Initial US Approval:
2020
Key Clinical Studies:
inMIND (NCT04680052)
Drug Class/Description:
CD19-directed cytolytic antibody
Indications and Usage:
MONJUVI is a CD19-directed cytolytic antibody indicated:
- in combination with lenalidomide for the treatment of adult patients 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). This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
- in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL).
- Limitations of Use:
MONJUVI is not indicated and is not recommended for the treatment of patients with relapsed or refractory marginal zone lymphoma outside of controlled clinical trials.
Dosage and Administration:
- Administer premedications prior to starting MONJUVI.
- See Full Prescribing Information for instructions on preparation and administration.
Diffuse Large B-cell Lymphoma
- The recommended dosage of MONJUVI is 12 mg/kg as an intravenous infusion according to the following dosing schedule:
- Cycle 1: Days 1, 4, 8, 15, and 22 of the 28-day cycle.
- Cycles 2 and 3: Days 1, 8, 15, and 22 of each 28-day cycle.
- Cycle 4 and beyond: Days 1 and 15 of each 28-day cycle.
- Cycle 1: Days 1, 4, 8, 15, and 22 of the 28-day cycle.
- Administer MONJUVI in combination with lenalidomide for a maximum of 12 cycles and then continue MONJUVI as monotherapy until disease progression or unacceptable toxicity.
Follicular Lymphoma
- The recommended dosage of MONJUVI is 12 mg/kg as an intravenous infusion according to the following dosing schedule:
- Cycles 1 to 3: Days 1, 8, 15, and 22 of each 28-day cycle.
- Cycles 4 to 12: Days 1 and 15 of each 28-day cycle.
- Administer MONJUVI in combination with lenalidomide (Cycles 1 to 12) and rituximab (Cycles 1 to 5).
Dosage Forms and Strengths:
For injection: 200 mg of tafasitamab-cxix as lyophilized powder in single-dose vial for reconstitution.
Contraindications:
None.
Warnings and Precautions:
- Infusion-Related Reactions: Monitor patients frequently during infusion. Interrupt or discontinue infusion based on severity.
- Myelosuppression: Monitor complete blood counts. Manage using dose modifications and growth factor support. Interrupt or discontinue MONJUVI based on severity.
- Infections: Bacterial, fungal and viral infections can occur during and following MONJUVI. Monitor patients for infections.
- Embryo-Fetal Toxicity: May cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and use of effective contraception.
Adverse Reactions:
The most common adverse reactions (≥ 20%) in patients with relapsed or refractory DLBCL are neutropenia, respiratory tract infection, fatigue, anemia, diarrhea, thrombocytopenia, cough, pyrexia, peripheral edema, and decreased appetite.
The most common adverse reactions (≥ 20%), excluding laboratory abnormalities, in patients with relapsed or refractory FL are respiratory tract infections, diarrhea, rash, fatigue, constipation, musculoskeletal pain, and cough. The most common Grade 3 or 4 laboratory abnormalities (≥ 20%) are decreased neutrophils and decreased lymphocytes.
Use in Specific Populations:
Lactation: Advise not to breastfeed.
Adapted From:
Every health-care provider should make their own determination regarding specific safe and appropriate patient care practices, including drug dosages and indications. The provider should always consult the most recent prescribing/product information. FDA Focus information is not guaranteed to be accurate, complete, or current. JADPRO and its editors, authors, reviewers, and commentators cannot be held responsible for any liability incurred as a consequence of the application of any of the information listed within.
