Important Safety Information

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

Noninfectious Pneumonitis:...

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Indication

AFINITOR® (everolimus) Tablets and AFINITOR DISPERZ® (everolimus tablets for oral suspension) are indicated in adult and pediatric patients 1 year and older with tuberous sclerosis complex (TSC) for the treatment of subependymal giant cell astrocytoma (SEGA) that requires therapeutic intervention but cannot be curatively resected.

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AFINITRAC

AfiniTRAC® is a 1-to-1 patient support program. AfiniTRAC is not intended to take the place of care provided by physicians and their office staff.

AfiniTRAC: Support for Patients Taking AFINITOR or AFINITOR DISPERZ

A dedicated, one-to-one Care Champion provides informational support related to each patient’s treatment journey while taking AFINITOR® (everolimus) Tablets or AFINITOR DISPERZ® (everolimus tablets for oral suspension). The AfiniTRAC program does not provide medical treatment or medical advice.

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Program benefits include:

  • A single point of contact
  • Insurance benefits verification, including information on denials/appeals
  • Information about financial assistance that may be available
  • Free trial of AFINITOR or AFINITOR DISPERZ
  • Access to information in more than 160 languages

AfiniTRAC Care Champions provide:

  • Personal phone calls that fit into patients’ schedules
  • Review of educational information about their medication
  • Help creating a customized dosing and mealtime routine
  • Financial assistance information

AfiniTRAC does not replace patients’ regular interactions with their health care team.

Patient Brochure       Enrollment Form

Co-Pay Assistance

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Patients may be eligible for immediate co-pay savings on their next prescription.

  • Eligible patients with private insurance may pay $0 per month

  • Novartis will pay the remaining co-pay, up to $15,000 per calendar year*

*Limitations apply. This offer is only available to patients with private insurance. The program is not available for patients who are enrolled in Medicare, Medicaid, or any other federal or state health care program. Novartis reserves the right to rescind, revoke, or amend this program without notice. For full Terms and Conditions, visit Copay.NovartisOncology.com or call 1-877-577-7756. 

Encourage your patients to find out if they are eligible to enroll in the Novartis Oncology Universal Co-pay Program by visiting Copay.NovartisOncology.com or calling 1-877-577-7756.

Free Trial

7-Day Free TrialThe AFINITOR 7-Day Free Trial helps eligible patients start therapy quickly. A 7-day supply is shipped directly to a patient’s home or another convenient location. This one-time trial is available to all patients prescribed AFINITOR for a US Food and Drug Administration (FDA)-approved indication without regard to purchase of AFINITOR or any other product.

Novartis Service Request Form

 

Appeals Authorization & Patient Resources Support Guide

The AFINITOR Appeals Authorization & Patient Resources Support Guide is an informational resource to help physicians and office staff who may encounter AFINITOR coverage restrictions. It includes tips for submitting a tiering exception if AFINITOR is very costly for the patient and formulary exceptions if AFINITOR is not included on the health plan’s formulary. The content includes:

  • An overview of the process for submitting prior authorizations (PAs) and appeals
  • Steps to take when submitting a PA, and common reasons for denial
  • Considerations when filing an appeal to a denied PA
  • How providing proper ICD-10 diagnosis codes may assist in the review process
  • Specific clinical information and documentation to include with appeals to improve the likelihood of approval
  • Five sample letters that help guide physicians and office staff in writing and submitting their own original letters:
    • Sample appeal letter (written by provider)
    • Sample appeal letter (written by patient)
    • Sample letter of medical necessity
    • Sample tiering exception request letter
    • Sample formulary exception request letter
  • Instructions for filing tiering and formulary exception requests with Medicare plans, which require office staff to fill out the Coverage Determination Request Form

In addition, this guide includes patient resources and access support, including information about the Novartis Co-pay Card, the AfiniTRAC Patient Support Program, the AFINITOR 7-Day Free Trial, and the Novartis Patient Assistance Foundation, Inc.

Appeals Authorization & Patient Resources Support Guide

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Frequently Asked Questions About AfiniTRAC

What is AfiniTRAC?

AfiniTRAC is a treatment and reimbursement support program provided by Novartis Pharmaceuticals Corporation for patients who are prescribed AFINITOR or AFINITOR DISPERZ.

What are the benefits of enrolling in the AfiniTRAC program?

Patients who enroll in AfiniTRAC will receive a series of phone calls from a specially trained Care Champion to support and guide them through various aspects of their treatment journey. The Care Champion will provide personal phone calls that fit into the patients' schedule, review of educational information about AFINITOR, help creating a customized dosing and mealtime routine, and financial assistance information.

What is an insurance benefits verification?

An AfiniTRAC Care Champion will call the patient's insurance company to determine if the patient is eligible to participate in the AfiniTRAC program. If the patient is eligible, the Care Champion will then call the patient.

