Generic drug: tafasitamab-cxix

Brand name: Monjuvi

What is Monjuvi (tafasitamab-cxix), and how does it work?

Monjuvi (tafasitamab-cxix) is a prescription medicine given with lenalidomide to treat adults with certain types of diffuse large B-cell lymphoma (DLBCL) that has come back (relapsed) or that did not respond to previous treatment (refractory) and who cannot receive a stem cell transplant.

It is not known if Monjuvi is safe and effective in children.

What are the side effects of Monjuvi?

Monjuvi may cause serious side effects, including:

  • Infusion reactions. Your healthcare provider will monitor you for infusion reactions during your infusion of Monjuvi. Tell your healthcare provider right away if you get chills, flushing, headache, or shortness of breath during an infusion of Monjuvi.
  • Low blood cell counts (platelets, red blood cells, and white blood cells). Low blood cell counts are common with Monjuvi, but can also be serious or severe. Your healthcare provider will monitor your blood counts during treatment with Monjuvi. Tell your healthcare provider right away if you get a fever of 100.4°F (38°C) or above, or any bruising or bleeding.
  • Infections. Serious infections, including infections that can cause death, have happened in people during treatment with Monjuvi and after the last dose. Tell your healthcare provider right away if you get a fever of 100.4°F (38°C) or above, or develop any signs or symptoms of an infection.

The most common side effects of Monjuvi include:

These are not all the possible side effects of Monjuvi.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the dosage for Monjuvi?

Recommended Dosage

The recommended dose of Monjuvi is 12 mg/kg based on actual body weight administered as an intravenous infusion according to the dosing schedule in Table 1.

Administer Monjuvi in combination with lenalidomide 25 mg for a maximum of 12 cycles, then continue Monjuvi as monotherapy until disease progression or unacceptable toxicity. Refer to the lenalidomide prescribing information for lenalidomide dosage recommendations.

Table 1: Monjuvi Dosing Schedule

Cycle* 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
*Each treatment cycle is 28-days.

Monjuvi should be administered by a healthcare professional with immediate access to emergency equipment and appropriate medical support to manage infusion-related reactions (IRRs).

Recommended Premedications

  • Administer premedications 30 minutes to 2 hours prior to starting Monjuvi infusion to minimize infusion-related reactions. Premedications may include acetaminophen, histamine H1 receptor antagonists, histamine H2 receptor antagonists, and/or glucocorticosteroids.
  • For patients not experiencing infusion-related reactions during the first 3 infusions, premedication is optional for subsequent infusions.
  • If a patient experiences an infusion-related reaction, administer premedications before each subsequent infusion.

Dosage Modifications For Adverse Reactions

The recommended dosage modifications for adverse reactions are summarized in Table 2.

Table 2: Dosage Modifications for Adverse Reactions

Adverse Reaction Severity Dosage Modification
Infusion-related reactions Grade 2 (moderate)
  • Interrupt infusion immediately and manage signs and symptoms.
  • Once signs and symptoms resolve or reduce to Grade 1, resume infusion at no more than 50% of the rate at which the reaction occurred. If the patient does not experience further reaction within 1 hour and vital signs are stable, the infusion rate may be increased every 30 minutes as tolerated to the rate at which the reaction occurred.
Grade 3 (severe)
  • Interrupt infusion immediately and manage signs and symptoms.
  • Once signs and symptoms resolve or reduce to Grade 1, resume infusion at no more than 25% of the rate at which the reaction occurred. If the patient does not experience further reaction within 1 hour and vital signs are stable, the infusion rate may be increased every 30 minutes as tolerated to a maximum of 50% of the rate at which the reaction occurred.
  • If after rechallenge the reaction returns, stop the infusion immediately.
Grade 4 (life-threatening)
  • Stop the infusion immediately and permanently discontinue Monjuvi.
Myelosuppression Platelet count of 50,000/ mcL or less
  • Withhold Monjuvi and lenalidomide and monitor complete blood count (CBC) weekly until platelet count is 50,000/mcL or higher.
  • Resume Monjuvi at the same dose and lenalidomide at a reduced dose. Refer to lenalidomide prescribing information for dosage modifications.
Neutrophil count of 1,000/ mcL or less for at least 7 days OR
Neutrophil count of 1,000/ mcL or less with an increase of body temperature to 100.4°F (38°C) or higher OR
Neutrophil count less than 500/mcL
  • Withhold Monjuvi and lenalidomide and monitor CBC weekly until neutrophil count is 1,000/ mcL or higher.
  • Resume Monjuvi at the same dose and lenalidomide at a reduced dose. Refer to lenalidomide prescribing information for dosage modifications.

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What drugs interact with Monjuvi?

No information provided

Is Monjuvi safe to use while pregnant or breastfeeding?

  • Based on its mechanism of action, Monjuvi may cause fetal B-cell depletion when administered to a pregnant woman.
  • There are no available data on Monjuvi use in pregnant women to evaluate for a drug-associated risk.
  • There are no data on the presence of tafasitamab-cxix in human milk or the effects on the breastfed child or milk production.
  • Maternal immunoglobulin G is known to be present in human milk.
  • The effects of local gastrointestinal exposure and limited systemic exposure in the breastfed infant to Monjuvi are unknown.
  • Because of the potential for serious adverse reactions in the breastfed child, advise women not to breastfeed during treatment with Monjuvi and for at least 3 months after the last dose. Refer to lenalidomide prescribing information for additional information.

Summary

Monjuvi (tafasitamab-cxix) is a prescription medicine given with lenalidomide to treat adults with certain types of diffuse large B-cell lymphoma (DLBCL) that has come back (relapsed) or that did not respond to previous treatment (refractory) and who cannot receive a stem cell transplant. Serious side effects of Monjuvi include infusion reactions, low blood cell counts, and infections.

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Medically Reviewed on 6/17/2021
References
All sections courtesy of the U.S. Food and Drug Administration