AfiniTRAC® Comprehensive Support Throughout Your
Patients' Journey

AfiniTRAC may help patients navigate the insurance process

With AfiniTRAC, your patients get the comprehensive support they need.

AfiniTRAC connects each eligible patient with a Care Facilitator to:

  • Navigate patients and caregivers through treatment education, prescription coverage, and social services
  • Coordinate contact between patient, insurance plan, and pharmacy
  • Offer local resources

Comprehensive support* also includes a patient information kit that contains:

Patient information kit
  • Patient information brochure
  • Dosage and administration pamphlet
  • Treatment planner

For questions, call 1-888-9AfiniTRAC (1-888-923-4648).

AfiniTRAC offers comprehensive reimbursement support for eligible patients

  • Insurance benefits verification within 24-48 hours
  • Information on appeals of denied claims or coverage
  • Prior-authorization assistance
  • Afinitor co-pay program
  • Patient assistance programs

Afinitor: Comprehensive support in 3 steps†

Complete the
1-page AfiniTRAC
enrollment form

Print and sign the
enrollment form

An important reminder for
healthcare providers: Both you
and your patient must sign the
AfiniTRAC enrollment form.

Fax completed
enrollment form to
1-877-705-2282
and AfiniTRAC
does the rest

Pharmacists or dispensing physicians, order Afinitor by calling ASD Healthcare at 1-800-746-6273 or visiting www.ASDHealthcare.com.

 

*The Reimbursement Support Line and Novartis Pharmaceuticals Corporation do not guarantee success in obtaining reimbursement, nor do we submit appeals on behalf of providers or patients. Third-party payment for medical products and services is affected by numerous factors, not all of which can be anticipated or resolved by Reimbursement Support Line staff.

†It is not necessary for the patient to fill out the Enrollment Form to receive Afinitor. However, it is necessary to complete the Enrollment Form to receive the benefits of AfiniTRAC.

‡The Afinitor Co-pay Program is not valid for prescriptions for which payment may be made in whole or in part under federal or state healthcare programs, including but not limited to, Medicare or Medicaid, or for residents in MA. Limitations apply.

Afinitor Co-pay Program

Whether your patient is a self-payer or has private (commercial) insurance with a co-pay, the Afinitor Co-pay Program‡ provides
assistance to eligible patients.

Learn more

AFINITOR is indicated for the treatment of patients with subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis (TS) who require therapeutic intervention but are not candidates for curative surgical resection.

The effectiveness of AFINITOR 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.

Important Safety Information

AFINITOR is contraindicated in patients with hypersensitivity to everolimus, to other rapamycin derivatives, or to any of the excipients.

Non-infectious Pneumonitis: Non-infectious pneumonitis is a class effect of rapamycin derivatives, including AFINITOR. Fatal outcomes have been observed. If symptoms are moderate, patients should be managed with dose interruption until symptoms improve. If symptoms are severe, AFINITOR therapy should be discontinued. Under both circumstances, corticosteroids may be indicated and AFINITOR may be re-initiated at a daily dose approximately 50% lower than the dose previously administered depending on the individual clinical circumstances.

Infections: AFINITOR has immunosuppressive properties and may predispose patients to bacterial, fungal, viral, or protozoal infections, including infections with opportunistic pathogens. Localized and systemic infections, including pneumonia, mycobacterial infections, other bacterial infections, invasive fungal infections, and viral infections including reactivation of hepatitis B virus have occurred. Some of these infections have been severe (e.g., leading to respiratory or hepatic failure) or fatal. Treatment of pre-existing invasive fungal infections should be completed prior to starting treatment. While taking AFINITOR, be vigilant for signs and symptoms of infection; if a diagnosis of infection is made, institute appropriate treatment promptly and consider interruption or discontinuation of AFINITOR. If a diagnosis of invasive systemic fungal infection is made, discontinue AFINITOR and treat with appropriate antifungal therapy.

Oral Ulceration: Oral ulcerations (i.e., mouth ulcers, stomatitis, and oral mucositis) have occurred in patients treated with AFINITOR. In the SEGA study, 86% of AFINITOR-treated patients developed stomatitis which was mostly CTCAE grade 1 or 2. In such cases, topical treatments are recommended, but alcohol- or peroxide-containing mouthwashes should be avoided. Antifungal agents should not be used unless fungal infection has been diagnosed.

Renal Failure: Cases of renal failure (including acute renal failure), some with a fatal outcome, have been observed in patients treated with AFINITOR.

Laboratory Tests and Monitoring: Elevations of serum creatinine, proteinuria, glucose, lipids, and triglycerides, and reductions of hemoglobin, lymphocytes, neutrophils, and platelets have been reported. Renal function, blood glucose, lipids, and hematologic parameters should be evaluated prior to treatment and periodically thereafter. When possible, optimal glucose and lipid control should be achieved before starting a patient on AFINITOR.

Drug-drug Interactions: Avoid co-administration with strong CYP3A4 inhibitors. Use caution and reduce the AFINITOR dose if co-administration with a moderate CYP3A4 and/or PgP inhibitor is required. Avoid co-administration with strong CYP3A4 inducers (e.g., phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital); however, if co-administration is required, increase the AFINITOR dose.

Hepatic Impairment: AFINITOR should not be used in patients with severe hepatic impairment. Exposure of everolimus was increased in patients with moderate hepatic impairment. In these patients, adjustment to the starting dose may not be needed; however, subsequent dosing should be individualized based on therapeutic drug monitoring.

Vaccinations: The use of live vaccines and close contact with those who have received live vaccines should be avoided during treatment with AFINITOR. The timing of routine vaccinations in pediatric patients with SEGA should be considered prior to the start of AFINITOR therapy.

Use in Pregnancy: Fetal harm can occur if AFINITOR is administered to a pregnant woman. Women of childbearing potential should be advised to use an effective method of contraception while using AFINITOR and for up to 8 weeks after ending treatment.

Adverse Reactions: The most common adverse reactions (incidence ≥30%, all grades) were stomatitis (86%), upper respiratory tract infection (82%), sinusitis (39%), otitis media (36%), and pyrexia (32%). The most common grade 3 adverse reactions (incidence ≥3%) were convulsion (7%), sinusitis (4%), pneumonia (4%), viral bronchitis (4%), tooth infection (4%), stomatitis (4%), aspiration (4%), cyclic neutropenia (4%), sleep apnea syndrome (4%), vomiting (4%), dizziness (4%), white blood cell count decreased (4%), and neutrophil count decreased (4%). A grade 4 convulsion (4%) was reported.

Laboratory Abnormalities: The most common laboratory abnormalities (incidence ≥50%, all grades) were elevations in aspartate transaminase (AST) concentrations (89%), total cholesterol (68%), and reductions in white blood cell counts (54%). Grade 3 laboratory abnormalities were elevated AST concentrations (4%) and low absolute neutrophil count (4%).

Please see full Prescribing Information for Afinitor.