Leukemias, lymphomas, and other hematologic cancers:
Indications for MONJUVI:
In combination with lenalidomide for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT).
Adult:
Premedicate with antipyretic, antihistamines and/or corticosteroids ≥30–120mins prior to initiation (optional for subsequent infusions if no infusion-related reactions during 1st 3 infusions). Give by IV infusion. First infusion: infuse at 70mL/hr for 1st 30mins, then increase rate to administer within 1.5–2.5hrs. Subsequent infusions: infuse within 1.5–2hrs. Administer 12mg/kg based on dosing schedule (Cycle 1: Days 1, 4, 8, 15 and 22; Cycles 2 and 3: Days 1, 8, 15, and 22; Cycle 4 and beyond: Days 1 and 15) in combination with lenalidomide for max 12 cycles, then continue as monotherapy until disease progression or unacceptable toxicity. Dose modifications for adverse reactions: see full labeling.
Children:
Not established.
Warnings/Precautions:
Should be administered by a healthcare professional. Have emergency equipment and medical support readily available. Monitor frequently for infusion-related reactions; interrupt or discontinue based on severity. Monitor CBCs prior to each cycle and during therapy. Manage myelosuppression using dose modifications; consider granulocyte colony stimulating factor administration. Monitor for infections (eg, bacteria, fungal, viral). Embryo-fetal toxicity (also refer to lenalidomide labeling). Advise females of reproductive potential to use effective contraception during and for ≥3 months after the last dose. Pregnancy. Nursing mothers: not recommended (during and for ≥3 months after the last dose).
Pharmacologic Class:
CD19-directed cytolytic monoclonal antibody.
Adverse Reactions:
Neutropenia, fatigue, anemia, diarrhea, thrombocytopenia, cough, pyrexia, peripheral edema, respiratory tract infection, decreased appetite; opportunistic infections, lab abnormalities.
Generic Availability:
NO
How Supplied:
Single-dose vial—1
