Mosunetuzumab

Mosunetuzumab is used to treat follicular lymphoma (a cancer of the lymphatic system) in adults whose cancer has come back or did not respond to another treatment and who have had at least two previous cancer treatments.

Mosunetuzumab may also be used for reasons not mentioned in this medication guide.

Follow all directions on your prescription label and read all medication guides or instruction sheets.

A healthcare provider will give you this medicine. Your doctor will decide how many treatment cycles you will receive of this medicine.

You may be given other medications to help reduce your risk of cytokine release syndrome (CRS). Keep taking these medicines for as long as your doctor has prescribed.

Your healthcare provider will check for CRS while you are being treated with mosunetuzumab and may treat you in a hospital if you develop signs and symptoms of CRS.

You will need frequent medical tests and your cancer treatments may be delayed or discontinued based on the results.

Mosunetuzumab can cause a serious, sometimes life-threatening reaction called cytokine release syndrome (CRS). Tell your medical caregivers if you have symptoms such as fever, chills, trouble breathing, vomiting, or severe tiredness.

Call your doctor if you have signs and symptoms of neurological problems such as headache, dizziness, tremors, problems walking, confusion and disorientation, muscle problems or weakness.

You may get infections more easily, even serious or fatal infections. Call your doctor if you have fever, chills, sore throat, body aches, unusual tiredness, loss of appetite, bruising or bleeding.

Tell your doctor if you have or have ever had:

• an infusion reaction after receiving mosunetuzumab;
• an infection or a long-lasting or recurring infection; or
• Epstein-Barr Virus (mononucleosis).

May harm an unborn baby. You may need a pregnancy test before starting this treatment. Use effective birth control while using mosunetuzumab and for at least 3 months after your last dose. Tell your doctor if you become pregnant.

Do not breastfeed while using mosunetuzumab, and for at least 3 months after your last dose.

Get emergency medical help if you have signs of an allergic reaction: hives, difficulty breathing, swelling of your face, lips, tongue, or throat.

Tell your medical caregivers if you have signs of cytokine release syndrome (CRS), a serious side effect: fever, chills, trouble breathing, confusion, severe vomiting or diarrhea, fast or irregular heartbeats, feeling light-headed or very tired.

Mosunetuzumab may cause serious side effects. Call your doctor at once if you have:

• signs and symptoms of nervous system disorders--headache; numbness or tingling in arms, legs, hands, or feet; dizziness, confusion, or disorientation; problems with balance, coordination, or muscle movement; sleepiness or sleeping problems; amnesia or forgetfulness; trouble speaking, writing, or reading; or seizures;
• low blood cell counts--mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed;
• liver problems--loss of appetite, nausea, vomiting, stomach pain (upper right side), itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• signs or symptoms of tumor related problems--chest pain, cough, breathing problems, tender or swollen lymph nodes, pain or swelling at tumor site; or
• signs of infection--fever, chills, sore throat, body aches, unusual tiredness.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common side effects of mosunetuzumab may include:

• pain, bruising, swelling, or irritation where the medicine was injected;
• abnormal lab results;
• diarrhea;
• COVID-19 Infection;
• fever, tiredness;
• rash, itching;
• headache, muscle and joint pain;
• cough; or
• numbness, tingling, or pain in your hands or feet.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Usual Adult Dose for Follicular Lymphoma:

Cycle oneDay 1: IV infusion of 1mg once over at least 4 hoursDay 8: IV infusion of 2mg once over at least 4 hoursDay 15: IV infusion of 60mg once over at least 4 hoursCycle twoDay 1: IV infusion of 60mg once over at least 2 hours if infusions from Cycle 1 were well-toleratedCycle three onwardsDay 1: IV infusion of 30mg once over at least 2 hours if infusions from Cycle 1 were well-toleratedDuration of therapy: Treatment duration based on complete or partial response unless unacceptable toxicity or disease progression occurs:-Patients with complete response: 8 cycles -Patients with partial response: 17 cycles total (8 initial cycles + 9 more cycles)Comments:-Premedicate before each dose during Cycle 1 and Cycle 2; ensure adequate hydration prior to administering this drug.-Do not use an in-line filter to administer this drug.-Patients who achieved a partial response or stable disease after 8 cycles of treatment with this drug are eligible for an additional 9 cycles of treatment (17 cycles total) unless they experience unacceptable toxicity or disease progression.-Refer to the manufacturer's prescribing information for premedication and recommendations for restarting therapy with this drug after a dose delay.Use: For the treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy

Call your doctor for instructions if you miss an appointment to receive Lunsumio.

In a medical setting, an overdose would be treated quickly.

Avoid driving or doing anything dangerous until you understand how mosunetuzumab will affect you. Your reactions may be impaired.

Other drugs may affect mosunetuzumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Inform your doctor about all other medicines you are using.