Formulation and specifications: Injection: 80mg (2ml)/bottle, 240mg (6ml)/bottle
Indications: For locally advanced or metastatic uroepithelial carcinoma that has failed platinum-containing chemotherapy including neoadjuvant or adjuvant chemotherapy progressing within 12 months.
Key points for rational drug use:
1. The recommended dose of teraplizumab is 3 mg/kg. administered by intravenous infusion every 2 weeks until disease progression or intolerable toxicity occurs.
2. The safety and efficacy of treprolizumab in moderate to severe hepatic and renal impairment has not been established and is not recommended for use in patients with moderate to severe hepatic and renal impairment. Patients with mild hepatic or renal impairment should be used under medical supervision without dose adjustment.
3. Use under medical supervision without dose adjustment is recommended in elderly patients (≥65 years of age); safety and efficacy data in children and adolescents under 18 years of age have not been established.
4. The first intravenous infusion of Tremelimumab should be administered over at least 60 minutes; if the first infusion is well tolerated, the second infusion may be shortened to 30 minutes; if the patient also tolerates the 30-minute infusion well, all subsequent infusions may be completed over 30 minutes; no intravenous push or single rapid intravenous infusion should be used for administration.
5. Immune-related adverse reactions can occur during and after discontinuation of Tremelimumab treatment and may involve any tissue or organ. Suspected immune-related adverse reactions should be adequately evaluated as well as other causes ruled out. Most immune-related adverse reactions are reversible and can be managed by interruption of treprolizumab, glucocorticoid therapy, and/or supportive therapy. Withholding of drug administration is required for most grade 3-4 and certain specific grade 2 immune-related adverse reactions, and permanent discontinuation is required for grade 4 and certain specific grade 3 immune-related adverse reactions.
6. Tremelimumab is not metabolized by CYP450 enzymes or other drug-metabolizing enzymes; therefore, inhibition or induction of these enzymes by the drugs used in combination is not expected to affect the pharmacokinetics of tremelimumab.