and resume the planned treatment schedule.
2 mg Cycle 1 Day 81 week to 2 weeksAdminister 60 mg (Cycle 1 Day 15), then resume the planned treatment schedule.
Greater than 2 weeks to less than 6 weeksRepeat 2 mg (Cycle 1 Day 8), then administer 60 mg (Cycle 1 Day 15) and resume the planned treatment schedule.
Greater than or equal to 6 weeksRepeat 1 mg (Cycle 1 Day 1) and 2 mg (Cycle 1 Day 8), then administer 60 mg (Cycle 1 Day 15) and resume the planned treatment schedule.
60 mg Cycle 1 Day 151 week to less than 6 weeksAdminister 60 mg (Cycle 2 Day 1), then resume the planned treatment schedule.
Greater than or equal to 6 weeksRepeat 1 mg (Cycle 2 Day 1) and 2 mg (Cycle 2 Day 8), then administer 60 mg (Cycle 2 Day 15), followed by 30 mg (Cycle 3 Day 1) and then resume the planned treatment schedule.
60 mg Cycle 2 Day 13 weeks to less than 6 weeksAdminister 30 mg (Cycle 3 Day 1), then resume the planned treatment schedule.
Greater than or equal to 6 weeksRepeat 1 mg (Cycle 3 Day 1) and 2 mg (Cycle 3 Day 8), then administer 30 mg (Cycle 3 Day 15)For the Day 1, Day 8, and Day 15 doses in the next cycle, administer premedication as per Table 3 for all patients., followed by 30 mg (Cycle 4 Day 1) and then resume the planned treatment schedule.
30 mg Cycle 3 onwards3 weeks to less than 6 weeksAdminister 30 mg, then resume the planned treatment schedule.
Greater than or equal to 6 weeksRepeat 1 mg on Day 1 and 2 mg on Day 8 during the next cycle, then administer 30 mg on Day 15, followed by 30 mg on Day 1 of subsequent cycles.
", "
Table 3. Premedication to be Administered to Patients Prior to LUNSUMIO Intravenous Infusion
Treatment CyclePatients Requiring PremedicationPremedicationDosageAdministration
Cycle 1 and Cycle 2All patientsCorticosteroidDexamethasone 20 mg (preferred) intravenous or methylprednisolone 80 mg intravenousComplete at least 1 hour prior to infusion
AntihistamineDiphenhydramine hydrochloride 50 mg to 100 mg or equivalent oral or intravenous antihistamineAt least 30 minutes prior to infusion
AntipyreticOral acetaminophen (500 mg to 1,000 mg)At least 30 minutes prior to infusion
Cycles 3+Patients who experienced any grade CRS with the previous dose CorticosteroidDexamethasone 20 mg (preferred) intravenous or methylprednisolone 80 mg intravenousComplete at least 1 hour prior to infusion
AntihistamineDiphenhydramine hydrochloride 50 mg to 100 mg or equivalent oral or intravenous antihistamineAt least 30 minutes prior to infusion
AntipyreticOral acetaminophen (500 mg to 1,000 mg)At least 30 minutes prior to infusion
", "
Table 4. Recommendations for Management of Cytokine Release Syndrome with LUNSUMIO Intravenous Infusion
GradeBased on American Society for Transplantation and Cellular Therapy (ASTCT) 2019 grading for CRS.Presenting SymptomsActionsIf CRS is refractory to management, consider other causes including hemophagocytic lymphohistiocytosis [see Warnings and Precautions (5.4)].
Grade 1Fever ≥ 100.4°F (38°C)Premedication may mask fever, therefore if clinical presentation is consistent with CRS, follow these management guidelines.Withhold current infusion of LUNSUMIO and manage per current practice guidelines.If symptoms resolve, restart infusion at the same rate.Ensure CRS symptoms are resolved for at least 72 hours prior to the next dose of LUNSUMIO.Refer to Table 2 for information on restarting LUNSUMIO after dose delays [see Dosage and Administration (2.2)].Administer premedicationRefer to Table 3 for additional information on premedication. prior to next dose of LUNSUMIO and monitor patient more frequently.
Grade 2Fever ≥ 100.4°F (38°C) with: Hypotension not requiring vasopressors and/or hypoxia requiring low-flow oxygenLow-flow oxygen defined as oxygen delivered at < 6 L/minute; high-flow oxygen defined as oxygen delivered at ≥ 6 L/minute. by nasal cannula or blow-by.Withhold current infusion of LUNSUMIO and manage per current practice guidelines.If symptoms resolve, restart infusion at 50% rate.Ensure CRS symptoms are resolved for at least 72 hours prior to the next dose of LUNSUMIO.Administer premedication prior to next dose of LUNSUMIO and consider infusing the next dose at 50% rate.For the next dose of LUNSUMIO, monitor more frequently and consider hospitalization.
Recurrent Grade 2 CRSManage per Grade 3 CRS.
Grade 3Fever ≥ 100.4°F (38°C) with: Hypotension requiring a vasopressor (with or without vasopressin) and/or hypoxia requiring high flow oxygen by nasal cannula, face mask, non-rebreather mask, or Venturi mask.Withhold LUNSUMIO, manage per current practice guidelines and provide supportive therapy, which may include intensive care.Ensure CRS symptoms are resolved for at least 72 hours prior to the next dose of LUNSUMIO.Administer premedication prior to next dose of LUNSUMIO and infuse the next dose at 50% rate.Hospitalize for the next dose of LUNSUMIO.
Recurrent Grade 3 CRSPermanently discontinue LUNSUMIO.Manage CRS per current practice guidelines and provide supportive therapy, which may include intensive care.
Grade 4Fever ≥ 100.4°F (38°C) with: Hypotension requiring multiple vasopressors (excluding vasopressin) and/or hypoxia requiring oxygen by positive pressure (e.g., CPAP, BiPAP, intubation and mechanical ventilation).Permanently discontinue LUNSUMIO.Manage CRS per current practice guidelines and provide supportive therapy, which may include intensive care.
", "
Table 5. Recommendations for Management of Neurologic Toxicity (including ICANS)
Adverse ReactionSeverityBased on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0.,Based on American Society for Transplantation and Cellular Therapy (ASTCT) 2019 grading for ICANS.Actions
Neurologic Toxicity (including ICANS)Grade 1Continue LUNSUMIO and monitor neurologic toxicity symptoms.If ICANS, manage per current practice guidelines.
Grade 2Withhold LUNSUMIO until neurologic toxicity symptoms improve to Grade 1 or baseline for at least 72 hours.See Table 2 for recommendations on restarting LUNSUMIO after dose delays [see Dosage and Administration (2.2)].Provide supportive therapy, and consider neurologic evaluation.If ICANS, manage per current practice guidelines.
Grade 3Withhold LUNSUMIO until neurologic toxicity symptoms improve to Grade 1 or baseline for at least 72 hours.Provide supportive therapy, which may include intensive care, and consider neurology evaluation.If ICANS, manage per current practice guidelines.If recurrence of ICANS, permanently discontinue LUNSUMIO.
Grade 4Permanently discontinue LUNSUMIO.Provide supportive therapy, which may include intensive care, and consider neurology evaluation.If ICANS, manage per current practice guidelines.
", "
Table 6. Recommended Dosage Modification for Other Adverse Reactions
Adverse ReactionsBased on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0.SeverityActions
Infections [see Warnings and Precautions (5.3)]Grades 1 – 4Withhold LUNSUMIO in patients with active infection until the infection resolves.See Table 2 for recommendations on restarting LUNSUMIO after dose delays [see Dosage and Administration (2.2)].For Grade 4, consider permanent discontinuation of LUNSUMIO.
Neutropenia [see Warnings and Precautions (5.4)]Absolute neutrophil count less than 0.5 × 109/LWithhold LUNSUMIO until absolute neutrophil count is 0.5 × 109/L or higher.
Other Adverse Reactions [see Warnings and Precautions (5.5) and Adverse Reactions (6.1)]Grade 3 or higherWithhold LUNSUMIO until the toxicity resolves to Grade 1 or baseline.
