Afinitor FAQ

Your patients may have questions about Afinitor and what to expect with Afinitor treatment. Below are the most frequently asked questions patients have. Use this guide as a resource to answer questions about these topics:

Product Information FAQ

Dosage and Administration FAQ

Safety FAQ

Disease State FAQ

General Concerns

Other Topics

PRODUCT INFORMATION

What is the generic name of Afinitor?

The generic name of Afinitor is everolimus.

For what is Afinitor used?1

Afinitor is a prescription medicine used to treat people with advanced kidney cancer (advanced renal cell carcinoma or advanced RCC) after failure of treatment with sunitinib or sorafenib.

When was Afinitor approved?2

The FDA approved Afinitor as a prescription medicine used to treat people with advanced kidney cancer (advanced renal cell carcinoma or advanced RCC) after failure of treatment with sunitinib or sorafenib on March 30, 2009.

What type of medication is Afinitor?1

Afinitor is an oral prescription medication that inhibits mTOR.

Afinitor stops cancer cells from making new cancer cells and also cuts off the blood supply to the cancer. This may slow the growth and spread of kidney cancer.

Afinitor has not been studied in children.

What is an mTOR inhibitor?1

An mTOR inhibitor is a drug that blocks the mTOR kinase (mammalian target of rapamycin). The mTOR pathway does not function properly in several human cancers.

How does Afinitor work?1

The active ingredient in Afinitor, everolimus, stops the cancer from making new cells and cuts off the blood supply to the cancer. This may slow down the growth and spread of the kidney cancer.

What does Afinitor look like?1

Afinitor 5-mg tablet: White to slightly yellow, elongated tablets with a bevelled edge and no score, engraved with "5" on one side and "NVR" on the other.

Afinitor 10-mg tablet: White to slightly yellow, elongated tablets with a bevelled edge and no score, engraved with "UHE" on one side and "NVR" on the other.

What are the ingredients of Afinitor?1

Afinitor is supplied as tablets for oral administration containing 5 mg and 10 mg of everolimus as an active ingredient together with butylated hydroxytoluene, magnesium stearate, lactose monohydrate, hypromellose, crospovidone, and lactose anhydrous as inactive ingredients.

How is Afinitor supplied to the pharmacy?1

Afinitor 5-mg tablets are supplied in blister packs of 28 tablets. Each carton contains 4 blister cards of 7 tablets each.

Afinitor 10-mg tablets are supplied in blister packs of 28 tablets. Each carton contains 4 blister cards of 7 tablets each.

Where is Afinitor manufactured?1

Afinitor is manufactured by Novartis Pharma Stein AG in Stein, Switzerland.



DOSAGE AND ADMINISTRATION

When and how often should Afinitor be taken?

Afinitor should be taken orally once daily at the same time every day, with or without food.

Can Afinitor be taken with or without food?

Yes, Afinitor can be taken with or without food.

Can Afinitor be cut or crushed?

Afinitor tablets should be swallowed whole with a glass of water. The tablets should not be chewed or crushed.

Can a patient drink grapefruit juice while taking Afinitor?

Do not drink grapefruit juice or eat grapefruit during your treatment with Afinitor. It may make the amount of Afinitor in your blood increase to a harmful level.

What should the patient do if he or she misses a dose?

If patients miss a dose of Afinitor, they may still take it up to 6 hours after the time they normally take it. If it is more than 6 hours after the patient normally takes Afinitor, skip the dose for that day. The next day, Afinitor should be taken at the usual time. The patient should not take 2 doses to make up for the one that was missed.

Can the patient take an extra dose?

No. Continue taking Afinitor as directed by your physician.

Can the patient stop taking Afinitor if he or she feels better?

No. The patient should continue taking Afinitor as directed by the physician.

How soon can the patient expect to see improvement?

Results will vary for each patient.

How should Afinitor be stored?

  • Keep Afinitor at room temperature, between 59°F to 86°F (15°C to 30°C)
  • Keep Afinitor in the original package
  • Open blister package just before taking Afinitor; use scissors to open blister
  • Keep the package and tablets dry
  • Keep Afinitor out of light
  • Safely throw away Afinitor that is out of date or no longer needed
  • Keep this and all medicines out of the reach and sight of children


SAFETY

What are the possible side effects of Afinitor?

Possible serious side effects include:

  • Lung or breathing problems (pneumonitis): Afinitor can cause lung or breathing problems. The patient should tell you immediately if he or she has new or worsening cough, shortness of breath, difficulty breathing, or wheezing. In some patients lung or breathing problems have been severe, and can even lead to death. The patient may need to stop Afinitor for a while or use a lower dose
  • Infections: Afinitor can make a patient more likely to have an infection such as pneumonia or a bacterial or fungal infection. In some patients infections have been severe, and can even lead to death. The patient may need to be treated as soon as possible. A temperature of 100.5° F or above, chills, or any other symptoms should be reported to a healthcare provider immediately

Common side effects:

  • Mouth ulcers. Afinitor can cause mouth ulcers and sores. If patients have pain, discomfort, or open sores in their mouth they might need treatment with a special mouthwash or mouth gel
  • Infections
  • Feeling weak or tired
  • Cough, shortness of breath, and lung or breathing problems
  • Diarrhea
  • Rash, dry skin, and itching
  • Nausea and vomiting
  • Fever
  • Loss of appetite
  • Swelling of arms, hands, feet, ankles, face, or other parts of the body
  • Abnormal taste
  • Inflammation of lining of the digestive system
  • Headache
  • Nose bleeds
  • Pain in arms and legs

Patients should tell their healthcare provider of any side effect that bothers them or does not go away.

