Consumer medicine information

1. Why am I being given KIMMTRAK?

KIMMTRAK contains the active ingredient tebentafusp. KIMMTRAK is used to treat rare eye cancer called uveal melanoma.
For more information, see Section 1. Why am I being given KIMMTRAK? in the full CMI.

2. What should I know before I am given KIMMTRAK?

Do not use if you have ever had an allergic reaction to KIMMTRAK or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I am given KIMMTRAK? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with KIMMTRAK and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How will I be given KIMMTRAK?

KIMMTRAK will be given to you by a healthcare professional in a hospital or clinic through an infusion (drip) into your vein (intravenous) over 15-20 minutes.
More instructions can be found in Section 4. How will I be given KIMMTRAK? in the full CMI.

5. What should I know about being given KIMMTRAK?

6. Are there any side effects?

Very common side effects include decreased appetite, prickling, tingling or numbness in any section of the body, cough, diarrhoea, stomach pain, chills, and abnormal blood tests.
Serious side effects include symptoms of cytokine release syndrome (CRS) such as fever, dizziness, light headedness, difficulty breathing, nausea, vomiting, fatigue, muscle pain, joint pain, swelling, low blood pressure, rapid heart rate, and headache.
Other serious side effects include itchy skin, rash, severe hives, peeling or flaking skin, swelling of body and/or skin around the eyes.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

Boxed Warnings

Cytokine release syndrome. Cytokine release syndrome (CRS), which may be serious or life-threatening, can occur in patients receiving tebentafusp. Only administer in an appropriate setting. Monitor for at least 16 hours following each of the first three infusions, and then as clinically indicated.

1 Name of Medicine

Tebentafusp.

2 Qualitative and Quantitative Composition

Each vial contains 0.1 milligrams of tebentafusp in 0.5 mL of concentrated solution for infusion.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Concentrated solution for infusion.
Sterile, preservative-free, clear, colourless to slightly yellowish solution in a single-dose vial.

4 Clinical Particulars

4.9 Overdose

There is no information on overdose with tebentafusp. In case of overdose, patients should be closely monitored for signs or symptoms of adverse reactions and appropriate symptomatic treatment should be instituted immediately.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. No genotoxicity studies have been conducted with tebentafusp.
Carcinogenicity. No carcinogenicity studies have been conducted with tebentafusp.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical structure. Tebentafusp is a bispecific gp100-targeted T cell receptor fusion protein with an approximate molecular weight of 77 kDa. Tebentafusp is produced by recombinant DNA technology in Escherichia coli cells.
CAS number. 1874157-95-5.

7 Medicine Schedule (Poisons Standard)

Schedule 4 - Prescription Only Medicine.

Summary Table of Changes

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