Helpful Documents

These Documents May Be Useful When Navigating the MONJUVI^® (tafasitamab-cxix) Patient Journey

My MISSION Support Program Brochure (150 KB)

A comprehensive guide describing the services offered by My MISSION Support and how to access them

My MISSION Support Enrollment Form (100 KB)

Program offerings can be initiated with the completion of the Enrollment Form

MONJUVI Product Information and Ordering Sheet (623 KB)

MONJUVI is available through a select network of Specialty Distributors and Specialty Pharmacies.

Sample Letter of Medical Necessity (61 KB)

A patient's insurance company may request a letter of medical necessity for prescribing MONJUVI. Use this sample as a guide to develop your own response to this type of request

Medical Exceptions Guide (3 MB)

The My MISSION Support Medical Exceptions & Patient Support Services Guide provides tools and information that can help address potential medical exceptions

Sample Letter of Medical Exceptions (63 KB)

An exception request is a specific type of coverage determination asking a payer to reconsider an adverse tiering or formulary decision. Use this sample as a guide to create your own letter requesting an exception for MONJUVI

Sample Appeal Letter (63 KB)

If your claim is denied, use this sample outlining specific appeal requirements to create your own letter

MONJUVI Billing & Coding Guide (4 MB)

Utilizing appropriate codes on claim forms is required in order to obtain timely and appropriate reimbursement. Use this sample guide to provide information about relevant codes for MONJUVI, including:

Product Codes
Procedure Codes
National Drug Codes (NDCs)
Revenue codes for the physician office setting as well as the hospital outpatient setting

Sample Claim Forms:

Enroll in My MISSION Support

Important Safety Information

Contraindications

None.

Warnings and Precautions:

Infusion-Related Reactions (IRRs). MONJUVI can cause IRRs, including chills, flushing, dyspnea, and hypertension. Premedicate patients and monitor frequently during infusion. Based on the severity of the IRR, interrupt or discontinue MONJUVI and institute appropriate medical management.
Myelosuppression. MONJUVI can cause serious or severe myelosuppression, including neutropenia, thrombocytopenia, and anemia. Monitor complete blood counts (CBC) prior to administration of each treatment cycle and throughout treatment. Monitor patients with neutropenia for signs of infection. Consider granulocyte colony stimulating factor administration. Withhold MONJUVI based on the severity of the adverse reaction. Refer to the lenalidomide prescribing information for dosage modifications.
Infections. Fatal and serious infections, including opportunistic infections, occurred in patients during treatment with MONJUVI and following the last dose. 73% of the 81 patients developed an infection. The most frequent infections were respiratory tract infection, urinary tract infection, bronchitis, nasopharyngitis and pneumonia. Grade 3 or higher infection occurred (30% of 81 patients). The most frequent grade 3 or higher infection was pneumonia. Infection-related deaths were reported (2.5% of 81 patients). Monitor patients for signs and symptoms of infection and manage infections as appropriate.
Embryo-Fetal Toxicity. Based on its mechanism of action, MONJUVI may cause fetal B-cell depletion when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus and women of reproductive potential to use effective contraception during treatment with MONJUVI and for at least 3 months after the last dose. The combination of MONJUVI with lenalidomide is contraindicated in pregnant women. Refer to the lenalidomide prescribing information on use during pregnancy.

Adverse Reactions:

The most common adverse reactions (≥20%) were neutropenia, fatigue, anemia, diarrhea, thrombocytopenia, cough, pyrexia, peripheral edema, respiratory tract infection, and decreased appetite.

Indications & Usage

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).

You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to MORPHOSYS US INC. at (844) 667-1992.

Please see the full Prescribing Information for additional Important Safety Information.

Indications & Usage

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).

Expand

Important Safety Information

Contraindications

None.

Warnings and Precautions:

Infusion-Related Reactions (IRRs). MONJUVI can cause IRRs, including chills, flushing, dyspnea, and hypertension. Premedicate patients and monitor frequently during infusion. Based on the severity of the IRR, interrupt or discontinue MONJUVI and institute appropriate medical management.
Myelosuppression. MONJUVI can cause serious or severe myelosuppression, including neutropenia, thrombocytopenia, and anemia. Monitor complete blood counts (CBC) prior to administration of each treatment cycle and throughout treatment. Monitor patients with neutropenia for signs of infection. Consider granulocyte colony stimulating factor administration. Withhold MONJUVI based on the severity of the adverse reaction. Refer to the lenalidomide prescribing information for dosage modifications.
Infections. Fatal and serious infections, including opportunistic infections, occurred in patients during treatment with MONJUVI and following the last dose. 73% of the 81 patients developed an infection. The most frequent infections were respiratory tract infection, urinary tract infection, bronchitis, nasopharyngitis and pneumonia. Grade 3 or higher infection occurred (30% of 81 patients). The most frequent grade 3 or higher infection was pneumonia. Infection-related deaths were reported (2.5% of 81 patients). Monitor patients for signs and symptoms of infection and manage infections as appropriate.
Embryo-Fetal Toxicity. Based on its mechanism of action, MONJUVI may cause fetal B-cell depletion when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus and women of reproductive potential to use effective contraception during treatment with MONJUVI and for at least 3 months after the last dose. The combination of MONJUVI with lenalidomide is contraindicated in pregnant women. Refer to the lenalidomide prescribing information on use during pregnancy.

Adverse Reactions:

The most common adverse reactions (≥20%) were neutropenia, fatigue, anemia, diarrhea, thrombocytopenia, cough, pyrexia, peripheral edema, respiratory tract infection, and decreased appetite.

Indications & Usage

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).

You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to MORPHOSYS US INC. at (844) 667-1992.

Please see the full Prescribing Information for additional Important Safety Information.

Indications & Usage

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).