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

hikma pharmaceuticals usa inc. - 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 and 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 posttransplant concurrently in combination with reduced doses of tacrolimus and with corticosteroids [see warnings and precautions (5.5) and 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

Israel - English - Ministry of Health

abic marketing ltd, israel - everolimus - tablets - everolimus 10 mg - everolimus - • for the treatment of patients with sega associated with tuberous sclerosis complex (tsc) who require therapeutic intervention but are not candidates for curative surgical resection. the effectiveness of everolimus is based on an analysis of change in sega volume. clinical benefit such as improvement in disease-related symptoms or increase in overall survival has not been demonstrated. • treatment of progressive neuroendocrine tumors of pancreatic origin (pnet) in patients with unresectable, locally advanced or metastatic disease. the safety and effectiveness of everolimus in the treatment of patients with carcinoid tumors have not been established.• for the treatment of hormone receptor – positive, her2/neu negative advanced breast cancer, in combination with exemestane, in postmenopausal women without symptomatic visceral disease after recurrence or progression follwing a non – steroidal aromatase inhibitor.• everolimus teva is indicated for the treatment of adult patients with renal angiomyolipoma and tuberous sclerosis complex (tsc), not requiring immediate surgery. the effectiveness of everolimus in treatment of renal angiomyolipoma is based on an analysis of durable objective responses in patients treated for a median of 8.3 months. further follow-up of patients is required to determine long-term outcomes.• everolimus teva is indicated for the treatment of patients with advanced renal cell carcinoma, whose disease has progressed on or after treatment with vegf-targeted therapy.•treatment of unresectable, locally advanced or metastatic, well-differentiated (grade 1 or grade 2) non-functional neuroendocrine tumours of gastrointestinal or lung origin in adults with progressive disease

Israel - English - Ministry of Health

abic marketing ltd, israel - everolimus - tablets - everolimus 2.5 mg - everolimus - • for the treatment of patients with sega associated with tuberous sclerosis complex (tsc) who require therapeutic intervention but are not candidates for curative surgical resection. the effectiveness of everolimus is based on an analysis of change in sega volume. clinical benefit such as improvement in disease-related symptoms or increase in overall survival has not been demonstrated. • treatment of progressive neuroendocrine tumors of pancreatic origin (pnet) in patients with unresectable, locally advanced or metastatic disease. the safety and effectiveness of everolimus in the treatment of patients with carcinoid tumors have not been established.• for the treatment of hormone receptor – positive, her2/neu negative advanced breast cancer, in combination with exemestane, in postmenopausal women without symptomatic visceral disease after recurrence or progression follwing a non – steroidal aromatase inhibitor.• everolimus teva is indicated for the treatment of adult patients with renal angiomyolipoma and tuberous sclerosis complex (tsc), not requiring immediate surgery. the effectiveness of everolimus in treatment of renal angiomyolipoma is based on an analysis of durable objective responses in patients treated for a median of 8.3 months. further follow-up of patients is required to determine long-term outcomes.• everolimus teva is indicated for the treatment of patients with advanced renal cell carcinoma, whose disease has progressed on or after treatment with vegf-targeted therapy.• treatment of unresectable, locally advanced or metastatic, well-differentiated (grade 1 or grade 2) non-functional neuroendocrine tumours of gastrointestinal or lung origin in adults with progressive disease

Israel - English - Ministry of Health

abic marketing ltd, israel - everolimus - tablets - everolimus 5 mg - everolimus - • for the treatment of patients with sega associated with tuberous sclerosis complex (tsc) who require therapeutic intervention but are not candidates for curative surgical resection. the effectiveness of everolimus is based on an analysis of change in sega volume. clinical benefit such as improvement in disease-related symptoms or increase in overall survival has not been demonstrated. • treatment of progressive neuroendocrine tumors of pancreatic origin (pnet) in patients with unresectable, locally advanced or metastatic disease. the safety and effectiveness of everolimus in the treatment of patients with carcinoid tumors have not been established.• for the treatment of hormone receptor – positive, her2/neu negative advanced breast cancer, in combination with exemestane, in postmenopausal women without symptomatic visceral disease after recurrence or progression follwing a non – steroidal aromatase inhibitor.• everolimus teva is indicated for the treatment of adult patients with renal angiomyolipoma and tuberous sclerosis complex (tsc), not requiring immediate surgery. the effectiveness of everolimus in treatment of renal angiomyolipoma is based on an analysis of durable objective responses in patients treated for a median of 8.3 months. further follow-up of patients is required to determine long-term outcomes.• everolimus teva is indicated for the treatment of patients with advanced renal cell carcinoma, whose disease has progressed on or after treatment with vegf-targeted therapy.• treatment of unresectable, locally advanced or metastatic, well-differentiated (grade 1 or grade 2) non-functional neuroendocrine tumours of gastrointestinal or lung origin in adults with progressive disease

