Pronunciation: mon-JOO-vee
Generic name: tafasitamab
Dosage form: single-dose vial for intravenous infusion (200 mg)
Drug class: CD19 monoclonal antibodies

Medically reviewed by Carmen Pope, BPharm. Last updated on Jun 23, 2025.

What is Monjuvi?

Monjuvi is used to treat relapsed or refractory diffuse large B-cell lymphoma (DLBCL) or relapsed or refractory follicular lymphoma (FL). It is given as an intravenous infusion by a healthcare provider, two to five times during a 28-day cycle.

Monjuvi is a targeted immunotherapy treatment that works by binding to CD19 markers expressed on the surface of pre-B and mature-B lymphocytes and several B-cell cancers, including DLBCL and FL. Once bound, Monjuvi signals the immune system to attack and destroy these cells. Monjuvi belongs to the drug class called  CD19-directed cytolytic antibodies.

Monjuvi (tafasitamab-cxix) gained FDA approval on July 31, 2020, for DLBCL. Approval was extended on June 18, 2025, to include FL. There is no generic.

FDA approvals and uses

Monjuvi is FDA approved for adults 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), in combination with lenalidomide
  • This approval is under the accelerated approval designation, and continued approval may be contingent upon a continued clinical benefit being shown in confirmatory trials.
• Relapsed or refractory follicular lymphoma (FL) in combination with lenalidomide and rituximab.
  • Not indicated for relapsed or refractory marginal zone lymphoma outside of controlled clinical trials.

Monjuvi FDA approval was granted to Incyte and MorphoSys AG based on the following positive results from the clinical trial L-MIND (NCT02399085), an open-label Phase 2 study, which reported

• 55% of Monjuvi patients reach remission at 1 year
• 37% had a complete remission
• 18% had a partial remission.

Side effects

The most common side effects of Monjuvi when given with lenalidomide in DLBCL are:

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

The most common side effects of Monjuvi when given with lenalidomide and rituximab in FL are:

• respiratory tract infections
• diarrhea
• rash
• feeling tired or weak
• muscle and bone pain
• constipation
• cough.

Warnings and serious side effects 

Monjuvi may cause the following serious side effects:

• 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, or fever, mouth sores, skin sores, sore throat, cough, trouble breathing.

• 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, such as:
  • cough with mucus, chest tightness, shortness of breath
  • fever above 100.4 degrees F (38 degrees C)
  • pain or burning when you urinate.

As with any medication, allergic reactions may happen. Get emergency medical help if you have signs of an allergic reaction to Monjuvi: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Monjuvi may harm an unborn baby. Use effective birth control to prevent pregnancy while using Monjuvi and for at least 3 months after your last dose. Carefully follow all instructions about the use of birth control while you are using Monjuvi in combination with lenalidomide.

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Related/similar drugs

Before taking

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
• are breastfeeding or plan to breastfeed.

Pregnancy

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.

Monjuvi is used in combination with lenalidomide. Both men and women using lenalidomide must use effective birth control. Even one dose can cause severe, life-threatening birth defects or death of a baby if the mother or the father is taking lenalidomide at the time of conception or during pregnancy. You should also read the lenalidomide Medication Guide for important information about pregnancy, contraception, blood and sperm donation.

Breastfeeding

 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.

How is Monjuvi given?

Monjuvi will be given to you by your healthcare provider as an intravenous (IV) infusion into one of your veins.

• Your healthcare provider will administer premedications 30 minutes to 2 hours before starting the 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.
• This medicine must be given slowly, and the infusion can take up to 2.5 hours to complete.

Each treatment cycle of Monjuvi lasts for 28 days.

• Monjuvi will be given 2 to 5 times during the 28-day cycle, depending on the type of cancer you have or how many weeks through your treatment you are.
• Your healthcare provider will decide how many treatments you need.
• Your healthcare provider may need to delay or completely stop treatment with Monjuvi if you have severe side effects.
• If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment.
• Monjuvi affects your immune system. You may get infections more easily, even serious or fatal infections. Your doctor will need to examine you regularly.

Dosing information

Adult Dose of Monjuvi for DLBCL 

 The recommended dosage is 12 mg/kg as an IV 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 the 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 occurs.

Adult Dose of Monjuvi for FL 

 The recommended dosage is 12 mg/kg as an IV 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). 

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your Monjuvi injection.

What other drugs will affect this medicine?

Other drugs may interact with Monjuvi, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. 

Ingredients

Active ingredient: tafasitamab-cxix.

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

Monjuvi is supplied as 200 mg of tafasitamab-cxix as lyophilized powder in a single-dose vial for reconstitution.

Company

Monjuvi is manufactured by the Incyte Corporation, located in Wilmington, DE 19803.

Monjuvi Biosimilars

Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.

Reference products

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for Monjuvi.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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