About MONJUVI

Follicular lymphoma (FL) is a type of cancer that affects the lymph nodes, bone marrow, and other organs. It is incurable and tends to grow more slowly than other types of cancer. Relapse is a common part of the FL journey and may result in patients having to experience multiple treatments.

About MONJUVI

MONJUVI is not chemotherapy. MONJUVI is targeted immunotherapy, which means it works with your immune system to help find and kill cancer cells.

About MONJUVI

B cells are part of a person’s immune system. They help your body fight infection. In FL, B cells grow out of control, both in size and number. MONJUVI targets cancerous B cells directly and activates your immune system to fight FL. MONJUVI can also affect healthy B cells.

About MONJUVI

MONJUVI was studied in 548 adults whose FL returned, got worse, or didn’t respond to treatment. There were 2 different treatment groups in the study, and both groups received treatment for up to 12 months.

  • Group 1: 273 people received MONJUVI in combination with rituximab and lenalidomide
  • Group 2: 275 people received placebo in combination with rituximab and lenalidomide

A placebo is a substance with no active ingredient. How your condition progresses and how you may respond to MONJUVI depends on your individual circumstances.

About MONJUVI

After a 14.1-month median follow-up in the clinical study, MONJUVI + rituximab and lenalidomide lowered the risk of disease progression or death by 57% compared to placebo + rituximab and lenalidomide.

The median progression-free survival (PFS) was 22 months in the group of people who received MONJUVI in combination with rituximab and lenalidomide compared to 14 months in the placebo group.

Median PFS is defined as the length of time after the start of study treatment in which half of the people in a treatment group were alive without their disease getting worse (disease progression).

A total of 84% of people (228/273) reached remission* in the MONJUVI group vs 72% of people (199/275) who reached remission* in the placebo group.

*People reached either complete or partial remission.

Complete remission: the disappearance of all signs of cancer in response to treatment. This does not always mean the cancer has been cured.

Partial remission: a decrease (usually at least 50% in FL) in the size of a tumor, or in the extent of cancer in the body, in response to treatment.

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What to expect with MONJUVI

Your 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 your initial infusion, all subsequent MONJUVI infusions will typically take between 1 ½ and 2 hours.

Your healthcare team may need to delay or completely stop treatment with MONJUVI if you have severe side effects. They 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.

Your MONJUVI Journey

MONJUVI is an outpatient treatment which means you can receive treatment in a nearby clinic or infusion center. You can choose to stay with your current healthcare team and begin treatment as soon as you’re ready.

Your MONJUVI Journey

MONJUVI is given for up to 12 cycles. Each cycle lasts for 28 days.

  • Cycles 1 to 3: 1 infusion every week
  • Cycles 4 to 12: 1 infusion every 2 weeks

MONJUVI is given in combination with rituximab and lenalidomide throughout treatment.

Your healthcare provider will decide how many treatments you need. If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment.

Your MONJUVI Journey

The most common side effects of MONJUVI when given with lenalidomide and rituximab in people with FL include:

  • Respiratory tract infections
  • Diarrhea
  • Rash
  • Feeling tired or weak
  • Muscle and bone pain
  • Constipation
  • Cough

Tell your healthcare team right away if you get:

  • Fevers, chills, rash, flushing, headache, or shortness of breath during an infusion of MONJUVI
  • A fever of 100.4 °F (38 °C) or above, or any bruising or bleeding
  • A fever of 100.4 °F (38 °C) or above, or develop any signs or symptoms of an infection

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 the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Incyte Medical Information at 1-855-463-3463.

In the clinical study, people received study treatment for up to 12 months. Time to next treatment was defined as the time from the start of study treatment to the start of a different, or “next,” treatment for FL for any reason.

For people who received MONJUVI + rituximab and lenalidomide, there was a 78% chance of not starting a different FL treatment at 2 years after the start of study treatment.

In the placebo + rituximab and lenalidomide group, there was a 57% chance of not starting a different FL treatment at 2 years after the start of study treatment.

For people in the study, the decision to start a next treatment was based on their doctor’s clinical judgment. The data described above are not conclusive and should be interpreted with caution. Talk to your doctor if you have any questions.

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Support for MONJUVI

Talking to your healthcare team about different treatment options is an important next step for your journey. It may feel overwhelming to try something new. Thinking through your priorities ahead of time can help you feel more prepared.

A few key questions may be:

  • How is this treatment different from what I’ve tried before?
  • Can I receive treatment from my current healthcare team? Is it given on an outpatient basis?
  • How much logistical and caregiver support might I need if I have to travel for treatment?
  • What side effects might I experience?

Treatment Considerations

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