Lomustinum - search results

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

lomustine- lomustine powder

h3 medical inc - lomustine (unii: 7brf0z81kg) (lomustine - unii:7brf0z81kg) -

lomustine ''''medac'''' 40mg

central procurement & supplies unit ub002 industrial estate, san gwann sgn 3000, malta - lomustine - hard capsule - lomustine 40 milligram(s) - antineoplastic agents

Malta - English - Medicines Authority

lomustine "medac" 40 mg

pharmachemic trading agency company limited 72, gorg borg oivier street, rabat, malta - lomustine - hard capsule - lomustine 40 mg - antineoplastic agents

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

gleostine- lomustine capsule, gelatin coated

nextsource biotechnology, llc - lomustine (unii: 7brf0z81kg) (lomustine - unii:7brf0z81kg) - lomustine 40 mg - gleostine is indicated for the treatment of patients with primary and metastatic brain tumors following appropriate surgical and/or radiotherapeutic procedures. gleostine is indicated as a component of combination chemotherapy for the treatment of patients with hodgkin's lymphoma whose disease has progressed following initial chemotherapy. none. risk summary based on animal data and its mechanism of action, gleostine can cause fetal harm when administered to a pregnant woman [see clinical pharmacology ( 12.1)] . there are no available data on gleostine exposure in pregnant women. lomustine was teratogenic in rats and embryotoxic in rabbits at total dose levels approximately two to four times the total human dose of 130 mg/m 2 over 6 weeks (0.18 to 0.27 times the single human dose of 130 mg/m 2 ) based on bsa [see data] . advise pregnant women of the potential risk to a fetus. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. data animal data lomustine was administered by intraperitoneal injection daily to pregnant rats during the period of organogenesis at dose levels of 0, 2, 4, 6, and 8 mg/kg. resorption rates and post-implantation loss occurred at doses greater than or equal to 4 mg/kg (approximately 0.18 times the clinical dose of 130 mg/m 2 based on bsa or approximately twice the total clinical dose of lomustine over 6 weeks). malformations (omphalocele, ectopia cordis, scoliosis, syndactyly, hydrocephalus, microphthalmia, anophthalmia, anomalies of aortic arch, dextrocardia, malpositioning of the ovaries and testes, sternoschisis, and shortened/misshapen bone of the fore or hind limbs) and decreased fetal body weight occurred at all dose levels. in pregnant rabbits treated with lomustine at 3 mg/kg (approximately 0.27 times the 130 mg/m 2 clinical dose based on bsa or approximately four times the total clinical dose of lomustine over 6 weeks) during organogenesis, there were increases in abortions and decreases in surviving pup weight that persisted postnatally. risk summary there is no information on the presence of lomustine or its metabolites in human milk, its effects on the breastfed infant, or its effects on milk production. because of the potential for serious adverse reactions in breastfed infants from gleostine, advise women not to breastfeed during treatment with gleostine and for 2 weeks after the final dose. contraception females based on animal data and its mechanism of action, gleostine can cause fetal harm [see use in specific populations ( 8.1)] . advise females of reproductive potential to use effective contraception during treatment and for 2 weeks after the final dose. males based on gleostine's mechanism of action, advise males with female partners of reproductive potential to use effective contraception during treatment with gleostine and for 3.5 months after the final dose [see clinical pharmacology ( 12.1)] . infertility based on animal findings and its mechanism of action, gleostine may result in reduced fertility in males and females of reproductive potential [see nonclinical toxicology ( 13.1)] . pediatric use, including dose, is not based on adequate and well-controlled clinical studies. no data in the clinical studies of gleostine are available for patients 65 years of age and over to determine whether they respond differently than younger patients. other reported clinical experience has not identified differences in responses between elderly and younger patients. in general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy. lomustine and its metabolites are 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 renal function should be monitored.