Not actual patients or healthcare providers.
My MISSION Support Is A Robust Access and Support Services Program
for Patients Taking MONJUVI® (tafasitamab-cxix)
My MISSION Support offers educational resources and practical tools to help providers and patients navigate the treatment journey.
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).
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OK CancelThe My MISSION Support Commercial Copay Assistance Program—Terms & Conditions
To receive benefits under the Copay Assistance Program, the patient must enroll in the My MISSION Support Copay Assistance Program and be accepted as eligible.
- Patient must have private/commercial health insurance that provides coverage for the cost of MONJUVI® (tafasitamab-cxix) under a medical benefit plan.
- The Copay Assistance Program is not valid for patients covered, in whole or in part, under Medicaid (including Medicaid patients enrolled in a qualified health plan purchased through a health insurance exchange [marketplace] established by a state government or the federal government), Medicare, a Medicare Part D or Medicare Advantage plan (regardless of whether a specific prescription is covered), TRICARE, CHAMPUS, Puerto Rico Government Health Insurance Plan (“Healthcare Reform”), or any other state or federal medical or pharmaceutical benefit program or pharmaceutical assistance program (collectively, “Government Programs”).
- The Copay Assistance Program is not valid for uninsured patients.
- Patient must have an out-of-pocket cost for MONJUVI and be administered MONJUVI prior to the expiration date of the Copay Assistance Program. The benefit available under the Copay Assistance Program is valid for the patient's out-of-pocket cost for MONJUVI only. It is not valid for any other out-of-pocket costs (for example, office visit charges or medication administration charges) even if such costs are associated with the administration of MONJUVI. A claim for MONJUVI must be submitted by the provider to patient's private health insurance separately from any other services and products.
- Eligible patients will pay $0 of copay per administration of MONJUVI. The benefit available under the Copay Assistance Program is limited to the amount the patient's private health insurance company indicates on the Explanation of Benefits (EOB) that the patient is obligated to pay for MONJUVI up to an annual maximum. The maximum Copay Assistance Program benefit per patient, per calendar year (January 1 through December 31), is $25,000. Enrolled patients are responsible for all copays and any other balances not covered by the Copay Assistance Program.
- An Explanation of Benefits (EOB) from patient's private health insurance must be submitted within 180 days of the date of administration for the patient to receive any applicable copay assistance benefit; provided, however, that no EOB may be submitted more than 180 days after the expiration date of Copay Assistance Program. The EOB must reflect the patient's out-of-pocket cost for MONJUVI and submission of the claim by the patient's provider for the cost of MONJUVI.
- Patient and provider agree not to seek reimbursement for all or any part of the benefit received by the patient through the Copay Assistance Program. Patient and provider are responsible for reporting receipt of Copay Assistance Program benefits to any insurer, health plan, or other third party who pays for or reimburses any part of the medication cost paid for by the Copay Assistance Program, as may be required.
- Patient must be a resident of the United States or the Commonwealth of Puerto Rico. Product must originate and be administered to patient in the United States or the Commonwealth of Puerto Rico.
- The Copay Assistance Program may apply to patient out-of-pocket costs incurred for MONJUVI within 180 days prior to the date patient is enrolled in the Copay Assistance Program, subject to annual Program maximum and the applicable Terms and Conditions based on MONJUVI administration date. Patient or provider may contact My MISSION Support for more information.
- No other purchase is necessary.
- The Copay Assistance Program is not insurance. If your insurance status changes, you must notify My MISSION Support immediately.
- The Copay Assistance Program is void where prohibited by law, taxed, or restricted. The Copay Assistance Program is not transferable. No substitutions are permitted.
- The Copay Assistance Program benefit cannot be combined with any other Copay Assistance Program, free trial, discount, prescription savings card, or other offer.
- If acquiring MONJUVI from a Specialty Pharmacy (to be later administered in a physician office or outpatient institution), additional documentation may be required.
- MorphoSys reserves the right to rescind, revoke, or amend the Copay Assistance Program at any time without notice.
- The Copay Assistance Program is not contingent on any past or commercial sale of any MONJUVI.
- The Copay Assistance Program does not assist with inpatient hospital claims, or in any bundled payment arrangement where there is no separate patient copay for MONJUVI, and does not assist with healthcare premiums.
- These Terms and Conditions are valid for MONJUVI administered between July 31, 2020, and December 31, 2021.