", "
Table 7. Dilution of LUNSUMIO
Dose of LUNSUMIOVolume of LUNSUMIOSize of 0.9% or 0.45% Sodium Chloride Injection Infusion Bag
1 mg1 mL50 mL or 100 mL
2 mg2 mL50 mL or 100 mL
60 mg60 mL100 mL or 250 mL
30 mg30 mL50 mL, 100 mL, or 250 mL
" ], "dosage_forms_and_strengths": [ "3 DOSAGE FORMS AND STRENGTHS LUNSUMIO is a sterile, colorless solution for intravenous infusion available as: Injection: 1 mg/mL in a single-dose vial Injection: 30 mg/30 mL (1 mg/mL) in a single-dose vial Injection: 1 mg/mL solution in a single-dose vial. ( 3 ) 30 mg/30 mL (1 mg/mL) solution in a single-dose vial. ( 3 )" ], "contraindications": [ "4 CONTRAINDICATIONS None. None. ( 4 )" ], "warnings_and_cautions": [ "5 WARNINGS AND PRECAUTIONS Neurologic Toxicity, including Immune Effector Cell-Associated Neurotoxicity Syndrome : Can cause serious and life-threatening neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome (ICANS). Monitor patients for signs and symptoms of neurologic toxicity during treatment; withhold or permanently discontinue based on severity. ( 5.2 ) Infections : Can cause serious or fatal infections. Monitor patients for signs and symptoms of infection, including opportunistic infections, and treat as needed. ( 5.3 ) Hemophagocytic Lymphohistiocytosis: Can cause serious or fatal reactions. For suspected cases, interrupt LUNSUMIO and evaluate and treat promptly. ( 5.4 ) Cytopenias : Monitor complete blood cell counts during treatment. ( 5.5 ) Tumor Flare : Can cause serious tumor flare reactions. Monitor patients at risk for complications of tumor flare. ( 5.6 ) Risk of Medication Errors with Incorrect Product Use : Ensure that the correct formulation is being prescribed, dispensed, and administered. ( 5.7 ) Embryo-Fetal Toxicity : May cause fetal harm. Advise females of reproductive potential of the potential risk to the fetus and to use effective contraception. ( 5.8 , 8.1 , 8.3 ) 5.1 Cytokine Release Syndrome LUNSUMIO can cause CRS, including serious or life-threatening reactions [see Adverse Reactions (6.1 )] . CRS occurred in 39% of patients who received LUNSUMIO at the recommended dosage in the clinical trial, with Grade 1 CRS occurring in 28%, Grade 2 in 15%, Grade 3 in 2%, and Grade 4 in 0.5% of patients. Among 86 patients who experienced CRS, CRS recurred in 28%. Most cases of CRS occurred following doses of 1 mg on Cycle 1 Day 1 (15%), 2 mg on Cycle 1 Day 8 (5%), and 60 mg on Cycle 1 Day 15 (33%). Five percent of patients experienced CRS after receiving 60 mg on Cycle 2 Day 1 with 1% of patients experiencing CRS following subsequent dosages of LUNSUMIO. The median time to onset of CRS from the start of administration of LUNSUMIO in Cycle 1 Day 1 was 5 hours (range: 1 hour to 3 days), Cycle 1 Day 8 was 28 hours (range: 5 hours to 3 days), Cycle 1 Day 15 was 25 hours (range: 0.1 hours to 16 days), and Cycle 2 Day 1 was 46 hours (range: 12 hours to 3 days). The median duration of CRS was 3 days (range: 1 to 29 days). Clinical signs and symptoms of CRS included, but were not limited to, fever, chills, hypotension, tachycardia, hypoxia, and headache. Concurrent neurologic adverse reactions occurred in 6% of patients and included but were not limited to headache, confusional state, and anxiety. Initiate therapy according to LUNSUMIO step-up dosing schedule to reduce the risk of CRS [see Dosage and Administration (2.3) ] . Administer pretreatment medications to reduce the risk of CRS, ensure adequate hydration, and monitor patients following administration of LUNSUMIO accordingly. At the first sign of CRS, immediately evaluate patients for hospitalization, manage per current practice guidelines and administer supportive care; withhold or permanently discontinue LUNSUMIO based on severity [see Dosage and Administration (2.4) ] . Patients who experience CRS (or other adverse reactions that impair consciousness) should be evaluated and advised not to drive and to refrain from operating heavy or potentially dangerous machinery until resolution. 5.2 Neurologic Toxicity, including Immune Effector Cell-Associated Neurotoxicity Syndrome LUNSUMIO can cause serious and life-threatening neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome (ICANS) [see Adverse Reactions (6.1) ] . Neurologic toxicity occurred in 39% of patients who received LUNSUMIO at the recommended dosage in the clinical trial, with Grade 3 neurologic toxicity occurring in 3% of patients. The most frequent neurologic toxicities were headache (21%), peripheral neuropathy (13%), dizziness (11%) and mental status changes (6%, including confusional state, disturbance in attention, cognitive disorder, delirium, encephalopathy, and somnolence). ICANS was reported in 1% of patients (Grade 1: 0.5%, Grade 2: 0.5%) who received LUNSUMIO at the recommended dosage in the clinical trial. Across a broader clinical trial population, ICANS or suspected ICANS occurred in 2.2% (21/949) of patients who received LUNSUMIO or LUNSUMIO VELO. The most frequent manifestations included confusional state and lethargy. Twenty patients had Grade 1-2 events and 1 patient had a Grade 3 event. The majority of cases (75%) occurred during the first cycle of treatment. The median time to onset was 17 days (range: 1 to 48 days). In total, 88% of cases resolved after a median duration of 3 days (range: 1 to 20 days). Coadministration of LUNSUMIO with other products that cause dizziness or mental status changes may increase the risk of neurologic toxicity. Monitor patients for signs and symptoms of neurologic toxicity during treatment. At the first sign of neurologic toxicity, including ICANS, immediately evaluate the patient, consider neurology evaluation as appropriate, and provide supportive therapy based on severity; withhold or permanently discontinue LUNSUMIO based on severity and follow management recommendations [see Dosage and Administration (2.4) ] . Patients who experience neurologic toxicity such as tremors, dizziness, insomnia, severe neurotoxicity, or any other adverse reactions that impair consciousness should be evaluated, including potential neurology evaluation, and patients at increased risk should be advised not to drive and to refrain from operating heavy or potentially dangerous machinery until resolution. 5.3 Infections LUNSUMIO can cause serious or fatal infections [see Adverse Reactions (6.1) ] . Among patients who received LUNSUMIO at the recommended dosage in the clinical trial, serious infections, including opportunistic infections, occurred in 17%, with Grade 3 or 4 infections in 14% and fatal infections in 0.9% of patients. The most common Grade 3 or greater infections were pneumonia, sepsis, and upper respiratory infection. Monitor patients for signs and symptoms of infection prior to and during treatment with LUNSUMIO and treat appropriately. LUNSUMIO should not be administered in the presence of active infection. Caution should be exercised when considering the use of LUNSUMIO in patients with a history of recurring or chronic infections (e.g., chronic, active Epstein-Barr Virus), with underlying conditions that may predispose to infections or who have had significant prior immunosuppressive treatment. Administer prophylactic antimicrobials according to guidelines. Withhold LUNSUMIO or consider permanent discontinuation of LUNSUMIO based on severity [see Dosage and Administration (2.4) ] . 5.4 Hemophagocytic Lymphohistiocytosis LUNSUMIO can cause fatal or serious hemophagocytic lymphohistiocytosis (HLH). HLH is a potentially life-threatening, hyperinflammatory syndrome that is independent of CRS. Common manifestations include fever, elevated ferritin, hemophagocytosis, cytopenias, coagulopathy, hepatitis, and splenomegaly. Across a broader clinical trial population, HLH occurred in 0.5% (7/1536) of patients. Most cases (5/7) were identified within the first 28 days following initiation of LUNSUMIO or LUNSUMIO VELO, with 3 cases preceded by diagnosed or suspected CRS. Of the 7 cases of HLH, 6 had fatal outcomes, with 2 deaths from HLH alone and 4 deaths with concurrent unresolved HLH. Of the 7 cases of HLH, 4 occurred in the context of concurrent EBV and/or CMV infection. Monitor for clinical signs and symptoms of HLH. Consider HLH when the presentation of CRS is atypical or prolonged, or when there are features of macrophage activation. For suspected HLH, interrupt LUNSUMIO and evaluate and treat promptly for HLH per current practice guidelines. 5.5 Cytopenias LUNSUMIO can cause serious or severe cytopenias, including lymphopenia, neutropenia, anemia, and thrombocytopenia [see Adverse Reactions (6.1) ] . Among patients who received LUNSUMIO at the recommended dosage in the clinical trial, Grade 3 or 4 decreased lymphocytes occurred in 92%, decreased neutrophils in 38%, decreased hemoglobin in 19%, and decreased platelets in 12% of patients. Grade 4 decreased lymphocytes occurred in 71%, decreased neutrophils in 19%, and decreased platelets in 5% of patients. Febrile neutropenia occurred in 2% of patients. Monitor complete blood counts throughout treatment. Based on the severity of cytopenias, temporarily withhold, or permanently discontinue LUNSUMIO. Consider prophylactic granulocyte colony-stimulating factor administration as applicable [see Dosage and Administration (2.4) ] . 