Država: Združene države Amerike
Jezik: angleščina
Source: NLM (National Library of Medicine)
topotecan hydrochloride (UNII: 956S425ZCY) (topotecan - UNII:7M7YKX2N15)
Sagent Pharmaceuticals
topotecan hydrochloride
topotecan 1 mg in 1 mL
INTRAVENOUS
PRESCRIPTION DRUG
Topotecan injection, as a single agent, is indicated for the treatment of patients with metastatic carcinoma of the ovary after disease progression on or after initial or subsequent chemotherapy. Topotecan injection, as a single agent, is indicated for the treatment of patients with small cell lung cancer with platinum-sensitive disease who progressed at least 60 days after initiation of first-line chemotherapy. Topotecan injection in combination with cisplatin is indicated for the treatment of patients with Stage IV-B, recurrent, or persistent carcinoma of the cervix not amenable to curative treatment. Topotecan injection is contraindicated in patients who have a history of severe hypersensitivity reactions to topotecan. Risk Summary Based on animal data, topotecan can cause fetal harm when administered to a pregnant woman. Topotecan caused embryolethality, fetotoxicity, and teratogenicity in rats and rabbits when administered during organogenesis at doses similar to the clinical dose [see Data]. There are
Topotecan Injection is supplied as follows: Topotecan injection is supplied in 4 mg per 4 mL (1 mg per mL, topotecan free base equivalent) single-dose vials. Each vial contains 4 mL of the sterile, clear, light yellow to greenish solution. Store refrigerated between 2°C and 8°C (36°F and 46°F). Handle and dispose of topotecan injection consistent with recommendations for the handling and disposal of hazardous drugs1 . Protect from light. Retain in carton until time of use. Discard unused portion. Sterile, Nonpyrogenic, Preservative-free.
New Drug Application
TOPOTECAN- TOPOTECAN INJECTION, SOLUTION, CONCENTRATE SAGENT PHARMACEUTICALS ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE TOPOTECAN INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR TOPOTECAN INJECTION. TOPOTECAN INJECTION, FOR INTRAVENOUS USE INITIAL U.S. APPROVAL: 1996 WARNING: BONE MARROW SUPPRESSION _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ TOPOTECAN CAN CAUSE SEVERE MYELOSUPPRESSION. ADMINISTER ONLY TO PATIENTS WITH BASELINE NEUTROPHIL COUNTS GREATER THAN OR EQUAL TO 1,500 CELLS/MM AND PLATELET COUNT GREATER THAN OR EQUAL TO 100,000/MM . MONITOR BLOOD CELL COUNTS. (5.1) RECENT MAJOR CHANGES Indications and Usage, Ovarian Cancer (1.1) 12/2017 Dosage and Administration, Ovarian Cancer (2.1) 12/2017 INDICATIONS AND USAGE Topotecan injection is a topoisomerase inhibitor indicated for: metastatic carcinoma of the ovary after disease progression on or after initial or subsequent chemotherapy. (1.1) small cell lung cancer platinum-sensitive disease in patients who progressed after first-line chemotherapy. (1.2) combination therapy with cisplatin for Stage IV-B, recurrent, or persistent carcinoma of the cervix which is not amenable to curative treatment. (1.3) DOSAGE AND ADMINISTRATION Ovarian cancer and small cell lung cancer: 1.5 mg/m by intravenous infusion over 30 minutes daily for 5 consecutive days, starting on Day 1 of a 21-day course. (2.1, 2.2) Cervical cancer: 0.75 mg/m by intravenous infusion over 30 minutes on Days 1, 2, and 3 repeated every 21 days in combination with cisplatin 50 mg/m on Day 1. (2.3) Renal impairment: Dose reduce topotecan injection in patients with moderate renal impairment (20 to 39 mL/min). (2.4) DOSAGE FORMS AND STRENGTHS Injection: 4 mg per 4 mL (1 mg per mL, topotecan free base equivalent) solution in single-dose vial (3) CONTRAINDICATIONS History of severe hypersensitivity reactions to topotecan. (4) WARNINGS AND PRECAUTIONS Bone marrow suppression: Administer topoteca Preberite celoten dokument