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:
- feeling tired or weak
- 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.
What is the dosage for Monjuvi?
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 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).
- 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)||
|Grade 3 (severe)||
|Grade 4 (life-threatening)||
|Myelosuppression||Platelet count of 50,000/ mcL or less||
|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
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.
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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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