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Monjuvi Generic Name & Formulations
Legal Class
Rx
General Description
Tafasitamab-cxix 200mg; per vial; lyophilized pwd for IV infusion after reconstitution and dilution; preservative-free.
Pharmacological Class
CD19-directed cytolytic monoclonal antibody.
How Supplied
Single-dose vial—1
Manufacturer
Generic Availability
NO
Monjuvi Indications
Indications
In combination with lenalidomide for 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).
Monjuvi Dosage and Administration
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.
Monjuvi Contraindications
Not Applicable
Monjuvi Boxed Warnings
Not Applicable
Monjuvi Warnings/Precautions
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).
Monjuvi Pharmacokinetics
See Literature
Monjuvi Interactions
Not Applicable
Monjuvi Adverse Reactions
Adverse Reactions
Neutropenia, fatigue, anemia, diarrhea, thrombocytopenia, cough, pyrexia, peripheral edema, respiratory tract infection, decreased appetite; opportunistic infections, lab abnormalities.
Monjuvi Clinical Trials
See Literature
Monjuvi Note
Not Applicable
Monjuvi Patient Counseling
See Literature
