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

pfizer australia pty ltd - sirolimus, quantity: 1 mg/ml - oral liquid, solution - excipient ingredients: polysorbate 80; propylene glycol; ethanol; ascorbyl palmitate; phosphatidyl choline; mono- and di- glycerides; soy fatty acids - indications as at 9 february 2004: rapamune is indicated for the prophylaxis of organ rejection in patients at mild to moderate immunological risk receiving renal transplants. therapeutic drug monitoring of sirolimus is required.

USA - engelsk - NLM (National Library of Medicine)

nobelpharma america, llc - sirolimus (unii: w36zg6ft64) (sirolimus - unii:w36zg6ft64) - hyftor is indicated for the treatment of facial angiofibroma associated with tuberous sclerosis in adults and pediatric patients 6 years of age and older. hyftor is contraindicated in patients with a history of hypersensitivity to sirolimus or any other component of hyftor. reactions to sirolimus have included anaphylactic/anaphylactoid reactions, angioedema, exfoliative dermatitis, and hypersensitivity vasculitis [see warning and precautions (5.1)] . risk summary based on animal studies and mechanism of action, oral sirolimus can cause fetal harm when administered to a pregnant woman. hyftor is systemically absorbed after topical administration and may result in fetal exposure. the available data from case reports on hyftor use in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. animal reproduction studies have not been conducted with hyftor. in an animal reproduction study, oral administration of 0.5 mg/kg/day sirolimus caused embryo-fetal lethality in pregnant rats when administered during the period of organogenesis (see data). the available data do not allow the calculation of relevant comparisons between the systemic exposure of sirolimus observed in animal studies to the systemic exposure that would be expected in humans after topical use of hyftor. the background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. 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. data animal data in embryo-fetal development studies in rats, oral administration of sirolimus to pregnant rats during the period of organogenesis (gestation days 6 -15) induced embryo-fetal lethality at 0.5 mg/kg/day, reduced fetal body weight at 1.0 mg/kg/day and caused maternal toxicity at 2.0 mg/kg/day. no treatment related embryo-fetal developmental effects were observed at 0.1 mg/kg/day. in embryo-fetal development studies in rabbits, oral administration of sirolimus to pregnant rabbits during the period of organogenesis (gestation days 6 -18) induced maternal toxicity (decreased body weight) at 0.05 mg/kg/day, which was associated with embryo-fetal loss or early resorption. no treatment related developmental effects were observed at 0.025 mg/kg/day. in a pre- and postnatal development toxicity study, oral administration of sirolimus to pregnant rats during gestation and lactation (gestation day 6 through lactation day 20) increased the incidence of dead pups, resulting in reduced live litter size at 0.5 mg/kg/day. no treatment related developmental effects were observed at 0.1 mg/kg/day. sirolimus did not cause maternal toxicity or affect developmental parameters in the surviving offspring (morphological development, motor activity, learning, or fertility assessment) at 0.5 mg/kg/day, the highest dose tested. risk summary there are no available data on the presence of sirolimus in human milk, the effects on the breastfed infant, or the effects on milk production. after oral administration, sirolimus was present in the milk of lactating rats. because of the potential for serious adverse reactions in the breastfed infant, breastfeeding is not recommended during treatment with hyftor. contraception based on animal studies with oral sirolimus, hyftor may cause fetal harm when administered to pregnant women. females of reproductive potential are recommended to avoid becoming pregnant and to use an effective contraceptive method. effective contraception should be initiated before hyftor therapy and used throughout treatment and for 12 weeks after the final dose of hyftor [see warnings and precautions (5.7), use in specific populations (8.1)] . infertility based on clinical findings and findings in animal studies, male and female fertility may be compromised by the treatment with sirolimus [see warnings and precautions (5.8), nonclinical toxicology (13.1)]. ovarian cysts and menstrual disorders (including amenorrhea and menorrhagia) have been reported in females with the use of oral sirolimus. azoospermia has been reported in males with the use of oral sirolimus and have been reversible upon discontinuation of sirolimus in most cases. the safety and effectiveness of hyftor have been established in pediatric patients aged 6 years and older for the topical treatment of facial angiofibroma associated with tuberous sclerosis. use of hyftor in this age group is supported by data from a randomized, vehicle-controlled, double-blind 12-week trial along with additional efficacy and long-term safety data from a 104-week open label safety trial. a total of 13 pediatric subjects aged 6 years to 17 years received hyftor in the phase 3 clinical trial along with 48 pediatric subjects aged 3 years to 17 years in the 104-week open label safety trial. adverse reactions occurred with similar frequency in adult and pediatric subjects [see adverse reaction (6.1), clinical studies (14)]. the safety and effectiveness of hyftor for this indication have not been established in pediatric patients less than 6 years of age. clinical studies of hyftor did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger patients.

