Tebentafusp

What is Tebentafusp?

• Tebentafusp (Kimmtrak) is a bispecific gp100 peptide-HLA-directed CD3 T cell engager used to treat unresectable or metastatic uveal melanoma.

What are the uses of this medicine?

• Tebentafusp (Kimmtrak) is a prescription medicine used to treat HLA-A*02:01-positive adults with uveal melanoma that cannot be removed by surgery or has spread.
• Your doctor will test you for a presence of HLA-A*02:01 gene to make sure Kimmtrak is right for you.

How does this medicine work?

• A fusion protein containing a modified form of human T-cell receptor (TCR) specific for the gp100 antigen and fused to an anti-CD3 single-chain antibody fragment, with potential antineoplastic activity.
• Upon direct intratumoral administration of tebentafusp into the melanoma lesion, the TCR moiety of this agent targets and binds to the tumor associated antigen (TAA) gp100 presented on the melanoma tumor cell; the anti-CD3 fragment moiety binds to CD3- expressing T lymphocytes, thereby selectively cross-linking tumor cells and T-lymphocytes.
• This may lead to the recruitment of cytotoxic T lymphocytes (CTL) to the T lymphocyte/tumor cell aggregates and result in CTL-mediated death of gp100-expressing melanoma cancer cells.

Who Should Not Use this medicine ?

• This medicine have no usage limitations.

What drug interactions can this medicine cause?

• No formal drug interaction studies have been conducted.

Is this medicine FDA approved?

• It was approved for medical use in the United States in January 2022.

How should this medicine be used?

• Select patients for treatment of unresectable or metastatic uveal melanoma with Kimmtrak based on a positive HLA-A*02:01 genotyping test.

Recommended dosage: The recommended dosage of Kimmtrak administered intravenously is:

• 20 mcg on Day 1
• 30 mcg on Day 8
• 68 mcg on Day 15
• 68 mcg once every week thereafter
• Treat patients until unacceptable toxicity or disease progression occur.

Administration:

• Kimmtrak will be given to you by intravenous (IV) infusion into your vein for 15 to 20 minutes.
• Kimmtrak is usually given every week.
• Your healthcare provider will decide how many treatments you need.
• Your healthcare provider will keep you under observation for at least 16 hours following the first three Kimmtrak treatments and for at least 30 minutes after future treatments.
• Your healthcare provider may delay your treatment of Kimmtrak if you have certain side effects.
• Your healthcare provider may do blood tests regularly during treatment with Kimmtrak.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Injection: 100 mcg/0.5 mL solution in a single-dose vial.

This medicine is available in fallowing brand namesː

• Kimmtrak

What side effects can this medication cause?

The most common side effects of this medicine include:

• cytokine release syndrome (CRS)
• rash
• fever
• itching
• tiredness
• nausea
• chills
• stomach pain
• swelling
• low blood pressure (symptoms may include dizziness or light headedness)
• dry skin
• headache
• vomiting
• abnormal liver blood tests

Kimmtrak can cause serious side effects, including:

• Cytokine Release Syndrome (CRS)
• Skin reactions
• Abnormal liver blood tests

What special precautions should I follow?

• Cytokine release syndrome (CRS), which may be life threatening, occurred in patients receiving Kimmtrak. Ensure that healthcare providers administering Kimmtrak have immediate access to medications and resuscitative equipment to manage CRS. Ensure patients are euvolemic prior to initiating the infusions. Closely monitor patients for signs or symptoms of CRS following infusions of Kimmtrak.
• Skin reactions, including rash, pruritus, and cutaneous edema occurred in patients treated with Kimmtrak. If skin reactions occur, treat based on persistence and severity of symptoms.
• Increases in alanine aminotransferase or aspartate aminotransferase were observed in 65% of patients treated with Kimmtrak. Monitor ALT, AST, and total bilirubin.
• Based on the mechanism of action, Kimmtrak may cause fetal harm when administered to a pregnant woman. Advise patients of reproductive potential of the potential risk to the fetus and to use effective contraception.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• Based on the mechanism of action, Kimmtrak may cause fetal harm when administered to a pregnant woman.
• There are no available data with Kimmtrak in pregnant woman.

Can this medicine be used in children?

• Safety and efficacy of Kimmtrak have not been established in pediatric patients.

What are the active and inactive ingredients in this medicine?

• Active ingredient: tebentafusp
• Inactive ingredients: citric acid monohydrate, di-sodium hydrogen phosphate, mannitol, polysorbate 20, trehalose, and Water for injection.

Who manufactures and distributes this medicine?

Manufactured by:

• Immunocore Limited
• 92 Park Drive, Milton Park
• Abingdon, Oxfordshire
• United Kingdom, OX144RY

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

• Store Kimmtrak vials in the original carton refrigerated at 2°C to 8°C (36°F to 46°F) and protect from light until time of use.
• Do not freeze.
• Do not shake.

• Dailymed label info on Tebentafusp
• FDA Tebentafusp

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