Does insurance cover AFINITOR?

Insurance coverage varies on an individual basis. AfiniTRAC can help by contacting your patient's health insurance company to determine the coverage he or she has for AFINITOR or AFINITOR DISPERZ.

What are the hours of operation?

The program is open Monday through Friday from 8 AM to 8 PM ET.

What is the phone number?

1-888-9AfiniTRAC (1-888-923-4648).

Product Ordering

TO ORDER AFINITOR or AFINITOR DISPERZ, pharmacists or dispensing physicians can call 1-800-746-6273 or visit www.ASDHealthcare.com today.

IMPORTANT SAFETY INFORMATION

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

Noninfectious Pneumonitis: Noninfectious pneumonitis is a class effect of rapamycin derivatives. Noninfectious pneumonitis was reported in up to 19% of patients treated with AFINITOR/AFINITOR DISPERZ in clinical trials, some cases reported with pulmonary hypertension (including pulmonary arterial hypertension) as a secondary event. The incidence of grade 3 and 4 noninfectious pneumonitis was up to 4.0% and up to 0.2%, respectively. Fatal outcomes have been observed. Consider a diagnosis of noninfectious pneumonitis in patients presenting with nonspecific respiratory signs and symptoms. Consider opportunistic infections such as Pneumocystis jiroveci pneumonia (PJP) in the differential diagnosis. Advise patients to report promptly any new or worsening respiratory symptoms. Continue AFINITOR/AFINITOR DISPERZ without dose alteration in patients who develop radiological changes suggestive of noninfectious pneumonitis and have few or no symptoms. Imaging appears to overestimate the incidence of clinical pneumonitis. For grade 2 to 4 noninfectious pneumonitis, withhold or permanently discontinue AFINITOR/AFINITOR DISPERZ based on severity. Corticosteroids may be indicated until clinical symptoms resolve. Administer prophylaxis for PJP when concomitant use of corticosteroids or other immunosuppressive agents are required. The development of pneumonitis has been reported even at a reduced dose.

Infections: AFINITOR/AFINITOR DISPERZ has immunosuppressive properties and may predispose patients to bacterial, fungal, viral, or protozoal infections, including those with opportunistic pathogens. Localized and systemic infections, including pneumonia, mycobacterial infections, other bacterial infections; invasive fungal infections, such as aspergillosis, candidiasis, or PJP; and viral infections, including reactivation of hepatitis B virus, have occurred. Some of these infections have been severe (eg, sepsis, sepsis shock, or resulting in multisystem organ failure) or fatal. The incidence of grade 3 and 4 infections was up to 10% and up to 3%, respectively. The incidence of serious infections was reported at a higher frequency in patients <6 years of age. Complete treatment of preexisting invasive fungal infections prior to starting treatment. Monitor for signs and symptoms of infection. Withhold or permanently discontinue AFINITOR/AFINITOR DISPERZ based on severity of infection. Administer prophylaxis for PJP when concomitant use of corticosteroids or other immunosuppressive agents are required.

Severe Hypersensitivity Reactions: Hypersensitivity reactions to AFINITOR/AFINITOR DISPERZ have been observed and include anaphylaxis, dyspnea, flushing, chest pain, and angioedema (eg, swelling of the airways or tongue, with or without respiratory impairment). The incidence of grade 3 hypersensitivity reactions was up to 1%. Permanently discontinue AFINITOR/AFINITOR DISPERZ for the development of clinically significant hypersensitivity.

Angioedema With Concomitant Use of Angiotensin-Converting Enzyme (ACE) Inhibitors: Patients taking concomitant ACE inhibitor with AFINITOR/AFINITOR DISPERZ may be at increased risk for angioedema (eg, swelling of the airways or tongue, with or without respiratory impairment). In a pooled analysis, the incidence of angioedema in patients taking everolimus with an ACE inhibitor was 6.8% compared to 1.3% in the control arm with an ACE inhibitor. Permanently discontinue AFINITOR/AFINITOR DISPERZ for angioedema.

Stomatitis: Stomatitis, including mouth ulcers and oral mucositis, has occurred in patients treated with AFINITOR/AFINITOR DISPERZ at an incidence ranging from 44% to 78% across the clinical trial experience. Grade 3/4 stomatitis was reported in 4% to 9% of patients. Stomatitis most often occurs within the first 8 weeks of treatment. When starting AFINITOR/AFINITOR DISPERZ, initiating dexamethasone alcohol-free oral solution as a swish and spit mouthwash reduces the incidence and severity of stomatitis. If stomatitis does occur, mouthwashes and/or other topical treatments are recommended, but alcohol-, hydrogen peroxide-, iodine-, or thyme-containing products 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 occurred in patients taking AFINITOR. Elevations of serum creatinine and proteinuria have been reported in patients taking AFINITOR/AFINITOR DISPERZ. The incidence of grade 3 and 4 elevations of serum creatinine was up to 2% and up to 1%, respectively. The incidence of grade 3 and 4 proteinuria was up to 1% and up to 0.5%, respectively. Monitor renal function prior to starting AFINITOR/AFINITOR DISPERZ and annually thereafter. Monitor renal function at least every 6 months in patients who have additional risk factors for renal failure.

