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Glossary of important terms

    A
    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
    Bispecific antibody

    Bispecific antibodies are designed to target 2 different sites on different cells or the same cell. For example, a bispecific antibody binding to 2 different cells is thought to bring the cells together, such as an immune cell and 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.

    C
    Complete remission

    Also called complete response—the disappearance of all signs of cancer in response to treatment. This does not mean the cancer has been cured.

    Cytokine release syndrome (CRS)

    A side effect when your immune system responds too strongly by rapidly releasing a large amount of substances known as cytokines. It may cause fever, nausea, or other symptoms.

    F
    Follicular lymphoma

    The most common type of indolent non-Hodgkin’s lymphoma (NHL). With NHL, abnormal lymphocytes build up in the lymph nodes, bone marrow, and spleen. FL can be a chronic disease.

    L
    Lymph nodes

    Small bean-shaped organs that store white blood cells.

    O
    Overall response

    A partial or complete remission.

    P
    Partial remission

    Also called partial response—some measurable decrease in size of the cancer.

    Phase 2 clinical trial

    The second phase of a clinical trial that studies an investigational treatment to test how well it works and monitors for potential side effects.

    R
    Refractory

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

    Relapsed

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

    Remission

    A term used to describe a response to treatment. Partial remission means the cancer is significantly improved, but evidence of the cancer remains. Complete remission means all evidence of the cancer is gone for a period of time. Overall response is a term that may be used when speaking about remission and means any partial or complete remission.

    S
    Spleen

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

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Important Safety Information & Indication

What is LUNSUMIO?

LUNSUMIO (mosunetuzumab-axgb) 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 for their cancer.

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

The conditional approval of LUNSUMIO 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?

LUNSUMIO may cause Cytokine Release Syndrome (CRS), a serious side effect that is common during treatment with LUNSUMIO 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 of LUNSUMIO on Day 15 of your first cycle of treatment  
  • If your dose of LUNSUMIO 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  

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

What are the possible side effects of LUNSUMIO?

LUNSUMIO may cause serious side effects, including:

  • Neurologic problems. Your healthcare provider will check you for neurologic problems during treatment with LUNSUMIO. 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, 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 with LUNSUMIO, 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 with LUNSUMIO. 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 with LUNSUMIO: 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 with LUNSUMIO 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.

Before receiving LUNSUMIO, 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 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
  • Females who are able to become pregnant:
    • your healthcare provider should do a pregnancy test before you start treatment with LUNSUMIO
    • you should use an effective method of birth control during your treatment and for 3 months after the last dose of LUNSUMIO
  • 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 of LUNSUMIO

Tell your health care 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?

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 the possible side effects of LUNSUMIO. Talk to your health care provider for more information about the benefits and risks of LUNSUMIO.

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.