5.6 Tumor Flare LUNSUMIO can cause serious or severe tumor flare [see Adverse Reactions (6.1) ] . Among patients who received LUNSUMIO at the recommended dosage in the clinical trial, tumor flare occurred in 4%. Manifestations included new or worsening pleural effusions, localized pain and swelling at the sites of lymphoma lesions, and tumor inflammation. Patients with bulky tumors or disease located in close proximity to airways or a vital organ should be monitored closely during initial therapy. Monitor for signs and symptoms of compression or obstruction due to mass effect secondary to tumor flare. If compression or obstruction develops, institute standard treatment of these complications. 5.7 Risk of Medication Errors with Incorrect Product Use Mosunetuzumab-axgb is available in two formulations: as an injection for intravenous use (LUNSUMIO) and as an injection for subcutaneous use (LUNSUMIO VELO). Check the product labels to ensure that the correct formulation is being prescribed, dispensed, and administered to the patient [see Dosage and Administration (2.2 and 2.5) ] . Do not substitute LUNSUMIO for or with LUNSUMIO VELO. 5.8 Embryo-Fetal Toxicity Based on its mechanism of action, LUNSUMIO may cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to the fetus. Advise females of reproductive potential to use effective contraception during treatment with LUNSUMIO and for 3 months after the last dose [see Use in Specific Populations (8.1 , 8.3) ] ." ], "adverse_reactions": [ "6 ADVERSE REACTIONS The following adverse reactions are described elsewhere in the labeling: Cytokine Release Syndrome [see Warnings and Precautions (5.1) ] Neurologic Toxicity, including Immune Effector Cell-associated Neurotoxicity Syndrome [see Warnings and Precautions (5.2) ] Infections [see Warnings and Precautions (5.3) ] Hemophagocytic Lymphohistiocytosis [see Warnings and Precautions (5.4) ] Cytopenias [see Warnings and Precautions (5.5) ] Tumor Flare [see Warnings and Precautions (5.6) ] The most common adverse reactions (≥ 20%) in patients with follicular lymphoma are CRS, fatigue, rash, headache, pyrexia, musculoskeletal pain, cough, pruritus, and peripheral neuropathy. The most common Grade 3 to 4 laboratory abnormalities (≥ 10%) are decreased lymphocyte count, decreased phosphate, increased glucose, decreased neutrophil count, increased uric acid, decreased hemoglobin, and decreased platelets. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Genentech at 1-888-835-2555 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The pooled safety population described in the WARNINGS AND PRECAUTIONS reflects exposure to LUNSUMIO as a single agent in GO29781 in 218 patients with hematologic malignancies in an open-label, multicenter, multi-cohort study. Patients received step-up doses of 1 mg on Cycle 1 Day 1 and 2 mg on Cycle 1 Day 8, followed by 60 mg on Cycle 1 Day 15, and 60 mg on Cycle 2 Day 1, then 30 mg every 3 weeks in subsequent cycles. Each treatment cycle was 21 days. Among 218 patients who received LUNSUMIO, 52% were exposed for at least 8 cycles and 8% were exposed for 17 cycles. In this pooled safety population, the most common (≥ 20%) adverse reactions were CRS (39%), fatigue (36%), rash (34%), pyrexia (24%), and headache (21%). The most common Grade 3 to 4 laboratory abnormalities (≥ 10%) were decreased lymphocyte count (92%), decreased phosphate (41%), increased glucose (40%), decreased neutrophil count (38%), decreased hemoglobin (19%), increased uric acid (15%), and decreased platelets (12%). Relapsed or Refractory Follicular Lymphoma The safety of LUNSUMIO was evaluated in GO29781, an open-label, multicenter, multi-cohort study which included a cohort of 90 patients with relapsed or refractory follicular lymphoma (FL) [see Clinical Studies (14) ] . In this cohort, patients with relapsed or refractory FL were required to have received at least two prior lines of systemic therapy, including an anti-CD20 monoclonal antibody and an alkylating agent. Patients received step-up doses of 1 mg on Cycle 1 Day 1 and 2 mg on Cycle 1 Day 8, followed by 60 mg on Cycle 1 Day 15 and 60 mg on Cycle 2 Day 1, then 30 mg every 3 weeks in subsequent cycles. A treatment cycle was 21 days. The median number of cycles was 8 (range: 1 to 17). In the relapsed or refractory FL cohort, 77% were exposed for at least 8 cycles and 12% were exposed for 17 cycles. The median age was 60 years (range: 29 to 90 years), 61% were male, 82% were White, 4% were Black or African American, 9% were Asian, and 8% were Hispanic or Latino. Serious adverse reactions occurred in 47% of patients who received LUNSUMIO. Serious adverse reactions in ≥ 2% of patients included CRS, infection (including sepsis, pneumonia, urinary tract infection, EBV viremia, COVID-19, and upper respiratory tract infection), renal insufficiency, pyrexia, and tumor flare. Permanent discontinuation of LUNSUMIO due to an adverse reaction occurred in 3% of patients. Adverse reactions resulting in permanent discontinuation of LUNSUMIO included CRS and EBV viremia. Dosage interruptions of LUNSUMIO due to an adverse reaction occurred in 37% of patients. Adverse reactions which required dosage interruption in ≥ 5% of patients included neutropenia, infection, and CRS. Table 8 summarizes the adverse reactions in patients with relapsed or refractory FL treated with LUNSUMIO in GO29781. Table 8. Adverse Reactions (≥ 10%) in Patients with Relapsed or Refractory FL Who Received LUNSUMIO Intravenous Infusion in GO29781 Adverse Reaction Adverse reactions were graded based on CTCAE Version 4.0, with the exception of CRS, which was graded per ASTCT 2019 criteria. LUNSUMIO (N = 90) All Grades (%) Grade 3 or 4 (%) Immune system disorders Cytokine release syndrome 44 2.2 General disorders and administration site conditions Fatigue Fatigue includes fatigue, asthenia, and lethargy. 42 0 Pyrexia 29 1.1 Only Grade 3 adverse reactions occurred. Edema Edema includes edema, edema peripheral, peripheral swelling, face edema, swelling face, pulmonary edema, fluid overload, and fluid retention. 17 1.1 Chills 13 1.1 Skin and subcutaneous tissue disorders Rash Rash includes rash, rash erythematous, exfoliative rash, rash macular, rash maculo-papular, rash papular, rash pruritic, rash pustular, erythema, palmar erythema, dermatitis, and dermatitis acneiform. 39 4.4 Pruritus 21 0 Dry skin 16 0 Skin exfoliation 10 0 Nervous system Headache Headache includes headache and migraine. 32 1.1 Peripheral neuropathy Peripheral neuropathy includes peripheral neuropathy, peripheral sensory neuropathy, paresthesia, dysesthesia, hypoesthesia, burning sensation, and neuralgia. 20 0 Dizziness Dizziness includes dizziness and vertigo. 12 0 Musculoskeletal and connective tissue disorders Musculoskeletal pain Musculoskeletal pain includes musculoskeletal pain, back pain, myalgia, musculoskeletal chest pain, and neck pain. 28 1.1 Arthralgia 11 0 Respiratory, thoracic, and mediastinal disorders Cough Cough includes cough, productive cough, and upper airway cough syndrome. 22 0 Dyspnea Dyspnea includes dyspnea and dyspnea exertional. 11 1.1 Gastrointestinal disorders Diarrhea 17 0 Nausea 17 0 Abdominal pain Abdominal pain includes abdominal pain, lower abdominal pain, and abdominal discomfort. 12 1.1 Infections Upper respiratory tract infection Upper respiratory tract infection includes upper respiratory tract infection, nasopharyngitis, sinusitis, and rhinovirus infection. 14 2.2 Urinary tract infection Urinary tract infection includes urinary tract infection and acute pyelonephritis. 10 1.1 Psychiatric disorder Insomnia 12 0 Clinically relevant adverse reactions in < 10% of patients who received LUNSUMIO included pneumonia, sepsis, COVID-19, EBV viremia, mental status changes, tumor lysis syndrome, renal insufficiency, anxiety, motor dysfunction (including ataxia, gait disturbance and tremor), tumor flare, and ICANS. Table 9 summarizes the laboratory abnormalities in patients with relapsed or refractory FL treated with LUNSUMIO in GO29781. Table 9. Select Laboratory Abnormalities (≥ 20%) That Worsened from Baseline in Patients with Relapsed or Refractory FL Who Received LUNSUMIO Intravenous Infusion in GO29781 Laboratory Abnormality LUNSUMIO The denominator used to calculate the rate varied from 72 to 90 based on the number of patients with a baseline value and at least one post-treatment value. All Grades (%) Grade 3 or 4 (%) Hematology Lymphocyte count decreased 100 98 Hemoglobin decreased 68 12 Neutrophils decreased 58 40 Platelets decreased 46 10 Chemistry Phosphate decreased 78 46 Glucose increased 42 42 Aspartate aminotransferase increased 39 4.4 Gamma-glutamyl transferase increased 34 9 Magnesium decreased 34 0 Potassium decreased 33 6 Alanine aminotransferase increased 32 7 Uric acid increased 22 22" ], "adverse_reactions_table": [ "
Table 8. Adverse Reactions (≥ 10%) in Patients with Relapsed or Refractory FL Who Received LUNSUMIO Intravenous Infusion in GO29781
Adverse ReactionAdverse reactions were graded based on CTCAE Version 4.0, with the exception of CRS, which was graded per ASTCT 2019 criteria.LUNSUMIO (N = 90)
All Grades (%)Grade 3 or 4 (%)
Immune system disorders
Cytokine release syndrome442.2
General disorders and administration site conditions
FatigueFatigue includes fatigue, asthenia, and lethargy.420
Pyrexia291.1Only Grade 3 adverse reactions occurred.
