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Side Effects

Possible Side Effects With COLUMVI®

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Cytokine Release Syndrome (CRS)
Other Possible Side Effects

Cytokine release syndrome

COLUMVI can cause cytokine release syndrome (CRS), a serious side effect that is common during treatment with COLUMVI, and can also be serious and lead to death.

Call or see your healthcare provider or get emergency help right away if you experience symptoms of CRS.

Symptoms of CRS may include:

  • Fever of 100.4ºF (38ºC) or higher
  • Chills or shaking
  • Fast or irregular heartbeat
  • Dizziness or light-headedness
  • Trouble breathing
  • Shortness of breath

Helping to reduce the risk of CRS

Your healthcare provider will have you take medicines before each dose of COLUMVI to help reduce the risk of CRS and infusion-related reactions.

Common premedications include: acetaminophen, antihistamines, and steroid medications.

To help reduce the risk of CRS, your first 2 doses of COLUMVI are given as 2 smaller doses called “step-up” doses.

During and for 24 hours after receiving the first step-up dose, you will be hospitalized to be monitored for symptoms of CRS. Your healthcare provider may need to hospitalize you during and for 24 hours after receiving the second step-up dose if you experienced CRS during the first step-up dose. For subsequent infusions, your healthcare provider may need to hospitalize you during and for 24 hours after receiving your next dose of COLUMVI if you had more than mild CRS with your previous dose.

The majority of CRS events occurred early in treatment (Cycles 1 and 2). CRS occurred in 102 of 145 patients and resolved in all patients except 2.

Other possible side effects

COLUMVI may cause serious side effects, including:

  • Cytokine release syndrome
  • Neurologic problems
  • Serious infections
  • Growth in your tumor or worsening of tumor-related problems (tumor flare)

The most common side effects of COLUMVI include: CRS, muscle and bone pain, rash, and tiredness. These are not all the possible side effects of COLUMVI. Call your healthcare provider for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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Important Safety Information & Indication

What is COLUMVI?

COLUMVI (glofitamab-gxbm) is a prescription medicine to treat adults with certain types of diffuse large B-cell lymphoma (DLBCL) or large B-cell lymphoma (LBCL) that has come back (relapsed) or that did not respond to previous treatment (refractory), and who have received 2 or more prior treatments for their cancer.

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

The conditional approval of COLUMVI is based on response rate and durability of response. There are ongoing studies to establish how well the drug works.

What is the most important information I should know about COLUMVI?

COLUMVI can cause Cytokine Release Syndrome (CRS), a serious side effect that is common during treatment with COLUMVI, and can also be serious and lead to death.

Call your healthcare provider or get emergency medical help right away if you develop any signs or symptoms of CRS, including:

  • fever of 100.4°F (38°C) or higher
  • chills or shaking
  • fast or irregular heartbeat
  • dizziness or light-headedness
  • trouble breathing
  • shortness of breath

Due to the risk of CRS, you will receive COLUMVI on a “step-up dosing schedule”.

  • A single dose of a medicine called obinutuzumab will be given to you on the first day of your first treatment cycle (Day 1 of Cycle 1).
  • You will start the COLUMVI step-up dosing schedule a week after the obinutuzumab dose. The step-up dosing schedule is when you receive smaller “step-up” doses of COLUMVI on Day 8 and Day 15 of Cycle 1. This is to help reduce your risk of CRS. You should be hospitalized during your infusion and for 24 hours after receiving the first step-up dose on Day 8. You should be hospitalized during your infusion and for 24 hours after receiving the second step-up dose on Day 15 if you experienced CRS during the first step-up dose.
  • You will receive your first full dose of COLUMVI a week after the second step-up dose (this will be Day 1 of Cycle 2).
  • If your dose of COLUMVI is delayed for any reason, you may need to repeat the “step-up dosing schedule”.
  • If you had more than mild CRS with your previous dose of COLUMVI, you should be hospitalized during and for 24 hours after receiving your next dose of COLUMVI.
  • Before each dose of COLUMVI, you will receive medicines to help reduce your risk of CRS and infusion-related reactions.

Your healthcare provider will monitor you for CRS during treatment with COLUMVI 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 COLUMVI if you have severe side effects.

