Important Safety Information

There have been reports of noninfectious pneumonitis (including some with pulmonary hypertension as a secondary event), infections, and renal failure (including acute renal failure) in patients...

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Indication AFINITOR® (everolimus) Tablets is indicated for the treatment of postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer (advanced HR+ BC) in combination with exemestane after failure of treatment with letrozole or anastrozole.

Access

We’ve Got It Covered

When It Comes to Patient Support—We’ve Got It Covered from the very beginning

Help start patients off on the right track. The programs can help counsel patients, secure alternative funding, answer insurance questions, and connect patients with free medication trials. The We’ve Got It Covered Program has what patients need to help navigate the treatment journey.

14-Day Trial

Patients receive a free 14-day supply of AFINITOR® (everolimus) Tablets at treatment initiation, allowing them to get on therapy promptly. Enrollment is easy—download the form at www.hcp.novartis.com/access.

Financial Assistance

Patient Assistance Now Oncology

pano

Novartis Oncology shares your commitment to helping patients who are living with cancer receive the medicines they need. Patient Assistance Now Oncology (PANO) offers quick and easy access to information about our wide range of resources available to your patients.

You can get information about our PANO support programs in 2 ways:

  • Call 1-800-282-7630 to speak with a member of our knowledgeable staff dedicated to making access to therapy as simple and convenient as possible; or
  • Visit our website at: www.hcp.novartis.com

Support for patients includes:

  • Insurance verification
  • Medicare education
  • Therapy-specific support programs for out-of-pocket costs
  • Alternative funding searches and referrals to federal or state assistance programs
  • Information on independent charitable foundations for assistance with co-pay costs
  • Patient assistance for low-income and uninsured patients
  • Patients prequalified via phone screening for the Patient Assistance Program (PAP) will be sent a 30-day supply of their needed medication while completing the application

Co-Pay Card

copay card

  • Most eligible patients pay no more than $25 for their prescription
  • Co-pay cards can be found online at www.copay.novartisoncology.com
  • Limitations apply. See program terms and conditions. Up to $15,000 per calendar year

Terms and Conditions

This offer is valid only for those with commercial insurance. Offer not valid under Medicare, Medicaid, or any other federal or state program. Not valid for cash-paying patients, where product is not covered by patient’s commercial insurance, or where plan reimburses you for entire cost of your prescription drug. Offer is not valid where prohibited by law. Valid only in the United States and Puerto Rico. This program is not health insurance. Offer may not be combined with any other rebate, coupon, or offer. The card is the property of Novartis Pharmaceuticals Corporation and must be returned upon request. Novartis reserves the right to rescind, revoke, or amend the program without notice. Patient certifies responsibility for complying with applicable limitations, if any, of any commercial insurance and reporting receipt of program rewards, if necessary, to any commercial insurer. This offer expires on December 31, 2017.

Patient Resources

Finding a pharmacy

pharmacy


If a patient's plan requires a specific pharmacy to fill an AFINITOR prescription, simply call 1-877-433-8067 to reach our dedicated We've Got It Covered patient support counselors for help.

 

 

 

Day-to-Day Patient Support Resources

The Novartis Oncology Day-to-Day Patient Support Resources give patients information about a range of independent support organizations that can provide services to complement their treatment plan and care.

Transportation and lodging services
Organizations that can help patients access free or reduced air, lodging, and ground transportation services so that they can attend their medical appointments.

 

Preparing healthy meals
Easy-to-prepare recipes created specifically for your patient’s unique treatment needs while on therapy.


Mind and body
Links to help patients access options like yoga, meditation, and more.

Home cleaning
Free or low-cost cleaning options to help keep the patient’s home in order during treatment.

Additional resources
Independent organizations that specialize in financial assistance, support groups, and much more.

All organizations listed are not-for-profit and/or government agencies, and are independent from Novartis Pharmaceuticals Corporation. Novartis has no financial interest in any organization listed, but may provide occasional funding support to these organizations. All descriptions are copyright of the respective organizations.

 

Patient Counseling Kit

The kit includes a patient education brochure, products, and resources patients can use while on therapy.

  

AFINITOR-Resources.com

This website is a convenient one-stop resource for a variety of education and counseling materials for you and your patients, including coverage, financial assistance, education, patient support, and adverse reaction resources.

AFINITOR-Coverage.com

This is a website specifically designed for office reimbursement staff to help them understand plan-specific coverage criteria and gain access to prior authorization forms, AFINITOR counseling resources, and educational materials.

 

Indication

AFINITOR is indicated for the treatment of postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer (advanced HR+ BC) in combination with exemestane after failure of treatment with letrozole or anastrozole.