USA - engelsk - NLM (National Library of Medicine)

aadi bioscience - sirolimus (unii: w36zg6ft64) (sirolimus - unii:w36zg6ft64) - fyarro™ is indicated for the treatment of adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (pecoma). fyarro is contraindicated in patients with a history of severe hypersensitivity to sirolimus, other rapamycin derivatives, or albumin [see warnings and precautions (5.8)] . risk summary based on animal studies and the mechanism of action, fyarro can cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)] . although there are no data on the use of fyarro in pregnant women, there are limited data on the use of sirolimus during pregnancy. in animal studies, oral sirolimus was embryo/fetotoxic in rats [see data] at sub-therapeutic doses. advise pregnant women of the potential risk to a fetus. the estimated 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. data animal data reproductive studies in animals have not been performed with fyarro. studies with an oral formulation of sirolimus have shown that it crosses the placenta and is toxic to the conceptus. in rat embryo-fetal development studies, pregnant rats were administered an oral formulation of sirolimus during the period of organogenesis (gestational day 6-15). sirolimus produced embryo-fetal lethality at 0.5 mg/kg and reduced fetal weight at 1 mg/kg. the no observed adverse effect level (noael) for fetal toxicity in rats was 0.1 mg/kg. maternal toxicity (weight loss) was observed at 2 mg/kg. the noael for maternal toxicity was 1 mg/kg. in rabbit embryo-fetal development studies, pregnant rabbits were administered an oral formulation of sirolimus during the period of organogenesis (gestational day 6-18). there were no effects on embryo-fetal development at doses up to 0.05 mg/kg; however, at doses of 0.05 mg/kg and above, the ability to sustain a pregnancy was impaired (i.e., embryo-fetal abortion or early resorption). maternal toxicity (decreased body weight) was observed at 0.05 mg/kg. the noael for maternal toxicity was 0.025 mg/kg. in a pre- and post-natal development study in rats, pregnant females were dosed with an oral formation of sirolimus during gestation and lactation (gestational day 6 through lactation day 20). an increased incidence of dead pups occurred at 0.5 mg/kg, resulting in reduced live litter size. at 0.1 mg/kg, there were no adverse effects on offspring. sirolimus did not cause maternal toxicity or affect developmental parameters in the surviving offspring (e.g., morphological development, motor activity, learning, or fertility assessment) at 0.5 mg/kg, the highest oral dose tested. risk summary there are no data on the presence of fyarro in human milk or its effects on the breastfed child or on milk production. it is not known whether sirolimus is present in human milk. there are no data on its effects on the breastfed infant or milk production. the pharmacokinetic and safety profiles of sirolimus in infants are not known. sirolimus is present in the milk of lactating rats. there is potential for serious adverse effects from sirolimus in breastfed infants based on mechanism of action [see clinical pharmacology (12.1)] . because of the potential for serious adverse reactions in breastfed infants from fyarro, advise women not to breastfeed during treatment with fyarro and for 2 weeks after the last dose. fyarro can cause fetal harm when administered to a pregnant woman [see warnings and precautions (5.9), use in specific populations (8.1)] . pregnancy testing verify pregnancy status of females of reproductive potential prior to initiating fyarro. contraception females advise females of reproductive potential to use effective contraception during treatment with fyarro and for 12 weeks after the last dose. males advise males with female partners of reproductive potential to use effective contraception during treatment with fyarro and for 12 weeks after the last dose. infertility although there are no data on the impact of fyarro on fertility, based on available clinical findings with oral formulation of sirolimus and findings in animals, male and female fertility may be compromised by the treatment with fyarro [see warnings and precautions (5.10), nonclinical toxicology (13.1)] . ovarian cysts and menstrual disorders (including amenorrhea and menorrhagia) have been reported in females with the use of oral formulation of sirolimus. azoospermia has been reported in males with the use of oral formulation sirolimus and has been reversible upon discontinuation in most cases. the safety and efficacy of fyarro in pediatric patients have not been established. of the 34 patients treated with fyarro, 44% were 65 years of age and older, and 6% were 75 years of age and older. clinical studies of fyarro did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients. fyarro is not recommended for use in patients with severe hepatic impairment. reduce fyarro dosage in patients with mild or moderate hepatic impairment [see dosage and administration (2.4), clinical pharmacology (12.3)] .

