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Generic Name: tafasitamab-cxix
Trade Name: Monjuvi®

How is Monjuvi used? Monjuvi is approved in combination with lenalidomide to treat adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). This indication is approved under accelerated approval based on overall response rate; continued approval may be contingent upon efficacy verification in ongoing clinical trials.

What is the mechanism of action? Monjuvi is a monoclonal antibody that targets a protein on the surface of B lymphocytes called CD19.

How is Monjuvi given (administered)? Monjuvi is administered intravenously.

How are patients monitored? Patients will usually have scheduled meetings with their healthcare provider while they are being treated with Monjuvi. Typically, blood will be drawn to check levels of blood cells and platelets and to monitor functions of some organ systems, such as the kidney or liver. Patients may also undergo physical examinations, scans or other measures to assess side effects and response to therapy.

What are the most common side effects of treatment with Monjuvi?

  • Low blood cell counts (red, white and/or platelets)
  • Fatigue
  • Diarrhea
  • Cough
  • Fever
  • Swelling in hands or feet
  • Respiratory tract infection
  • Decreased appetite

This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.

Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.

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What can patients do to help alleviate or prevent discomfort and side effects?

  • Pay careful attention to your healthcare provider’s instructions and inform your doctor of any side effects.

Are there any special precautions patients should be aware of before starting treatment?

  • Patients should inform their physician about all medical conditions including recent or active infections.
  • Patients should inform their physician of any other medication or supplement they are taking (whether prescription or over-the-counter).
  • Talk to your doctor if your partner is pregnant or planning to become pregnant. Females should use an effective method of birth control during treatment and for 3 months after the last dose of Monjuvi.
  • Do not breastfeed during treatment or for 3 months after the last dose of Monjuvi.
  • You should also read the lenalidomide medication guide for side effect information.

When should patients notify their physician?

Tell your doctor if you experience any side effects that bother you or don’t go away. Tell your healthcare provider right away if you experience:

  • Infusion reaction symptoms: chills, flushing, headache or shortness of breath.
  • Low blood cell count symptoms: fever or bruising or bleeding
  • Infection symptoms.

What is a package insert?

A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers. A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.

Last updated on 04/21.