Important Safety Information

AFINITOR 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 reported with pulmonary hypertension (including pulmonary arterial hypertension) as a secondary event. The incidence of Common Terminology Criteria (CTC) grade 3 and 4 noninfectious pneumonitis was up to 4.0% and up to 0.2%, respectively. Fatal outcomes have been observed. Monitor for clinical symptoms or radiological changes
  • Opportunistic infections such as Pneumocystis jiroveci pneumonia (PJP) should be considered in the differential diagnosis
  • Manage noninfectious pneumonitis by dose interruption until symptoms resolve, follow with a dose reduction, and consider the use of corticosteroids. Discontinue AFINITOR if toxicity recurs at grade 3 or for grade 4 cases. For patients who require use of corticosteroids, prophylaxis for PJP may be considered
  • The development of pneumonitis has been reported even at a reduced dose

Infections

  • AFINITOR 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, leading to sepsis, respiratory failure, or hepatic failure) or fatal
  • Physicians and patients should be aware of the increased risk of infection with AFINITOR. Treatment of preexisting invasive fungal infections should be completed prior to starting treatment with AFINITOR
  • Be vigilant for signs and symptoms of infection and institute appropriate treatment promptly; interruption or discontinuation of AFINITOR should be considered
  • Discontinue AFINITOR if invasive systemic fungal infection is diagnosed and institute appropriate antifungal treatment
  • PJP has been reported in patients who received everolimus, sometimes with a fatal outcome. This may be associated with concomitant use of corticosteroids or other immunosuppressive agents; consider prophylaxis for PJP when concomitant use of these agents is required

Angioedema With Concomitant Use of Angiotensin-Converting Enzyme (ACE) Inhibitors

  • Patients taking concomitant ACE inhibitor therapy 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

Oral Ulceration

  • Mouth ulcers, stomatitis, and oral mucositis have occurred in patients treated with AFINITOR 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
  • In such cases, topical treatments are recommended, but alcohol-, hydrogen peroxide-, iodine-, or thyme-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

Impaired Wound Healing

  • Everolimus 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 in the perisurgical period

Geriatric Patients

  • In the randomized advanced hormone receptor-positive, HER2-negative breast cancer study, the incidence of deaths due to any cause within 28 days of the last AFINITOR dose was 6% in patients ≥65 years of age compared with 2% in patients <65 years of age
  • Adverse reactions leading to permanent discontinuation occurred in 33% of patients ≥65 years of age compared with 17% in patients <65 years of age
  • Careful monitoring and appropriate dose adjustments for adverse reactions are recommended

Laboratory Tests and Monitoring

  • Elevations of serum creatinine and proteinuria have been reported. Renal function (including measurement of blood urea nitrogen, urinary protein, or serum creatinine) should be evaluated prior to treatment and periodically thereafter, particularly in patients who have additional risk factors that may further impair renal function
  • Hyperglycemia, hyperlipidemia, and hypertriglyceridemia have been reported. Blood glucose and lipids should be evaluated prior to treatment and periodically thereafter. More frequent monitoring is recommended when AFINITOR is coadministered with other drugs that may induce hyperglycemia. Management with appropriate medical therapy is recommended. When possible, optimal glucose and lipid control should be achieved before starting a patient on AFINITOR
  • Reductions in hemoglobin, lymphocytes, neutrophils, and platelets have been reported. Monitoring of complete blood count is recommended prior to treatment and periodically thereafter

Drug-Drug Interactions

  • Avoid coadministration with strong CYP3A4/PgP inhibitors (eg, ketoconazole, itraconazole, clarithromycin, atazanavir, nefazodone, saquinavir, telithromycin, ritonavir, indinavir, nelfinavir, voriconazole)
  • Use caution and reduce the AFINITOR dose to 2.5 mg daily if coadministration with a moderate CYP3A4/PgP inhibitor is required (eg, amprenavir, fosamprenavir, aprepitant, erythromycin, fluconazole, verapamil, diltiazem)
  • Avoid coadministration with strong CYP3A4/PgP inducers (eg, phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital); however, if coadministration is required, consider doubling the daily dose of AFINITOR using increments of 5 mg or less

Hepatic Impairment

  • Exposure to everolimus was increased in patients with hepatic impairment
  • For patients with severe hepatic impairment (Child-Pugh class C), AFINITOR may be used at a reduced dose if the desired benefit outweighs the risk. For patients with mild (Child-Pugh class A) or moderate (Child-Pugh class B) hepatic impairment, a dose reduction is recommended

Vaccinations

  • The use of live vaccines and close contact with those who have received live vaccines should be avoided during treatment with AFINITOR

Embryo-Fetal Toxicity

  • Fetal harm can occur if AFINITOR is administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise female patients of reproductive potential of the potential risk to a fetus and to use effective contraception while using AFINITOR and for 8 weeks after ending treatment

Adverse Reactions

  • The most common adverse reactions (incidence ≥30%) were stomatitis (67%), infections (50%), rash (39%), fatigue (36%), diarrhea (33%), and decreased appetite (30%)
  • The most common grade 3/4 adverse reactions (incidence ≥2%) were stomatitis (8%), infections (5%), hyperglycemia (5%), fatigue (4%), dyspnea (4%), pneumonitis (4%), and diarrhea (2%)

Laboratory Abnormalities

  • The most common laboratory abnormalities (incidence ≥50%) were hypercholesterolemia (70%), hyperglycemia (69%), increased aspartate transaminase (AST, 69%), anemia (68%), leukopenia (58%), thrombocytopenia (54%), lymphopenia (54%), increased alanine transaminase (ALT, 51%), and hypertriglyceridemia (50%)
  • The most common grade 3/4 laboratory abnormalities (incidence ≥3%) were lymphopenia (12%), hyperglycemia (9%), anemia (7%), decreased potassium (4%), increased AST (4%), increased ALT (4%), and thrombocytopenia (3%)

Please see full Prescribing Information.