Tebentafusp is used to treat adults with a type of cancer in the eye called uveal melanoma that cannot be removed by surgery or has spread.

Your doctor will make sure you have the correct tumor type to be treated with tebentafusp.

Tebentafusp may also be used for purposes not listed in this medication guide.

Tell your medical caregivers if you have signs of cytokine release syndrome (CRS), a serious side effect: fever, chills, trouble breathing, confusion, severe vomiting or diarrhea, fast or irregular heartbeats, feeling light-headed or very tired.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Tebentafusp is injected into a vein by a healthcare provider for 15 to 20 minutes. This medicine is usually given every week.

You will be under observation for at least 16 hours following the first three treatments and for at least 30 minutes after future treatments.

Your treatment may be delayed or permanently discontinued if you have certain side effects.

You will need blood tests to check your liver function before you start tebentafusp and during treatment with this medicine.

Usual Adult Dose for Malignant Melanoma:

20 mcg IV on Day 1, 30 mcg IV on Day 8, 68 mcg IV on Day 15, and then 68 mcg IV once a week thereafter
Duration of therapy: Until unacceptable toxicity or disease progression occur

Comments:
-Patient selection should be based on a positive human leukocyte antigen-A*02:01 (HLA-A*02:01) genotyping test.
---A US FDA-approved test for the detection of HLA-A*02:01 genotyping is not currently available.

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

Tell your doctor if you have ever had:

• liver problems.

You may need to have a negative pregnancy test before starting this treatment.

May harm an unborn baby. Do not use if you are pregnant. Use effective birth control while using tebentafusp and for at least 1 week after your last dose. Tell your doctor if you become pregnant.

Do not breastfeed while using tebentafusp, and for at least 1 week after your last dose.

Call your doctor for instructions if you miss an appointment for your tebentafusp injection.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Tell your medical caregivers if you have signs of cytokine release syndrome (CRS), a serious side effect: fever, chills, trouble breathing, confusion, severe vomiting or diarrhea, fast or irregular heartbeats, feeling light-headed or very tired.

Tebentafusp may cause serious side effects. Call your doctor at once if you have:

• rash, itching, or skin swelling that will not go away; or

• symptoms of liver problems--right-sided stomach pain or jaundice (yellowing of the skin or eyes).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Common side effects of tebentafusp may include:

• fever, chills, trouble breathing, confusion, severe vomiting or diarrhea, fast or irregular heartbeats, tiredness;

• feeling dizzy or light-headed;

• nausea, stomach pain;

• rash, itching, dry skin;

• headache;

• swelling; or

• abnormal liver function tests.

Other drugs may affect tebentafusp, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.