EdemaEdema includes edema, edema peripheral, peripheral swelling, face edema, swelling face, pulmonary edema, fluid overload, and fluid retention.171.1
Chills 131.1
Skin and subcutaneous tissue disorders
RashRash includes rash, rash erythematous, exfoliative rash, rash macular, rash maculo-papular, rash papular, rash pruritic, rash pustular, erythema, palmar erythema, dermatitis, and dermatitis acneiform.394.4
Pruritus210
Dry skin160
Skin exfoliation100
Nervous system
HeadacheHeadache includes headache and migraine.321.1
Peripheral neuropathyPeripheral neuropathy includes peripheral neuropathy, peripheral sensory neuropathy, paresthesia, dysesthesia, hypoesthesia, burning sensation, and neuralgia.200
DizzinessDizziness includes dizziness and vertigo.120
Musculoskeletal and connective tissue disorders
Musculoskeletal painMusculoskeletal pain includes musculoskeletal pain, back pain, myalgia, musculoskeletal chest pain, and neck pain.281.1
Arthralgia110
Respiratory, thoracic, and mediastinal disorders
CoughCough includes cough, productive cough, and upper airway cough syndrome.220
DyspneaDyspnea includes dyspnea and dyspnea exertional.111.1
Gastrointestinal disorders
Diarrhea170
Nausea170
Abdominal painAbdominal pain includes abdominal pain, lower abdominal pain, and abdominal discomfort.121.1
Infections
Upper respiratory tract infectionUpper respiratory tract infection includes upper respiratory tract infection, nasopharyngitis, sinusitis, and rhinovirus infection.142.2
Urinary tract infectionUrinary tract infection includes urinary tract infection and acute pyelonephritis.101.1
Psychiatric disorder
Insomnia120
", "
Table 9. Select Laboratory Abnormalities (≥ 20%) That Worsened from Baseline in Patients with Relapsed or Refractory FL Who Received LUNSUMIO Intravenous Infusion in GO29781
Laboratory AbnormalityLUNSUMIOThe denominator used to calculate the rate varied from 72 to 90 based on the number of patients with a baseline value and at least one post-treatment value.
All Grades (%)Grade 3 or 4 (%)
Hematology
Lymphocyte count decreased10098
Hemoglobin decreased6812
Neutrophils decreased5840
Platelets decreased4610
Chemistry
Phosphate decreased7846
Glucose increased4242
Aspartate aminotransferase increased394.4
Gamma-glutamyl transferase increased349
Magnesium decreased340
Potassium decreased336
Alanine aminotransferase increased327
Uric acid increased2222
" ], "drug_interactions": [ "7 DRUG INTERACTIONS Effect of LUNSUMIO on CYP450 Substrates LUNSUMIO causes release of cytokines [see Clinical Pharmacology (12.2) ] that may suppress activity of CYP450 enzymes, resulting in increased exposure of CYP450 substrates. Increased exposure of CYP450 substrates is more likely to occur after the first dose of LUNSUMIO on Cycle 1 Day 1 and up to 14 days after the 60 mg dose on Cycle 2 Day 1 and during and after CRS [see Warnings and Precautions (5.1) ] . Monitor for toxicity or concentrations of drugs that are CYP450 substrates where minimal concentration changes may lead to serious adverse reactions. Consult the concomitant CYP450 substrate drug prescribing information for recommended dosage modification." ], "use_in_specific_populations": [ "8 USE IN SPECIFIC POPULATIONS Lactation: Advise not to breastfeed. ( 8.2 ) 8.1 Pregnancy Risk Summary Based on the mechanism of action, LUNSUMIO may cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1) ] . There are no available data on the use of LUNSUMIO in pregnant women to evaluate for a drug-associated risk. No animal reproductive or developmental toxicity studies have been conducted with mosunetuzumab-axgb. Mosunetuzumab-axgb causes T-cell activation and cytokine release; immune activation may compromise pregnancy maintenance. In addition, based on expression of CD20 on B-cells and the finding of B-cell depletion in non-pregnant animals, mosunetuzumab-axgb can cause B-cell lymphocytopenia in infants exposed to mosunetuzumab-axgb in-utero. Human immunoglobulin G (IgG) is known to cross the placenta; therefore, LUNSUMIO has the potential to be transmitted from the mother to the developing fetus. Advise women of the potential risk to the fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% – 4% and 15% – 20%, respectively. 8.2 Lactation Risk Summary There is no information regarding the presence of mosunetuzumab-axgb in human milk, the effect on the breastfed child, or milk production. Because human IgG is present in human milk, and there is potential for mosunetuzumab-axgb absorption leading to B-cell depletion, advise women not to breastfeed during treatment with LUNSUMIO and for 3 months after the last dose. 8.3 Females and Males of Reproductive Potential LUNSUMIO may cause fetal harm when administered to a pregnant woman [see Use in Specific Populations (8.1) ] . Pregnancy Testing Verify pregnancy status in females of reproductive potential prior to initiating LUNSUMIO. Contraception Females Advise females of reproductive potential to use effective contraception during treatment with LUNSUMIO and for 3 months after the last dose. 8.4 Pediatric Use The safety and efficacy of LUNSUMIO have not been established in pediatric patients. 8.5 Geriatric Use Among the 90 patients with relapsed or refractory follicular lymphoma treated with LUNSUMIO, 33% were 65 years of age or older, and 8% were 75 years of age or older. There is an insufficient number of patients 65 years of age or older and 75 years of age or older to assess whether there are differences in safety or effectiveness in patients 65 years of age and older compared to younger adult patients." ], "pregnancy": [ "8.1 Pregnancy Risk Summary Based on the mechanism of action, LUNSUMIO may cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1) ] . There are no available data on the use of LUNSUMIO in pregnant women to evaluate for a drug-associated risk. No animal reproductive or developmental toxicity studies have been conducted with mosunetuzumab-axgb. Mosunetuzumab-axgb causes T-cell activation and cytokine release; immune activation may compromise pregnancy maintenance. In addition, based on expression of CD20 on B-cells and the finding of B-cell depletion in non-pregnant animals, mosunetuzumab-axgb can cause B-cell lymphocytopenia in infants exposed to mosunetuzumab-axgb in-utero. Human immunoglobulin G (IgG) is known to cross the placenta; therefore, LUNSUMIO has the potential to be transmitted from the mother to the developing fetus. Advise women of the potential risk to the fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% – 4% and 15% – 20%, respectively." ], "pediatric_use": [ "8.4 Pediatric Use The safety and efficacy of LUNSUMIO have not been established in pediatric patients." ], "geriatric_use": [ "8.5 Geriatric Use Among the 90 patients with relapsed or refractory follicular lymphoma treated with LUNSUMIO, 33% were 65 years of age or older, and 8% were 75 years of age or older. There is an insufficient number of patients 65 years of age or older and 75 years of age or older to assess whether there are differences in safety or effectiveness in patients 65 years of age and older compared to younger adult patients." ], "description": [ "11 DESCRIPTION Mosunetuzumab-axgb is a bispecific CD20-directed CD3 T-cell engager. It is a humanized monoclonal anti-CD20xCD3 T-cell-dependent bispecific antibody of the immunoglobulin G1 (IgG1) isotype. Mosunetuzumab-axgb is produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology. The approximate molecular weight is 146 kDa. LUNSUMIO (mosunetuzumab-axgb) injection is a sterile, preservative-free, colorless solution for intravenous use. Each single-dose vial contains a 1 mL solution of mosunetuzumab-axgb (1 mg), acetic acid (0.4 mg), histidine (1.6 mg), methionine (1.5 mg), polysorbate 20 (0.6 mg), sucrose (82.1 mg), and Water for Injection, USP. The pH is 5.8. Each single-dose vial contains a 30 mL solution of mosunetuzumab-axgb (30 mg), acetic acid (12.8 mg), histidine (46.6 mg), methionine (44.8 mg), polysorbate 20 (18 mg), sucrose (2,462.4 mg), and Water for Injection, USP. The pH is 5.8." ], "clinical_pharmacology": [ "12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Mosunetuzumab-axgb is a T-cell engaging bispecific antibody that binds to the CD3 receptor expressed on the surface of T-cells and CD20 expressed on the surface of lymphoma cells and some healthy B-lineage cells. In vitro, mosunetuzumab-axgb activated T-cells, caused the release of proinflammatory cytokines, and induced lysis of B-cells. 