Israel - English - Ministry of Health

abic marketing ltd, israel - everolimus - tablets - everolimus 7.5 mg - everolimus - • for the treatment of patients with sega associated with tuberous sclerosis complex (tsc) who require therapeutic intervention but are not candidates for curative surgical resection. the effectiveness of everolimus is based on an analysis of change in sega volume. clinical benefit such as improvement in disease-related symptoms or increase in overall survival has not been demonstrated. • treatment of progressive neuroendocrine tumors of pancreatic origin (pnet) in patients with unresectable, locally advanced or metastatic disease. the safety and effectiveness of everolimus in the treatment of patients with carcinoid tumors have not been established.• for the treatment of hormone receptor – positive, her2/neu negative advanced breast cancer, in combination with exemestane, in postmenopausal women without symptomatic visceral disease after recurrence or progression follwing a non – steroidal aromatase inhibitor.• everolimus teva is indicated for the treatment of adult patients with renal angiomyolipoma and tuberous sclerosis complex (tsc), not requiring immediate surgery. the effectiveness of everolimus in treatment of renal angiomyolipoma is based on an analysis of durable objective responses in patients treated for a median of 8.3 months. further follow-up of patients is required to determine long-term outcomes.• everolimus teva is indicated for the treatment of patients with advanced renal cell carcinoma, whose disease has progressed on or after treatment with vegf-targeted therapy.• treatment of unresectable, locally advanced or metastatic, well-differentiated (grade 1 or grade 2) non-functional neuroendocrine tumours of gastrointestinal or lung origin in adults with progressive disease

Israel - English - Ministry of Health

taro international ltd, israel - everolimus - tablets - everolimus 10 mg - everolimus - - for the treatment of patients with sega associated with tuberous sclerosis complex (tsc) who require therapeutic intervention but are not candidates for curative surgical resection. the effectiveness of everolimus taro is based on an analysis of change in sega volume. clinical benefit such as improvement in disease-related symptoms or increase in overall survival has not been demonstrated.- treatment of progressive neuroendocrine tumors of pancreatic origin (pnet) in patients with unresectable, locally advanced or metastatic disease.the safety and effectiveness of everolimus taro in the treatment of patients with carcinoid tumors have not been established.- for the treatment of hormone receptor – positive, her2/neu negative advanced breast cancer, in combination with exemestane, in postmenopausal women without symptomatic visceral disease after recurrence or progression follwing a non – steroidal aromatase inhibitor.- everolimus taro is indicated for the treatment of adult patients with renal angiomyolipoma and tuberous sclerosis complex (tsc), not requiring immediate surgery. the effectiveness of everolimus taro in treatment of renal angiomyolipoma is based on an analysis of durable objective responses in patients treated for a median of 8.3 months. further follow-up of patients is required to determine long-term outcomes.- everolimus taro is indicated for the treatment of patients with advanced renal cell carcinoma, whose disease has progressed on or after treatment with vegf-targeted therapy.- treatment of unresectable, locally advanced or metastatic, well-differentiated (grade 1 or grade 2) non-functional neuroendocrine tumours of gastrointestinal or lung origin in adults with progressive disease.

Israel - English - Ministry of Health

taro international ltd, israel - everolimus - tablets - everolimus 2.5 mg - everolimus - - for the treatment of patients with sega associated with tuberous sclerosis complex (tsc) who require therapeutic intervention but are not candidates for curative surgical resection. the effectiveness of everolimus taro is based on an analysis of change in sega volume. clinical benefit such as improvement in disease-related symptoms or increase in overall survival has not been demonstrated.- treatment of progressive neuroendocrine tumors of pancreatic origin (pnet) in patients with unresectable, locally advanced or metastatic disease.the safety and effectiveness of everolimus taro in the treatment of patients with carcinoid tumors have not been established.- for the treatment of hormone receptor – positive, her2/neu negative advanced breast cancer, in combination with exemestane, in postmenopausal women without symptomatic visceral disease after recurrence or progression follwing a non – steroidal aromatase inhibitor.- everolimus taro is indicated for the treatment of adult patients with renal angiomyolipoma and tuberous sclerosis complex (tsc), not requiring immediate surgery. the effectiveness of everolimus taro in treatment of renal angiomyolipoma is based on an analysis of durable objective responses in patients treated for a median of 8.3 months. further follow-up of patients is required to determine long-term outcomes.- everolimus taro is indicated for the treatment of patients with advanced renal cell carcinoma, whose disease has progressed on or after treatment with vegf-targeted therapy.- treatment of unresectable, locally advanced or metastatic, well-differentiated (grade 1 or grade 2) non-functional neuroendocrine tumours of gastrointestinal or lung origin in adults with progressive disease.

