Monjuvi (tafasitamab-cxix)

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:

• feeling tired or weak
• diarrhea
• cough
• fever
• swelling of lower legs or hands
• respiratory tract infection
• decreased appetite

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.

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

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

• 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.