Ország: Egyesült Államok
Nyelv: angol
Forrás: NLM (National Library of Medicine)
TOPOTECAN HYDROCHLORIDE (UNII: 956S425ZCY) (TOPOTECAN - UNII:7M7YKX2N15)
Meitheal Pharmaceuticals Inc.
INTRAVENOUS
PRESCRIPTION DRUG
Topotecan Hydrochloride for Injection, as a single agent, is indicated for the treatment of patients with metastatic ovarian cancer after disease progression on or after initial or subsequent chemotherapy. Topotecan Hydrochloride for Injection, as a single agent, is indicated for the treatment of patients with small cell lung cancer (SCLC) with platinum-sensitive disease who progressed at least 60 days after initiation of first-line chemotherapy. Topotecan Hydrochloride for Injection, in combination with cisplatin, is indicated for the treatment of patients with Stage IV-B, recurrent, or persistent cervical cancer not amenable to curative treatment. Topotecan hydrochloride is contraindicated in patients who have a history of severe hypersensitivity reactions to topotecan. Reactions have included anaphylactoid reactions [see Adverse Reactions (6.2)]. Risk Summary Based on animal data and its mechanism of action, topotecan hydrochloride can cause fetal harm when administered to a pregnant woman. There are no av
Topotecan Hydrochloride for Injection is supplied as a lyophilized, buffered, light yellow to greenish powder for reconstitution as follows:
Abbreviated New Drug Application
TOPOTECAN- TOPOTECAN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION MEITHEAL PHARMACEUTICALS INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE TOPOTECAN HYDROCHLORIDE FOR INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR TOPOTECAN HYDROCHLORIDE FOR INJECTION. TOPOTECAN HYDROCHLORIDE FOR INJECTION, FOR INTRAVENOUS USE INITIAL U.S. APPROVAL: 1996 WARNING: MYELOSUPPRESSION _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ TOPOTECAN HYDROCHLORIDE CAN CAUSE SEVERE MYELOSUPPRESSION. ADMINISTER FIRST CYCLE ONLY TO PATIENTS WITH BASELINE NEUTROPHIL COUNTS GREATER THAN OR EQUAL TO 1,500/MM AND PLATELET COUNTS GREATER THAN OR EQUAL TO 100,000/MM . MONITOR BLOOD CELL COUNTS (2.4, 5.1). INDICATIONS AND USAGE Topotecan Hydrochloride for Injection is a topoisomerase inhibitor indicated for treatment of: Patients with metastatic ovarian cancer after disease progression on or after initial or subsequent chemotherapy, as a single agent (1.1) Patients with small cell lung cancer (SCLC) platinum-sensitive disease who progressed at least 60 days after initiation of first-line chemotherapy, as a single agent (1.2) Patients with Stage IV-B, recurrent, or persistent cervical cancer which is not amenable to curative treatment, in combination with cisplatin (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 cycle (2.1, 2.2) Cervical Cancer: 0.75 mg/m by intravenous infusion over 30 minutes on Days 1, 2, and 3, with cisplatin 50 mg/m on Day 1, of a 21-day cycle (2.3) Renal Impairment: Reduce dose if creatinine clearance (CLcr) 20 to 39 mL/min (2.6) DOSAGE FORMS AND STRENGTHS For injection: 4 mg (free base) lyophilized powder in single-dose vial (3) CONTRAINDICATIONS History of severe hypersensitivity reactions to topotecan (4) WARNINGS AND PRECAUTIONS Interstitial Lung Disease (ILD): Fatal case Olvassa el a teljes dokumentumot