Israel - English - Ministry of Health

taro international ltd, israel - everolimus - tablets - everolimus 5 mg - everolimus - - for the treatment of patients with sega associated with tuberous sclerosis complex (tsc) who require therapeutic intervention but are not candidates for curative surgical resection. the effectiveness of everolimus taro is based on an analysis of change in sega volume. clinical benefit such as improvement in disease-related symptoms or increase in overall survival has not been demonstrated.- treatment of progressive neuroendocrine tumors of pancreatic origin (pnet) in patients with unresectable, locally advanced or metastatic disease.the safety and effectiveness of everolimus taro in the treatment of patients with carcinoid tumors have not been established.- for the treatment of hormone receptor – positive, her2/neu negative advanced breast cancer, in combination with exemestane, in postmenopausal women without symptomatic visceral disease after recurrence or progression follwing a non – steroidal aromatase inhibitor.- everolimus taro is indicated for the treatment of adult patients with renal angiomyolipoma and tuberous sclerosis complex (tsc), not requiring immediate surgery. the effectiveness of everolimus taro in treatment of renal angiomyolipoma is based on an analysis of durable objective responses in patients treated for a median of 8.3 months. further follow-up of patients is required to determine long-term outcomes.- everolimus taro is indicated for the treatment of patients with advanced renal cell carcinoma, whose disease has progressed on or after treatment with vegf-targeted therapy.- treatment of unresectable, locally advanced or metastatic, well-differentiated (grade 1 or grade 2) non-functional neuroendocrine tumours of gastrointestinal or lung origin in adults with progressive disease.

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

par pharmaceutical, inc. - 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 is to be administered in combination with basiliximab induction and concurrently with reduced doses of cyclosporine and with corticosteroids. 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) and clinical studies (14.2) ]. therapeutic drug monitoring (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 no

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

breckenridge pharmaceutical, inc. - 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 established in the following populations: - kidney transplant patients at high immunologic risk - recipients of transplanted organs other than kidney and liver [see warnings and precautions (5.7)] - pediatric patients (less than 18 years). everolimus is contraindicated in patients with known hypersensitivity to everolimus, sirolimus, or to components of the drug product. 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 insufficient to inform a drug associated risk of adverse developmental outcomes. reproductive studies in animals have demonstrated that everolimus was maternally toxic in rabbits and caused embryo-fetal toxicities in rats and rabbits, at exposures near or below those achieved in human transplant patients. 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; however, in the u.s. general population, the estimated background risk of major birth defects is 2% to 4% and of miscarriage is 15% to 20% of clinically recognized pregnancies. data animal data everolimus crossed the placenta and was toxic to the conceptus. everolimus administered daily to pregnant rats by oral gavage at 0.1 mg/kg (approximately one tenth the exposure in humans administered the lowest starting dose of 0.75 mg twice daily), from before mating through organogenesis, resulted in increased preimplantation loss and embryonic resorptions. these effects occurred in the absence of maternal toxicities. everolimus administered daily by oral gavage to pregnant rabbits during organogenesis resulted in abortions, maternal toxicity and lethality, and increased fetal resorptions. at these doses, exposure to everolimus (auc) was approximately one-tenth, one-half, and one and one-half fold the exposures in humans administered the starting clinical dose, respectively. in a pre- and post-natal development study in rats, animals were dosed from implantation through lactation. at a 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) and in survival of offspring (~5%). there were no drug-related effects on the developmental parameters (morphological development, motor activity, learning, or fertility assessment) in the offspring. risk summary there is no data regarding the presence of everolimus in human milk, the effects on breastfed infants, or the effects on milk production. everolimus and/or its metabolites are readily transferred into milk of lactating rats at a concentration 3.5 times higher than in maternal rat serum. in pre-post-natal and juvenile studies in rats, exposure to everolimus during the postnatal period caused developmental toxicity [see use in specific populations (8.1), nonclinical toxicology (13.2)]. advise lactating women not to breastfeed because of the potential for serious adverse reactions in infants exposed to everolimus. contraception females should not be pregnant or become pregnant while receiving everolimus. advise females of reproductive potential that animal studies have been performed showing everolimus to be harmful to the mother and developing fetus [ see use in specific populations (8.1)] . females of reproductive potential are recommended to use highly effective contraception methods while receiving everolimus and up to 8 weeks after treatment has been stopped. infertility females amenorrhea occurred in female patients taking everolimus [ see adverse reactions (6.2)]. everolimus may cause pre-implantation loss in females based on animal data [see nonclinical toxicology (13.1)]. female fertility may be compromised by treatment with everolimus. males everolimus treatment may impair fertility in males based on human [see warnings and precautions (5.18), adverse reactions (6.2, 6.3)] and animal findings [see nonclinical toxicology (13.1)]. the safe and effective use of everolimus in kidney or liver transplant patients younger than 18 years of age has not been established. there is limited clinical experience on the use of everolimus in patients of age 65 years or older. there is no evidence to suggest that elderly patients will require a different dosage recommendation from younger adult patients [see clinical pharmacology (12.5)] . everolimus whole blood trough concentrations should be closely monitored in patients with impaired hepatic function. for patients with mild hepatic impairment (child-pugh class a), the dose should be reduced by approximately one-third of the normally recommended daily dose. for patients with moderate or severe hepatic impairment (child-pugh b or c), the initial daily dose should be reduced to approximately half of the normally recommended daily dose. further dose adjustment and/or dose titration should be made if a patient's whole blood trough concentration of everolimus, as measured by an lc/ms/ms assay, is not within the target trough concentration range of 3 to 8 ng/ml [see clinical pharmacology (12.6)]. no dose adjustment is needed in patients with renal impairment [see clinical pharmacology (12.6)].