Pronunciation:

te-BEN-ta-fusp - tebn

Brand Names:

• Kimmtrak

Dosage Forms:

• Solution

Warnings:

Warning: Cytokine Release SyndromeCytokine Release Syndrome (CRS), which may be serious or life-threatening, occurred in patients receiving tebentafusp-tebn. Monitor for at least 16 hours following first three infusions and then as clinically indicated .

Classifications:

Therapeutic—

Antineoplastic Agent

Uses of This Medicine:

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.

Before Using This Medicine:

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.

Children—

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.

Older adults—

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

Breast-feeding—

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.

Other medicines—

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 of This Medicine:

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 While Using This Medicine:

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 of This Medicine:

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

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. 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

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.