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Important Safety Information & Indication

What is LUNSUMIO or LUNSUMIO VELO?

LUNSUMIO (mosunetuzumab-axgb) or LUNSUMIO VELO is a prescription medicine used to treat adults with follicular lymphoma whose cancer has come back or did not respond to previous treatment, and who have already received two or more treatments.

It is not known if LUNSUMIO or LUNSUMIO VELO is safe and effective in children.

The conditional approval for this use is based on response rate. There are ongoing studies to establish how well the drug works.

What is the most important information I should know about LUNSUMIO or LUNSUMIO VELO?

LUNSUMIO or LUNSUMIO VELO can cause Cytokine Release Syndrome (CRS), a serious side effect that is common during treatment with LUNSUMIO or LUNSUMIO VELO, 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 or LUNSUMIO VELO on a “step-up dosing schedule.”

  • The step-up dosing schedule is when you receive smaller “step-up” doses before receiving higher doses of LUNSUMIO or LUNSUMIO VELO during your first cycle of treatment
  • If your dose of LUNSUMIO or LUNSUMIO VELO is delayed for any reason, you may need to repeat the “step-up dosing schedule”
  • You may receive medicines to help reduce your risk of CRS before your dose

Your healthcare provider will check you for CRS during treatment with LUNSUMIO or LUNSUMIO VELO 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 with LUNSUMIO or LUNSUMIO VELO, if you have severe side effects.

What are the possible side effects of LUNSUMIO or LUNSUMIO VELO?

LUNSUMIO or LUNSUMIO VELO can cause serious side effects, including:

  • Neurologic problems. LUNSUMIO or LUNSUMIO VELO can cause serious and life-threatening neurologic problems. Your healthcare provider will check you for neurologic problems during treatment with LUNSUMIO or LUNSUMIO VELO. 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 with LUNSUMIO or LUNSUMIO VELO, 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
    • tiredness
  • Serious infections. LUNSUMIO or LUNSUMIO VELO 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 with LUNSUMIO or LUNSUMIO VELO, 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
  • Hemophagocytic lymphohistiocytosis (HLH). LUNSUMIO or LUNSUMIO VELO can cause overactivity of the immune system, a condition called hemophagocytic lymphohistiocytosis. HLH can be life-threatening and has led to death in people treated with LUNSUMIO or LUNSUMIO VELO. Your healthcare provider will check you for HLH especially if your CRS lasts longer than expected. Signs and symptoms of HLH include:
    • fever
    • enlarged spleen
    • easy bruising
    • low blood cell counts
    • liver problems
  • Low blood cell counts. Low blood cell counts are common during treatment with LUNSUMIO or LUNSUMIO VELO and can also be serious or severe. Your healthcare provider will check your blood cell counts during treatment with LUNSUMIO or LUNSUMIO VELO. LUNSUMIO or LUNSUMIO VELO can cause the following low blood cell counts:
    • low white blood cell counts (lymphopenia [for LUNSUMIO VELO only] and 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 or LUNSUMIO VELO can 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 with LUNSUMIO or LUNSUMIO VELO:
    • chest pain
    • cough
    • trouble breathing
    • tender or swollen lymph nodes
    • pain or swelling at the site of the tumor

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

The most common side effects of LUNSUMIO include: CRS, tiredness, rash, headache, fever, muscle pain, cough, itching, and numbness, tingling, or pain in the hands or feet (nerve damage).
The most common side effects of LUNSUMIO VELO include: injection site reactions, tiredness, rash, CRS, COVID-19, muscle and joint pain, and diarrhea.
The most common severe abnormal blood test results with LUNSUMIO include: decreased phosphate, increased glucose, and increased uric acid levels.
The most common severe abnormal blood test results with LUNSUMIO VELO include: decreased white blood cell counts and increased uric acid levels.