Carry the COLUMVI Patient Wallet Card with you at all times and show it to all of your healthcare providers. The COLUMVI Patient Wallet Card lists the signs and symptoms of CRS you should get emergency medical help for right away.

What are the possible side effects of COLUMVI?

COLUMVI may cause serious side effects, including:

  • Cytokine Release Syndrome.
  • Neurologic problems. COLUMVI can cause serious neurologic problems that may lead to death. Your healthcare provider will monitor you for neurologic problems during treatment with COLUMVI. 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, including:
    • headache
    • confusion or disorientation
    • difficulty paying attention or understanding things
    • trouble speaking
    • sleepiness
    • memory problems
    • numbness, tingling, or weakness of the hands or feet
    • dizziness
    • shaking (tremors)
  • Serious Infections. COLUMVI can cause serious infections that may lead to death. Your healthcare provider will monitor you for signs and symptoms of infection and treat you as needed. Tell your health care provider right away if you develop any signs of an infection, including: fever, chills, weakness, cough, shortness of breath, or sore throat.
  • Growth in your tumor or worsening of tumor related problems (tumor flare). Tell your healthcare provider if you get any of these signs or symptoms of tumor flare:
    • tender or swollen lymph nodes
    • pain or swelling at the site of the tumor
    • chest pain
    • cough
    • trouble breathing

The most common side effects of COLUMVI include: CRS, muscle and bone pain, rash, and tiredness.

The most common severe abnormal lab test results with COLUMVI include: decreased white blood cells, decreased phosphate (an electrolyte), increased uric acid levels, and decreased fibrinogen (a protein that helps with blood clotting).

Your healthcare provider may temporarily stop or completely stop treatment with COLUMVI if you develop certain side effects.

Before receiving COLUMVI, tell your healthcare provider about all of your medical conditions, including if you:

  • have an infection
  • have kidney problems
  • are pregnant or plan to become pregnant. COLUMVI may harm your unborn baby
  • Females who are able to become pregnant:
    • Your healthcare provider should do a pregnancy test before you start treatment with COLUMVI.
    • You should use effective birth control (contraception) during treatment and for 1 month after your last dose of COLUMVI. Talk to your healthcare provider about what birth control method is right for you during this time.
    • Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with COLUMVI.
  • are breastfeeding or plan to breastfeed. COLUMVI may pass into your breast milk. Do not breastfeed during treatment and for 1 month after your last dose of COLUMVI.

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

These are not all the possible side effects of COLUMVI. Talk to your health care provider for more information about the benefits and risks of COLUMVI.

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 COLUMVI full Prescribing Information and Medication Guide.

  • Antibody

    A special protein made by the immune system (B cells) to help protect from harmful invaders like viruses or bacteria.

  • B cell

    A type of white blood cell in your immune system that helps protect your body from infection and disease.

  • Bispecific antibody

    Bispecific antibodies are designed to target 2 different cells to bring them closer together, such as an immune cell and cancer cell.

  • 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.

  • Continuous treatment

    Designed for use until disease worsens or unacceptable side effects occur.

  • Cycle

    The time between one round of treatment until the start of the next.

  • 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.

  • Diffuse large B-cell lymphoma (DLBCL)

    A type of aggressive blood cancer that affects B cells. It is the most common form of non-Hodgkin lymphoma.

  • Fixed-duration therapy

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

  • Large B-cell lymphoma (LBCL)

    The most common type of B-cell non-Hodgkin lymphoma (NHL). With NHL, abnormal lymphocytes build up in the lymph nodes, bone marrow, and spleen, DLBCL is a subtype of LBCL.

  • Overall response

    A partial or complete remission.

  • Partial remission

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

  • Phase 1/2 clinical trial

    The first 2 phases of a clinical trial program that studies an investigational treatment.

    • Phase 1 tests the safety, side effects, best dose, administration, timing of treatment, and effect of treatment on the body
    • Phase 2 tests 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.

  • Step-up dose

    A smaller dose of COLUMVI that you receive on Day 8 and Day 15 of your first cycle of treatment.

  • T cell

    A type of white blood cell. T cells are part of the immune system and protect the body from infection. They can also help recognize and destroy abnormal cells like cancer cells.

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