Formulation and specifications: Powder injection: 200mg/vial
Indications:
1. This product is used for the treatment of patients with advanced nasopharyngeal carcinoma whose disease has progressed or is intolerable after receiving previous second-line or higher chemotherapy.
2. This product is used in combination with cisplatin and gemcitabine for the first-line treatment of patients with locally recurrent or metastatic nasopharyngeal carcinoma.
Key points for rational drug use:
1. The recommended dose for locally recurrent or metastatic nasopharyngeal carcinoma is 200 mg/dose by intravenous infusion every 3 weeks until disease progression or intolerable toxicity occurs.
2. It is possible that atypical reactions may be observed. If a patient’s clinical symptoms are stable or continue to decrease, even if there is preliminary evidence of disease progression on imaging, the physician may consider whether to continue treatment with this product based on a judgment of the patient’s overall clinical benefit until disease progression or intolerable toxicity is confirmed.
3. When cariolizumab is administered in combination with chemotherapy, cariolizumab should be given first as an intravenous drip, with an interval of at least 30 minutes before chemotherapy is given.
4. The most common adverse reactions are reactive capillary hyperplasia, elevated AST, elevated ALT, hypothyroidism, malaise, proteinuria, fever, and leukopenia. The majority of adverse reactions reported with monotherapy were grade 1 or 2 in severity, and the most common > grade 3 adverse reactions were: anemia, hyponatremia, elevated gamma-glutamyl transferase, and elevated AST.
5. For suspected immune-related adverse reactions, adequate evaluation should be performed to exclude other etiologies. Most immune-related adverse reactions are reversible and can be treated by interrupting karrelylizumab and supporting with glucocorticoids. 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 glucocorticosteroid therapy, immunosuppressive therapy other than glucocorticosteroids should be added.
6. Reactive capillary hyperplasia occurs mostly in the skin of the body, with a few seen in the oral mucosa, nasal mucosa, and eyelid conjunctiva. Reactive capillary hyperplasia occurs in the skin and initially appears as bright red dots on the surface of the body, <2mm in diameter, with the increase in the number of drugs, the lesions can gradually increase in extent, mostly nodular, but also patchy, bright red or dark red.
7. 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.
8. Systemic glucocorticoids and other immunosuppressive agents should be avoided prior to initiation of treatment with this product because of possible interference with its pharmacodynamic activity. However, systemic glucocorticoids and other immunosuppressive agents may be used after initiation of treatment for immune-related adverse reactions.