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.

Your healthcare provider will test you for a presence of HLA-A*02:01 gene to make sure Kimmtrak is right for you. It is not known if this medicine is safe and effective in children.

Kimmtrak can cause serious side effects that can be severe or, life threatening, and usually happens within the first three infusions. These side effects include:

• Cytokine Release Syndrome (CRS). Tell your healthcare provider right away if you get any of the following symptoms:
  • fever
  • tiredness or weakness
  • vomiting
  • chills
  • nausea
  • low blood pressure
  • dizziness and light headedness
  • headache
  • wheezing and trouble breathing
  • rash

Your healthcare provider will check for these problems during treatment. Your healthcare provider may temporarily stop or completely stop your treatment if you have severe side effects.

See Kimmtrak side effects for more information about side effects.

• Kimmtrak will be given to you by intravenous (IV) infusion into your vein for 15 to 20 minutes.
• Kimmtrak is usually given every week.
• Your healthcare provider will decide how many treatments you need.
• Your healthcare provider will keep you under observation for at least 16 hours following the first three treatments and for at least 30 minutes after future treatments.
• Your healthcare provider may delay your treatment if you have certain side effects.
• Your healthcare provider may do blood tests regularly during treatment.

Usual Adult Dose for Uveal Melanoma

- 20 mcg intravenously on Day 1, 30 mcg intravenously on Day 8, 68 mcg intravenously on Day 15, and 68 mcg intravenously once every week thereafter. 

- Use: treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma.

Before you receive 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.

For females who are able to become pregnant:

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

Kimmtrak can cause serious side effects, including:

• See Important information.
• 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. 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 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 possible side effects. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA1088.

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