Lunsumio is a prescription medicine used to treat adults with follicular lymphoma, a cancer of the lymphatic system in which B lymphocytes (B cells) become cancerous and accumulate in 'follicles' in the lymph nodes. It the most common slow-growing form of non-Hodgkin’s lymphoma.

Lunsumio contains mosunetuzumab, a first-in-class bispecific antibody that targets CD20 on the surface of B cells and CD3 on the surface of T cells. It works by activating and redirecting the T cells to engage and eliminate the target B cells.

What is Lunsumio used to treat?

Lunsumio is used to treat adults with follicular lymphoma whose cancer has come back (relapsed) or did not respond to previous treatment (refractory), and who have already received two or more treatments for their cancer.

It is not known if this medicine is safe and effective in children.

Lunsumio may cause Cytokine Release Syndrome (CRS), a serious side effect that is common during treatment, and can also be severe or life-threatening. Get medical help right away if you develop any signs or symptoms of CRS at any time, including:

• fever of 100.4°F (38°C) or higher
• chills
• low blood pressure
• fast or irregular heartbeat
• tiredness or weakness
• difficulty breathing
• headache
• confusion
• feeling anxious
• dizziness or light-headedness
• nausea
• vomiting

Due to the risk of CRS, you will receive Lunsumio on a "step-up dosing schedule".

• The step-up dosing schedule is when you receive smaller “step-up” doses of Lunsumio on Day 1 and Day 8 of your first cycle of treatment.
• You will receive a higher dose on Day 15 of your first cycle of treatment.
• If your dose is delayed for any reason, you may need to repeat the "step-up dosing schedule."
• Before each dose in Cycle 1 and Cycle 2, you will receive medicines to help reduce your risk of CRS.
• See How will I receive Lunsumio? for more information.

Your healthcare provider will check you for CRS during treatment, and may treat you in a hospital if you develop signs and symptoms of CRS. Your healthcare provider may temporarily stop or completely stop your treatment if you have severe side effects.

See Lunsumio side effects for more information about side effects.

• Lunsumio will be given to you by your healthcare provider by infusion through a needle placed in a vein (intravenous infusion).
• After you complete the weekly "step-up dosing schedule" in Cycle 1, Lunsumio is given every 21 days.
• After Cycle 1 and Cycle 2, your healthcare provider will decide if you need to continue to take other medicines to help reduce side effects from Lunsumio during future cycles.
• Your healthcare provider will decide how many treatment cycles you will receive.

See Important information for more information about how you will receive Lunsumio.

Usual Adult Dose for Follicular Lymphoma 

A treatment cycle is 21 days. 

Comment: Premedicate to reduce risk of cytokine release syndrome and infusion-related reactions. Administer only as an intravenous infusion. Administer for 8 cycles, unless patients experience unacceptable toxicity or disease progression. 

Use: treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.
This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Before you start treatment, tell your healthcare provider about all of your medical conditions, including if you:

• have ever had an infusion reaction after receiving Lunsumio.
• have an infection or have had an infection in the past which lasted a long time or keeps coming back.
• have or had Epstein-Barr Virus.
• are pregnant or plan to become pregnant. Lunsumio may harm your unborn baby. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment.
  Females who are able to become pregnant:
  • your healthcare provider should do a pregnancy test before you start treatment.
  • you should use an effective method of birth control during your treatment and for 3 months after the last dose.
• are breastfeeding or plan to breastfeed. It is not known if Lunsumio passes into your breast milk. Do not breastfeed during treatment and for 3 months after the last dose.

Do not drive, operate heavy machinery, or do other dangerous activities if you develop dizziness, confusion, tremors, sleepiness, or any other symptoms that impair consciousness until your signs and symptoms go away. These may be signs and symptoms of CRS or neurologic problems.

See Important information and Lunsumio side effects for more information about signs and symptoms of CRS and neurologic problems.

Lunsumio may cause serious side effects, including:

See Important information

• Neurologic problems. Your healthcare provider will check you for neurologic problems during treatment. Your healthcare provider may also refer you to a healthcare provider who specializes in neurologic problems. Tell your healthcare provider right away if you develop any signs or symptoms of neurologic problems during or after treatment, including:
  • headache
  • numbness and tingling of the arms, legs, hands, or feet
  • dizziness
  • confusion and disorientation
  • difficulty paying attention or understanding things
  • forgetting things or forgetting who or where you are
  • trouble speaking, reading, or writing
  • sleepiness or trouble sleeping
  • tremors
  • loss of consciousness
  • seizures
  • muscle problems or muscle weakness
  • loss of balance or trouble walking
• Serious infections. Lunsumio can cause serious infections that may lead to death. Your healthcare provider will check you for signs and symptoms of infection before and during treatment. Tell your healthcare provider right away if you develop any signs or symptoms of infection during treatment, including:
  • fever of 100.4°F (38°C) or higher
  • cough
  • chest pain
  • tiredness
  • shortness of breath
  • painful rash
  • sore throat
  • pain during urination
  • feeling weak or generally unwell
• Low blood cell counts. Low blood cell counts are common during treatment with Lunsumio and can also be severe.
  
  Your healthcare provider will check your blood cell counts during treatment. Lunsumio may cause the following low blood cell counts:
  • low white blood cell counts (neutropenia). Low white blood cells can increase your risk for infection.
  • low red blood cell counts (anemia). Low red blood cells can cause tiredness and shortness of breath.
  • low platelet counts (thrombocytopenia). Low platelet counts can cause bruising or bleeding problems.
  • Growth in your tumor or worsening of tumor related problems (Tumor flare). Lunsumio may cause serious or severe worsening of your tumor.

Tell your healthcare provider if you develop any of these signs or symptoms of tumor flare during your treatment: tender or swollen lymph nodes, chest pain, cough, trouble breathing, and pain or swelling at the site of the tumor.

Your healthcare provider may temporarily stop or permanently stop treatment if you develop severe side effects.

The most common side effects of Lunsumio include tiredness, rash, fever, and headache.

The most common severe abnormal lab test results with Lunsumio include decreased phosphate, increased glucose, and increased uric acid levels.

These are not all the possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.