Australia - English - Department of Health (Therapeutic Goods Administration)

alphapharm pty ltd - topotecan hydrochloride -

Australia - English - Department of Health (Therapeutic Goods Administration)

alphapharm pty ltd - topotecan hydrochloride -

United States - English - NLM (National Library of Medicine)

accord healthcare inc. - topotecan (unii: 7m7ykx2n15) (topotecan - unii:7m7ykx2n15) - topotecan injection is indicated for the treatment of: - small cell lung cancer sensitive disease after failure of first-line chemotherapy. in clinical studies submitted to support approval, sensitive disease was defined as disease responding to chemotherapy but subsequently progressing at least 60 days (in the phase 3 study) or at least 90 days (in the phase 2 studies) after chemotherapy [see clinical studies ( 14) ] . topotecan injection in combination with cisplatin is indicated for the treatment of: - stage iv-b, recurrent, or persistent carcinoma of the cervix which is not amenable to curative treatment with surgery and/or radiation therapy. topotecan injection is contraindicated in patients who have a history of severe hypersensitivity reactions (e.g., anaphylactoid reactions) to topotecan or to any of its ingredients. topotecan injection should not be used in patients with severe bone marrow depression. pregnancy category d [see warnings and precautions ( 5.4) ]. topotecan injection can cause fetal harm when administered to a pregnant woman. in rabbits, a dose of 0.1 mg/kg/day (about equal to the clinical dose of 1.5 mg/m 2 ) given on days 6 through 20 of gestation caused maternal toxicity, embryolethality, and reduced fetal body weight. in the rat, a dose of 0.23 mg/kg/day (about equal to the clinical dose of 1.5 mg/m 2 ) given for 14 days before mating through gestation day 6 caused fetal resorption, microphthalmia, pre-implant loss, and mild maternal toxicity. a dose of 0.1 mg/kg/day (about half the clinical dose of 1.5 mg/m 2 ) given to rats on days 6 through 17 of gestation caused an increase in post-implantation mortality. this dose also caused an increase in total fetal malformations. the most frequent malformations were of the eye (microphthalmia, anophthalmia, rosette formation of the retina, coloboma of the retina, ectopic orbit), brain (dilated lateral and third ventricles), skull, and vertebrae. there are no adequate and well controlled studies of topotecan injection in pregnant women. if this drug is used during pregnancy, or if a patient becomes pregnant while receiving topotecan injection, the patient should be apprised of the potential hazard to the fetus. [see warnings and precautions ( 5.4) ] rats excrete high concentrations of topotecan into milk. lactating female rats given 4.72 mg/m 2 iv (about three times the clinical dose of 1.5 mg/m 2 ) excreted topotecan into milk at concentrations up to 48-fold higher than those in plasma. it is not known whether the drug is excreted in human milk. because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from topotecan injection, discontinue breastfeeding when women are receiving topotecan injection. safety and effectiveness in pediatric patients have not been established. of the 879 patients in a combined experience of topotecan which included patients with small cell lung cancer, 32% (n=281) were 65 years of age and older, while 3.8% (n=33) were 75 years of age and older. of the 140 patients with stage iv-b, relapsed, or refractory cervical cancer in clinical studies of topotecan injection who received topotecan injection plus cisplatin in the randomized clinical trial, 6% (n = 9) were 65 years of age and older, while 3% (n = 4) were 75 years of age and older. no overall differences in effectiveness or safety were observed between these patients and younger adult patients, and other reported clinical experience has not identified differences in responses between the elderly and younger adult patients, but greater sensitivity of some older individuals cannot be ruled out. there were no apparent differences in the pharmacokinetics of topotecan in elderly patients, once the age-related decrease in renal function was considered [see clinical pharmacology ( 12.3) ]. this drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function [see dosage and administration ( 2.3) ]. no dosage adjustment of topotecan injection appears to be required for patients with mild renal impairment (cl cr 40 to 60 ml/min.). dosage reduction is recommended for patients with moderate renal impairment (cl cr 20 to 39 ml/min.). insufficient data are available in patients with severe renal impairment to provide a dosage recommendation for topotecan injection. [see dosage and administration ( 2.3) and clinical pharmacology ( 12.3) ].

Australia - English - Department of Health (Therapeutic Goods Administration)

accord healthcare pty ltd - topotecan hydrochloride, quantity: 1.09 mg (equivalent: topotecan, qty 1 mg) - injection, concentrated - excipient ingredients: hydrochloric acid; water for injections; tartaric acid; sodium hydroxide - topotecan intas is indicated as single agent therapy for the treatment of patients with:,? small cell lung carcinoma after failure of first line chemotherapy.,? metastatic carcinoma of the ovary after failure of first-line or subsequent therapy.,topotecan intas is indicated in combination with cisplatin for the treatment of patients with:,? histologically confirmed stage iv-b, recurrent, or persistent carcinoma of the cervix, which is not amenable to curative treatment with surgery and/or radiation therapy.

United States - English - NLM (National Library of Medicine)

mylan institutional llc - topotecan hydrochloride (unii: 956s425zcy) (topotecan - unii:7m7ykx2n15) - topotecan injection 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 injection 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 injection can cause fetal harm when administered to a pregnant woman. there are no available clinical data on the use of topotecan in pregnancy. topotecan caused embryolethality, fetotoxicity, and teratogenicity in rats and rabbits when administered during organogenesis at doses similar to the clinical dose (see data). advise pregnant women of the potential risk to a fetus. in the u.s. general population, the background risk of major birth defects is 2% to 4% and of miscarriage is 15% to 20% of clinically recognized pregnancies. data an

United States - English - NLM (National Library of Medicine)

hospira, inc. - topotecan hydrochloride (unii: 956s425zcy) (topotecan - unii:7m7ykx2n15) - topotecan injection 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 injection 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 injection can cause fetal harm when administered to a pregnant woman. there are no available clinical data on the use of topotecan in pregnancy. topotecan caused embryolethality, fetotoxicity, and teratogenicity in rats and rabbits when administered during organogenesis at doses similar to the clinical dose (see data). advise pregnant women of the potential risk to a fetus. in the u.s. general population, the background risk of major birth defects is 2% to 4% and of miscarriage is 15% to 20% of clinically recognized pregnancies. data an

Israel - English - Ministry of Health

novartis israel ltd - topotecan as hydrochloride - hard gelatin capsules - topotecan as hydrochloride 0.25 mg - topotecan - topotecan - indicated for the treatment of patients with relapsed small cell lung cancer (sclc) for whom re-treatment with the first-line regimen is not considered appropriate.

Israel - English - Ministry of Health

novartis israel ltd - topotecan as hydrochloride - hard gelatin capsules - topotecan as hydrochloride 1 mg - topotecan - topotecan - indicated for the treatment of patients with relapsed small cell lung cancer (sclc) for whom re-treatment with the first-line regimen is not considered appropriate.

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

pfizer ltd - topotecan hydrochloride - solution for infusion - 1mg/1ml

Ireland - English - HPRA (Health Products Regulatory Authority)

fresenius kabi oncology plc - topotecan hydrochloride equivalent to topotecan - concentrate for soln for inf - 1 mg/ml - other antineoplastic agents