Before receiving LUNSUMIO or LUNSUMIO VELO, 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 have had Epstein-Barr Virus
  • are pregnant or plan to become pregnant. LUNSUMIO or LUNSUMIO VELO may harm your unborn baby. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with LUNSUMIO or LUNSUMIO VELO
  • Females who are able to become pregnant:
    • your healthcare provider should do a pregnancy test before you start treatment with LUNSUMIO or LUNSUMIO VELO
    • use an effective method of birth control (contraception) during your treatment and for 3 months after the last dose of LUNSUMIO or LUNSUMIO VELO
  • are breastfeeding or plan to breastfeed. It is not known if LUNSUMIO or LUNSUMIO VELO passes into your breast milk. Do not breastfeed during treatment and for 3 months after the last dose of LUNSUMIO or LUNSUMIO VELO

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

What should I avoid while receiving LUNSUMIO or LUNSUMIO VELO?

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.

These are not all of the possible side effects of LUNSUMIO or LUNSUMIO VELO. Talk to your healthcare provider for more information about the benefits and risks of LUNSUMIO or LUNSUMIO VELO.

You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555.

Please see Important Safety Information, including Serious Side Effects, as well as the LUNSUMIO full Prescribing Information and Medication Guide and LUNSUMIO VELO full Prescribing Information and Medication Guide.

  • Antibody treatment

    A type of immunotherapy used to find and destroy specific cells within the body (for example, the cells where follicular lymphoma starts). Antibody treatment can also harm healthy cells in the body.

  • B cell

    A type of white blood cell that makes antibodies. B cells are part of the immune system and develop from stem cells in the bone marrow. FL is a type of B-cell lymphoma.

  • Bispecific antibody

    Bispecific antibodies are designed to target 2 different cells at the same time. For example, a bispecific antibody attaching to 2 different cells is thought to bring the cells together, such as an immune cell and a cancer cell.

  • Bone marrow

    The soft spongy material that fills the inside of bones. Bone marrow is the source of new blood cells, and platelets are made in the bone marrow.

  • Complete remission

    Also called “complete response,” it is the disappearance of all signs of cancer in response to treatment. This does not mean the cancer has been cured.

  • Cycle

    A period of treatment followed by a period of rest (no treatment) that is repeated on a regular schedule.

  • Cytokine

    Chemicals in your immune system that act like “messengers” and tell other cells in your immune system how to protect your body.

  • Cytokine release syndrome (CRS)

    A serious side effect that happens when your immune system responds too strongly by rapidly releasing a large amount of substances known as cytokines. CRS may cause fever, fast or irregular heartbeat, low blood pressure, chills, or difficulty breathing.

  • Fixed-duration treatment

    A treatment that is designed to be administered for a prespecified number of cycles and with a targeted completion.

  • Follicular lymphoma (FL)

    The most common type of indolent (slow-growing) non-Hodgkin lymphoma (NHL). With NHL, abnormal lymphocytes (white blood cells) build up in the lymph nodes, bone marrow, and spleen. FL develops when the body makes abnormal B lymphocytes, making it a type of B-cell lymphoma. FL can be a chronic disease.

  • Intravenous (IV) infusion

    Medicine delivered through a needle in your vein over a period of time.

  • Lymph node

    A small bean-shaped organ that stores white blood cells.

  • Non-Hodgkin lymphoma

    A type of cancer that starts in white blood cells called lymphocytes, which are part of the body's immune system. Follicular lymphoma (FL) is a type of non-Hodgkin lymphoma.

  • Overall response

    A partial or complete remission.

  • Partial remission

    Also called “partial response,” a measurable decrease of cancer in the body.

  • Phase 2 clinical trial

    A type of clinical trial that studies an investigational treatment to test how well it works and monitors for potential side effects.

  • Refractory

    A term used to describe disease that has not responded to treatment.

  • Relapsed

    A term used to describe disease that has returned after responding to previous treatment.

  • Remission

    The reduction in (partial) or disappearance of (complete) signs and symptoms of cancer in response to treatment.

  • Spleen

    An organ that is part of the lymphatic system. The spleen makes lymphocytes (white blood cells), filters blood, stores blood cells, and destroys old blood cells. It is located on the left side of the abdomen near the stomach.

  • Step-up dose

    A smaller dose of LUNSUMIO or LUNSUMIO VELO that you receive on Day 1 and Day 8 of your first cycle of treatment.

  • Subcutaneous injection

    Medicine delivered under your skin, usually in your thigh or lower stomach area.

  • T cell

    A type of white blood cell. T cells are part of the immune system, helping to protect the body from infection and may also help fight cancer. A subset, cytotoxic T cells, bind to and kill infected cells and cancer cells.