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Printer friendlyYour 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
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 with renal cancer. Please see section 8.4 of the Prescribing Information.
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 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.
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 2.5-mg tablet: White to slightly yellow, elongated tablets with a beveled edge and no score, engraved with "LCL" on one side and "NVR" on the other.
What are the ingredients of Afinitor?1
Afinitor is supplied as tablets for oral administration containing 2.5 mg, 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 10-mg tablets are supplied in blister packs of 28 tablets. Each carton contains 4 blister cards of 7 tablets each.
Afinitor 5-mg tablets are supplied in blister packs of 28 tablets. Each carton contains 4 blister cards of 7 tablets each.
Afinitor 2.5-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, consistently with or consistently without food.
Can Afinitor be taken consistently with or consistently without food?
Yes, Afinitor should be taken consistently with or consistently 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. For patients unable to swallow tablets, AFINITOR tablet(s) should be dispersed completely in a glass of water (containing approximately 30 mL) by gently stirring immediately prior to drinking. The glass should be rinsed with the same volume of water and the rinse should be swallowed to ensure the entire dose is administered.
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 25°C (77°F); excursions permitted between 15°C to 30°C (59°F to 86°F)
- 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
- 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): Patients may develop 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: Patients may be more likely to develop an infection, such as pneumonia, or a bacterial, fungal, or viral infection. Viral infections may include active hepatitis B in people who have had hepatitis B in the past (reactivation). In some patients infections may be 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 if they do not feel well should be reported to a healthcare provider right away.
- Fever
- Skin rash
- Joint pain and inflammation
- Tiredness
- Loss of appetite
- Nausea
- Pale stool or dark urine
- Yellowing of the skin
- Pain in your upper right side
- Kidney Failure: Afinitor may cause kidney failure. In some people this may be severe and can even lead to death. Patients should have tests to check their kidney function before and during their treatment with Afinitor.
Symptoms of hepatitis B or infection may include the following:
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 that does not contain alcohol or peroxide
- Infections
- Feeling weak or tired
- Cough, shortness of breath
- 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.
Patients should not drink grapefruit juice, or eat grapefruit during treatment.
Afinitor may 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)
- Medicines that suppress your immune system
If your patient is taking any medicines for the conditions listed above, you might need to prescribe a different medicine or the dose of Afinitor may need to be changed. 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)?
Approximately 58,240 Americans (35,370 men and 22,870 women) were diagnosed with kidney and renal pelvis cancer in the United States in 2010.
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®)
- Temsirolimus (Torisel®)
Can your patient take Afinitor while pregnant or breast-feeding?
Pregnancy: It is not known if AFINITOR will harm an unborn baby. Women should use effective birth control while using AFINITOR and for 8 weeks after stopping treatment.
Breast-Feeding: It is not known if AFINITOR passes into your breast milk. You and your healthcare provider should decide if you will take AFINITOR or breastfeed. You 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 with advanced RCC.
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:
- Have or has had kidney problems
- Has or has had liver problems
- Has diabetes or high blood sugar
- Has high cholesterol levels
- Has any infections
- Previously had hepatitis B
- Is scheduled to receive any vaccinations. Patients should not receive a live vaccine or be around people who have recently received a live vaccine during treatment with Afinitor
- Is pregnant, or could become pregnant. It is not known if Afinitor may harm the unborn baby. 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 that can help you navigate through the insurance process for you and your 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).
Rapamune® and Torisel® are registered trademarks of Pfizer Inc.
References
- Afinitor [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; 2011.
- Press Release. US Food and Drug Administration. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm149550.htm. Accessed August 21, 2009.
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: Non-infectious pneumonitis was reported in 11-14% of patients treated with Afinitor. The incidence of Common Terminology Criteria (CTC) grade 3 and 4 non-infectious pneumonitis was 1.6%-4.0% and 0.1%, respectively. Fatal outcomes have been observed. If symptoms are moderate, patients should be managed with dose interruption until symptoms improve. If symptoms are severe, AFINITOR therapy should be discontinued. Under both circumstances, corticosteroids may be indicated and AFINITOR may be reintroduced at 5 mg daily depending on the individual clinical circumstances. The development of pneumonitis has been reported even at a reduced dose.
Infections: AFINITOR has immunosuppressive properties and may predispose patients to localized or systemic bacterial, fungal, viral, or protozoal infections (including those with opportunistic pathogens). Viral infections may include reactivation of hepatitis B infection. Some of these infections have been severe (e.g., leading to respiratory or hepatic failure) or fatal. Physicians and patients should be aware of the increased risk of infection with Afinitor. Treatment of pre-existing invasive fungal infections should be completed prior to starting treatment. 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 treatment.
Oral Ulceration: Oral ulcerations (i.e., mouth ulcers, stomatitis, and oral mucositis) are the most frequently occurring adverse event and occur in approximately 70% of advanced PNET patients, 44% of advanced RCC patients, and 86% of SEGA patients, which were mostly Grade 1 or 2. Grade 3 or 4 stomatitis was reported in 6% of patients with neuroendocrine tumors. 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.
Renal Failure: Cases of renal failure (including acute renal failure), some with a fatal outcome, have been observed in patients treated with AFINITOR.
Laboratory Tests and Monitoring: Elevations of serum creatinine, proteinuria, glucose, lipids, and triglycerides, and reductions of hemoglobin, lymphocytes, neutrophils, and platelets have been reported. Renal function, blood glucose, lipids, and hematologic parameters 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.
Drug-drug Interactions: Avoid co-administration with strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, atazanavir, nefazodone, saquinavir, telithromycin, ritonavir, indinavir, nelfinavir, voriconazole). Use caution and reduce the AFINITOR dose to 2.5 mg daily if co-administration with a moderate CYP3A4 and/or PgP inhibitor is required (e.g., amprenavir, fosamprenavir, aprepitant, erythromycin, fluconazole, verapamil, diltiazem). Avoid co-administration with strong CYP3A4 inducers (e.g., phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital); however, if co-administration is required, increase the AFINITOR dose from 10 mg daily up to 20 mg daily, using 5 mg increments.
Hepatic Impairment: AFINITOR should not be used in patients with severe hepatic impairment. Exposure of everolimus was increased in patients with moderate hepatic impairment. AFINITOR dose should be reduced to 5 mg daily for patients with moderate hepatic impairment.
Vaccinations: The use of live vaccines and close contact with those who have received live vaccines should be avoided during treatment with AFINITOR.
Use in Pregnancy: Fetal harm can occur if AFINITOR is administered to a pregnant woman. Women of childbearing potential should be advised to use an effective method of contraception while using AFINITOR and for up to 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%). Deaths due to acute respiratory failure (0.7%), infection (0.7%), and acute renal failure (0.4%) were observed on the AFINITOR arm.
Laboratory Abnormalities: The most common laboratory abnormalities (incidence ≥ 50%, all grades) were: decreased hemoglobin (92%) and lymphocytes (51%); 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 for AFINITOR.
