Mitotane - search results

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

lysodren- mitotane tablet

e.r. squibb & sons, l.l.c. - mitotane (unii: 78e4j5ib5j) (mitotane - unii:78e4j5ib5j) - mitotane 500 mg - lysodren is indicated for the treatment of patients with inoperable, functional or nonfunctional, adrenal cortical carcinoma. none. lysodren can cause fetal harm. limited postmarketing cases report preterm births and early pregnancy loss in women treated with lysodren during pregnancy. animal reproduction studies have not been conducted with mitotane. advise pregnant women of the potential risk to a fetus. the background risk of major birth defects and miscarriage for the indicated population is unknown. 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. mitotane is excreted in human milk; however, the effect of lysodren on the breastfed infant, or effect on milk production is unknown. because of the potential for serious adverse reactions in the breastfed infant, advise nursing women that breastfeeding is not recommended during treatment with lysodren and after discontinuation of treatment

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

lysodren- mitotane tablet

hra pharma rare diseases - mitotane (unii: 78e4j5ib5j) (mitotane - unii:78e4j5ib5j) - lysodren is indicated for the treatment of patients with inoperable, functional or nonfunctional, adrenocortical carcinoma (acc). none. risk summary lysodren can cause fetal harm. limited postmarketing cases report preterm births and early pregnancy loss in women treated with lysodren during pregnancy. animal reproduction studies have not been conducted with mitotane. 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% to 4% and 15% to 20%, respectively. risk summary mitotane is excreted in human milk; however, the effect of lysodren on the breastfed child, or on milk production is unknown. because of the potential for serious adverse reactions in a breastfed child, advise women not to breastfeed during treatment with lysodren and after discontinuation of treatment for as long as mitotane plasma levels are detectable. pregnancy testing verify the pregnancy status of females of reproductive potential prior to initiating lysodren [see use in specific populations (8.1)] . contraception lysodren can cause fetal harm when administered to a pregnant woman [see use in specific populations (8.1)] . females advise females of reproductive potential to use effective nonhormonal contraception during treatment with lysodren and after discontinuation of therapy for as long as mitotane plasma levels are detectable [see clinical pharmacology (12.3)] . lysodren can render hormonal contraceptives ineffective [see drug interaction (7.2)] . effectiveness in pediatric patients has not been established. based on published case reports, mitotane may negatively impact neuro-psychological development (e.g., motor and speech delay, memory impairment) in children and adolescents. in cases of cognitive dysfunction, thyroid function should be evaluated as mitotane may induce hypothyroidism. other effects of mitotane observed in pediatric patients that are cited in medical literature or in a pharmacovigilance database include growth delay and estrogenic-like effects such as uterine bleeding, breast development in females and gynecomastia in males. clinical studies of lysodren did not include sufficient numbers of patients aged 65 years and older to determine whether they respond differently than younger patients. other reported clinical experience has not identified differences in responses between the older and younger patients. in general, dose selection for an older patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. mitotane is metabolized through the liver and mitotane plasma levels may increase if liver function is impaired. because of the increased risk of adverse reactions in patients with mild or moderate hepatic impairment, monitor mitotane plasma levels more frequently and modify the dosage as needed [see dosage and administration (2.3)]. lysodren is not recommended for use in patients with severe hepatic impairment [see warnings and precautions (5.4)] . mitotane is eliminated through the kidney and mitotane plasma levels may increase if renal function is impaired. because of the increased risk of adverse reactions in patients with mild and moderate renal impairment, monitor mitotane plasma levels more frequently and modify the dosage as needed [see dosage and administration (2.4)]. lysodren is not recommended for use in patients with severe renal impairment.

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

mitotane powder

bluebay shandong co.,ltd - mitotane (unii: 78e4j5ib5j) (mitotane - unii:78e4j5ib5j) -

Israel - English - Ministry of Health

lysodren

cts ltd - mitotane - tablets - mitotane 500 mg - mitotane - symptomatic treatment of advanced (unresectable, metastatic or relapsed) adrenal cortical carcinoma (acc).

European Union - English - EMA (European Medicines Agency)

lysodren

hra pharma rare diseases - mitotane - adrenal cortex neoplasms - antineoplastic agents - symptomatic treatment of advanced (unresectable, metastatic or relapsed) adrenal cortical carcinoma. the effect of lysodren on non-functional adrenal cortical carcinoma is not established.