Remember that your healthcare team is the single best source of medical advice regarding your health. Please consult your healthcare team if you have any questions about your treatment.
MONJUVI is not chemotherapy, which makes it different from some of the other DLBCL treatments you may have taken or read about.
MONJUVI is targeted immunotherapy, which means it helps the immune system find and kill cancerous cells. Because of the way MONJUVI works with your immune system, treatment is given on a long-term basis to help you achieve and maintain control of your disease.
B cells are part of a person's immune system. They help your body fight infection. In DLBCL, B cells grow out of control, both in size and number. MONJUVI targets cancerous B cells directly and activates your immune system to fight relapsed or refractory DLBCL. MONJUVI can also affect healthy cells.
The combination of MONJUVI and lenalidomide was studied in 71 people whose DLBCL came back, got worse, or didn’t respond to treatment and who could not receive a stem cell transplant. They received this treatment for up to 12 cycles. Then they were given MONJUVI alone.
Please consult your healthcare team if you have any questions about this study information. Remember, your healthcare team is the single best source of medical advice regarding your treatment.
In the first analysis,* 55% of people (39 out of 71) reached either complete or partial remission.
37% of people reached complete remission, the disappearance of all signs of cancer in response to treatment. This does not always mean the cancer has been cured
18% of people reached partial remission, a decrease (usually at least 50% in DLBCL) in the size of a tumor, or in the extent of cancer in the body, in response to treatment
*People in this study had several follow-up visits with their doctor to see how their treatment was going. Results from these visits were measured at two points in time: 12 months (first analysis) and 35 months (later analysis) after the last patient started treatment.
MONJUVI is outpatient treatment. You can receive MONJUVI in a nearby clinic or infusion center. This means you can choose to stay with your current healthcare team and begin treatment as soon as you’re ready.
MONJUVI is given along with lenalidomide, a once-daily oral capsule, throughout the first year of treatment. Lenalidomide is another kind of medicine that helps the immune system respond to cancer. Taking MONJUVI and lenalidomide together may help treat your relapsed or refractory DLBCL.
Each treatment cycle of MONJUVI lasts for 28 days.
You will receive MONJUVI on days 1, 4, 8, 15, and 22 during your first cycle.
You will receive MONJUVI on days 1, 8, 15, and 22 during your second and third cycles.
After your first 3 cycles, you will receive MONJUVI once every 2 weeks, on days 1 and 15.
After 12 cycles, you will receive only MONJUVI as maintenance therapy on days 1 and 15 of each cycle.
Your doctor will also prescribe a 25-mg lenalidomide capsule for you to take on days 1 to 21 of each treatment cycle, for the first 12 cycles. Starting MONJUVI
Because of the way MONJUVI works with your immune system, treatment is given on a long-term basis to help you achieve and maintain control of your disease.
Treatment may continue for as long as you and your healthcare team choose, or until your disease progresses. Your healthcare team will monitor and may adjust your dose of lenalidomide as needed throughout your treatment.
Starting MONJUVIYour first infusion of MONJUVI takes 1 ½ to 2 ½ hours from start to finish. Nurses and other healthcare professionals will be available to help you during your treatment. After that, the infusion time will be between 90 minutes and 2 hours.
Your healthcare team may need to delay or completely stop treatment with MONJUVI if you have severe side effects.
Your doctor will also prescribe a 25-mg lenalidomide capsule for you to take orally once a day on days 1 to 21 of each treatment cycle, for the first 12 cycles.
Your healthcare provider will give you medicines before each infusion to decrease your chance of infusion reactions. If you do not have any reactions, your healthcare provider may decide that you do not need these medicines with later infusions. It is important to take these medicines as directed by your healthcare team.
MONJUVI may cause serious side effects, including
Infusion reactions. Your healthcare provider will monitor you for infusion reactions during your infusion of MONJUVI. Tell your healthcare provider right away if you get fever, chills, flushing, headache, or shortness of breath during an infusion of MONJUVI.
Low blood cell counts (platelets, red blood cells, and white blood cells). Low blood cell counts are common with MONJUVI, but can also be serious or severe. Your healthcare provider will monitor your blood counts during treatment with MONJUVI. Tell your healthcare provider right away if you get a fever of 100.4 °F (38 °C) or above, or any bruising or bleeding.
Infections. Serious infections, including infections that can cause death, have happened in people during treatment with MONJUVI and after the last dose. Tell your healthcare provider right away if you get a fever of 100.4 °F (38 °C) or above, or develop any signs or symptoms of an infection.
The most common side effects of MONJUVI include
feeling tired or weak
diarrhea
cough
fever
swelling of lower legs or hands
respiratory tract infection
decreased appetite
These are not all the possible side effects of MONJUVI.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
IncyteCARES for MONJUVI is a patient support program that can help you:
Find financial assistance if you are eligible
Work with your healthcare provider to help you get started on your prescribed treatment
Incyte provides a savings program to help cover your out-of-pocket costs for MONJUVI. If you have commercial insurance, you may be eligible. Other terms and conditions apply. Learn More at IncyteCARES.com/MONJUVI