Important Safety Information

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

Noninfectious pneumonitis was reported in up to 19% of patients...

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Indication

AFINITOR® (everolimus) Tablets is indicated for the treatment of adults with advanced renal cell carcinoma after failure of treatment with sunitinib or sorafenib.

Access

We've Got It Covered

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When it Comes to Patient Support—We’ve Got It Covered

We know that our patients need prompt access to affordable medication right from the beginning. That’s why the We’ve Got It Covered Program helps patients get started on the therapy you prescribe and then works to help them stay on it. Whatever the insurance coverage challenge, we’re committed to helping make AFINITOR® (everolimus) Tablets accessible to eligible patients.

AFINITOR 14-Day Supply

Bridging the Gap—With a 14-day Supply

The AFINITOR 14-Day Free Trial helps eligible patients start therapy quickly. A 14-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 Oncology shares your commitment to helping patients receive the medicines they need. Patient Assistance Now Oncology (PANO) provides access to information and our wide range of resources available to your patients in over 160 languages.

Support for patients includes: 

  • Insurance benefits verification and guidance on denials/appeals 
  • Information about financial assistance that may be available 
  • Patient Support Counselors who are able to provide information in over 160 languages 
  • Patient Navigators (varies by product)
  • Free trial of medication (varies by product) 
  • One dedicated case manager/single point of contact per case

Co-pay Program

Universal Co-pay Card Program

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

  • Commercially insured patients pay $0 per month
  • Novartis will pay the remaining co-pay, up to $15,000 per calendar year*

Universal Co-pay Card

*Limitations apply. See program terms and conditions at www.CoPay.NovartisOncology.com. Offer is not valid under Medicare, Medicaid, or any other federal or state program. Novartis reserves the right to rescind, revoke, or amend this program without notice.

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. Additional Terms and Conditions may apply.

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

Patient Instructions

Patients with commercial insurance are responsible for $0 for a 28-day supply and Novartis pays up to $15,000 per calendar year. If patient reaches the maximum annual cap per calendar year of $15,000, patient will be responsible for the difference. This offer expires on December 31, 2017. Patient questions should be directed to: 1-877-577-7756. When you use this offer, you are certifying that you understand the program rules, regulations, and terms and conditions, and that you will disclose and report the use of this offer as may be required by your insurer. You are not eligible if prescriptions are paid by any federal or state program, or where prohibited by law; and you will otherwise comply with the terms and conditions above.

dosing

Adverse Reactions:

  • The most common adverse reactions (incidence ≥30%) were stomatitis (44%), infections (37%), asthenia (33%), fatigue (31%), cough (30%), and diarrhea (30%)
  • The most common grade 3/4 adverse reactions (incidence ≥5%) were infections (10%), dyspnea (7%), stomatitis (5%), and fatigue (5%)

 

 

Abbreviations: CI, confidence interval; HR, hazard ratio; PFS, progression-free survival.

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

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 female patients of reproductive potential 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 (44%), infections (37%), asthenia (33%), fatigue (31%), cough (30%), and diarrhea (30%)
  • The most common grade 3/4 adverse reactions (incidence ≥5%) were infections (10%), dyspnea (7%), stomatitis (5%), and fatigue (5%)

Laboratory Abnormalities:

  • The most common laboratory abnormalities (incidence ≥50%, all grades) were: decreased hemoglobin (92%) and lymphocytes (51%); and increased cholesterol (77%), triglycerides (73%), glucose (57%), and creatinine (50%)
  • The most common grade 3/4 laboratory abnormalities (incidence ≥5%) were decreased hemoglobin (13%), lymphocytes (18%), and phosphate (6%), and increased glucose (16%)

Please see full Prescribing Information.