Monjuvi (Tafasitamab): Uses, Side Effects and Dosage

What is MONJUVI?

MONJUVI is a prescription medicine given:

• in combination 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.
• in combination with a lenalidomide and rituximab, to treat adults with follicular lymphoma (FL) that has come back or that did not respond to previous treatment.

MONJUVI should not be used and is not recommended outside of clinical trials to treat people with a certain type of lymphoma, called marginal zone lymphoma, that has come back or that did not respond to previous treatment.

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

Before you receive MONJUVI, tell your healthcare provider about all of your medical conditions, including if you:

• have an active infection or have had one recently.

• are pregnant or plan to become pregnant. MONJUVI may harm your unborn baby. You should not become pregnant during treatment with MONJUVI. Do not receive treatment with MONJUVI in combination with lenalidomide if you are pregnant because lenalidomide can cause birth defects and death of your unborn baby.

  • You should use an effective method of birth control (contraception) during treatment and for 3 months after your last dose of MONJUVI.
  • Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with MONJUVI.
• are breastfeeding or plan to breastfeed. It is not known if MONJUVI passes into your breastmilk. Do not breastfeed during treatment and for at least 3 months after your last dose of MONJUVI.

You should also read the lenalidomide Medication Guide for important information about pregnancy, contraception, and blood and sperm donation.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How will I receive MONJUVI?

• MONJUVI will be given to you by your healthcare provider as an intravenous (IV) infusion into one of your veins.
• Your healthcare provider will give you medicines before each infusion to decrease your chance of infusion reactions. If you do not have any reactions, your healthcare provider may decide that you do not need these medicines with later infusions.
• Each treatment cycle of MONJUVI lasts for 28 days.
• Your healthcare provider may need to delay or completely stop treatment with MONJUVI if you have severe side effects.
• Your healthcare provider will decide how many treatments you need.
• If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment.

What are the possible 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 fever, chills, rash, 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 when given with lenalidomide in people with DLBCL include :

• respiratory tract infection
• feeling tired or weak
• diarrhea
• cough

• fever
• swelling of lower legs or hands
• decreased appetite

The most common side effects of MONJUVI when given with lenalidomide and rituximab in people with FL include:

• respiratory tract infections
• diarrhea
• rash
• feeling tired or weak

• muscle and bone pain
• constipation
• cough

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.

General information about the safe and effective use of MONJUVI.

Medicines are sometimes prescribed for purposes other than those listed in this Patient Information. If you would like more information about MONJUVI, talk with your healthcare provider. You can ask your healthcare provider for information about MONJUVI that is written for health professionals.

What are the ingredients in MONJUVI?

Active ingredient: tafasitamab-cxix.

Inactive ingredients: citric acid monohydrate, polysorbate 20, sodium citrate dihydrate, and trehalose dihydrate.

Manufactured by: Incyte Corporation, Wilmington, DE 19803

U.S. License No. 2228

MONJUVI and the MONJUVI logo are registered trademarks of Incyte.

© 2025 Incyte Corporation. All rights reserved.

Patent Information: www.incyte.com/patents

For more information, call 1-855-463-3463 or go to www.MONJUVI.com.