Tevimbra Application Scope

Tevimbra (tislelizumab-jsgr) is an FDA-approved anti-PD-1 monoclonal antibody immunotherapy used to treat adults with unresectable or metastatic esophageal squamous cell carcinoma (ESCC), either in combination with chemotherapy or as a single agent after prior systemic chemotherapy.

tevimbra

Characteristics

Ingredients:
- Tislelizumab-jsgr

Properties:
- Tevimbra is a humanized IgG4 monoclonal antibody that binds to the PD-1 receptor, blocking its interaction with PD-L1 and PD-L2.
- This action releases PD-1 pathway-mediated inhibition of the immune response, enhancing T-cell activity against tumors
Packaging Specification: Supplied as a 100 mg/10 mL (10 mg/mL) solution in a single-dose vial

Storage:
- Unopened Vials: Store refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not freeze or shake
- Diluted Solution: If not used immediately, store at room temperature (20°C to 25°C) for up to 4 hours or under refrigeration (2°C to 8°C) for up to 20 hours. Discard after these time frames. Do not freeze
Expiry Date: Refer to the packaging for the specific expiration date
Executive Standard: Approved under FDA Biologics License Application (BLA) standards
Approval Number: BLA 761232
Date of Revision: March 2024
Manufacturer: BeiGene USA, Inc.

Guidelines for the Use of Tevimbra

Dosage and Administration:
- Administer 200 mg as an intravenous infusion every 3 weeks
- The initial injection should be delivered over 60 minutes
- If tolerated, subsequent infusions may be administered over 30 minutes
- Do not coadminister other drugs through the same infusion line

Adverse Reactions:
- Common side effects include fatigue, decreased appetite, nausea, diarrhea, rash, and pruritus
- Serious immune-mediated adverse reactions may occur, such as pneumonitis, colitis, hepatitis, endocrinopathies, and nephritis

Contraindications: Tevimbra is contraindicated in patients with a history of severe hypersensitivity to tislelizumab or any of its excipients
Precautions:
- Monitor patients for signs and symptoms of immune-mediated adverse reactions
- Tevimbra can cause fetal harm
- Advise females of reproductive potential to use effective contraception during treatment and for at least 4 months after the last dose

Interactions

Drug Interactions:
- No formal drug interaction studies have been conducted with Tevimbra
- However, immunosuppressive agents may diminish the efficacy of Tevimbra

Note:

If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
It is only for internal discussion among medical staff and does not serve as a basis for medication. For specific medication guidelines, please consult the attending physician.