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

par pharmaceutical, inc. - everolimus (unii: 9hw64q8g6g) (everolimus - unii:9hw64q8g6g) - everolimus tablets are indicated for the treatment of postmenopausal women with advanced hormone receptor-positive, her2-negative breast cancer in combination with exemestane, after failure of treatment with letrozole or anastrozole. everolimus tablets are indicated for the treatment of adult patients with progressive neuroendocrine tumors of pancreatic origin (pnet) with unresectable, locally advanced or metastatic disease. limitations of use : everolimus tablets are not indicated for the treatment of patients with functional carcinoid tumors [see clinical studies (14.2)]. everolimus tablets are indicated for the treatment of adult patients with advanced rcc after failure of treatment with sunitinib or sorafenib. everolimus tablets are indicated for the treatment of adult patients with renal angiomyolipoma and tsc, not requiring immediate surgery. everolimus tablets are indicated in adult and pediatric patients aged 1 year and older with tsc for the treatment of sega that requires therapeutic intervention bu

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

teva pharmaceuticals usa, inc. - everolimus (unii: 9hw64q8g6g) (everolimus - unii:9hw64q8g6g) - everolimus tablets are indicated for the treatment of postmenopausal women with advanced hormone receptor-positive, her2-negative breast cancer in combination with exemestane, after failure of treatment with letrozole or anastrozole. everolimus tablets are indicated for the treatment of adult patients with progressive neuroendocrine tumors of pancreatic origin (pnet) with unresectable, locally advanced or metastatic disease. everolimus tablets are indicated for the treatment of adult patients with progressive, well-differentiated, non-functional net of gastrointestinal (gi) or lung origin with unresectable, locally advanced or metastatic disease. limitations of use: everolimus tablets are not indicated for the treatment of patients with functional carcinoid tumors [see clinical studies (14.2)] . everolimus tablets are indicated for the treatment of adult patients with advanced rcc after failure of treatment with sunitinib or sorafenib. everolimus tablets are indicated for the treatment of adult patient

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

hikma pharmaceuticals usa inc. - everolimus (unii: 9hw64q8g6g) (everolimus - unii:9hw64q8g6g) - everolimus is indicated for the treatment of adult patients with advanced rcc after failure of treatment with sunitinib or sorafenib. everolimus is indicated for the treatment of adult patients with renal angiomyolipoma and tsc, not requiring immediate surgery. everolimus is contraindicated in patients with clinically significant hypersensitivity to everolimus or to other rapamycin derivatives [see warnings and precautions (5.3)] . risk summary based on animal studies and the mechanism of action [see clinical pharmacology (12.1)] , everolimus can cause fetal harm when administered to a pregnant woman. there are limited case reports of everolimus use in pregnant women; however, these reports are not sufficient to inform about risks of birth defects or miscarriage. in animal studies, everolimus caused embryo-fetal toxicities in rats when administered during the period of organogenesis at maternal exposures that were lower than human exposures at the recommended dose of everolimus 10 mg orally once daily [see data]. advise pregnant women of the potential risk to the fetus. in the u.s. general population, the estimated background risk of major birth defects and miscarriage is 2% to 4% and 15% to 20% of clinically recognized pregnancies, respectively. data animal data: in animal reproductive studies, oral administration of everolimus to female rats before mating and through organogenesis induced embryo-fetal toxicities, including increased resorption, pre-implantation and post-implantation loss, decreased numbers of live fetuses, malformation (e.g., sternal cleft), and retarded skeletal development. these effects occurred in the absence of maternal toxicities. embryo-fetal toxicities in rats occurred at doses ≥0.1 mg/kg (0.6 mg/m2 ) with resulting exposures of approximately 4% of the human exposure at the recommended dose of everolimus 10 mg orally once daily based on area under the curve (auc). in rabbits, embryo-toxicity evident as an increase in resorptions occurred at an oral dose of 0.8 mg/kg (9.6 mg/m2 ). the effect in rabbits occurred in the presence of maternal toxicities. in a pre- and post-natal development study in rats, animals were dosed from implantation through lactation. at the dose of ≥0.1 mg/kg (0.6 mg/m2 ), there were no adverse effects on delivery and lactation or signs of maternal toxicity; however, there were reductions in body weight (up to 9% reduction from the control) and in survival of offspring (~5% died or missing). there were no drug-related effects on the developmental parameters (morphological development, motor activity, learning, or fertility assessment) in the offspring. risk summary there are no data on the presence of everolimus or its metabolites in human milk, the effects of everolimus on the breastfed infant or on milk production. everolimus and its metabolites passed into the milk of lactating rats at a concentration 3.5 times higher than in maternal serum. because of the potential for serious adverse reactions in breastfed infants from everolimus, advise women not to breastfeed during treatment with everolimus and for 2 weeks after the last dose. pregnancy testing verify the pregnancy status of females of reproductive potential prior to starting everolimus [see use in specific populations (8.1)] . contraception everolimus can cause fetal harm when administered to pregnant women [see use in specific populations (8.1)] . females: advise female patients of reproductive potential to use effective contraception during treatment with everolimus and for 8 weeks after the last dose. males: advise male patients with female partners of reproductive potential to use effective contraception during treatment with everolimus and for 4 weeks after the last dose. infertility females: menstrual irregularities, secondary amenorrhea, and increases in luteinizing hormone (lh) and follicle stimulating hormone (fsh) occurred in female patients taking everolimus. based on these findings, everolimus may impair fertility in female patients [see adverse reactions (6.1) and nonclinical toxicology (13.1)] . males: cases of reversible azoospermia have been reported in male patients taking everolimus. in male rats, sperm motility, sperm count, plasma testosterone levels and fertility were diminished at auc similar to those of the clinical dose of everolimus 10 mg orally once daily. based on these findings, everolimus may impair fertility in male patients [see nonclinical toxicology (13.1)] . the safety and effectiveness of everolimus in pediatric patients have not been established in: in record-1, 41% of patients with renal cell carcinoma treated with everolimus were ≥ 65 years of age, while 7% were ≥ 75 years of age. no overall differences in safety or effectiveness were observed between elderly and younger patients. everolimus exposure may increase in patients with hepatic impairment [see clinical pharmacology (12.3)] . for patients with rcc and tsc-associated renal angiomyolipoma who have hepatic impairment, reduce the everolimus dose as recommended [see dosage and administration (2.10)] .

