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:

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.