Tuoyi Toripalimab Injection 80 mg

1. Indications and Usage
Melanoma: Treatment of adult patients with unresectable or metastatic melanoma who have failed prior systemic therapies.
Head and Neck Cancer: Treatment of recurrent or metastatic nasopharyngeal carcinoma (NPC) after failed prior systemic therapy.
Urothelial Cancer: Treatment of locally advanced or metastatic urothelial carcinoma after failed prior platinum-containing chemotherapy.
Non-Small Cell Lung Cancer (NSCLC): Indicated in combination with pemetrexed and platinum chemotherapy for EGFR/ALK-negative unresectable advanced or metastatic NSCLC.
Esophageal Cancer: Indicated in combination with paclitaxel and cisplatin for unresectable locally advanced or recurrent/metastatic esophageal squamous cell carcinoma.
2. Dosage and Administration
Route of Administration: Intravenous infusion ONLY.
Recommended Dosage: 3 mg/kg every 2 weeks for melanoma, NPC, and urothelial carcinoma; or 240 mg every 3 weeks for combined therapy in NSCLC and ESCC.
Duration: Treatment continues until disease progression or unacceptable toxicity.
Critical Administration Instructions:
Infusion Rate: The initial infusion must be administered over at least 60 minutes; the second infusion over at least 30 minutes. If tolerated, subsequent infusions may be completed within 30 minutes.
Dilution: Dilute to a final concentration of 1 to 3 mg/mL using 0.9% Sodium Chloride Injection.
Filtration: Use a sterile, pyrogen-free, low-protein-binding filter with a pore size of 0.2 or 0.22 μm. Do not administer as a bolus.
3. Mechanism of Action
PD-1 Blockade: Toripalimab is a humanized monoclonal antibody that binds to programmed cell death-1 (PD-1).
Immune Restoration: By blocking the interaction between PD-1 and its ligands (PD-L1 and PD-L2), it restores the endogenous anti-tumor immune response and mediates T-cell-mediated tumor cell killing.
4. Safety and Warnings
Immune-Mediated Adverse Reactions: May cause severe or fatal immune-mediated pneumonitis, colitis, hepatitis, endocrinopathies (e.g., hypothyroidism, adrenal insufficiency), and dermatitis.
Infusion-Related Reactions: Common reactions include fever, chills, and flushing.
Hepatotoxicity: Elevations in liver enzymes have been observed; liver function must be monitored regularly.
Embryo-Fetal Toxicity: May cause fetal harm; effective contraception is required during and after treatment.
5. Adverse Reactions and Clinical Research
Most Common Adverse Reactions: Anemia, elevated ALT/AST, fatigue, pyrexia, hypothyroidism, rash, pruritus, and decreased appetite.
Clinical Research Highlights: Clinical trials have demonstrated significant objective response rates and durable clinical benefits across multiple tumor types.
6. Drug Interactions
Immunosuppressants: Avoid using systemic corticosteroids or other immunosuppressants before initiating therapy as they may interfere with the pharmacodynamic activity of toripalimab.
Live Vaccines: Live or live-attenuated vaccines should be avoided during treatment.
7. Pharmaceutical Information
Chemical Composition: Active Ingredient: Toripalimab.
Appearance: Clear to slightly opalescent, colorless to pale yellow liquid.
Packaging: Single-dose vials (e.g., 80 mg/2 mL, 240 mg/6 mL).
Storage: Store in a refrigerator at 2°C to 8°C. Do not freeze or shake. Protect from light.