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

mylan pharmaceuticals inc. - everolimus (unii: 9hw64q8g6g) (everolimus - unii:9hw64q8g6g) - everolimus tablets are indicated for the treatment of postmenopausal women with advanced hormone receptor-positive, her2-negative breast cancer in combination with exemestane, after failure of treatment with letrozole or anastrozole. everolimus tablets are indicated for the treatment of adult patients with progressive, well-differentiated, non-functional net of gastrointestinal (gi) or lung origin with unresectable, locally advanced or metastatic disease. limitations of use : everolimus tablets are not indicated for the treatment of patients with functional carcinoid tumors [see clinical studies (14.2)]. everolimus tablets are indicated for the treatment of adult patients with renal angiomyolipoma and tsc, not requiring immediate surgery. everolimus tablets are indicated in adult and pediatric patients aged 1 year and older with tsc for the treatment of sega that requires therapeutic intervention but cannot be curatively resected. everolimus is contraindicated in patients with clinically significant hypersen

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

breckenridge pharmaceutical, inc. - everolimus (unii: 9hw64q8g6g) (everolimus - unii:9hw64q8g6g) - everolimus tablets are indicated for the treatment of postmenopausal women with advanced hormone receptor-positive, her2-negative breast cancer in combination with exemestane, after failure of treatment with letrozole or anastrozole. everolimus tablets are indicated for the treatment of adult patients with progressive neuroendocrine tumors of pancreatic origin (pnet) with unresectable, locally advanced or metastatic disease. everolimus tablets are indicated for the treatment of adult patients with progressive, well-differentiated, non-functional net of gastrointestinal (gi) or lung origin with unresectable, locally advanced or metastatic disease. limitations of use: everolimus tablets are not indicated for the treatment of patients with functional carcinoid tumors [see clinical studies (14.2)]. everolimus tablets are indicated for the treatment of adult patients with advanced rcc after failure of treatment with sunitinib or sorafenib. everolimus tablets are indicated for the treatment of adult patients with

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

natco pharma limited - everolimus (unii: 9hw64q8g6g) (everolimus - unii:9hw64q8g6g) - everolimus tablets are indicated for the treatment of postmenopausal women with advanced hormone receptor-positive, her2-negative breast cancer in combination with exemestane, after failure of treatment with letrozole or anastrozole. everolimus tablets are indicated for the treatment of adult patients with progressive neuroendocrine tumors of pancreatic origin (pnet) with unresectable, locally advanced or metastatic disease. everolimus tablets are indicated for the treatment of adult patients with progressive, well-differentiated, non-functional net of gastrointestinal (gi) or lung origin with unresectable, locally advanced or metastatic disease. limitations of use:  everolimus tablets are not indicated for the treatment of patients with functional carcinoid tumors [see clinical studies (14.2)] . everolimus tablets are indicated for the treatment of adult patients with advanced rcc after failure of treatment with sunitinib or sorafenib. everolimus tablets are indicated for the treatment of adult patients wi

