Formulation and specifications: Injection: 80mg (2ml)/bottle, 240mg (6ml)/bottle
Indications: For the treatment of patients with recurrent/metastatic nasopharyngeal carcinoma who have failed previous second-line and higher systemic therapy.
Key points for rational drug use:
1. The recommended dose for advanced nasopharyngeal carcinoma is 3 mg/kg by intravenous infusion every 2 weeks until disease progression or intolerable toxicity occurs. Some patients treated with this product may have an atypical tumor response. If patients have stable or persistently decreasing clinical symptoms, even with preliminary evidence of disease progression on imaging, continued treatment with this product may be considered until disease progression is confirmed based on a judgment of overall clinical benefit.
2. Adverse reactions are anemia, elevated ALT, malaise, elevated AST, rash, fever, elevated blood thyroid stimulating hormone, decreased white blood cell count, cough, pruritus, hypothyroidism, decreased appetite, elevated blood glucose, and elevated blood bilirubin.
3. For suspected immune-related adverse reactions, adequate evaluation should be performed to rule out other etiologies. Most immune-related adverse reactions are reversible and can be managed by interruption of teraplizumab, glucocorticoid therapy and/or supportive therapy. Withholding of dosing is required for most Grade 3-4 and certain specific Grade 2 immune-related adverse reactions. Permanent discontinuation is required for Grade 4 and certain specific Grade 3 immune-related adverse reactions. For Grade 3-4 and certain specific Grade 2 immune-related adverse reactions, administer 1 to 2 mg/(kg-d) of prednisone equivalent and other therapy until improvement to ≤ Grade 1. Glucocorticoids need to be tapered over a period of at least one month until discontinuation, and rapid taper may cause worsening or recurrence of adverse reactions. If adverse reactions continue to worsen or do not improve after glucocorticoid therapy, additional non-glucocorticoid-based immunosuppressive therapy should be added.
4. For grade 4 and certain specific grade 3 immune-related adverse reactions, and any recurrent grade 3 immune-related adverse reactions, grade 2 to 3 immune-related adverse reactions that do not improve to grade 0 to 1 within 12 weeks of the last dose (except for endocrine disease), and failure to reduce glucocorticoids to ≤10 mg/d prednisone equivalent dose within 12 weeks of the last dose, the drug should be permanently discontinued.
5. Contraindications: (1) Prohibited in patients with hypersensitivity reactions to the active ingredients or excipients of Tremelimumab Injection. (2) Do not mix or dilute with other drugs, and do not reuse the remaining drug in the vial. (3) Do not use intravenous push or single rapid intravenous injection to administer the drug.
6. Systemic glucocorticoids and other immunosuppressive agents should be avoided before starting treatment with this drug because of possible interference with the pharmacodynamic activity of this drug. However, systemic glucocorticoids and other immunosuppressive agents may be used after initiation of treatment for immune-related adverse reactions.