Afinitor(everolimus)
AFINITOR DISPERZ 2 MG Tablet for Oral Suspension
NO BOXED WARNING
Dosage & Administration
Do not combine AFINITOR and AFINITOR DISPERZ to achieve the total daily dose.
Modify the dose for patients with hepatic impairment or for patients taking drugs that inhibit or induce P-glycoprotein (P-gp) and CYP3A4.
Breast Cancer:
NET:
RCC:
TSC-Associated Renal Angiomyolipoma:
TSC-Associated SEGA:
TSC-Associated Partial-Onset Seizures:
Get Your Patient on Afinitor
See your patient's specific prior authorization requirements including coverage restrictions and step therapies
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Afinitor Prescribing Information
Afinitor Prior Authorization Resources
Most recent state uniform prior authorization forms
Verified: Sep 24, 2024Arizona - Uniform Prior Authorization Form
Verified: Sep 24, 2024Colorado - Uniform Prior Authorization Form
Verified: Sep 24, 2024Hawaii - Uniform Prior Authorization Form
Verified: Sep 24, 2024Illinois - Uniform Prior Authorization Form
Verified: Sep 24, 2024Indiana - Uniform Prior Authorization Form
Verified: Sep 24, 2024Louisiana - Uniform Prior Authorization Form
Verified: Sep 24, 2024Minnesota - Uniform Prior Authorization Form
Verified: Sep 24, 2024New Hampshire - Uniform Prior Authorization Form
Verified: Sep 24, 2024New Mexico - Uniform Prior Authorization Form
Verified: Sep 24, 2024Oregon - Uniform Prior Authorization Form
Verified: Sep 24, 2024Texas - Uniform Prior Authorization Form
Verified: Oct 05, 2024Washington - Uniform Prior Authorization Form
Verified: Oct 05, 2024Wisconsin - Uniform Prior Authorization Form
Benefits investigation
Afinitor Financial Assistance Options
Copay savings program
Learn More
Overview
- Reduce patient OOP costs for drug (and occasionally for drug administration/infusion costs or drug-related test costs)
Patient benefit
- A portion (or all) of patient OOP (deductible, copay), typically up to monthly and/or annual max
Patient eligibility
- Patient must enroll or activate (may permit HCPs to enroll on patient’s behalf for HCP-administered drugs)
- Generally, must have commercial insurance (rarely, may permit uninsured patients to use)
- May never be used with government insurance
How to sign up
- Cards may be downloadable digital cards or hard copies
- Some pharmacos offer debit cards with pre-loaded copay benefit
- Typically, available through multiple channels (e.g., rep to HCP to patient; pharmacy to patient; patient via website, Hub live agent, or copay vendor (live agent or IVR); patient and HCP via Hub enrollment form)
- Some HCP-administered product programs permit HCPs to enroll on a patient’s behalf through via Hub form
Foundation programs
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Overview
- Charitable 501(c)(3) organizations provide direct cost-sharing and other support (e.g., travel, counseling) through disease-state funds to indigent patients on first-come first-served basis
- These organizations may receive financial contributions from drug manaufacturers for particular disease-state funds that cannot provide funds directly to patients - the foundation must be independent/unaligned
Patient benefit
- Patients apply for grants that cover a portion (or all) of their out-of-pocket costs (deductibles and copays) until the grant is exhausted
Patient eligibility
- Patients must apply and meet eligibility criteria including income level (typically a multiple of federal poverty line), specific diagnosis, insurance status, etc.
How to sign up
- Patients submit proof of out-of-pocket drug costs to charities for reimbursement
Afinitor PubMed™ News
Afinitor Patient Education
To share resource; ask patient to:
1.Pull out phone
2.Open camera
3.Scan QR code with camera
4.Tap link
Afinitor FAQs
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.
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.
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.
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.
Females of reproductive potential should have their pregnancy status verified prior to starting 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.
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.
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.
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.
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.
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.
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.
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.
Hepatic impairment can increase AFINITOR/AFINITOR DISPERZ exposure.
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.
We receive information directly from the FDA and PrescriberPoint is updated as frequently as change are made available