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)

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

European Union - English - EMA (European Medicines Agency)

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.

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).

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

hra pharma uk ltd - mitotane - tablet - 500mg

Canada - English - Health Canada

hra pharma rare diseases - mitotane - tablet - 500mg - mitotane 500mg - antineoplastic agents

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

pronat group australia pty ltd - arnica montana, quantity: 105 mg/g (equivalent: arnica montana, qty 10.5 mg/g); calendula officinalis, quantity: 25 mg/g (equivalent: calendula officinalis, qty 2.5 mg/g); menthol, quantity: 25 mg/g; melaleuca alternifolia, quantity: 10 mg/g (equivalent: cineole, qty 1.5 mg/g); hypericum perforatum, quantity: 25 mg/g (equivalent: hypericum perforatum, qty 2.5 mg/g) - gel - excipient ingredients: purified water; pentylene glycol; peg-100 stearate; olive oil; synthetic beeswax; sodium cetostearyl sulfate; sodium hydroxide; cetostearyl alcohol; glyceryl monostearate; carbomer u-10 - anti-inflammatory/relieve inflammation ; analgesic/anodyne/relieve pain ; aid/assist in the healing of minor body tissue injuries ; relieve mild tissue oedema ; maintain/support body tissue repair/regeneration ; decrease/reduce/relieve symptoms of soft tissue trauma ; decrease/reduce/relieve mild rheumatic aches and pains ; decrease/reduce/relieve symptoms of mild arthritis/mild osteoarthritis ; decrease/reduce/relieve mild joint inflammation/swelling ; decrease/reduce/relieve mild joint pain/soreness ; rubefaciant/stimulate blood flow to skin ; helps decrease/reduce/relieve mild muscle spasms/twitches ; aid/assist/helps in the healing of minor muscle injuries ; decrease/reduce/relieve symptoms of muscle injury/ailments ; reduce/decrease mild muscle inflammation ; aid/assist/helps in the management of muscle sprain/strain ; helps decrease/reduce/relieve symptoms of muscle sprain/strain ; decrease/reduce/relieve muscle pain/ache/soreness ; helps enhance/improve/promote/increase muscle performance/endurance/stamina ; aid/assist/helps post exercise recovery ; helps enhance/improve muscle recovery time ; enhance/improve/promote healing of bruises ; decrease/reduce/relieve bruise pain ; decrease/reduce/relieve bruise swelling

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

pronat group australia pty ltd - arnica montana, quantity: 105 mg/g (equivalent: arnica montana, qty 10.5 mg/g); melaleuca alternifolia, quantity: 10 mg/g (equivalent: cineole, qty 1.5 mg/g); calendula officinalis, quantity: 25 mg/g (equivalent: calendula officinalis, qty 2.5 mg/g); hypericum perforatum, quantity: 25 mg/g (equivalent: hypericum perforatum, qty 2.5 mg/g); menthol, quantity: 25 mg/g - gel - excipient ingredients: sodium hydroxide; acrylates/c10-30 alkyl acrylate crosspolymer; pentylene glycol; glyceryl monostearate; peg-100 stearate; purified water; carbomer u-10 - anti-inflammatory/relieve inflammation ; analgesic/anodyne/relieve pain ; aid/assist in the healing of minor body tissue injuries ; relieve mild tissue oedema ; maintain/support body tissue repair/regeneration ; decrease/reduce/relieve symptoms of soft tissue trauma ; decrease/reduce/relieve mild rheumatic aches and pains ; decrease/reduce/relieve symptoms of mild arthritis/mild osteoarthritis ; decrease/reduce/relieve mild joint inflammation/swelling ; decrease/reduce/relieve mild joint pain/soreness ; rubefaciant/stimulate blood flow to skin ; helps decrease/reduce/relieve mild muscle spasms/twitches ; aid/assist/helps in the healing of minor muscle injuries ; decrease/reduce/relieve symptoms of muscle injury/ailments ; reduce/decrease mild muscle inflammation ; aid/assist/helps in the management of muscle sprain/strain ; helps decrease/reduce/relieve symptoms of muscle sprain/strain ; decrease/reduce/relieve muscle pain/ache/soreness ; helps enhance/improve/promote/increase muscle performance/endurance/stamina ; aid/assist/helps post exercise recovery ; helps enhance/improve muscle recovery time ; enhance/improve/promote healing of bruises ; decrease/reduce/relieve bruise pain ; decrease/reduce/relieve bruise swelling

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

pronat group australia pty ltd - arnica montana,boswellia serrata,calendula officinalis,hypericum perforatum,menthol,melaleuca alternifolia,nigella sativa,wintergreen oil -