Instructions for Tebentafusp-tebn

1. Name: Tebentafusp-tebn, KIMMTRAK, IMCgp100

2. Indications:

Tebentafusp-tebn is indicated for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma.

3. Usage and dosage:

1. Recommended dose: The recommended dose of intravenous tebenforsi solution is 20 micrograms on the first day; 30 micrograms on the 8th day; 68 micrograms on the 15th day; thereafter, 68 micrograms once a week, and the patient is treated until unacceptable toxicity or disease progression occurs.

Inject the first three doses of tebenforx solution by intravenous infusion over 15-20 minutes in an appropriate medical setting, monitor the patient during the infusion and for at least 16 hours after completion;If the patient does not develop Grade 2 or worse hypotension (requiring medical intervention) during or after the third infusion, administer subsequent doses in an appropriate outpatient care setting and monitor the patient for at least 30 minutes after each infusion.

2. Dose adjustment: It is not recommended to reduce the dose of tebenforsi.

4. Adverse reactions:

The most common adverse reactions (≥30%) in patients treated with tebenforx were cytokine release syndrome, rash, pyrexia, pruritus, fatigue, nausea, chills, abdominal pain, edema, hypotension, dry skin, headache, and vomiting; the most common adverse reactions (≥50%) in patients treated with tebenforx were decreased lymphocyte count, increased creatinine, increased glucose, pan>AST increases, ALT increases, hemoglobin decreases, and phosphate decreases; 28% of patients treated with tibenforx experienced serious adverse reactions, including cytokine release syndrome, rash, fever, and hypotension, and one patient (0.4%) experienced a fatal adverse reaction, pulmonary embolism.

5. Storage:

Normally store vials of Tebenforsi solution in the original carton refrigerated at2°C to 8°C (36°F to 46°F) and protect from light until use; do not freeze; do not shake.

6. Special groups:

1. Women: According to the mechanism of action, pregnant women taking Tebenforsi may cause fetal harm. Women of reproductive potential should use effective contraceptive measures during treatment and within 1 week after the last dose of Tebenforsi. Patients are advised not to breastfeed during treatment with Tebenforsi and for at least 1 week after the last dose.

7. Mechanism of action:

Tebenforsi is a bispecificgp100 peptide-HLA-A*02:01 directed T cell receptor CD3 T cell engager. The TCR arm binds to the gp100 peptide presented by human leukocyte antigen-A*02:01 (HLA-A*02:01) on the cell surface of uveal melanoma tumor cells. In vitro, tibenforx binds to HLA-A*02:01-positive uveal melanoma cells and activated polyclonal T cells, releasing inflammatory cytokines and cytolytic proteins, which results in direct lysis of uveal melanoma tumor cells.

The original drug of Tibenforsi is not currently on the market in China, nor has it been included in medical insurance. After Tebenforx is approved for marketing, there may be less price and other related information. For more drug information and specific prices, please consult a medical consultant.