Description and Brand Names

Drug information provided by: Merative, Micromedex®

US Brand Name

  1. Kimmtrak

Descriptions


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 perform a test to check for the HLA-A*02:01 gene to make sure this medicine is right for you.

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

This product is available in the following dosage forms:

  • Solution

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of tebentafusp-tebn injection in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of tebentafusp-tebn injection in the elderly.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other Interactions

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

Other Medical Problems

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

  • Liver disease—Use with caution. May make this condition worse.

Proper Use

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.

Precautions

It is very important that your doctor check your progress at regular visits to make sure that 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 keep from 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 may 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.

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

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

More common

  1. Blurred vision
  2. chills
  3. confusion
  4. diarrhea
  5. dizziness
  6. dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  7. faintness
  8. fast, pounding, or irregular heartbeat or pulse
  9. feeling of warmth
  10. fever
  11. general feeling of discomfort or illness
  12. headache
  13. muscle or joint pain
  14. nausea
  15. nervousness
  16. pounding in the ears
  17. rash, itching, or skin swelling
  18. redness of the face, neck, arms and occasionally, upper chest
  19. redness of the skin
  20. sweating
  21. unusual tiredness or weakness
  22. unusually warm skin
  23. vomiting

Rare

  1. Anxiety
  2. chest pain
  3. clay colored stools
  4. cough
  5. dark urine
  6. loss of appetite
  7. problems with movement, walking, or speech
  8. seizures
  9. stomach pain or tenderness
  10. swelling of the feet or lower legs
  11. trouble breathing
  12. 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. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

  1. Back pain
  2. burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  3. constipation
  4. difficulty in moving
  5. dry skin
  6. joint pain or swelling
  7. lightening of the normal skin color
  8. loss or thinning of the hair
  9. muscle aches, cramps, pain, or stiffness
  10. night sweats
  11. pain in the arms or legs
  12. runny nose
  13. shivering
  14. sore throat
  15. 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.

Portions of this document last updated: Feb. 01, 2024

Original article: https://www.mayoclinic.org/ar/drugs-supplements/tebentafusp-tebn-intravenous-route/precautions/drg-20529404