Topotecan Hydrochloride for Injection

Anti-tumor activity: This drug shows strong anti-tumor activity and a wide anti-cancer spectrum. In preclinical in vivo tumor inhibition tests, it has significant efficacy on animal transplanted tumors such as P388 and L121 leukemia, B16 melanoma, B16/F10 melanoma substrain, Lew's lung cancer, ADJ-PC6 plasmacytoma, M5076 ovarian sarcoma, breast cancer 16/c, colon adenocarcinoma 38 and 51, Wadison lung cancer, etc. Mode of action: This drug is an inhibitor of topoisomerase I. Topoisomerase I can induce reversible breaks in single-stranded DNA and loosen the DNA helical chain. This drug can bind to the topoisomerase I-DNA complex and prevent the reconnection of these single-stranded broken chains. Its cytotoxic effect is in the synthesis of DNA. It is a specific drug for the S phase cell cycle. When the ternary complex formed by this drug, topoisomerase I and DNA interacts with the replication enzyme, it produces damage to double-stranded DNA, and mammalian cells cannot effectively repair these double-stranded DNA chain interruptions.

This product is a sterile lyophilized product of topotecan hydrochloride.

Small cell lung cancer. Advanced metastatic ovarian cancer who have failed first-line chemotherapy.

Dosage: The recommended dose is 1.2 mg/m2/day, intravenous infusion for 30 minutes, for 5 days, 21 days as a course of treatment. For patients with severe neutropenia during treatment, the dose can be reduced by 0.2 mg/m2 in the subsequent course of treatment or used simultaneously with G-CSF. The use starts from the 6th day, that is, 24 hours after the continuous use of this product for 5 days, and then G-CSF is used again. Preparation of injection: Dissolve this product in 1 ml of sterile water for injection at a ratio of 1 mg, draw the solution at a dose of 1.2 mg/m2/day, dilute with 0.9% sodium chloride or 5% glucose injection solution and then intravenously infuse. Dosage adjustment for special populations Patients with hepatic insufficiency: Patients with hepatic insufficiency (plasma bilirubin 1.5-10 mg/dl) have reduced plasma clearance, but generally no dose adjustment is required. Renal insufficiency: Generally, no dose adjustment is required for mild renal insufficiency (CLcr 40-60ml/min). For moderate renal insufficiency (CLcr 20-39ml/min), the dose is adjusted to 0.6mg/m2. There is insufficient data to prove whether it can be used in patients with severe renal insufficiency. Elderly: Generally, no dose adjustment is required unless renal insufficiency occurs. Overdose: It is not clear how to detoxify this product in overdose. The main complication of overdose is bone marrow suppression.

Blood system: There are reactions such as leukopenia, thrombocytopenia, and anemia. Bone marrow suppression (mainly neutrophils) is the dose-limiting toxicity of this product. Peripheral blood routine should be monitored during treatment. During treatment, neutrophils should be restored to >1500/mm3, platelets should be restored to 100,000/mm3, and hemoglobin should be restored to 9.0g/dl before continued use (G-CSF or component blood can be used when necessary). Bone marrow suppression may be aggravated when used in combination with other cytotoxic drugs. Digestive system: Nausea, vomiting, diarrhea, constipation, intestinal obstruction, abdominal pain, stomatitis, and anorexia. Skin and appendages: Hair loss, occasional severe dermatitis and itching. Neuromuscular: Headache, joint pain, muscle pain, body pain, and paresthesia. Respiratory system: Can cause dyspnea. Although it is not certain whether it will cause death, it should attract the attention of doctors. Liver: Sometimes abnormal liver function and elevated transaminase occur. Systemic: Fatigue, discomfort, and fever. Local: During intravenous injection, if the drug solution leaks outside the blood vessels, it may cause local irritation and swelling. Allergic reaction: Rare allergic reaction and angioedema.

Allergic to camptothecin or any of its ingredients. Severe bone marrow suppression, neutrophil count 1500/mm3. Pregnant or lactating women.

1. This product can increase cytotoxicity when used in combination with other anti-tumor drugs, and the degree of increase depends on the tumor type, exposure time, drug concentration, calculation method and drug sequence. 2. This product can accelerate the killing of hamster V79 cells and many human cancer cells when used in combination with cisplatin, carmustine or melphalan.

Keep tightly closed in a cool, dark place.

1 mg