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

sumitomo pharma america, inc - relugolix (unii: p76b05o5v6) (relugolix - unii:p76b05o5v6) - orgovyx is indicated for the treatment of adult patients with advanced prostate cancer. orgovyx is contraindicated in patients with severe hypersensitivity to relugolix or to any of the product components. risk summary the safety and efficacy of orgovyx have not been established in females. based on findings in animals and mechanism of action, orgovyx can cause fetal harm and loss of pregnancy when administered to a pregnant female [see clinical pharmacology (12.1)] . there are no human data on the use of orgovyx in pregnant females to inform the drug-associated risk. in an animal reproduction study, oral administration of relugolix to pregnant rabbits during organogenesis caused embryo-fetal lethality at maternal exposures that were 0.3 times the human exposure at the recommended dose of 120 mg daily based on auc ( see data ). advise patients of the potential risk to the fetus. data animal data in an embryo-fetal development study, oral administration of relugolix to pregnant rabbits during the period of organogenesis resulted in abortion, total litter loss, or decreased number of live fetuses at a dose of 9 mg/kg/day (approximately 0.3 times the human exposure at the recommended dose of 120 mg daily based on auc). risk summary the safety and efficacy of orgovyx at the recommended dose of 120 mg daily have not been established in females. there are no data on the presence of relugolix in human milk, the effects on the breastfed child, or the effects on milk production. relugolix and/or its metabolites were present in milk of lactating rats (see data) . data animal data in lactating rats administered a single oral dose of 30 mg/kg radiolabeled relugolix on post-partum day 14, relugolix and/or its metabolites were present in milk at concentrations up to 10-fold higher than in plasma at 2 hours post-dose. contraception males based on findings in animals and mechanism of action, advise male patients with female partners of reproductive potential to use effective contraception during treatment and for 2 weeks after the last dose of orgovyx [see use in specific populations (8.1)]. infertility males based on findings in animals and mechanism of action, orgovyx may impair fertility in males of reproductive potential [see clinical pharmacology (12.1)and nonclinical toxicology (13.1)]. the safety and efficacy of orgovyx in pediatric patients have not been established. of the 622 patients who received orgovyx in the hero study, 81% were 65 years of age or older, while 35% were 75 years of age or older. no overall differences in safety or effectiveness were observed between these subjects and younger subjects. there was no clinically relevant impact of age on the pharmacokinetics of orgovyx or testosterone response based on population pharmacokinetic and pharmacokinetic/pharmacodynamic analyses in men 45 to 91 years of age.

