Tebentafusp-tebn (Intravenous)

Tebentafusp-tebn injection is used to treat uveal melanoma (eye cancer) that has spread or cannot be removed by surgery in patients who are HLA-A*02:01 positive. Your doctor will do a test to check for the HLA-A*02:01 gene to ensure this medicine is suitable for you.

This medicine is to be given only by or under the direct supervision of your doctor.

It is very important that your doctor check your progress at regular visits to ensure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Receiving this medicine while you are pregnant can harm your unborn baby. If you are a woman who can bear children, your doctor may give you a pregnancy test before you start using this medicine to make sure you are not pregnant. Use an effective form of birth control to prevent getting pregnant during treatment with this medicine and for at least 1 week after the last dose. If you think you have become pregnant while receiving the medicine, tell your doctor right away.

This medicine may cause cytokine release syndrome (CRS), which can be life-threatening and requires immediate attention. Tell your doctor right away if you have fever, chills, headache, nausea, lightheadedness, dizziness, fainting, skin rash, trouble breathing, or tiredness or weakness.

This medicine may cause skin reactions. Check with your doctor right away if you have a rash, itching, or swelling of the skin.

Check with your doctor right away if you have dark urine, clay-colored stools, stomach pain, or yellow eyes or skin. These may be symptoms of a serious liver problem.

In deciding to use a medicine, you and your doctor will weigh the risks against the benefits. For this medicine, consider the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know about any other allergies you have, including to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

There have not been appropriate studies on how age affects the effects of tebentafusp-tebn injection in children. Its safety and effectiveness have not been established for this age group.

Geriatric

Studies done so far have not shown any specific problems in elderly patients that would limit the use of tebentafusp-tebn injection.

Breast Feeding

There are no adequate studies in women to determine if there is a risk to infants when using this medication while breastfeeding. Weigh the potential benefits against the potential risks before using this medicine during breastfeeding.

Interactions with Medicines

Some medicines should not be used together, while in other cases, two different medicines may be used together even if there might be an interaction. In such cases, your doctor may need to adjust the dose or take other precautions. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used around the time of eating food or certain types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also cause interactions. Discuss with your healthcare professional how to use your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical problems may affect the use of this medicine. Make sure to tell your doctor if you have any other medical issues, especially:

• Liver disease—Use with caution. May worsen this condition.

Along with its needed effects, a medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they may need medical attention.

Check with your doctor or nurse right away if any of the following side effects occur:

More common

• Blurred vision
• chills
• confusion
• diarrhea
• dizziness
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• faintness
• fast, pounding, or irregular heartbeat or pulse
• feeling of warmth
• fever
• general feeling of discomfort or illness
• headache
• muscle or joint pain
• nausea
• nervousness
• pounding in the ears
• rash, itching, or skin swelling
• redness of the face, neck, arms and occasionally, upper chest
• redness of the skin
• sweating
• unusual tiredness or weakness
• unusually warm skin
• vomiting

Rare

• Anxiety
• chest pain
• clay colored stools
• cough
• dark urine
• loss of appetite
• problems with movement, walking, or speech
• seizures
• stomach pain or tenderness
• swelling of the feet or lower legs
• trouble breathing
• yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your health care professional may also be able to tell you how to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue, are bothersome, or if you have any questions about them:

More common

• Back pain
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• constipation
• difficulty in moving
• dry skin
• joint pain or swelling
• lightening of the normal skin color
• loss or thinning of the hair
• muscle aches, cramps, pain, or stiffness
• night sweats
• pain in the arms or legs
• runny nose
• shivering
• sore throat
• trouble sleeping

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Kimmtrak

Available Dosage Forms:

• Solution

Therapeutic Class: Antineoplastic Agent

Find detailed information on biosimilars for this medication.

Medicines used to treat cancer are very strong and can have many unwanted effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.

A nurse or other trained health professional will give you this medicine in a medical facility. It is given through a needle placed into one of your veins. The medicine must be given slowly, so the needle will have to remain in place for at least 15 to 20 minutes. The injection is usually given every week.

Your doctor will check you closely for at least 16 hours after receiving the first 3 treatments and for at least 30 minutes after future treatments with this medicine.