Impaired Wound Healing: AFINITOR/AFINITOR DISPERZ delays wound healing and increases the occurrence of wound-related complications like wound dehiscence, wound infection, incisional hernia, lymphocele, and seroma. These wound-related complications may require surgical intervention. Exercise caution with the use of AFINITOR/AFINITOR DISPERZ in the perisurgical period.

Metabolic Disorders: Hyperglycemia, hypercholesterolemia, and hypertriglyceridemia have been reported in patients taking AFINITOR/AFINITOR DISPERZ at an incidence up to 75%, 86%, and 73%, respectively. The incidence of these grade 3 and 4 laboratory abnormalities was up to 15% and up to 0.4%, respectively. In nondiabetic patients, monitor fasting serum glucose prior to starting AFINITOR/AFINITOR DISPERZ and annually thereafter. In diabetic patients, monitor fasting serum glucose more frequently as clinically indicated. Monitor lipid profile prior to starting AFINITOR/AFINITOR DISPERZ and once yearly thereafter. When possible, achieve optimal glucose and lipid control prior to starting AFINITOR/AFINITOR DISPERZ. For grade 3 to 4 metabolic events, withhold or permanently discontinue AFINITOR/AFINITOR DISPERZ based on severity.

Myelosuppression: Anemia, lymphopenia, neutropenia, and thrombocytopenia have been reported in patients taking AFINITOR/AFINITOR DISPERZ. The incidence of these grade 3 and 4 laboratory abnormalities was up to 16% and up to 2%, respectively. Monitor complete blood count prior to starting AFINITOR/AFINITOR DISPERZ every 6 months for the first year of treatment and annually thereafter. Withhold or permanently discontinue AFINITOR/AFINITOR DISPERZ based on severity.

Risk of Infection or Reduced Immune Response With Vaccinations: The safety of immunization with live vaccines during AFINITOR/AFINITOR DISPERZ therapy has not been studied. Due to the potential increased risk of infection and/or reduced immune response to the vaccine, avoid the use of live vaccines and close contact with individuals who have received live vaccines during treatment with AFINITOR/AFINITOR DISPERZ. Due to the potential increased risk of infection or reduced immune response with vaccination, complete the recommended childhood series of live vaccinations according to American Council on Immunization Practices (ACIP) guidelines prior to the start of therapy. An accelerated vaccination schedule may be appropriate.

Embryo-Fetal Toxicity: 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 clinical dose of 10 mg once daily. Advise pregnant women of the potential risk to a fetus. Advise female patients of reproductive potential to avoid becoming pregnant and to use effective contraception during treatment with AFINITOR/AFINITOR DISPERZ and for 8 weeks after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with AFINITOR/AFINITOR DISPERZ and for 4 weeks after the last dose.

Adverse Reactions: In patients with TSC-associated SEGA the most common adverse reactions (incidence ≥30%, all grades) were stomatitis (62%) and respiratory tract infection (31%). The most common grade 3/4 adverse reactions (incidence ≥2%) were stomatitis, pyrexia, pneumonia, gastroenteritis, aggression, agitation, and amenorrhea. Updated safety information from 111 patients treated with AFINITOR for a median duration of 47 months identified the following additional notable adverse reactions: decreased appetite (14%), hypertension (11%), urinary tract infection (9%), cellulitis (6%), abdominal pain (5%), and decreased weight (5%).

Laboratory Abnormalities: In patients with TSC-associated SEGA, the most common key laboratory abnormalities (incidence ≥50%, all grades) were hypercholesterolemia (81%) and elevated partial thromboplastin time (72%). The most common grade 3/4 laboratory abnormality (incidence ≥3%) was neutropenia (9%). Updated safety information from 111 patients treated with AFINITOR for a median duration of 47 months identified the following additional key laboratory abnormalities: hyperglycemia (13%), decreased fibrinogen (8%), elevated creatinine (5%), and azoospermia (1%).

Please see full Prescribing Information.

Indication

AFINITOR® (everolimus) Tablets and AFINITOR DISPERZ® (everolimus tablets for oral suspension) are indicated in adult and pediatric patients 1 year and older with tuberous sclerosis complex (TSC) for the treatment of subependymal giant cell astrocytoma (SEGA) that requires therapeutic intervention but cannot be curatively resected.