12.2 Pharmacodynamics After intravenous administration of the recommended dosage of LUNSUMIO, peripheral B-cell counts decreased to undetectable levels (< 5 cells/microliter) in most patients (95%) by Cycle 2 Day 1 and the depletion was sustained at later cycles including at Cycle 4 and Cycle 8. LUNSUMIO caused hypogammaglobulinemia (defined as IgG levels < 500 mg/dL). Among 67 patients with baseline IgG levels ≥ 500 mg/dL, 40% had their IgG level decreased to < 500 mg/dL after administration of the recommended dosage of LUNSUMIO. Plasma concentrations of cytokines (IL-2, IL-6, IL-10, TNF-α, and IFN-γ) were measured, and transient elevation of cytokines were observed at doses of 0.4 mg and above. After administration of the recommended dosage of LUNSUMIO, the highest elevation of cytokines was observed within 24 hours after the first dose on Cycle 1 Day 1 and after the first 60 mg dose on Cycle 1 Day 15. The elevated cytokine levels generally returned to baseline prior to the next infusion on Cycle 1 Day 8 and on Cycle 2 Day 1. 12.3 Pharmacokinetics Mosunetuzumab-axgb PK exposure increased proportionally over a dose range from 0.2 mg to 60 mg (0.007 to 2 times the recommended treatment dosage). PK exposures for the recommended dosage of LUNSUMIO are summarized in Table 10 and Figure 1 . Table 10. Exposure Parameters of Mosunetuzumab-axgb Intravenous Infusion AUC (day∙μg/mL) Values are geometric mean with geometric CV%. C max (μg/mL) C trough (μg/mL) All values reported are model-predicted exposure metrics. Cycle 1 (0 ‒ 21 days) 35.2 (36.6) 11.1 (36.7) 2.6 (54.0) Cycle 2 (21 ‒ 42 days) 90.3 (48.5) 13.6 (37.7) 2.0 (83.1) Cycle 3 (42 – 63 days) 59.0 (48.9) 7.6 (40.1) 1.4 (75.6) Steady state Steady state values are approximated at Cycle 4 (63 ‒ 84 days). 52.9 (40.7) 7.0 (37.9) 1.3 (59.9) Figure 1. Model-Predicted Mosunetuzumab-axgb Intravenous Infusion Concentration Time Profile Pharmacokinetic parameters ( Table 11 ) were evaluated at the recommended dosage and are presented as geometric mean (CV%) unless otherwise specified. Table 11. Mosunetuzumab-axgb Pharmacokinetic Parameters in Patients with Relapsed or Refractory Follicular Lymphoma Parameter LUNSUMIO via Intravenous Infusion T max = time to peak concentration T max median (range), hours Steady-state. 4.0 (4.0 – 4.0) T max is at the end of intravenous infusion. Volume of distribution a (L) 5.5 (31%) Half-life a (days) 16.1 (17%) Systemic clearance (L/day) 1.1 (63%) at baseline 0.58 (18%) at steady state Figure 1 Specific Populations There were no clinically significant differences in the pharmacokinetics of mosunetuzumab-axgb based on age (19 to 96 years), sex, race (Asian and Non-Asian), ethnicity (Hispanic/Latino and not Hispanic/Latino), mild or moderate renal impairment (estimated creatinine clearance [CrCL] by Cockcroft-Gault formula: 30 to 89 mL/min), or mild hepatic impairment (total bilirubin less than or equal to upper limit of normal [ULN] with AST greater than ULN or total bilirubin greater than 1 to 1.5 times ULN with any AST). The effects of severe renal impairment (CrCL 15 to 29 mL/min) or moderate to severe hepatic impairment (total bilirubin greater than 1.5 times ULN with any AST) on the pharmacokinetics of mosunetuzumab-axgb are unknown. Drug Interaction Studies No clinical studies evaluating the drug interaction potential of mosunetuzumab-axgb have been conducted. 12.6 Immunogenicity The observed incidence of anti-drug antibodies is highly dependent on the sensitivity and specificity of the assay. Differences in assay methods preclude meaningful comparisons of the incidence of anti-drug antibodies in the study described below with the incidence of anti-drug antibodies in other studies, including those of mosunetuzumab-axgb. During treatment in Study GO29781 (up to 12 months) [see Clinical Studies (14) ] , using an enzyme-linked immunosorbent assay (ELISA), no patients (N = 418) treated with LUNSUMIO developed anti-mosunetuzumab-axgb antibodies. Based on these data, the clinical relevance of anti-mosunetuzumab-axgb antibodies could not be assessed." ], "clinical_pharmacology_table": [ "
Table 10. Exposure Parameters of Mosunetuzumab-axgb Intravenous Infusion
AUC (day∙μg/mL)Values are geometric mean with geometric CV%.Cmax (μg/mL)Ctrough (μg/mL)
All values reported are model-predicted exposure metrics.
Cycle 1 (0 ‒ 21 days)35.2 (36.6)11.1 (36.7)2.6 (54.0)
Cycle 2 (21 ‒ 42 days)90.3 (48.5)13.6 (37.7)2.0 (83.1)
Cycle 3 (42 – 63 days)59.0 (48.9)7.6 (40.1)1.4 (75.6)
Steady stateSteady state values are approximated at Cycle 4 (63 ‒ 84 days).52.9 (40.7)7.0 (37.9)1.3 (59.9)
", "
Table 11. Mosunetuzumab-axgb Pharmacokinetic Parameters in Patients with Relapsed or Refractory Follicular Lymphoma
ParameterLUNSUMIO via Intravenous Infusion
Tmax = time to peak concentration
Tmax median (range), hoursSteady-state.4.0 (4.0 – 4.0)Tmax is at the end of intravenous infusion.
Volume of distributiona (L)5.5 (31%)
Half-lifea (days)16.1 (17%)
Systemic clearance (L/day)1.1 (63%) at baseline 0.58 (18%) at steady state
" ], "mechanism_of_action": [ "12.1 Mechanism of Action Mosunetuzumab-axgb is a T-cell engaging bispecific antibody that binds to the CD3 receptor expressed on the surface of T-cells and CD20 expressed on the surface of lymphoma cells and some healthy B-lineage cells. In vitro, mosunetuzumab-axgb activated T-cells, caused the release of proinflammatory cytokines, and induced lysis of B-cells." ], "pharmacodynamics": [ "12.2 Pharmacodynamics After intravenous administration of the recommended dosage of LUNSUMIO, peripheral B-cell counts decreased to undetectable levels (< 5 cells/microliter) in most patients (95%) by Cycle 2 Day 1 and the depletion was sustained at later cycles including at Cycle 4 and Cycle 8. LUNSUMIO caused hypogammaglobulinemia (defined as IgG levels < 500 mg/dL). Among 67 patients with baseline IgG levels ≥ 500 mg/dL, 40% had their IgG level decreased to < 500 mg/dL after administration of the recommended dosage of LUNSUMIO. Plasma concentrations of cytokines (IL-2, IL-6, IL-10, TNF-α, and IFN-γ) were measured, and transient elevation of cytokines were observed at doses of 0.4 mg and above. After administration of the recommended dosage of LUNSUMIO, the highest elevation of cytokines was observed within 24 hours after the first dose on Cycle 1 Day 1 and after the first 60 mg dose on Cycle 1 Day 15. The elevated cytokine levels generally returned to baseline prior to the next infusion on Cycle 1 Day 8 and on Cycle 2 Day 1." ], "pharmacokinetics": [ "12.3 Pharmacokinetics Mosunetuzumab-axgb PK exposure increased proportionally over a dose range from 0.2 mg to 60 mg (0.007 to 2 times the recommended treatment dosage). PK exposures for the recommended dosage of LUNSUMIO are summarized in Table 10 and Figure 1 . Table 10. Exposure Parameters of Mosunetuzumab-axgb Intravenous Infusion AUC (day∙μg/mL) Values are geometric mean with geometric CV%. C max (μg/mL) C trough (μg/mL) All values reported are model-predicted exposure metrics. Cycle 1 (0 ‒ 21 days) 35.2 (36.6) 11.1 (36.7) 2.6 (54.0) Cycle 2 (21 ‒ 42 days) 90.3 (48.5) 13.6 (37.7) 2.0 (83.1) Cycle 3 (42 – 63 days) 59.0 (48.9) 7.6 (40.1) 1.4 (75.6) Steady state Steady state values are approximated at Cycle 4 (63 ‒ 84 days). 52.9 (40.7) 7.0 (37.9) 1.3 (59.9) Figure 1. Model-Predicted Mosunetuzumab-axgb Intravenous Infusion Concentration Time Profile Pharmacokinetic parameters ( Table 11 ) were evaluated at the recommended dosage and are presented as geometric mean (CV%) unless otherwise specified. Table 11. Mosunetuzumab-axgb Pharmacokinetic Parameters in Patients with Relapsed or Refractory Follicular Lymphoma Parameter LUNSUMIO via Intravenous Infusion T max = time to peak concentration T max median (range), hours Steady-state. 4.0 (4.0 – 4.0) T max is at the end of intravenous infusion. Volume of distribution a (L) 5.5 (31%) Half-life a (days) 16.1 (17%) Systemic clearance (L/day) 1.1 (63%) at baseline 0.58 (18%) at steady state Figure 1 Specific Populations There were no clinically significant differences in the pharmacokinetics of mosunetuzumab-axgb based on age (19 to 96 years), sex, race (Asian and Non-Asian), ethnicity (Hispanic/Latino and not Hispanic/Latino), mild or moderate renal impairment (estimated creatinine clearance [CrCL] by Cockcroft-Gault formula: 30 to 89 mL/min), or mild hepatic impairment (total bilirubin less than or equal to upper limit of normal [ULN] with AST greater than ULN or total bilirubin greater than 1 to 1.5 times ULN with any AST). The effects of severe renal impairment (CrCL 15 to 29 mL/min) or moderate to severe hepatic impairment (total bilirubin greater than 1.5 times ULN with any AST) on the pharmacokinetics of mosunetuzumab-axgb are unknown. Drug Interaction Studies No clinical studies evaluating the drug interaction potential of mosunetuzumab-axgb have been conducted." ], "pharmacokinetics_table": [ "
Table 10. Exposure Parameters of Mosunetuzumab-axgb Intravenous Infusion
AUC (day∙μg/mL)Values are geometric mean with geometric CV%.Cmax (μg/mL)Ctrough (μg/mL)
All values reported are model-predicted exposure metrics.