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

sumitomo pharma america, inc - relugolix (unii: p76b05o5v6) (relugolix - unii:p76b05o5v6), estradiol hemihydrate (unii: cxy7b3q98z) (estradiol - unii:4ti98z838e), norethindrone acetate (unii: 9s44lic7oj) (norethindrone - unii:t18f433x4s) - myfembree is indicated for the management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women. myfembree is indicated for the management of moderate to severe pain associated with endometriosis in premenopausal women. use of myfembree should be limited to 24 months due to the risk of continued bone loss that may not be reversible [see warnings and precautions (5.2)]. myfembree is contraindicated in women: - with a high risk of arterial, venous thrombotic, or thromboembolic disorders [see boxed warningand warnings and precautions (5.1)] . examples include women over 35 years of age who smoke and women who are known to have: current or history of deep vein thrombosis or pulmonary embolism vascular disease (e.g., cerebrovascular disease, coronary artery disease, peripheral vascular disease) thrombogenic valvular or thrombogenic rhythm diseases of the heart (e.g., subacute bacterial endocarditis with valvular disease, or atrial fibrillation) inherited or acquired hypercoagulopathies uncontrolled hypertension headaches with focal neurological symptoms or migraine headaches with aura if over 35 years of age - current or history of deep vein thrombosis or pulmonary embolism - vascular disease (e.g., cerebrovascular disease, coronary artery disease, peripheral vascular disease) - thrombogenic valvular or thrombogenic rhythm diseases of the heart (e.g., subacute bacterial endocarditis with valvular disease, or atrial fibrillation) - inherited or acquired hypercoagulopathies - uncontrolled hypertension - headaches with focal neurological symptoms or migraine headaches with aura if over 35 years of age - who are pregnant. exposure to myfembree early in pregnancy may increase the risk of early pregnancy loss [see warnings and precautions (5.9)and use in specific populations (8.1)] . - with known osteoporosis, because of the risk of further bone loss [see warnings and precautions (5.2)]. - with current or history of breast cancer or other hormone-sensitive malignancies, and with increased risk for hormone-sensitive malignancies [see warnings and precautions (5.3)] . - with known hepatic impairment or disease [see warnings and precautions (5.5)] . - with undiagnosed abnormal uterine bleeding. - with known anaphylactic reaction, angioedema, or hypersensitivity to myfembree or any of its components. anaphylactoid reactions, urticaria, and angioedema have been reported [see warnings and precautions (5.14), adverse reactions (6.2)]. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to myfembree during pregnancy. pregnant females exposed to myfembree and healthcare providers are encouraged to call the myfembree pregnancy exposure registry at 1-855-428-0707. risk summary myfembree is contraindicated in pregnancy [see contraindications (4)and warnings and precautions (5.9)]. based on findings from animal studies and its mechanism of action, myfembree may cause early pregnancy loss. discontinue myfembree if pregnancy occurs during treatment [see warnings and precautions (5.9)and clinical pharmacology (12.1)] . the limited human data with the use of myfembree in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes [see data]. in animal reproduction studies, oral administration of relugolix in pregnant rabbits during organogenesis resulted in spontaneous abortion and total litter loss at relugolix exposures about half those at the maximum recommended human dose (mrhd) of 40 mg. in both rabbits and rats, no fetal malformations were present at any dose level tested which were associated with relugolix exposures about half and approximately 300 times exposures in women at the mrhd, respectively [see data]. epidemiologic studies and meta-analyses have not found an increased risk of genital or non-genital birth defects (including cardiac anomalies and limb-reduction defects) following exposure to estrogens and progestins before conception or during early pregnancy. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. there are insufficient data to conclude whether the presence of uterine fibroids or endometriosis reduces the likelihood of achieving pregnancy or increases the risk of adverse pregnancy outcomes. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the united states general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies are 2% to 4% and 15% to 20%, respectively. data animal data in an embryo-fetal development study, oral administration of relugolix to pregnant rabbits during the period of organogenesis (days 6 to 18 of gestation) resulted in abortion, total litter loss, or decreased number of live fetuses at a dose of 9 mg/kg/day (about half the human exposure at the maximum recommended human dose [mrhd] of 40 mg daily, based on auc). no treatment related malformations were observed in surviving fetuses. no treatment related effects were observed at 3 mg/kg/day (about 0.1-fold the mrhd) or lower. the binding affinity of relugolix for rabbit gnrh receptors is unknown. in a similar embryo-fetal development study, oral administration of relugolix to pregnant rats during the period of organogenesis (days 6 to 17 of gestation) did not affect pregnancy status or fetal endpoints at doses up to 1000 mg/kg/day (300 times the mrhd), a dose at which maternal toxicity (decreased body weight gain and food consumption) was observed. a no observed adverse effect level (noael) for maternal toxicity was 200 mg/kg/day (86 times the mrhd). in rats, the binding affinity of relugolix for gnrh receptors is more than 1000-fold lower than that in humans, and this study represents an assessment of non-pharmacological targets of relugolix during pregnancy. no treatment related malformations were observed up to 1000 mg/kg/day. in a pre- and postnatal developmental study in pregnant and lactating rats, oral administration of relugolix to rats during late pregnancy and lactation (day 6 of gestation to day 20 of lactation) had no effects on pre- and postnatal development at doses up to 1000 mg/kg/day (300 times the mrhd), a dose in which maternal toxicity was observed (effects on body weight gain). a noael for maternal toxicity was 100 mg/kg/day (34 times the mrhd). risk summary there are no data on the presence of relugolix or its metabolites in human milk, the effects on the breastfed child, or the effects on milk production. relugolix was detected in milk in lactating rats [see data]. when a drug is present in animal milk, it is likely that the drug will be present in human milk. detectable amounts of estrogen and progestin have been identified in the breast milk of women receiving estrogen plus progestin therapy and can reduce milk production in breast-feeding women. this reduction can occur at any time but is less likely to occur once breast-feeding is well established. the developmental and health benefits of breast-feeding should be considered along with the mother's clinical need for myfembree and any potential adverse effects on the breastfed child from myfembree or from the underlying maternal condition. data animal data in lactating rats administered a single oral dose of 30 mg/kg radiolabeled relugolix on post-partum day 14, relugolix and/or its metabolites were present in milk at concentrations up to 10-fold higher than in plasma at 2 hours post-dose. based on animal data and the mechanism of action, myfembree can cause early pregnancy loss if myfembree is administered to pregnant women [see use in specific populations (8.1)]. pregnancy testing myfembree may delay the ability to recognize pregnancy because it may reduce the intensity, duration, and amount of menstrual bleeding [see warnings and precautions (5.8)]. exclude pregnancy before initiating treatment with myfembree. perform pregnancy testing if pregnancy is suspected during treatment with myfembree and discontinue treatment if pregnancy is confirmed [see contraindications (4)and warnings and precautions (5.8)]. contraception advise women of reproductive potential to use effective non-hormonal contraception during treatment with myfembree and for at least 1 week following discontinuation. avoid concomitant use of hormonal contraceptives with myfembree. the use of estrogen-containing hormonal contraceptives may increase the risk of estrogen-associated adverse events and is expected to decrease the efficacy of myfembree [see warnings and precautions (5.8)] . safety and effectiveness of myfembree in pediatric patients have not been established. myfembree is contraindicated in women with hepatic impairment or disease [see contraindications (4)]. the use of e2 (a component of myfembree) in patients with hepatic impairment is expected to increase the exposure to e2 and increase the risk of e2-associated adverse reactions [see clinical pharmacology (12.3)] .

