Pronunciation: mon-JOO-vee
Generic name: tafasitamab [ TA-fa-SIT-a-mab ]
Dosage form: injection for infusion
Drug class: CD19 monoclonal antibodies

Medically reviewed by Melisa Puckey, BPharm. Last updated on Feb 26, 2025.

What is Monjuvi?

Monjuvi is a targeted immunotherapy used to treat relapsed or refractory diffuse large B-cell lymphoma (DLBCL). Monjuvi works by identifying and binding to CD19 markers on cancer cells, signaling the immune system to attack and destroy them. Monjuvi mechanism of action is as a CD19-directed cytolytic antibody.

Monjuvi is given as an IV infusion into a vein, by your healthcare provider. 

Monjuvi FDA approval is for the treatment of diffuse large B-cell lymphoma (DLBCL) when other cancer treatments have not worked or have stopped working, and the patient is not able to have an autologous stem cell transplant (ASCT). It is used for DLBCL that are not otherwise specified, including DLBCL arising from low-grade lymphoma. Monjuvi is used in combination with lenalidomide.

Monjuvi FDA approval was granted to Incyte and MorphoSys AG based on positive results from the clinical trial L-MIND (NCT02399085), an open-label Phase 2 study. Monjuvi FDA approval was granted under the accelerated approval program and continued approval will depend on confirmation of clinical benefit in the further trial(s).

The Monjuvi success rate

In the Monjuvi clinical trial L-MIND the success rate was:

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

Monjuvi side effects

Common Monjuvi side effects:

Common Monjuvi side effects may include:

• Neutropenia 51%
• Tiredness 38%
• Anemia 36%
• Diarrhea 36%
• Thrombocytopenia 31%
• Cough 26%
• Fever 24%
• Peripheral edema 24%
• Respiratory tract infection 24%
• Decreased appetite 22%

These common side effects occurred in 20% or more of Monjuvi-treated patients in the  L-MIND clinical trial.

Serious side effects 

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.

Some side effects may occur during the injection. Tell your caregiver if you feel chilled, warm, sweaty, anxious, or have a headache, trouble breathing, or pounding in your neck or ears.

Call your doctor at once if you have:

• cough with mucus, chest tightness, shortness of breath;
• fever above 100.4 degrees F (38 degrees C);
• pain or burning when you urinate;
• easy bruising, unusual bleeding, purple or red spots under your skin;
• low red blood cells (anemia) - pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet; or
• low white blood cell counts - fever, mouth sores, skin sores, sore throat, cough, trouble breathing.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

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 FDA at 1-800-FDA-1088.

Related/similar drugs

Warnings

Monjuvi affects your immune system. You may get infections more easily, even serious or fatal infections. Call your doctor right away if you have signs of infection (fever, cough with mucus, chest tightness, shortness of breath, or pain or burning when you urinate).

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.

Infusion-Related Reactions: You will be monitored frequently during infusion and your treatment may be Interrupted or discontinued if you have a reaction.

Myelosuppression: Your complete blood counts will be monitored and your doctor may do dose modifications and growth factor support if you have myelosuppression. Treatment may be interrupted or discontinued based on severity.

Before taking this medicine

Tell your doctor if you have any signs of infection, or if you have recently had an infection.

Tafasitamab may harm an unborn baby. Use effective birth control to prevent pregnancy while using this medicine and for at least 3 months after your last dose. Tell your doctor if you become pregnant.

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.

Carefully follow all instructions about the use of birth control while you are using Monjuvi in combination with other medicines.

Do not breastfeed while receiving Monjuvi, and for at least 3 months after your last dose.

How is Monjuvi given?

Monjuvi is given as an infusion into a vein. A healthcare provider will give you this injection.

Monjuvi is given in a 28-day treatment cycle. You may need to use the medicine only on certain days of each cycle. Your doctor will determine how long to treat you with this medicine.

This medicine must be given slowly, and the infusion can take up to 2.5 hours to complete.

You may be given other medications to help prevent serious side effects or an allergic reaction. Keep using these medicines for as long as your doctor has prescribed.

Monjuvi affects your immune system. You may get infections more easily, even serious or fatal infections. Your doctor will need to examine you on a regular basis.

Dosing information

Usual Adult Dose of Monjuvi for Lymphoma

The recommended Monjuvi dose: 12 mg/kg IV (based on actual body weight.

Doses may be modified due to adverse reactions

Administer in combination with lenalidomide 25 mg orally for a maximum of 12 cycles, then continue this drug as monotherapy until disease progression or unacceptable toxicity.

Monjuvi dosing schedule 

Cycle 1: Infusion on Days 1, 4, 8, 15, and 22
Cycle 2: Infusion on Days 1, 8, 15, and 22
Cycle 3: Infusion on Days 1, 8, 15, and 22
Cycle 4: Infusion on Days 1 and 15.

Each therapy cycle is 28 days.

For the first infusion, use an infusion rate of 70 mL/h for the first 30 minutes, then increase the rate so that the infusion is administered within 1.5 to 2.5 hours; administer all subsequent infusions within 1.5 to 2 hours.

General dosing information

• Administer premedications 30 minutes to 2 hours prior to starting 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.

Refer to the lenalidomide prescribing information for lenalidomide dosage recommendations.

What happens if I miss a dose?

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

What happens if I overdose?

Since this medicine is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

Monjuvi Package Insert 

HCPs and patients often use the Monjuvi Package Insert for more detailed information about this medicine. The Package Insert contains more comprehensive information on Indications and Usage, Dosage and Administration, Clinical Pharmacology, Clinical Studies, Drug Interaction, and more. Discuss any medical questions you have with your doctor or other health care provider. This is not all the information you need to know about this medicine for safe and effective use, and it does not take the place of talking to your doctor about your treatment.

The Package Insert is sometimes called Monjuvi Prescribing Information (PI) or the FDA label.

What other drugs will affect Monjuvi?

Other drugs may interact with tafasitamab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Ingredients

Active ingredient: tafasitamab-cxix.

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

Company

Manufactured by: MORPHOSYS US INC., Boston, MA 02210, U.S. License No. 2152,

Marketed by: MORPHOSYS US INC. and INCYTE Corporation.

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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