WARNING

Cytokine release syndrome (CRS), a potentially fatal reaction to bentafusp injection, has been reported. A doctor or nurse will keep a close eye on you throughout the infusion, for at least 16 hours following the first three infusions, and then for at least 30 minutes following each subsequent infusion. If you have an inflammatory illness or believe you may have an infection of any kind right now, let your doctor know. During and after your infusion, if you experience any of the following symptoms, call your doctor right away: fever, chills, fast or irregular heartbeat, muscle pain, shaking, diarrhea, exhaustion, weakness, difficulty breathing, shortness of breath, cough, confusion, nausea, vomiting, headache, dizziness, or lightheadedness.

Why is this medication prescribed?

When uveal melanoma (eye cancer) cannot be surgically removed or has migrated to other body parts, it may be treated with tebentafusp injection. As a CD3 T cell receptor engager, tebentafusp belongs to a group of drugs. In order to eliminate cancer cells, it activates the immune system.

How should this medicine be used?

When administered intravenously (into a vein) by a doctor or nurse in a medical setting, bentafusp injection is administered as a liquid. Usually administered once a week, it is slowly injected over a 15 to 20 minute period. Your body’s reaction to the drug and any adverse effects you experience will determine how long you need to receive therapy.

The manufacturer’s information for the patient can be obtained by asking your pharmacist or doctor.

Other uses for this medicine

Tebentafusp was primarily being investigated for the treatment of metastatic uveal melanoma. To obtain the most accurate and up-to-date information about Tebentafusp and its approved uses, it is best to consult with a healthcare professional or refer to reliable medical sources.

What special precautions should I follow?

• If you have an allergy to tebentafusp, any other medications, or any of the ingredients in tebentafusp injection, let your doctor and pharmacist know right away. Request an ingredient list from your pharmacist.
• Inform your doctor and pharmacist about any prescription and over-the-counter drugs, vitamins, or dietary supplements you are taking or intend to use. The dosage of your drugs may need to be adjusted, and your health may need to be closely watched for any negative effects.
• In case you have liver illness now or in the past, let your doctor know.
• Inform your doctor if you are expecting a baby or if you plan to do so. While having the tebentafusp injection, you shouldn’t get pregnant. Before beginning tebentafusp therapy, a pregnancy test will be required of you. While receiving treatment with the tebentafusp injection and for a week following the last dose, you should take birth control to avoid getting pregnant. Consult your doctor about the various birth control options available to you. The unborn child could suffer from tebentafusp. Call your doctor right away if you get pregnant while having tebentafusp injection.
• If you are nursing a child, let your doctor know. While having tebentafusp injection and for at least a week following your last dose, you shouldn’t breastfeed.

What special dietary instructions should I follow?

Regarding missed doses, if you forget to receive a scheduled dose of an intravenous medication like Tebentafusp, it is essential to contact your healthcare professional or the clinic administering the treatment. They will provide guidance on how to proceed, whether it involves rescheduling the missed dose or adjusting the treatment plan.

What should I do if I forget a dose?

Regarding missed doses, if you forget to receive a scheduled dose of an intravenous medication like Tebentafusp, it is essential to contact your healthcare professional or the clinic administering the treatment. They will provide guidance on how to proceed, whether it involves rescheduling the missed dose or adjusting the treatment plan.

What side effects can this medication cause?

Tebentafusp may have negative side effects. If any of these symptoms are severe or do not go away, consult your doctor right once:

• Rash
• Skin edema, itchiness, or redness
• Either skin darkening or lightening
• Changes in hair color or thinning hair
• Constipation
• Arms’ or legs’ swelling
• Reduced appetite
• Joint, back, arm, or leg pain
• Throat or mouth discomfort

There can be major negative effects. Call your doctor right away or seek emergency medical care if you have any of the following symptoms or any of those in the IMPORTANT WARNING section:

• Yellowing of the skin or eyes, or soreness or discomfort in the right upper stomach area

Other adverse effects of bentafusp could occur. If you have any strange side effects while taking this medicine, call your doctor right away.

What should I know about storage and disposal of this medication?

Storage:

• Follow the storage instructions provided with the medication or as directed by your healthcare professional.
• Store the medication at the recommended temperature and in the appropriate conditions (e.g., refrigeration or room temperature) to maintain its stability.

Disposal:

• Properly dispose of any unused Tebentafusp or medical waste as instructed by your healthcare professional or local regulations.
• Follow local guidelines for the disposal of sharps, such as needles or syringes, used during the administration of Tebentafusp.

In case of emergency/overdose

• In case of an emergency, such as a severe allergic reaction (anaphylaxis) or any other serious adverse event, immediately seek medical assistance or call emergency services.
• If you suspect an overdose of Tebentafusp or experience severe or unexpected symptoms after administration, contact your healthcare professional, a poison control center, or emergency services for guidance.

What other information should I know?

Do not miss any of your doctor’s or lab appointments. In order to monitor how your body is responding to the tebentafusp injection, your doctor may request specific lab tests.

It’s crucial that you keep a written record of every medication you take, including any vitamins, minerals, or other dietary supplements. This list should also include any over-the-counter (OTC) medications you use. When you visit a doctor or are admitted to the hospital, you should always bring this list with you. In case of crises, it is also crucial to have this information on hand.