MONJUVI® (tafasitamab-cxix) sponsored by Incyte


DLBCL Resources
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Physician Resources
Patient Resources
FL Resources
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Physician Resources
Patient Resources
Highlights of Indications & Usage

HIGHLIGHTS OF 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.

 

These highlights do not include all the information needed to use MONJUVI safely and effectively. See full Prescribing Information for MONJUVI.

Highlights of Dosage & Administration

HIGHLIGHTS OF 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.
  • 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).

 

HIGHLIGHTS OF DOSAGE FORMS AND STRENGTHS

For injection: 200 mg of tafasitamab-cxix as lyophilized powder in single-dose vial for reconstitution.

 

These highlights do not include all the information needed to use MONJUVI safely and effectively. See full Prescribing Information for MONJUVI.

Highlights of Contraindications

HIGHLIGHTS OF CONTRAINDICATIONS

None.

 

These highlights do not include all the information needed to use MONJUVI safely and effectively. See full Prescribing Information for MONJUVI.

Highlights of Warnings & Precautions

HIGHLIGHTS OF 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.

 

These highlights do not include all the information needed to use MONJUVI safely and effectively. See full Prescribing Information for MONJUVI.

Highlights of Adverse Reactions

HIGHLIGHTS OF 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.

To report SUSPECTED ADVERSE REACTIONS, contact Incyte Corporation at 1-855-463-3463 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

 

These highlights do not include all the information needed to use MONJUVI safely and effectively. See full Prescribing Information for MONJUVI.

Highlights of Use in Specific Populations

HIGHLIGHTS OF USE IN SPECIFIC POPULATIONS

Lactation: Advise not to breastfeed.

 

These highlights do not include all the information needed to use MONJUVI safely and effectively. See full Prescribing Information for MONJUVI.

MONJUVI and the MONJUVI logo are registered trademarks of Incyte.
Incyte and the Incyte logo are registered trademarks of Incyte.
© 2025, Incyte.  MAT-MON-00680  09/25

Please see the full Prescribing Information for more information about MONJUVI.

INDICATIONS & IMPORTANT SAFETY INFORMATION

INDICATIONS & USAGE

Diffuse Large B-cell Lymphoma

MONJUVI (tafasitamab-cxix), in combination with lenalidomide, is indicated 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).

Follicular Lymphoma

MONJUVI, in combination with lenalidomide and rituximab, is indicated 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.

Important Safety Information

Contraindications:

None.

Warnings and Precautions:

  • Infusion-Related Reactions (IRRs). MONJUVI (tafasitamab-cxix) can cause IRRs, including fever, chills, rash, flushing, dyspnea, and hypertension. Premedicate patients and monitor frequently during infusion. Based on the severity of the IRR, interrupt or discontinue MONJUVI and institute appropriate medical management.
  • Myelosuppression. MONJUVI can cause serious or severe myelosuppression, including neutropenia, lymphopenia, thrombocytopenia, and anemia. Monitor complete blood counts (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. Refer to the lenalidomide prescribing information for dosage modifications.
  • Infections. Fatal and serious infections, including opportunistic infections, occurred in patients during treatment with MONJUVI and following the last dose. In L-MIND, 73% of the 81 patients with DLBCL who received MONJUVI developed an infection. Grade 3 or higher infection occurred in 30%. 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%. 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.
  • 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 and women of reproductive potential to use effective contraception during treatment with MONJUVI and for 3 months after the last dose. The combination of MONJUVI with lenalidomide and of MONJUVI with lenalidomide and rituximab is contraindicated in pregnant women. Refer to the lenalidomide prescribing information on use during pregnancy.

Adverse Reactions:

The most common adverse reactions (≥20%) in patients with DLBCL were neutropenia (51%), respiratory tract infection (51%), fatigue (38%), anemia (36%), diarrhea (36%), thrombocytopenia (31%), cough (26%), pyrexia (24%), peripheral edema (24%), and decreased appetite (22%).

The most common adverse reactions (≥ 20%) in patients with FL receiving MONJUVI were respiratory tract infections (56%) (including COVID-19 infection and pneumonia), diarrhea (38%), rash (37%), fatigue (34%), constipation (29%), musculoskeletal pain (24%), and cough (21%). The most common Grade 3 or 4 laboratory abnormalities (≥ 20%) were decreased neutrophils (48%) and decreased lymphocytes (22%).

 

Please see the full Prescribing Information for more information about MONJUVI.