These are not all the possible side effects of Afinitor.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Are there any drug-to-drug interactions?

Ask your patient about all of the medicines he or she takes, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Afinitor can affect the way other medicines work, and other medicines can affect how Afinitor works. Using Afinitor with other medicines can cause serious side effects.

Specifically find out from your patients if they take any of the following:

  • St. John's Wort (also known as Hypericum perforatum)
  • Medicine for:
    • Fungal infections (antifungals like ketoconazole, itraconazole, voriconazole, and fluconazole)
    • Bacterial infections (antibiotics like clarithromycin, telithromycin, or erythromycin)
    • Tuberculosis (like rifampin or rifabutin)
    • Seizures (anti-epileptics like phenytoin, carbamazepine, or phenobarbital)
    • HIV-AIDS (like atazanavir, saquinavir, ritonavir, amprenavir, indinavir, nelfinavir, delavirdine, fosamprenavir)
    • Heart conditions or high blood pressure (like verapamil or diltiazem)
    • Immunosuppression

If your patient is taking any medicines for the conditions listed above, you might need to prescribe a different medicine. You should have your patient tell you if he or she starts taking any new medicine.



DISEASE STATE

What is renal cell carcinoma (cancer of the kidney)?

Renal cell carcinoma (RCC) is the most common type of kidney cancer. In RCC, cancerous cells develop in the tubules of the kidney and grow into a mass over time.

What is advanced renal cell carcinoma?

Advanced renal cell carcinoma is kidney cancer that has spread.

What causes renal cell carcinoma (cancer of the kidney)?

The exact cause of renal cancer has not been determined. A number of different factors may contribute to advanced renal cell cancer such as family history or genetic predisposition, smoking, occupational exposure to toxic compounds, obesity, polycystic kidney disease, Von Hippel-Lindau (VHL) disease or hereditary papillary renal cell carcinoma, or misuse of certain pain medicines.

What are the symptoms of renal cell carcinoma (cancer of the kidney)?

Symptoms of advanced renal cell cancer may include hematuria, flank pain, palpable abdominal mass, fatigue, weight loss, malaise, night sweats, anemia, or loss of appetite.

How many people in the US have renal cell carcinoma (cancer of the kidney)?

In the US in 2008, about 54,000 new cases of RCC were diagnosed.

Who is most likely to suffer from renal cell carcinoma (cancer of the kidney) in the US?

RCC is most commonly found in people between the ages of 55 and 84 and affects men more frequently than women.

Several factors can be attributed to an increased risk of RCC including smoking, misuse of certain pain medicines, and having certain genetic conditions such as von Hippel-Lindau disease, a rare genetic multi-system disorder characterized by abnormal blood vessel growth.



GENERAL CONCERNS

Who should not take Afinitor?

No one should take Afinitor if they are allergic to Afinitor or to any of its ingredients. Before taking this medicine find out if your patient is allergic to either of the following:

  • Sirolimus (Rapamune®, rapamycin)
  • Temsirolimus (Torisel®)

Can your patient take Afinitor while pregnant or breast-feeding?

Pregnancy: Afinitor may harm the patient's pregnancy or fetus. Advise your patient to use effective birth control while using Afinitor and for 8 weeks after stopping treatment.

Breast-Feeding: It is not known if Afinitor passes into the breast milk. Your patient should discuss with you and decide if she will take Afinitor or breast-feed. She should not do both.

Does Afinitor affect male and female fertility?

Afinitor may decrease male and female fertility. Please speak with your patient if he or she is concerned about fertility.

Is Afinitor safe for use in children?

Afinitor has not been studied in children.

Does Afinitor contain latex?

No. Afinitor does not contain latex.

Does Afinitor contain gelatin?

No. Afinitor does not contain gelatin.

Does Afinitor contain dye?

No. Afinitor does not contain dye.

Does Afinitor contain gluten?

Novartis Pharmaceuticals Corporation does not knowingly or intentionally include gluten in its products. However, due to multi-sourcing of certain inactive ingredients we cannot guarantee the absence of gluten from our products.

Does Afinitor contain lactose?

Afinitor does contain lactose as an inactive ingredient. Ask your patient if he or she is allergic.

Can your patient drink alcohol while on Afinitor?

Novartis does not recommend drinking alcohol while taking any medication.



OTHER TOPICS

What should your patient tell you before starting Afinitor?

