AFINITOR DISPERZ is contraindicated in patients with hypersensitivity to everolimus, to other rapamycin derivatives, or to any of the excipients.
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 Eligible Patients Taking AFINITOR DISPERZ
A dedicated, one-to-one Care Champion provides informational support related to each patient’s treatment journey while taking AFINITOR DISPERZ® (everolimus tablets for oral suspension). The AfiniTRAC program does not provide medical treatment or medical advice. Please contact your healthcare professional with any questions regarding your health or therapy.
Program benefits include:
- A single point of contact
- Insurance benefits verification
- 7-day Information about financial assistance
- Free trial of AFINITOR DISPERZ
- Translation services in more than 160 languages
AfiniTRAC Care Champions provide:
- Phone calls that fit into patients’ schedules
- Help creating a customized dosing routine
- Financial assistance information (if eligible)
The information obtained through the AfiniTRAC program is not intended to replace the advice and guidance of the patients’ health care team.
Universal Co-Pay Program
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, per product*
*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.
The AFINITOR DISPERZ 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 DISPERZ for a US Food and Drug Administration (FDA)-approved indication without regard to purchase of AFINITOR DISPERZ or any other product.
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 DISPERZ coverage restrictions. It includes tips for submitting a tiering exception if AFINITOR DISPERZ is very costly for the patient and formulary exceptions if AFINITOR DISPERZ is not included on the health plan’s formulary. The content includes:
- Overview of process for submitting prior authorizations (PAs) and appeals
- Steps to take when submitting a PA and common denial reasons
- Considerations for 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 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 a different form (the Coverage Determination Request Form)
In addition, this guide includes patient resources and access support including the Novartis Co-pay Card, the AfiniTRAC Patient Support Program, the AFINITOR DISPERZ 7-Day Free Trial, and the Novartis Patient Assistance Foundation, Inc.
Frequently Asked Questions About AfiniTRAC
What is AfiniTRAC?
AfiniTRAC is a treatment and reimbursement support program provided by Novartis Pharmaceuticals Corporation for eligible patients who are prescribed 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 help guide them through various aspects of their treatment journey. The Care Champion will provide phone calls that fit into the patients' schedule, help create a customized dosing routine, and provide 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 DISPERZ?
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 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?
TO ORDER AFINITOR DISPERZ, pharmacists or dispensing physicians can call 1-800-746-6273 or visit www.ASDHealthcare.com today.
AFINITOR DISPERZ® (everolimus tablets for oral suspension) is indicated for the adjunctive treatment of adult and pediatric patients aged 2 years and older with tuberous sclerosis complex (TSC)-associated partial-onset seizures.
IMPORTANT SAFETY INFORMATION
AFINITOR DISPERZ is contraindicated in patients with hypersensitivity to everolimus, to other rapamycin derivatives, or to any of the excipients.
Noninfectious Pneumonitis: Noninfectious pneumonitis was reported in up to 19% of patients treated with AFINITOR; some cases were 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% and up to 0.2%, respectively. Fatal outcomes have been observed. Monitor for clinical symptoms or radiological changes. Consider opportunistic infections such as Pneumocystis jiroveci pneumonia (PJP) in the differential diagnosis. For grade 2 to 4 noninfectious pneumonitis, withhold or permanently discontinue 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 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, septic 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 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 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 DISPERZ for the development of clinically significant hypersensitivity.
Angioedema With Concomitant Use of Angiotensin-Converting Enzyme (ACE) Inhibitors: Patients taking concomitant ACE inhibitors with 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 DISPERZ for angioedema.
Stomatitis: Stomatitis, including mouth ulcers and oral mucositis, has occurred in patients treated with AFINITOR or 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 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 or 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 DISPERZ and annually thereafter. Monitor renal function at least every 6 months in patients who have additional risk factors for renal failure.
Risk of Impaired Wound Healing: Impaired wound healing can occur in patients who receive drugs that inhibit the vascular endothelial growth factor (VEGF) signaling pathway. Therefore, AFINITOR DISPERZ has the potential to adversely affect wound healing. Withhold AFINITOR DISPERZ for at least 1 week prior to elective surgery. Do not administer for at least 2 weeks following major surgery and until adequate wound healing occurs. The safety of resuming treatment upon resolution of wound healing complications has not been established.
Metabolic Disorders: Hyperglycemia, hypercholesterolemia, and hypertriglyceridemia have been reported in patients taking AFINITOR or 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 DISPERZ and annually thereafter. In diabetic patients, monitor fasting serum glucose more frequently as clinically indicated. Monitor lipid profile prior to starting AFINITOR DISPERZ and once yearly thereafter. When possible, achieve optimal glucose and lipid control prior to starting AFINITOR DISPERZ. For grade 3 to 4 metabolic events, withhold or permanently discontinue AFINITOR DISPERZ based on severity.
Myelosuppression: Anemia, lymphopenia, neutropenia, and thrombocytopenia have been reported in patients taking AFINITOR or 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 DISPERZ, every 6 months for the first year of treatment, and annually thereafter. Withhold or permanently discontinue AFINITOR DISPERZ based on severity.
Risk of Infection or Reduced Immune Response With Vaccinations: The safety of immunization with live vaccines during 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 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.
Radiation Sensitization and Radiation Recall: Radiation sensitization and recall, in some cases severe, involving cutaneous and visceral organs (including radiation esophagitis and pneumonitis) have been reported in patients treated with radiation before, during, or after AFINITOR DISPERZ treatment. Monitor patients closely when administering AFINITOR DISPERZ during, or sequentially with, radiation treatment.
Embryo-Fetal Toxicity: Based on animal studies and the mechanism of action, 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 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 DISPERZ and for 4 weeks after the last dose.
Adverse Reactions: The most common adverse reaction reported for AFINITOR DISPERZ (incidence ≥30%, all grades) was stomatitis (55% low trough, 64% high trough). The most common grade 3/4 adverse reactions (incidence ≥2%) were stomatitis, pneumonia, and irregular menstruation. Updated safety information from 357 patients treated with AFINITOR DISPERZ for a median duration of 48 weeks identified the following additional notable adverse reactions: hypersensitivity (0.6%), angioedema (0.3%), and ovarian cyst (0.3%).
Laboratory Abnormalities: The most common laboratory abnormality (incidence ≥50%, all grades) was hypercholesterolemia (86% low trough, 85% high trough). The most common grade 3/4 laboratory abnormality (incidence ≥2%) was neutropenia.
Please see full Prescribing Information.