What is MONJUVI?

MONJUVI (tafasitamab-cxix), in combination with lenalidomide, is indicated for the treatment of adult patients 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).

This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

MONJUVI is second-line targeted immunotherapy for adult patients with DLBCL who are ineligible for transplant.1

MONJUVI (tafasitamab-cxix) is an Fc-modified monoclonal antibody that binds to the CD19 antigen expressed on the surface of pre-B and mature B lymphocytes and in several B-cell malignancies, including DLBCL.1 Read more about how MONJUVI works.

Dosage and administration highlights1

  1. The recommended dose of MONJUVI is 12 mg/kg based on actual body weight administered as an intravenous infusion according to the dosing schedule
  2. Administer MONJUVI in combination with lenalidomide 25 mg orally on days 1 to 21 of each 28-day cycle 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
  3. Dosing schedule for MONJUVI:
    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
  4. MONJUVI should be administered by a healthcare professional with immediate access to emergency equipment and appropriate medical support to manage infusion-related reactions (IRRs)

See the dosing and administration page for information on the dosing cycle and recommended premedications, and a video on preparation and administration.

See the full Prescribing Information for additional details on dosing and administration including preparing the infusion, prophylaxis for infusion-related reactions, and dose modifications for adverse reactions.

Download the MONJUVI product information sheet for additional details on availability, distribution, dispensing pack dimensions, storage, product expiration, reconstitution and dilution.

Adverse event reporting

Contact MorphoSys US Inc. or the FDA to report an adverse event:

MorphoSys US Inc.

(844) 667-1992
MedInfo@MorphoSys.com

FDA

(800) FDA-1088
www.fda.gov/medwatch

Product complaints and US medical information inquiries

For product complaints other than adverse event reporting, and for all medical information questions, please contact
MorphoSys US Inc. at:

Phone: (844) 667-1992 Email: MedInfo@MorphoSys.com