Cycle 1 (0 ‒ 21 days)35.2 (36.6)11.1 (36.7)2.6 (54.0)
Cycle 2 (21 ‒ 42 days)90.3 (48.5)13.6 (37.7)2.0 (83.1)
Cycle 3 (42 – 63 days)59.0 (48.9)7.6 (40.1)1.4 (75.6)
Steady stateSteady state values are approximated at Cycle 4 (63 ‒ 84 days).52.9 (40.7)7.0 (37.9)1.3 (59.9)
", "
Table 11. Mosunetuzumab-axgb Pharmacokinetic Parameters in Patients with Relapsed or Refractory Follicular Lymphoma
ParameterLUNSUMIO via Intravenous Infusion
Tmax = time to peak concentration
Tmax median (range), hoursSteady-state.4.0 (4.0 – 4.0)Tmax is at the end of intravenous infusion.
Volume of distributiona (L)5.5 (31%)
Half-lifea (days)16.1 (17%)
Systemic clearance (L/day)1.1 (63%) at baseline 0.58 (18%) at steady state
" ], "nonclinical_toxicology": [ "13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility No carcinogenicity or genotoxicity studies have been conducted with mosunetuzumab-axgb. No dedicated studies have been conducted to evaluate the effects of mosunetuzumab-axgb on fertility. No adverse effects on either male or female reproductive organs were identified in a 26-week repeat dose chronic toxicity study in sexually mature cynomolgus monkeys." ], "carcinogenesis_and_mutagenesis_and_impairment_of_fertility": [ "13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility No carcinogenicity or genotoxicity studies have been conducted with mosunetuzumab-axgb. No dedicated studies have been conducted to evaluate the effects of mosunetuzumab-axgb on fertility. No adverse effects on either male or female reproductive organs were identified in a 26-week repeat dose chronic toxicity study in sexually mature cynomolgus monkeys." ], "clinical_studies": [ "14 CLINICAL STUDIES The efficacy of LUNSUMIO was evaluated in an open-label, multicenter, multi-cohort study (GO29781, NCT02500407) in patients with relapsed or refractory follicular lymphoma (FL) who had received at least two prior therapies, including an anti-CD20 monoclonal antibody and an alkylating agent. The study excluded patients with active infections, history of autoimmune disease, prior allogeneic transplant, or any history of CNS lymphoma or CNS disorders. Patients received step-up doses of 1 mg on Cycle 1 Day 1 and 2 mg on Cycle 1 Day 8, followed by 60 mg on Cycle 1 Day 15, and 60 mg on Cycle 2 Day 1, then 30 mg via intravenous infusion every 3 weeks in subsequent cycles. A treatment cycle was 21 days. LUNSUMIO was administered for 8 cycles unless patients experienced progressive disease or unacceptable toxicity. After 8 cycles, patients with a complete response discontinued therapy; patients with a partial response or stable disease continued treatment up to 17 cycles, unless patients experienced progressive disease or unacceptable toxicity. Among the 90 patients with relapsed or refractory FL, the median age was 60 years (range: 29 to 90 years), 33% were 65 years of age or older, 61% were male, 82% were White, 9% were Asian, 4% were Black or African American, and 8% were Hispanic or Latino. A total of 77% of patients had Stage III-IV disease, 34% had bulky disease, and all patients had an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. The median number of prior therapies was 3 (range: 2 to 10), with 38% receiving 2 prior therapies, 31% receiving 3 prior therapies, and 31% receiving more than 3 prior therapies. Seventy-nine percent of patients were refractory to prior anti-CD20 monoclonal antibody therapy, 53% were refractory to both anti-CD20 monoclonal antibody and alkylator therapy, 9% received prior rituximab plus lenalidomide therapy, 21% received prior autologous stem cell transplant, and 3% received prior CAR-T therapy. Fifty-two percent of patients had progression of disease within 24 months of first systemic therapy. Efficacy was established on the basis of objective response rate (ORR) and duration of response (DOR) as assessed by an independent review facility according to standard criteria for NHL (Cheson 2007). The median follow-up for DOR was 14.9 months. The efficacy results are summarized in Table 12 . Table 12. Efficacy Results in Patients with Relapsed or Refractory FL Who Received LUNSUMIO Intravenous Infusion Response LUNSUMIO N = 90 CI = confidence interval; NR = not reached Objective response rate (ORR), n (%) 72 (80) (95% CI) (70, 88) Complete response (CR), n (%) 54 (60) (95% CI) (49, 70) Partial response (PR), n (%) 18 (20) (95% CI) (12, 30) Duration of response (DOR) N = 72 Median DOR DOR is defined as the time from the initial occurrence of a documented PR or CR until the patient experienced an event (documented disease progression or death due to any cause). , Kaplan-Meier estimate. , months (95% CI) 22.8 (10, NR) Rate of continued response At 12 months, % 62 (95% CI) (50, 74) At 18 months, % 57 (95% CI) (44, 70) The median time to first response was 1.4 months (range: 1.1 to 8.9)." ], "clinical_studies_table": [ "
Table 12. Efficacy Results in Patients with Relapsed or Refractory FL Who Received LUNSUMIO Intravenous Infusion
ResponseLUNSUMIO N = 90
CI = confidence interval; NR = not reached
Objective response rate (ORR), n (%)72 (80)
(95% CI)(70, 88)
Complete response (CR), n (%)54 (60)
(95% CI)(49, 70)
Partial response (PR), n (%)18 (20)
(95% CI)(12, 30)
Duration of response (DOR)N = 72
Median DORDOR is defined as the time from the initial occurrence of a documented PR or CR until the patient experienced an event (documented disease progression or death due to any cause).,Kaplan-Meier estimate., months (95% CI)22.8 (10, NR)
Rate of continued response
At 12 months, %62
(95% CI)(50, 74)
At 18 months, %57
(95% CI)(44, 70)
" ], "how_supplied": [ "16 HOW SUPPLIED/STORAGE AND HANDLING LUNSUMIO (mosunetuzumab-axgb) injection is a sterile, colorless, preservative-free solution for intravenous infusion supplied as follows: One 1 mg/mL single-dose vial in a carton (NDC 50242-159-01) One 30 mg/30 mL (1 mg/mL) single-dose vial in a carton (NDC 50242-142-01). Store refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not freeze. Do not shake." ], "storage_and_handling": [ "Store refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not freeze. Do not shake." ], "information_for_patients": [ "17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide). Cytokine Release Syndrome (CRS) – Discuss the signs and symptoms associated with CRS, including fever, chills, hypotension, tachycardia, hypoxia, and headache. Counsel patients to seek immediate medical attention should signs or symptoms of CRS occur at any time. Advise patients who experience symptoms that impair consciousness not to drive and refrain from operating heavy or potentially dangerous machinery until events resolve [see Warnings and Precautions (5.1) ] . Neurologic Toxicity, including ICANS – Discuss the signs and symptoms associated with neurologic toxicity, including ICANS, headache, peripheral neuropathy, dizziness, or mental status changes. Advise patients to immediately contact their healthcare provider if they experience any signs or symptoms of neurologic toxicity. Advise patients who experience neurologic toxicity that impairs consciousness to refrain from driving or operating heavy or potentially dangerous machinery until neurologic toxicity resolves [see Warnings and Precautions (5.2) ] . Infections – Discuss the signs or symptoms associated with infection [see Warnings and Precautions (5.3) ]. Hemophagocytic Lymphohistiocytosis (HLH) – Discuss the signs and symptoms associated with HLH, including fever, coagulopathy, cytopenias, and splenomegaly [see Warnings and Precautions (5.4) ] . Cytopenias – Discuss the signs and symptoms associated with cytopenias, including neutropenia and febrile neutropenia, anemia, and thrombocytopenia [see Warnings and Precautions (5.5) ] . Tumor Flare – Inform patients of the potential risk of tumor flare reaction and to report any signs and symptoms associated with this event to their healthcare provider for evaluation [see Warnings and Precautions (5.6) ]. Embryo-Fetal Toxicity – Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to inform their healthcare provider if they are pregnant or become pregnant [see Use in Specific Populations (8.1) ] . Advise females of reproductive potential to use effective contraception during treatment with LUNSUMIO and for 3 months after the last dose [see Use in Specific Populations (8.3) ] . Lactation – Advise women not to breastfeed during treatment with LUNSUMIO and for 3 months after the last dose [see Use in Specific Populations (8.2) ] ." ], "spl_unclassified_section": [ "Manufactured by: Genentech, Inc . A Member of the Roche Group 1 DNA Way South San Francisco, CA 94080-4990 LUNSUMIO is a registered trademark of Genentech, Inc. © 2025 Genentech, Inc. U.S. License No.: 1048" ], "spl_medguide": [ "This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: Dec 2025 MEDICATION GUIDE LUNSUMIO ® (lun-SUM-mee-oh) (mosunetuzumab-axgb) injection, for intravenous infusion What is the most important information I should know about LUNSUMIO? LUNSUMIO may cause Cytokine Release Syndrome (CRS), a serious side effect that is common during treatment with LUNSUMIO, and can also be severe or life-threatening. Get medical help right away if you develop any signs or symptoms of CRS at any time, including: fever of 100.4°F (38°C) or higher chills low blood pressure fast or irregular heartbeat tiredness or weakness difficulty breathing headache confusion feeling anxious dizziness or light-headedness nausea vomiting Due to the risk of CRS, you will receive LUNSUMIO on a \"step-up dosing schedule\". The step-up dosing schedule is when you receive smaller \"step-up\" doses of LUNSUMIO on Day 1 and Day 8 of your first cycle of treatment. You will receive a higher dose of LUNSUMIO on Day 15 of your first cycle of treatment. If your dose of LUNSUMIO is delayed for any reason, you may need to repeat the \"step-up dosing schedule.