Before taking Afinitor, you need to know about all of the patient's medical conditions including if he or she:

  • Has or has had liver problems
  • Has diabetes or high blood sugar
  • Has high cholesterol levels
  • Is scheduled for any immunization of a live vaccine or may be around people who have recently received an immunization with a live vaccine
  • Is pregnant, or could become pregnant. Afinitor may harm the pregnancy or fetus. Advise the patient to use effective birth control while using Afinitor and for 8 weeks after stopping treatment
  • Is breast-feeding or plans to breast-feed. It is not known if Afinitor passes into the mother's breast milk. The patient and healthcare provider should decide if she will take Afinitor or breast-feed. She should not do both

How much will Afinitor cost?

There is usually quite a bit of variability in prices from one pharmacy to another. It is best to check the price with your patient's pharmacy of choice.

Is there financial assistance available for Afinitor?

Novartis Pharmaceuticals Corporation is committed to providing access to our medications through a number of patient access programs. Please contact AfiniTRAC at 1-888-5AfiniTRAC (1-888-523-4648). Please keep in mind that Afinitor has been approved for patients with advanced renal cell carcinoma (RCC) after failure of treatment with sunitinib or sorafenib and only patients with this diagnosis will be eligible.

The following organizations and websites are independently operated and not managed by Novartis Pharmaceuticals Corporation. Novartis assumes no responsibility for any information they may provide.

For information about kidney cancer:

Kidney Cancer Association
www.Kidneycancerassociation.org
Phone: 847-859-7026

For information about cancer, emotional support, and free counseling by social workers:

Cancer Care
www.Cancercare.org
Phone: 800-813-4673

Will US health insurers cover Afinitor?

We cannot predict the decisions of health insurers; however, Novartis will provide information on Afinitor data to health insurers, demonstrating the unmet need that Afinitor addresses for patients with advanced kidney cancer.

Is Afinitor available at all pharmacies or just specialty pharmacies?

Yes, Afinitor is available at all participating pharmacies.

Where can people find information on reimbursement support for Afinitor in the US?

AfiniTRAC is a comprehensive reimbursement support program specifically for Afinitor patients from Novartis Oncology. It can help make the insurance process simpler for the Healthcare Professional and patients. The program offers benefit verification and financial support programs for eligible patients such as:

Afinitor Co-Pay card—commercially insured patients (outside of Massachusetts) who meet certain financial criteria will receive 100% co-pay support.

PAP—See Afinitor Patient Assistance Program.

Referrals to co-pay foundations—for Medicare patients.

For more information, please contact 1-888-5AfiniTRAC (1-888-523-4648).

Afinitor is indicated for the treatment of patients with advanced renal cell carcinoma after failure of treatment with sunitinib or sorafenib.

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 is a class effect of rapamycin derivatives, including Afinitor. Fatal outcomes have been observed. If symptoms are moderate or severe, patients should be managed with dose interruption until symptoms improve or discontinuation, respectively. Corticosteroids may be indicated. Afinitor may be reintroduced at 5 mg daily depending on the individual clinical circumstances.

Afinitor has immunosuppressive properties and may predispose patients to infections. Localized and systemic infections (bacterial and invasive fungal infections) have occurred. Some of these infections have been severe or fatal. Complete treatment of pre-existing invasive fungal infections prior to starting treatment. If a diagnosis of invasive systemic fungal infection is made, discontinue Afinitor and treat with appropriate antifungal therapy.

Oral ulcerations have occurred in patients treated with Afinitor. 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.

Elevations of serum creatinine, glucose, lipids, and triglycerides and reductions of hemoglobin, lymphocytes, neutrophils and platelets have been reported in clinical trials. Renal function, hematological parameters, blood glucose, and lipids 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.

Co-administration with strong or moderate inhibitors of CYP3A4 or PgP should be avoided. Increase in the Afinitor dose is recommended when co-administered with a strong CYP3A4 inducer.

Afinitor should not be used in patients with severe hepatic impairment.

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

Fetal harm can occur if Afinitor is administered to a pregnant woman.

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 ≥3%) were infections (9%), dyspnea (8%), fatigue (5%), stomatitis (4%), dehydration (4%), pneumonitis (4%), abdominal pain (3%), and asthenia (3%). The most common laboratory abnormalities (incidence ≥50%) were anemia (92%), hypercholesterolemia (77%), hypertriglyceridemia (73%), hyperglycemia (57%), lymphopenia (51%), and increased creatinine (50%). The most common grade 3/4 laboratory abnormalities (incidence ≥3%) were lymphopenia (18%), hyperglycemia (16%), anemia (13%), hypophosphatemia (6%), and hypercholesterolemia (4%). Deaths due to acute respiratory failure (0.7%), infection (0.7%), and acute renal failure (0.4%) were observed on the Afinitor arm.

Full Prescribing Information about Afinitor.

Back to Top

References
  • Afinitor [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; 2009.
  • Press Release. US Food and Drug Administration. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm149550.htm. Accessed August 21.