Formulation and specifications: Injection: 80mg (2ml)/bottle, 240mg (6ml)/bottle
Indications: Indicated for the treatment of unresectable or metastatic melanoma that has failed previous systemic systemic therapy.
Key points for rational drug use:
1. The recommended dose for the treatment of advanced melanoma is 3 mg/kg by intravenous infusion every 2 weeks until disease progression or intolerable toxicity occurs. An atypical tumor response has been observed in some patients treated with this product. 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. For advanced mucosal melanoma, PD-1 monoclonal antibody has limited efficacy alone, and treatment with teraplizumab (3 mg/kg by intravenous infusion every two weeks) in combination with axitinib (5 mg/dose twice daily) is recommended based on the CT13 study.
3. 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.
4. 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 treated with interruption of treprolizumab and glucocorticoid support. Most grade 3-4 and some specific grade 2 immune-related adverse reactions require suspension of dosing and administration of 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 recurrent immune-related adverse reactions. If adverse reactions continue to worsen or do not improve after glucocorticoid therapy, immunosuppressive therapy other than glucocorticoids should be added.
5. 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.
6. Contraindications: (1) Prohibited in patients with hypersensitivity reactions to the active ingredients or excipients of Tremelimumab Injection. (2) Not to be mixed or diluted with other drugs, and the remaining drug in the vial should not be reused. (3) Do not use intravenous push or single rapid intravenous injection to administer the drug.
7. 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.