\" Before each dose in Cycle 1 and Cycle 2, you will receive medicines to help reduce your risk of CRS. See \" How will I receive LUNSUMIO? \" for more information about how you will receive LUNSUMIO. Your healthcare provider will check you for CRS during treatment with LUNSUMIO and may treat you in a hospital if you develop signs and symptoms of CRS. Your healthcare provider may temporarily stop or completely stop your treatment with LUNSUMIO if you have severe side effects. See \" What are the possible side effects of LUNSUMIO? \" for more information about side effects. What is LUNSUMIO? LUNSUMIO is a prescription medicine used to treat adults with follicular lymphoma whose cancer has come back or did not respond to previous treatment, and who have already received two or more treatments for their cancer. It is not known if LUNSUMIO is safe and effective in children. Before receiving LUNSUMIO, tell your healthcare provider about all of your medical conditions, including if you: have ever had an infusion reaction after receiving LUNSUMIO. have an infection or have had an infection in the past which lasted a long time or keeps coming back. have or had Epstein-Barr Virus. are pregnant or plan to become pregnant. LUNSUMIO may harm your unborn baby. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with LUNSUMIO. Females who are able to become pregnant: your healthcare provider should do a pregnancy test before you start treatment with LUNSUMIO. you should use an effective method of birth control (contraception) during your treatment and for 3 months after the last dose of LUNSUMIO. are breastfeeding or plan to breastfeed. It is not known if LUNSUMIO passes into your breast milk. Do not breastfeed during treatment and for 3 months after the last dose of LUNSUMIO. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. How will I receive LUNSUMIO? LUNSUMIO will be given to you by your healthcare provider by infusion through a needle placed in a vein (intravenous infusion). After you complete the weekly \"step-up dosing schedule\" in Cycle 1, LUNSUMIO is given every 21 days. After Cycle 1 and Cycle 2, your healthcare provider will decide if you need to continue to take other medicines to help reduce side effects from LUNSUMIO during future cycles. Your healthcare provider will decide how many treatment cycles you will receive of LUNSUMIO. See \" What is the most important information I should know about LUNSUMIO? \" for more information about how you will receive LUNSUMIO. What should I avoid while receiving LUNSUMIO? Do not drive, operate heavy machinery, or do other dangerous activities if you develop dizziness, confusion, tremors, sleepiness, or any other symptoms that impair consciousness until your signs and symptoms go away. These may be signs and symptoms of CRS or neurologic problems. See \" What is the most important information I should know about LUNSUMIO? \" and \" What are the possible side effects of LUNSUMIO? \" for more information about signs and symptoms of CRS and neurologic problems. What are the possible side effects of LUNSUMIO? LUNSUMIO may cause serious side effects, including: See \" What is the most important information I should know about LUNSUMIO? \" neurologic problems. LUNSUMIO can cause serious and life-threatening neurologic problems. Your healthcare provider will check you for neurologic problems during treatment with LUNSUMIO. Your healthcare provider may also refer you to a healthcare provider who specializes in neurologic problems. Tell your healthcare provider right away if you develop any signs or symptoms of neurologic problems during or after treatment with LUNSUMIO, including: headache numbness and tingling of the arms, legs, hands, or feet dizziness confusion and disorientation difficulty paying attention or understanding things forgetting things or forgetting who or where you are trouble speaking, reading, or writing sleepiness or trouble sleeping tremors loss of consciousness seizures muscle problems or muscle weakness loss of balance or trouble walking tiredness serious infections. LUNSUMIO can cause serious infections that may lead to death. Your healthcare provider will check you for signs and symptoms of infection before and during treatment. Tell your healthcare provider right away if you develop any signs or symptoms of infection during treatment with LUNSUMIO, including: fever of 100.4°F (38°C) or higher cough chest pain tiredness shortness of breath painful rash sore throat pain during urination feeling weak or generally unwell hemophagocytic lymphohistiocytosis (HLH). LUNSUMIO can cause overactivity of the immune system, a condition called hemophagocytic lymphohistiocytosis (HLH). HLH can be life-threatening and has led to death in people treated with LUNSUMIO. Your healthcare provider will check you for HLH especially if your CRS lasts longer than expected. Signs and symptoms of HLH include: fever enlarged spleen easy bruising low blood cell counts liver problems low blood cell counts. Low blood cell counts are common during treatment with LUNSUMIO and can also be serious or severe. Your healthcare provider will check your blood cell counts during treatment with LUNSUMIO. LUNSUMIO can cause the following low blood cell counts: low white blood cell counts (neutropenia). Low white blood cells can increase your risk for infection. low red blood cell counts (anemia). Low red blood cells can cause tiredness and shortness of breath. low platelet counts (thrombocytopenia). Low platelet counts can cause bruising or bleeding problems. growth in your tumor or worsening of tumor related problems (tumor flare). LUNSUMIO can cause serious or severe worsening of your tumor. Tell your healthcare provider if you develop any of these signs or symptoms of tumor flare during your treatment with LUNSUMIO: chest pain cough trouble breathing tender or swollen lymph nodes pain or swelling at the site of the tumor Your healthcare provider may temporarily stop or permanently stop treatment with LUNSUMIO if you develop severe side effects. The most common side effects of LUNSUMIO include: cytokine release syndrome tiredness rash headache fever muscle pain cough itching numbness, tingling, or pain in the hands or feet (nerve damage) The most common severe abnormal blood test results with LUNSUMIO include: decreased blood cell counts, decreased phosphate, increased glucose, and increased uric acid levels. These are not all the possible side effects of LUNSUMIO. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. General information about the safe and effective use of LUNSUMIO. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. You can ask your pharmacist or healthcare provider for information about LUNSUMIO that is written for health professionals. What are the ingredients in LUNSUMIO? Active ingredient: mosunetuzumab-axgb Inactive ingredients: acetic acid, histidine, methionine, polysorbate 20, sucrose, and Water for Injection Manufactured by: Genentech, Inc. , A Member of the Roche Group, 1 DNA Way, South San Francisco, CA 94080-4990 U.S. License No.: 1048 LUNSUMIO is a registered trademark of Genentech, Inc. For more information, call 1-844-832-3687 or go to www.LUNSUMIO.com." ], "spl_medguide_table": [ "
This Medication Guide has been approved by the U.S. Food and Drug Administration.Revised: Dec 2025
MEDICATION GUIDE LUNSUMIO® (lun-SUM-mee-oh) (mosunetuzumab-axgb) injection, for intravenous infusion
What is the most important information I should know about LUNSUMIO? LUNSUMIO may cause Cytokine Release Syndrome (CRS), a serious side effect that is common during treatment with LUNSUMIO, and can also be severe or life-threatening.Get medical help right away if you develop any signs or symptoms of CRS at any time, including:
fever of 100.4°F (38°C) or higherchills low blood pressurefast or irregular heartbeattiredness or weaknessdifficulty breathingheadacheconfusionfeeling anxiousdizziness or light-headednessnauseavomiting
Due to the risk of CRS, you will receive LUNSUMIO on a "step-up dosing schedule".The step-up dosing schedule is when you receive smaller "step-up" doses of LUNSUMIO on Day 1 and Day 8 of your first cycle of treatment.You will receive a higher dose of LUNSUMIO on Day 15 of your first cycle of treatment. If your dose of LUNSUMIO is delayed for any reason, you may need to repeat the "step-up dosing schedule."Before each dose in Cycle 1 and Cycle 2, you will receive medicines to help reduce your risk of CRS. See "How will I receive LUNSUMIO?" for more information about how you will receive LUNSUMIO.
