Afinitor

Pronunciation: E-ver-OH-li-mus
Generic Name: Everolimus
Brand Name: Afinitor

Afinitor is used for:

Treating advanced kidney cancer in certain patients. It is used to treat a certain type of pancreatic cancer. It is also used to treat a type of brain tumor (subependymal giant cell astrocytoma [SEGA]) in certain patients. It may also be used for other conditions as determined by your doctor.

Afinitor is a kinase inhibitor. It works by preventing the growth of cancer cells.

Do NOT use Afinitor if:

• you are allergic to any ingredient in Afinitor or to other similar medicines (eg, sirolimus, temsirolimus)


• you have severe liver problems


• you are taking atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, St. John's wort, telithromycin, or voriconazole

Contact your doctor or health care provider right away if any of these apply to you.

Before using Afinitor:

Some medical conditions may interact with Afinitor. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are able to become pregnant


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have diabetes or high blood sugar, high cholesterol, bone marrow problems, certain blood problems (eg, low white blood cell or platelet levels), a weakened immune system, or a history of lung or breathing problems


• if you have any type of infection (including fungal infections) or a history of persistent or recurring infection


• if you have or have a history of hepatitis B or other liver problems, or kidney problems


• if you have recently received or will be receiving a vaccine (eg, measles, mumps), or if you will be in close contact with anyone who has received a live vaccine


• if you take medicine that may weaken your immune system. Check with your doctor or pharmacist if you are unsure if any of your medicines may weaken your immune system

Some MEDICINES MAY INTERACT with Afinitor. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Angiotensin-converting enzyme (ACE) inhibitors (eg, lisinopril) because they may increase the risk of a serious side effect called angioedema (swelling of the hands, face, lips, eyes, throat, or tongue; difficulty swallowing or breathing; unusual hoarseness)


• Anticoagulants (eg, warfarin) because the risk of severe bleeding may be increased


• Aprepitant, azole antifungals (eg, fluconazole, itraconazole, ketoconazole, voriconazole), calcium channel blockers (eg, diltiazem, verapamil), cyclosporine, delavirdine, HIV protease inhibitors (eg, ritonavir), macrolide antibiotics (eg, clarithromycin, erythromycin), nefazodone, or telithromycin because they may increase the risk of Afinitor's side effects


• Barbiturates (eg, phenobarbital), carbamazepine, dexamethasone, hydantoins (eg, phenytoin), rifamycins (eg, rifabutin, rifampin, rifapentine), or St. John's wort because they may decrease Afinitor's effectiveness

This may not be a complete list of all interactions that may occur. Ask your health care provider if Afinitor may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Afinitor:

Use Afinitor as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Afinitor. Talk to your pharmacist if you have questions about this information.


• Take Afinitor by mouth with or without food. It is important to take it consistently with regard to meals. If you take it with food, try to always take it with food. If you prefer to take it on an empty stomach, then always try to take it on an empty stomach.


• Swallow Afinitor whole. Do not break, crush, or chew before swallowing. Do not take a tablet that has been broken or crushed.


• Take Afinitor with a full glass of water (8 oz/240 mL).


• Do not remove the tablet from the blister package until you are ready to take Afinitor.


• If you cannot swallow Afinitor, you may dissolve the tablet in a glass containing 2 tablespoons (30 mL) of water. Stir to mix completely, and drink immediately. Do not store the mixture for use at a later time. After you drink the mixture, rinse the glass with another 2 tablespoons (30 mL) of water and drink to be sure that you receive the entire dose of Afinitor.


• Do not eat grapefruit or drink grapefruit juice while you use Afinitor.


• Afinitor works best if it is taken at the same time each day.


• If you miss a dose of Afinitor, take it as soon as possible. If it is more than 6 hours after you normally take your dose, skip the missed dose and go back to your regular dosing schedule the next day. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Afinitor.

Important safety information:

• Afinitor may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Take Afinitor with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Afinitor may cause dizziness; alcohol, hot weather, exercise, or fever may increase these effects. To prevent this, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of dizziness.


• Tell your doctor or dentist that you take Afinitor before you receive any medical or dental care, emergency care, or surgery.