European Union - English - EMA (European Medicines Agency)

accord healthcare s.l.u. - relugolix - prostatic neoplasms - endocrine therapy - orgovyx is indicated for the treatment of adult patients with advanced hormone-sensitive prostate cancer.

European Union - English - EMA (European Medicines Agency)

gedeon richter plc. - relugolix, norethisterone acetate, estradiol hemihydrate - leiomyoma - pituitary and hypothalamic hormones and analogues - ryeqo is indicated in adult women of reproductive age for:- treatment of moderate to severe symptoms of uterine fibroids,- symptomatic treatment of endometriosis in women with a history of previous medical or surgical treatment for their endometriosis.

Canada - English - Health Canada

sumitomo pharma switzerland gmbh - relugolix; estradiol; norethindrone acetate - tablet - 40mg; 1mg; 0.5mg - relugolix 40mg; estradiol 1mg; norethindrone acetate 0.5mg

Canada - English - Health Canada

sumitomo pharma switzerland gmbh - relugolix - tablet - 120mg - relugolix 120mg

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

gedeon richter australia pty ltd - relugolix, quantity: 40 mg; estradiol, quantity: 1 mg (equivalent: estradiol hemihydrate, qty 1.032 mg); norethisterone acetate, quantity: 0.5 mg - tablet, film coated - excipient ingredients: mannitol; sodium starch glycollate type a; magnesium stearate; lactose monohydrate; hyprolose; titanium dioxide; hypromellose; triacetin; iron oxide yellow - ryeqo is indicated in adult women of reproductive age for:,? treatment of moderate to severe symptoms of uterine fibroids,,?symptomatic treatment of endometriosis in women with a history of previous medical or surgical treatment for their endometriosis (see section 5.1 pharmacodynamic properties).

Bangladesh - English - DGDA (Directorate General of Drug Administration)

renata limited - relugolix - tablet - 120 mg

Bangladesh - English - DGDA (Directorate General of Drug Administration)

incepta pharmaceuticals ltd. (dhamrai unit) - relugolix - tablet - 120 mg

Bangladesh - English - DGDA (Directorate General of Drug Administration)

beacon pharmaceuticals plc - relugolix - tablet - 120 mg