openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Warnings sections page 1 of 1 · 1 matching rows.
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 VELO 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 VELO can cause CRS, including serious or life-threatening reactions [see Adverse Reactions (6.1) ] . CRS occurred in 30% of patients who received LUNSUMIO VELO at the recommended dosage in the clinical trial (N = 94), with Grade 1 CRS occurring in 20%, Grade 2 in 7%, and Grade 3 in 2.1% of patients. Among 28 patients who experienced CRS, CRS recurred in 14%. CRS occurred most commonly after the first two doses: 19% of patients experienced CRS after the Cycle 1 Day 1 dose, 13% after the Cycle 1 Day 8 dose, and 2.1% after the Cycle 1 Day 15 dose. The median time to CRS onset from the start of LUNSUMIO VELO administration was 17 hours (range: 7 to 33 hours) with the Cycle 1 Day 1 dose, and 62 hours (range: 30 to 113 hours) with the Cycle 1 Day 8 dose. CRS resolved in all patients, after a median duration of 2 days (range: 1 to 15 days). Clinical signs and symptoms of CRS included fever, hypotension, hypoxia, chills, tachycardia, and headache. Concurrent neurologic adverse reactions occurred in 5% of patients and included but were not limited to headache, dizziness, lethargy, memory impairment, and peripheral neuropathy. Initiate therapy according to LUNSUMIO VELO step-up dosing schedule to reduce the risk of CRS. Administer pretreatment medications to reduce the risk of CRS, ensure adequate hydration, and monitor patients following administration of LUNSUMIO VELO accordingly [see Dosage and Administration (2.2 and 2.3) ] . 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 VELO 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 VELO 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 53% of patients who received LUNSUMIO VELO at the recommended dosage in the clinical trial (N = 94), with Grade 3 neurologic toxicity occurring in 1.1% of patients. The most frequent neurologic toxicities were headache (17%), insomnia (15%), dizziness (10%), and mental status changes (7%, including confusion and lethargy). ICANS or suspected ICANS was reported in 3.1% of patients (all Grade 1). 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 reactions 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 VELO 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 VELO 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 VELO can cause serious or fatal infections [see Adverse Reactions (6.1) ]. Among patients who received LUNSUMIO VELO at the recommended dosage in the clinical trial, serious infections, including opportunistic infections, occurred in 17%, with Grade 3 or 4 infections in 16% and fatal infections in 3.2% of patients. The most common Grade 3 or greater infections were pneumonia, sepsis, and COVID-19. Monitor patients for signs and symptoms of infection prior to and during treatment with LUNSUMIO VELO and treat appropriately. LUNSUMIO VELO should not be administered in the presence of active infection. Caution should be exercised when considering use 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 VELO or consider permanent discontinuation based on severity [see Dosage and Administration (2.4) ]. 5.4 Hemophagocytic Lymphohistiocytosis LUNSUMIO VELO 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 who received LUNSUMIO or LUNSUMIO VELO. Most cases (5/7) were identified within the first 28 days following initiation of treatment, 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 VELO and evaluate and treat promptly for HLH per current practice guidelines. 5.5 Cytopenias LUNSUMIO VELO can cause serious or severe cytopenias, including lymphopenia, neutropenia, anemia, and thrombocytopenia [see Adverse Reactions (6.1) ] . Among patients who received LUNSUMIO VELO at the recommended dosage in the clinical trial (N = 94), Grade 3 or 4 decreased lymphocytes occurred in 69%, decreased neutrophils occurred in 26%, decreased hemoglobin in 10%, and decreased platelets in 6% of patients. Grade 4 decreased lymphocytes occurred in 22%, decreased neutrophils in 9% and decreased platelets in 3.2% of patients. Febrile neutropenia occurred in 2.1% of patients. Monitor complete blood counts throughout treatment. Based on the severity of cytopenias, temporarily withhold, or permanently discontinue LUNSUMIO VELO. Consider prophylactic granulocyte colony-stimulating factor administration as applicable [see Dosage and Administration (2.4) ] . 5.6 Tumor Flare LUNSUMIO VELO can cause serious or severe tumor flare [see Adverse Reactions (6.1) ] . Among patients who received LUNSUMIO VELO at the recommended dosage in the clinical trial (N = 94), tumor flare occurred in 1.1% of patients. Manifestations may include 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 subcutaneous use (LUNSUMIO VELO) and an injection for intravenous use (LUNSUMIO). 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 VELO for or with LUNSUMIO. 5.8 Embryo-Fetal Toxicity Based on its mechanism of action, LUNSUMIO VELO 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 VELO and for 3 months after the last dose [see Use in Specific Populations (8.1 , 8.3) ].