How KIMMTRAK works

Harnessing the power of your immune system

Your immune system protects your body from foreign threats, like viruses and cancer, by activating your T cells that can fight and kill these threats. Sometimes, T cells need help knowing which threats to attack.

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KIMMTRAK is only for adults with metastatic uveal melanoma who are HLA-A*02:01 positive. KIMMTRAK attaches to the HLA-A*02:01 target found on uveal melanoma tumor cells in those who are HLA-A*02:01 positive.

This helps your body’s T cells recognize, attack, and kill difficult-to-find uveal melanoma tumor cells. Normal skin cells could also be affected.

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What is HLA-A*02:01, and why is it important in metastatic uveal melanoma (mUM)?

  • Human leukocyte antigen (HLA) is a set of genes that may help the immune system find and destroy cancer.
  • Nearly half of adults are HLA-A*02:01 positive, and your status doesn’t change over time.
  • If you’re HLA-A*02:01 positive, you may be eligible for KIMMTRAK.

If you’ve been diagnosed with metastatic
uveal melanoma (mUM), it’s time to:

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ACT NOW. Request the test.

HLA testing and why it’s important

View more informative videos
KIMMTRAK was studied in a large phase 3 clinical trial.
Up next: Why KIMMTRAK?
Indication
 
Important Safety Information Including Boxed Warning

KIMMTRAK is a prescription medicine used to treat HLA-A*02:01–positive adults with uveal melanoma that cannot be removed by surgery or has spread.

KIMMTRAK can cause serious side effects that can be severe or life threatening and usually happen within the first three infusions, including:

  • Cytokine Release Syndrome (CRS). Symptoms of CRS may include:

Indication and Important Safety Information Including Boxed Warning

Usage

KIMMTRAK is a prescription medicine used to treat HLA-A*02:01–positive adults with uveal melanoma that cannot be removed by surgery or has spread.

Important Safety Information

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

KIMMTRAK can cause serious side effects that can be severe or life threatening and usually happen within the first three infusions, including:

  • Cytokine Release Syndrome (CRS). Symptoms of CRS may include:
    • fever
    • tiredness or weakness
    • vomiting
    • chills
    • nausea
    • low blood pressure
    • dizziness and light-headedness
    • headache
    • wheezing and trouble breathing
    • rash

Tell your healthcare provider right away if you get any of these symptoms. Your healthcare provider will check for these problems during treatment with KIMMTRAK. Your healthcare provider may temporarily stop or completely stop your treatment with KIMMTRAK if you have severe side effects.

See "KIMMTRAK can cause other serious side effects" for more information.

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

  • are pregnant or plan to become pregnant. KIMMTRAK may harm your unborn baby. Tell your healthcare provider if you become pregnant during treatment with KIMMTRAK.

    For females who are able to become pregnant:

    • Your healthcare provider should do a pregnancy test before you start treatment with KIMMTRAK.
    • Use an effective form of birth control during treatment with KIMMTRAK and for at least 1 week after the last dose of KIMMTRAK.
  • are breastfeeding or plan to breastfeed. It is not known if KIMMTRAK passes into your breast milk. Do not breastfeed during the treatment with KIMMTRAK and for at least 1 week after the last dose of KIMMTRAK.

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

KIMMTRAK can cause other serious side effects, including:

  • Skin reactions. KIMMTRAK may cause skin reactions that require treatment. Tell your healthcare provider if you get symptoms of skin reactions—such as rash, itching, or skin swelling—that are severe and do not go away.
  • Abnormal liver blood tests. Your healthcare provider will do blood tests to check your liver before you start KIMMTRAK and during treatment with KIMMTRAK. Tell your healthcare provider if you get symptoms of liver problems such as right-sided abdominal pain or yellowing of the skin or eyes.

The most common side effects of KIMMTRAK include:

  • cytokine release syndrome (CRS)
  • rash
  • fever
  • itching
  • tiredness
  • nausea
  • chills
  • stomach pain
  • swelling
  • low blood pressure (symptoms may include dizziness or light-headedness)
  • dry skin
  • headache
  • vomiting
  • abnormal liver blood tests

These are not all the side effects possible with KIMMTRAK.

Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 (1-800-332-1088).

Please read the accompanying Patient Information Leaflet before you receive KIMMTRAK and discuss any questions you have with your healthcare provider.

Please see KIMMTRAK Patient Information.

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