monjuvi

Important safety information

Infusion-Related Reactions : Monitor patients frequently during infusion. Interrupt or discontinue infusion based on severity. ( 2.5 , 5.1 ) Myelosuppression : Monitor complete blood counts. Manage using dose modifications and growth factor support. Interrupt or discontinue MONJUVI based on severity. ( 2.5 , 5.2 ) Infections : Bacterial, fungal and viral infections can occur during and following MONJUVI. Monitor patients for infections. ( 2.5 , 5.3 ) Embryo-Fetal Toxicity : May cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and use of effective contraception. ( 5.4 ) 5.1 Infusion-Related Reactions MONJUVI can cause infusion-related reactions [see Adverse Reactions ( 6.1 )] . In L-MIND, infusion-related reactions occurred in 6% of the 81 patients with DLBCL who received MONJUVI. Eighty percent of infusion-related reactions occurred during cycle 1 or 2. In inMIND, infusion-related reactions occurred in 16% of the 274 patients with FL who received MONJUVI in combination with lenalidomide and rituximab. Signs and symptoms included fever, chills, rash, flushing, dyspnea, and hypertension. These reactions were generally managed with temporary interruption of the infusion and/or with supportive medication. Premedicate patients prior to starting MONJUVI infusion [see Dosage and Administration ( 2.4 )] . Monitor patients frequently during infusion. Based on the severity of the infusion-related reaction, interrupt or discontinue MONJUVI [ see Dosage and Administration ( 2.5 )] . Institute appropriate medical management. 5.2 Myelosuppression MONJUVI can cause serious or severe myelosuppression, including neutropenia, lymphopenia, thrombocytopenia, and anemia [ see Adverse Reactions ( 6.1 ) ] . In L-MIND, among 81 patients with DLBCL who received MONJUVI, Grade 3 neutropenia was reported in 25%, Grade 3 thrombocytopenia in 12%, and Grade 3 anemia in 7%. Grade 4 neutropenia was reported in 25% and Grade 4 thrombocytopenia in 6%. Neutropenia led to treatment discontinuation in 3.7% of the patients with DLBCL. Febrile neutropenia occurred in 12%. In inMIND, among 274 patients with FL who received MONJUVI in combination with lenalidomide and rituximab, new or worsening Grade 3 or 4 cytopenias included decreased neutrophils in 48% (Grade 4, 19%), decreased lymphocytes in 22% (Grade 4, 1.8%), decreased hemoglobin in 9%, and decreased platelets in 8% (Grade 4, 4%). Febrile neutropenia occurred in 4.4%. Monitor CBCs before each treatment cycle and throughout treatment. Monitor patients with neutropenia for signs of infection. Consider granulocyte colony-stimulating factor administration. Withhold MONJUVI based on the severity of the adverse reaction [see Dosage and Administration ( 2.5 )]. Refer to the lenalidomide prescribing information for dosage modifications. 5.3 Infections Fatal and serious infections, including opportunistic infections, occurred in patients during treatment with MONJUVI and following the last dose [ see Adverse Reactions ( 6.1 )]. In L-MIND, 73% of the 81 patients with DLBCL who received MONJUVI developed an infection. Grade 3 or higher infection occurred in 30%. Infection-related deaths occurred in 2.5% of patients, including a case of progressive multifocal leukoencephalophathy (PML). The most frequent Grade 3 or higher infection was pneumonia (7%). The most frequent infections of any grade were respiratory tract infections (51%, including pneumonias) and urinary tract infection (17%). Among 274 patients with FL who received MONJUVI in combination with lenalidomide and rituximab in inMIND, Grade 3 or higher infections occurred in 24%, including fatal infections in 1.1% of patients. The most frequent Grade ≥ 3 infections were respiratory tract infections (19%), including Grade 3 or higher pneumonia (14%) and COVID-19 infection (11%). Opportunistic infections of any grade occurred in 6% of patients, including herpes simplex or zoster infection (5%), fungal pneumonia (1.1%, including Pneumocytis jirovecii pneumonia in 0.4%), and cytomegalovirus (CMV) reactivation (0.4%). Monitor patients for signs and symptoms of infection and manage infections as appropriate. Consider infection prophylaxis per institutional guidelines. Consider treatment with subcutaneous or intravenous immunoglobulin (IVIG) as appropriate. 5.4 Embryo-Fetal Toxicity Based on its mechanism of action, MONJUVI may cause fetal B-cell depletion when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with MONJUVI and for 3 months after the last dose [see Use in Specific Populations ( 8.1 , 8.3 )] . The combination of MONJUVI with lenalidomide and of MONJUVI with lenalidomide and rituximab is contraindicated in pregnant women because lenalidomide can cause birth defects and death of the unborn child. Refer to the lenalidomide prescribing information on use during pregnancy.