Your healthcare provider will check you for CRS during treatment with LUNSUMIO and may treat you in a hospital if you develop signs and symptoms of CRS. Your healthcare provider may temporarily stop or completely stop your treatment with LUNSUMIO if you have severe side effects. See "What are the possible side effects of LUNSUMIO?" for more information about side effects.
What is LUNSUMIO? LUNSUMIO is a prescription medicine used to treat adults with follicular lymphoma whose cancer has come back or did not respond to previous treatment, and who have already received two or more treatments for their cancer. It is not known if LUNSUMIO is safe and effective in children.
Before receiving LUNSUMIO, tell your healthcare provider about all of your medical conditions, including if you:have ever had an infusion reaction after receiving LUNSUMIO. have an infection or have had an infection in the past which lasted a long time or keeps coming back.have or had Epstein-Barr Virus.are pregnant or plan to become pregnant. LUNSUMIO may harm your unborn baby. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with LUNSUMIO. Females who are able to become pregnant:your healthcare provider should do a pregnancy test before you start treatment with LUNSUMIO.you should use an effective method of birth control (contraception) during your treatment and for 3 months after the last dose of LUNSUMIO.are breastfeeding or plan to breastfeed. It is not known if LUNSUMIO passes into your breast milk. Do not breastfeed during treatment and for 3 months after the last dose of LUNSUMIO.Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
How will I receive LUNSUMIO?LUNSUMIO will be given to you by your healthcare provider by infusion through a needle placed in a vein (intravenous infusion).After you complete the weekly "step-up dosing schedule" in Cycle 1, LUNSUMIO is given every 21 days.After Cycle 1 and Cycle 2, your healthcare provider will decide if you need to continue to take other medicines to help reduce side effects from LUNSUMIO during future cycles.Your healthcare provider will decide how many treatment cycles you will receive of LUNSUMIO.See "What is the most important information I should know about LUNSUMIO?" for more information about how you will receive LUNSUMIO.
What should I avoid while receiving LUNSUMIO? Do not drive, operate heavy machinery, or do other dangerous activities if you develop dizziness, confusion, tremors, sleepiness, or any other symptoms that impair consciousness until your signs and symptoms go away. These may be signs and symptoms of CRS or neurologic problems. See "What is the most important information I should know about LUNSUMIO?" and "What are the possible side effects of LUNSUMIO?" for more information about signs and symptoms of CRS and neurologic problems.
What are the possible side effects of LUNSUMIO? LUNSUMIO may cause serious side effects, including: See "What is the most important information I should know about LUNSUMIO?"neurologic problems. LUNSUMIO can cause serious and life-threatening neurologic problems. Your healthcare provider will check you for neurologic problems during treatment with LUNSUMIO. Your healthcare provider may also refer you to a healthcare provider who specializes in neurologic problems. Tell your healthcare provider right away if you develop any signs or symptoms of neurologic problems during or after treatment with LUNSUMIO, including:
headachenumbness and tingling of the arms, legs, hands, or feetdizzinessconfusion and disorientationdifficulty paying attention or understanding thingsforgetting things or forgetting who or where you aretrouble speaking, reading, or writingsleepiness or trouble sleepingtremorsloss of consciousnessseizuresmuscle problems or muscle weaknessloss of balance or trouble walkingtiredness
serious infections. LUNSUMIO can cause serious infections that may lead to death. Your healthcare provider will check you for signs and symptoms of infection before and during treatment. Tell your healthcare provider right away if you develop any signs or symptoms of infection during treatment with LUNSUMIO, including:
fever of 100.4°F (38°C) or highercoughchest paintirednessshortness of breathpainful rashsore throatpain during urinationfeeling weak or generally unwell
hemophagocytic lymphohistiocytosis (HLH). LUNSUMIO can cause overactivity of the immune system, a condition called hemophagocytic lymphohistiocytosis (HLH). HLH can be life-threatening and has led to death in people treated with LUNSUMIO. Your healthcare provider will check you for HLH especially if your CRS lasts longer than expected. Signs and symptoms of HLH include:
feverenlarged spleeneasy bruisinglow blood cell countsliver problems
low blood cell counts. Low blood cell counts are common during treatment with LUNSUMIO and can also be serious or severe. Your healthcare provider will check your blood cell counts during treatment with LUNSUMIO. LUNSUMIO can cause the following low blood cell counts:low white blood cell counts (neutropenia). Low white blood cells can increase your risk for infection.low red blood cell counts (anemia). Low red blood cells can cause tiredness and shortness of breath.low platelet counts (thrombocytopenia). Low platelet counts can cause bruising or bleeding problems.growth in your tumor or worsening of tumor related problems (tumor flare). LUNSUMIO can cause serious or severe worsening of your tumor. Tell your healthcare provider if you develop any of these signs or symptoms of tumor flare during your treatment with LUNSUMIO:
chest paincoughtrouble breathingtender or swollen lymph nodespain or swelling at the site of the tumor
Your healthcare provider may temporarily stop or permanently stop treatment with LUNSUMIO if you develop severe side effects. The most common side effects of LUNSUMIO include:
cytokine release syndrometirednessrashheadachefevermuscle paincoughitchingnumbness, tingling, or pain in the hands or feet (nerve damage)
The most common severe abnormal blood test results with LUNSUMIO include: decreased blood cell counts, decreased phosphate, increased glucose, and increased uric acid levels. These are not all the possible side effects of LUNSUMIO. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
General information about the safe and effective use of LUNSUMIO. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. You can ask your pharmacist or healthcare provider for information about LUNSUMIO that is written for health professionals.
What are the ingredients in LUNSUMIO? Active ingredient: mosunetuzumab-axgb Inactive ingredients: acetic acid, histidine, methionine, polysorbate 20, sucrose, and Water for Injection Manufactured by: Genentech, Inc., A Member of the Roche Group, 1 DNA Way, South San Francisco, CA 94080-4990 U.S. License No.: 1048 LUNSUMIO is a registered trademark of Genentech, Inc. For more information, call 1-844-832-3687 or go to www.LUNSUMIO.com.
" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 30 mg/30 mL Vial Carton NDC 50242-142-01 Lunsumio ® (mosunetuzumab-axgb) Injection 30 mg/30 mL (1 mg/mL) For Intravenous Infusion Only. Single-Dose Vial. Discard Unused Portion. ATTENTION: Dispense the enclosed Medication Guide to each patient. 1 vial Rx only Genentech 11042398 PRINCIPAL DISPLAY PANEL - 30 mg/30 mL Vial Carton", "PRINCIPAL DISPLAY PANEL - 1 mg/mL Vial Carton NDC 50242-159-01 Lunsumio ® (mosunetuzumab-axgb) Injection 1 mg/mL For Intravenous Infusion Only. Single-Dose Vial. Discard Unused Portion. ATTENTION: Dispense the enclosed Medication Guide to each patient. 1 vial Rx only Genentech 11042421 PRINCIPAL DISPLAY PANEL - 1 mg/mL Vial Carton" ], "set_id": "2ef0cf38-101c-4681-98fe-c05dc9ead443", "id": "2800ba90-bfda-4932-9aae-9ef9166cd7e8", "effective_time": "20251208", "version": "6", "openfda": { "application_number": [ "BLA761263" ], "brand_name": [ "Lunsumio" ], "generic_name": [ "MOSUNETUZUMAB" ], "manufacturer_name": [ "Genentech, Inc." ], "product_ndc": [ "50242-142", "50242-159" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "INTRAVENOUS" ], "substance_name": [ "MOSUNETUZUMAB" ], "rxcui": [ "2625129", "2625135", "2625137", "2625138" ], "spl_id": [ "2800ba90-bfda-4932-9aae-9ef9166cd7e8" ], "spl_set_id": [ "2ef0cf38-101c-4681-98fe-c05dc9ead443" ], "package_ndc": [ "50242-142-01", "50242-159-01" ], "is_original_packager": [ true ], "unii": [ "LDJ89SS0YG" ] } } ] }