Eye cancer:

Indications for: KIMMTRAK

Treatment of HLA-A*02:01-positive adults with unresectable or metastatic uveal melanoma.

Adult Dosage:

Confirm diagnosis based on a positive HLA-A*02:01 genotyping test. Give by IV infusion over 15–20mins. 20mcg on Day 1, 30mcg on Day 8, 68mcg on Day 15, then 68mcg once weekly thereafter. Continue until unacceptable toxicity or disease progression occur. Dose modifications for adverse reactions: see full labeling.

Children Dosage:

Not established.

Boxed Warning:

Cytokine release syndrome.

KIMMTRAK Warnings/Precautions:

Risk of life-threatening cytokine release syndrome (CRS). Withhold or discontinue therapy based on persistence and severity of CRS. Have medications and resuscitative equipment readily available. Ensure patients are euvolemic prior to initiation. Administer first 3 infusions in appropriate healthcare setting; monitor during and for at least 16hrs after infusions. If Grade ≥2 hypotension (requiring medical intervention) does not occur during or after the 3rd infusion, give subsequent doses in an ambulatory care setting; monitor for at least 30mins after each infusion. Monitor fluid status, vital signs, oxygenation levels. Monitor for skin reactions; treat with antihistamine, topical or systemic steroids if occur. Monitor ALT, AST, and total bilirubin prior to and during treatment. Embryo-fetal toxicity. Advise females of reproductive potential to use effective contraception during and for 1 week after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for at least 1 week after the last dose).

KIMMTRAK Classification:

Bispecific gp100 peptide-HLA-directed CD3 T cell engager.

Adverse Reactions:

CRS, rash, pyrexia, pruritus, fatigue, nausea, chills, abdominal pain, edema, hypotension, dry skin, headache, vomiting, lab abnormalities (decreased lymphocyte count, increased creatinine, increased glucose, increased AST/ALT, decreased hemoglobin, decreased phosphate).

Generic Drug Availability:

NO

How Supplied:

Single-dose vial—1