Patient Terms and Conditions: Update effective as of May 1, 2024. Patients must have minimum out-of-pocket costs of $.01 to redeem this offer. Annual benefit maximum applies, as may other restrictions. Patients will be responsible for any out-of-pocket costs above the maximum annual program benefit. Program benefit applies to medication cost only and does not cover any costs to administer the medication. Offer with program member number is valid through December 31 of the year of issue. On January 1 of the following year, the offer automatically resets and is subject to annual limits if the prescription benefit remains the same. Patients must have commercial prescription benefit coverage. Offer is not valid if a patient is uninsured, is paying cash for the treatment, or is covered by an Alternate Funding Program (AFP). Offer is not valid if a patient is enrolled in a federal or state prescription program (including Medicare Part B, Medicare Advantage, Medicaid, TRICARE, or any state medical or pharmaceutical assistance program). Patient enrollment in a copay adjustment program, such as a maximizer or accumulator program, may impact the value of this offer. If patients move or switch from commercial prescription benefit coverage to any government prescription benefit coverage, they will no longer be eligible. This offer is not insurance. Offer is valid only for an FDA-approved or compendia-recognized use. Patients are responsible for reporting receipt of program benefits to any commercial insurer that pays for or reimburses any part of the prescriptions filled with this program to the extent required by law or by the insurer. Patients agree not to seek reimbursement from their insurer or any other third party for all or any part of the benefit received through this offer. This offer may not be sold, purchased, traded, or transferred and is void if reproduced. Use of this offer does not obligate the patient to use or continue to use MONJUVI® (tafasitamab-cxix). No other purchase and no refills are necessary. This offer is limited to one (1) per person during this offering period. Patient is responsible for all taxes. There are no membership fees associated with this program. Offer is good only in the United States and Puerto Rico and is void where prohibited or otherwise restricted by law. Incyte Corporation reserves the right to rescind, revoke, or amend this program without notice. If questions arise, please call 1-855-452-5234.
INDICATIONS AND USAGE
Diffuse Large B-cell Lymphoma
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).
Follicular Lymphoma
MONJUVI, in combination with lenalidomide and rituximab, is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL).
Limitations of Use: MONJUVI is not indicated and is not recommended for the treatment of patients with relapsed or refractory marginal zone lymphoma outside of controlled clinical trials.
IMPORTANT SAFETY INFORMATION
Contraindications:
None.
Warnings and Precautions:
Infusion-Related Reactions (IRRs). MONJUVI (tafasitamab-cxix) can cause IRRs, including fever, chills, rash, 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, lymphopenia, thrombocytopenia, and anemia. Monitor complete blood counts (CBCs) before 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. In L-MIND, 73% of the 81 patients with DLBCL who received MONJUVI developed an infection. Grade 3 or higher infection occurred in 30%. The most frequent infections of any grade were respiratory tract infections (51%, including pneumonias) and urinary tract infection (17%). Among 274 patients with FL who received MONJUVI in combination with lenalidomide and rituximab in inMIND, Grade 3 or higher infections occurred in 24%. Monitor patients for signs and symptoms of infection and manage infections as appropriate. Consider infection prophylaxis per institutional guidelines. Consider treatment with subcutaneous or intravenous immunoglobulin (IVIG) 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 3 months after the last dose. The combination of MONJUVI with lenalidomide and of MONJUVI with lenalidomide and rituximab is contraindicated in pregnant women. Refer to the lenalidomide prescribing information on use during pregnancy.
Adverse Reactions:
The most common adverse reactions (≥20%) in patients with DLBCL were neutropenia (51%), respiratory tract infection (51%), fatigue (38%), anemia (36%), diarrhea (36%), thrombocytopenia (31%), cough (26%), pyrexia (24%), peripheral edema (24%), and decreased appetite (22%).
The most common adverse reactions (≥ 20%) in patients with FL receiving MONJUVI were respiratory tract infections (56%) (including COVID-19 infection and pneumonia), diarrhea (38%), rash (37%), fatigue (34%), constipation (29%), musculoskeletal pain (24%), and cough (21%). The most common Grade 3 or 4 laboratory abnormalities (≥ 20%) were decreased neutrophils (48%) and decreased lymphocytes (22%).
Please see the Full Prescribing Information for more information about MONJUVI.
INDICATIONS AND USAGE
Diffuse Large B-cell Lymphoma
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).
Follicular Lymphoma
MONJUVI, in combination with lenalidomide and rituximab, is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL).
Limitations of Use: MONJUVI is not indicated and is not recommended for the treatment of patients with relapsed or refractory marginal zone lymphoma outside of controlled clinical trials.
IMPORTANT SAFETY INFORMATION
Contraindications:
None.
Warnings and Precautions:
Infusion-Related Reactions (IRRs). MONJUVI (tafasitamab-cxix) can cause IRRs, including fever, chills, rash, 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, lymphopenia, thrombocytopenia, and anemia. Monitor complete blood counts (CBCs) before 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. In L-MIND, 73% of the 81 patients with DLBCL who received MONJUVI developed an infection. Grade 3 or higher infection occurred in 30%. The most frequent infections of any grade were respiratory tract infections (51%, including pneumonias) and urinary tract infection (17%). Among 274 patients with FL who received MONJUVI in combination with lenalidomide and rituximab in inMIND, Grade 3 or higher infections occurred in 24%. Monitor patients for signs and symptoms of infection and manage infections as appropriate. Consider infection prophylaxis per institutional guidelines. Consider treatment with subcutaneous or intravenous immunoglobulin (IVIG) 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 3 months after the last dose. The combination of MONJUVI with lenalidomide and of MONJUVI with lenalidomide and rituximab is contraindicated in pregnant women. Refer to the lenalidomide prescribing information on use during pregnancy.
Adverse Reactions:
The most common adverse reactions (≥20%) in patients with DLBCL were neutropenia (51%), respiratory tract infection (51%), fatigue (38%), anemia (36%), diarrhea (36%), thrombocytopenia (31%), cough (26%), pyrexia (24%), peripheral edema (24%), and decreased appetite (22%).
The most common adverse reactions (≥ 20%) in patients with FL receiving MONJUVI were respiratory tract infections (56%) (including COVID-19 infection and pneumonia), diarrhea (38%), rash (37%), fatigue (34%), constipation (29%), musculoskeletal pain (24%), and cough (21%). The most common Grade 3 or 4 laboratory abnormalities (≥ 20%) were decreased neutrophils (48%) and decreased lymphocytes (22%).
Please see the Full Prescribing Information for more information about MONJUVI.