What is KIMMTRAK used for?

1 INDICATIONS AND USAGE KIMMTRAK is indicated for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma. KIMMTRAK is a bispecific gp100 peptide-HLA-directed CD3 T cell engager indicated for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma ( 1 , 2.1 ).

How does KIMMTRAK work?

11 DESCRIPTION Tebentafusp-tebn is a bispecific gp100 peptide-HLA-directed T cell receptor CD3 T cell engager.

What pharmaceutical form is KIMMTRAK available in?

KIMMTRAK: Koncentrat do sporządzania roztworu do infuzji 100 mcg/0,5 ml (dożylna)

Is KIMMTRAK OTC or prescription only?

KIMMTRAK requires a doctor's prescription.

What are the side effects of KIMMTRAK?

6 ADVERSE REACTIONS The following serious adverse reactions are discussed in greater detail in other sections of the label: Cytokine Release Syndrome [ see Boxed Warning , Warnings and Precautions (5.1) ] Skin Reactions [ see Warnings and Precautions (5.2) ] Elevated Liver Enzymes [ see Warnings and Precautions (5.3) ] The most common adverse reactions (occurring in ≥ 30%) are cytokine release syndrome, rash, pyrexia, pruritus, fatigue, nausea, chills, abdominal pain, edema, hypotension, dry ski

Who should NOT take KIMMTRAK?

4 CONTRAINDICATIONS None. None ( 4 ).

Can KIMMTRAK be used during pregnancy?

8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Risk Summary Based on the mechanism of action, KIMMTRAK may cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1) ] . There are no available data with KIMMTRAK in pregnant woman. No animal reproductive and developmental toxicity studies have been conducted with KIMMTRAK. Molecules of similar molecular weight can cross the placenta resulting in fetal exposure. Advise women of the potential risk to the

Who manufactures KIMMTRAK?

Immunocore Ireland Ltd. (Holandia)

What ATC class does KIMMTRAK belong to?

KIMMTRAK: ATC L01XX75. ATC is the WHO Anatomical Therapeutic Chemical classification — it groups drugs by organ system and pharmacological mechanism.

KIMMTRAK

100 mcg/0,5 ml, Koncentrat do sporządzania roztworu do infuzji

INN: Tebentafuspum

Data updated: 2026-04-13

Available in:

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Form

Koncentrat do sporządzania roztworu do infuzji

Dosage

100 mcg/0,5 ml

Route

dożylna

Storage

—

About This Product

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