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

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)

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)

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

Israel - English - Ministry of Health

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

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

aquatain products pty ltd - polydimethylsiloxane - unknown - polydimethylsiloxane emulsifiers & surfactants-noni active 0.0 - active constituent

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

momentive performance materials inc. - trisiloxane ethoxylate - liquid - trisiloxane ethoxylate emulsifiers & surfactants-noni active 500.0 g/l - adjuvant - foliar nutrients additive | fungicide additive | growth regulator additive | insecticide additive | low volume application | ret - carrier - anti-evaporant | horticultural tree crops | spreading agent | vegetable - refer to label | vines - refer to label | wetting agent (use as directed) | adjuvant | apples | avocadoes | citrus | evaporant | herbicide application | improve penetrating properties | insecticide application | mangoes | olives | wetter

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

apvma permit - mitotane(500mg/tb) - antineoplastic

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

apvma permit - mitotane(500mg/tab) - antineoplastic

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

apvma permit - mitotane(500mg/tb) - antineoplastic

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

aquatain products pty ltd - polydimethylsiloxane - aqueous concentrate - polydimethylsiloxane emulsifiers & surfactants-noni active 754.0 g/l - insecticide - domestic and/or public area | standing water | channel | ditch | pond - mosquito | adult mosquitoes