Den europeiske union - maltesisk - EMA (European Medicines Agency)

pfizer europe ma eeig - temsirolimus - carcinoma, renal cell; lymphoma, mantle-cell - aġenti antineoplastiċi - renali taċ-ċelluli carcinomatorisel huwa indikat għall-kura tal-ewwel linja ta ' pazjenti adulti b'indeboliment avanzat tal-karċinoma taċ-ċellola (rcc) li jkollhom mill-inqas tlieta minn sitt fatturi tar-riskju pronjostiċi. f'forma ta'tubu taċ-ċelluli lymphomatorisel huwa indikat għall-kura ta ' pazjenti adulti b'all rikadut u / jew refrattorji f'forma ta'tubu taċ-ċellula tal-limfoma (mcl).

Den europeiske union - dansk - EMA (European Medicines Agency)

pfizer europe ma eeig - temsirolimus - carcinoma, renal cell; lymphoma, mantle-cell - antineoplastiske midler - nyre-celle carcinomatorisel er angivet for den første linje behandling af voksne patienter med avanceret renal celle carcinom (rcc), der har mindst tre af seks prognostiske risikofaktorer. mantle-celle lymphomatorisel er indiceret til behandling af voksne patienter med recidiverende og / eller ildfaste mantle-celle lymfom (mcl).

Taiwan - kinesisk - 衛生福利部食品藥物管理署 (Ministry of Health and Welfare, Food And Drug Administration)

美商惠氏藥廠（亞洲）股份有限公司台灣分公司 台北市信義區松仁路100號42、43樓 (23984410) - sirolimus nanosystems dispersion;;sirolimus - 糖衣錠 - 主成分 (active filler coat) ; sirolimus (9200039600) mg; sirolimus nanosystems dispersion (9200039620) - sirolimus - １、適用於與cyclosporine及皮質類固醇合併使用來預防病人腎臟移植後之器官排斥。２、適用於淋巴血管平滑肌增生症(lymphangioleiomyomatosis，簡稱lam)成人病人的治療。

Den europeiske union - tysk - EMA (European Medicines Agency)

pfizer europe ma eeig - temsirolimus - carcinoma, renal cell; lymphoma, mantle-cell - antineoplastische mittel - renal-cell carcinomatorisel ist angezeigt für die first-line-behandlung von erwachsenen patienten mit fortgeschrittenen, renal-cell carcinoma (rcc), die mindestens drei von sechs prognostischen risikofaktoren. mantel-zell-lymphomatorisel ist indiziert für die behandlung von erwachsenen patienten mit rezidiviertem und / oder refraktärem mantel-zell-lymphom (mcl).

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

pfizer australia pty ltd - sirolimus -

Taiwan - kinesisk - 衛生福利部食品藥物管理署 (Ministry of Health and Welfare, Food And Drug Administration)

美商惠氏藥廠（亞洲）股份有限公司台灣分公司 台北市信義區松仁路100號42、43樓 (23984410) - temsirolimus - 注射劑 - temsirolimus (9250001400) mg - temsirolimus - 治療晚期腎細胞癌；患者需具有下列六個風險因子中至少三個以上因子：(1)距離初次診斷出腎細胞癌之時間未達一年、(2)karnofsky performance scale (kps)介於60至70之間、(3)血色素低於正常值、(4)矯正後血鈣值超過10mg/dl、(5)乳酸脫氫酶(lactate dehydrogenase)超過1.5倍正常值上限、(6)超過一個以上的器官有轉移病灶。用於曾經接受兩種化療處方治療失敗的成人被套細胞淋巴瘤

Tyrkia - tyrkisk - TİTCK (Türkİye İlaç Ve Tibbİ Cİhaz Kurumu)

pfİzer pfe İlaÇlari a.Ş. - sirolimus - sirolimus