Afinitor
(everolimus)everolimus 10 MG Oral Tablet [Afinitor]everolimus 2 MG Tablet for Oral Suspension [Afinitor]
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Afinitor FAQs
Can AFINITOR/AFINITOR DISPERZ cause fetal harm when administered to a pregnant woman?Based on animal studies and the mechanism of action, AFINITOR/AFINITOR DISPERZ can cause fetal harm when administered to a pregnant woman. 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 AFINITOR 10 mg orally once daily. However, there are limited case reports of AFINITOR use in pregnant women, and these reports are not sufficient to inform about risks of birth defects or miscarriage.
What is the estimated background risk of major birth defects and miscarriage for the indicated population?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. However, the estimated background risk of major birth defects and miscarriage for the indicated population is unknown.
What does the animal data say about the effects of everolimus on fetal development?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, 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 with resulting exposures of approximately 4% of the human exposure at the recommended dose of AFINITOR 10 mg orally once daily based on area under the curve (AUC). In rabbits, embryotoxicity evident as an increase in resorptions occurred at an oral dose of 0.8 mg/kg, approximately 1.6 times the recommended dose of AFINITOR 10 mg orally once daily or the median dose administered to patients with tuberous sclerosis complex (TSC)-associated subependymal giant cell astrocytoma (SEGA), and 1.3 times the median dose administered to patients with TSC-associated partial-onset seizures based on BSA.
Is everolimus present in human milk and does it affect the breastfed child or milk production?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, women are advised not to breastfeed during treatment with AFINITOR/AFINITOR DISPERZ and for 2 weeks after the last dose.
What should be done prior to starting AFINITOR/AFINITOR DISPERZ in females of reproductive potential?Females of reproductive potential should have their pregnancy status verified prior to starting AFINITOR/AFINITOR DISPERZ.
What should be advised to female patients of reproductive potential during treatment with AFINITOR/AFINITOR DISPERZ?Female patients of reproductive potential should use effective contraception during treatment with AFINITOR/AFINITOR DISPERZ and for 8 weeks after the last dose.
What should be advised to male patients with female partners of reproductive potential during treatment with AFINITOR/AFINITOR DISPERZ?Male patients with female partners of reproductive potential should use effective contraception during treatment with AFINITOR/AFINITOR DISPERZ and for 4 weeks after the last dose.
Can AFINITOR/AFINITOR DISPERZ impair fertility?AFINITOR/AFINITOR DISPERZ may impair fertility in both female and male patients. Menstrual irregularities, secondary amenorrhea, and increases in luteinizing hormone (LH) and follicle stimulating hormone (FSH) occurred in female patients taking AFINITOR/AFINITOR DISPERZ. Reversible azoospermia has been reported in male patients taking AFINITOR.
What is the recommended use of AFINITOR/AFINITOR DISPERZ in pediatric patients with TSC-associated SEGA?AFINITOR/AFINITOR DISPERZ can be used in pediatric patients age 1 year and older with TSC-associated SEGA that requires therapeutic intervention but cannot be curatively resected. The safety and effectiveness of AFINITOR/AFINITOR DISPERZ have not been established in pediatric patients less than 1 year of age with TSC-associated SEGA.
What is the recommended use of AFINITOR DISPERZ in pediatric patients with TSC-associated partial-onset seizures?AFINITOR DISPERZ can be used for the adjunctive treatment of pediatric patients aged 2 years and older with TSC-associated partial-onset seizures. The safety and effectiveness of AFINITOR DISPERZ and AFINITOR have not been established for the adjunctive treatment of pediatric patients less than 2 years of age with TSC-associated partial-onset seizures.
What is the geriatric use of AFINITOR/AFINITOR DISPERZ?In clinical trials such as BOLERO-2, RECORD-1, and RADIANT-3, elderly patients (aged 65 years and older) were included and no overall differences in safety or effectiveness were observed between elderly and younger patients.
What is the incidence of deaths due to any cause in geriatric patients treated with AFINITOR?According to clinical trials such as BOLERO-2, the incidence of deaths due to any cause within 28 days of the last AFINITOR dose was 6% in patients aged 65 years and older compared to 2% in patients younger than 65 years old.
What are the adverse reactions leading to permanent treatment discontinuation in geriatric patients treated with AFINITOR?In clinical trials such as BOLERO-2, adverse reactions leading to permanent treatment discontinuation occurred in 33% of patients aged 65 years and older compared to 17% in patients younger than 65 years old.
What is the effect of hepatic impairment on AFINITOR/AFINITOR DISPERZ exposure?Hepatic impairment can increase AFINITOR/AFINITOR DISPERZ exposure.
How should the dose of AFINITOR/AFINITOR DISPERZ be adjusted for patients with hepatic impairment?For patients with breast cancer, NET, RCC, and TSC-associated renal angiomyolipoma who have hepatic impairment, reduce the AFINITOR dose as recommended. For patients with TSC-associated SEGA and TSC-associated partial-onset seizures who have severe hepatic impairment (Child-Pugh class C), reduce the starting dose of AFINITOR/AFINITOR DISPERZ as recommended and adjust the dose based on everolimus trough concentrations.
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