• Contact your doctor if you have a wound that does not heal properly while you are using Afinitor.


• Serious and sometimes fatal kidney problems have occurred in patients who have taken Afinitor. Contact your doctor immediately if you experience decreased urination or if you have any questions or concerns about this information.


• Pain, discomfort, or sores of the mouth or tongue may occur while you are taking Afinitor. Check with your doctor about how to treat these effects. Do not treat these effects with mouthwashes that contain alcohol or peroxide unless your doctor tells you otherwise.


• Afinitor may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.


• Do not receive a live vaccine (eg, measles, mumps) while you are taking Afinitor. Avoid close contact with anyone who has recently received a live vaccine. Talk with your doctor before you receive any vaccine.


• Afinitor may raise your blood sugar. High blood sugar may make you feel confused, drowsy, or thirsty. It can also make you flush, breathe faster, or have a fruit-like breath odor. If these symptoms occur, tell your doctor right away.


• Noninfectious pneumonitis is a severe and possibly fatal reaction that may occur with the use of Afinitor. Tell your doctor right away if you develop fever, shortness of breath, cough, or any other new or worsening breathing problems.


• If you may become pregnant, you must use an effective form of birth control while you take Afinitor and for 8 weeks after you stop taking it. If you have questions about effective birth control, talk with your doctor.


• Lab tests, including kidney function, everolimus levels, blood cholesterol levels, blood glucose levels, and complete blood cell counts, may be performed while you use Afinitor. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Afinitor should be used with extreme caution in CHILDREN younger than 3 years who have SEGA; safety and effectiveness in these children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: Afinitor may cause harm to the fetus. Do not become pregnant while you are taking it and for 8 weeks after you stop Afinitor. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of taking Afinitor while you are pregnant. It is not known if Afinitor is found in breast milk. Do not breast-feed while taking Afinitor.

Possible side effects of Afinitor:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Acne; constipation; diarrhea; dizziness; dry skin; fingernail or toenail changes; headache; joint, back, arm, or leg pain; loss of appetite; mild itching; muscle spasms; nausea; nosebleed; stomach pain or upset; stuffy or runny nose; taste changes; tiredness or weakness; trouble sleeping; vomiting; weight loss.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing or swallowing; flushing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); bloody stools; burning, numbness, or tingling (especially of the palms of the hands and soles of the feet); chest pain; decreased, difficult, or painful urination; dry mouth or increased thirst; fast or irregular heartbeat; fever, chills, or persistent sore throat; interrupted breathing while sleeping; new or worsening cough; pain, discomfort, or sores of the mouth or tongue; personality changes; seizure; severe or persistent diarrhea, nausea, stomach pain, or vomiting; severe or persistent dizziness or headache; severe or persistent tiredness or weakness; shortness of breath or other breathing problems; swelling of the arms, hands, feet, or ankles; symptoms of high blood sugar (eg, increased hunger, thirst, or urination; confusion; unusual drowsiness); unusual bruising or bleeding; wheezing; yellowing of the eyes or skin.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Afinitor side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Afinitor:

Store Afinitor at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store in original package away from heat, moisture, and light. Do not store in the bathroom. Keep Afinitor out of the reach of children and away from pets.

General information:

• If you have any questions about Afinitor, please talk with your doctor, pharmacist, or other health care provider.


• Afinitor is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Afinitor. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Afinitor resources

• Afinitor Side Effects (in more detail)
• Afinitor Dosage
• Afinitor Use in Pregnancy & Breastfeeding
• Drug Images
• Afinitor Drug Interactions
• Afinitor Support Group
• 1 Review for Afinitor - Add your own review/rating

• Afinitor Prescribing Information (FDA)


• Afinitor Consumer Overview


• Afinitor Monograph (AHFS DI)


• Afinitor Advanced Consumer (Micromedex) - Includes Dosage Information


• Everolimus Professional Patient Advice (Wolters Kluwer)


• Zortress Prescribing Information (FDA)


• Zortress Consumer Overview

Compare Afinitor with other medications

• Brain Tumor
• Pancreatic Cancer
• Renal Cell Carcinoma