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

natco pharma limited - everolimus (unii: 9hw64q8g6g) (everolimus - unii:9hw64q8g6g) - everolimus is indicated for the prophylaxis of organ rejection in adult patients at low-moderate immunologic risk receiving a kidney transplant [see clinical studies (14.1)]. everolimus is to be administered in combination with basiliximab induction and concurrently with reduced doses of cyclosporine and with corticosteroids. therapeutic drug monitoring (tdm) of everolimus and cyclosporine is recommended for all patients receiving these products [see dosage and administration (2.2, 2.3)] . everolimus is indicated for the prophylaxis of allograft rejection in adult patients receiving a liver transplant. everolimus is to be administered no earlier than 30 days post-transplant concurrently in combination with reduced doses of tacrolimus and with corticosteroids [see warnings and precautions (5.5), clinical studies (14.2)]. tdm of everolimus and tacrolimus is recommended for all patients receiving these products [see dosage and administration (2.3, 2.5)]. the safety and efficacy of everolimus has not been estab

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

biocon pharma inc. - everolimus (unii: 9hw64q8g6g) (everolimus - unii:9hw64q8g6g) - everolimus tablets are indicated for the treatment of postmenopausal women with advanced hormone receptor-positive, her2-negative breast cancer in combination with exemestane, after failure of treatment with letrozole or anastrozole. everolimus tablets are indicated for the treatment of adult patients with renal angiomyolipoma and tsc, not requiring immediate surgery. everolimus tablets are indicated in adult and pediatric patients aged 1 year and older with tsc for the treatment of sega that requires therapeutic intervention but cannot be curatively resected. everolimus are contraindicated in patients with clinically significant hypersensitivity to everolimus or to other rapamycin derivatives [see warnings and precautions (5.3)] . risk summary based on animal studies and the mechanism of action [see clinical pharmacology (12.1)] , everolimus tablets can cause fetal harm when administered to a pregnant woman. there are limited case reports of everolimus tablets use in pregnant women; however, these reports ar

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

mylan pharmaceuticals inc. - everolimus (unii: 9hw64q8g6g) (everolimus - unii:9hw64q8g6g) - everolimus tablets for oral suspension are indicated in adult and pediatric patients aged 1 year and older with tsc for the treatment of sega that requires therapeutic intervention but cannot be curatively resected. everolimus tablets for oral suspension are indicated for the adjunctive treatment of adult and pediatric patients aged 2 years and older with tsc-associated partial-onset seizures. everolimus tablets for oral suspension are contraindicated in patients with clinically significant hypersensitivity to everolimus or to other rapamycin derivatives [see warnings and precautions (5.3)] . based on animal studies and the mechanism of action [see clinical pharmacology (12.1)] , everolimus tablets for oral suspension can cause fetal harm when administered to a pregnant woman. there are limited case reports of afinitor use in pregnant women; however, these reports are not sufficient to inform about risks of birth defects or miscarriage. in animal studies, everolimus caused embryo-fetal toxicities in rats when

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

ascend laboratories, llc - everolimus (unii: 9hw64q8g6g) (everolimus - unii:9hw64q8g6g) - everolimus tablets are indicated for the prophylaxis of organ rejection in adult patients at low-moderate immunologic risk receiving a kidney transplant [see clinical studies (14.1) ] everolimus tablets are to be administered in combination with basiliximab induction and concurrently with reduced doses of cyclosporine and with corticosteroids. therapeutic drug monitoring (tdm) of everolimus tablets and cyclosporine is recommended for all patients receiving these products. [see dosage and administration (2.2, 2.3) ] everolimus tablets are indicated for the prophylaxis of allograft rejection in adult patients receiving a liver transplant. everolimus tablets are to be administered no earlier than 30 days post-transplant concurrently in combination with reduced doses of tacrolimus and with corticosteroids [see warnings and precautions (5.5), clinical studies (14.2) ]. therapeutic drug monitoring (tdm) of everolimus tablets and tacrolimus is recommended for all patients receiving these products [see dosage and adm