Afinitor Oral

Everolimus is used to treat kidney cancer. It works by slowing or stopping the growth of cancer cells.

Take this medication by mouth with or without food, usually once daily or as directed by your doctor. Swallow this medication whole with a glass of water. Do not crush, chew, or break the tablets.

Dosage is based on your medical condition, interacting drugs, and response to treatment.

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day.

Do not increase your dose or take this medication more often without your doctor's approval. Your condition will not improve any faster and the risk of serious side effects may be increased.

Avoid eating grapefruit or drinking grapefruit juice while using this medication unless your doctor instructs you otherwise. Grapefruit can increase the amount of this medication in your bloodstream. Consult your doctor or pharmacist for more details.

Since this drug can be absorbed through the skin and lungs, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the tablets.

Diarrhea, nausea/vomiting, decreased appetite, changes in taste, nosebleeds, dry skin, or headache may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Pain or sores in the mouth and throat may occur. Brush your teeth carefully/gently, avoid using mouthwash that contains alcohol or peroxide, and rinse your mouth frequently with cool water mixed with baking soda or salt. It may also be best to eat soft, moist foods.

Many people using this medication have serious side effects. However, your doctor has prescribed this drug because he or she has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.

Tell your doctor immediately if any of these unlikely but serious side effects occur: swelling hands/ankles/feet, increased thirst/urination.

Tell your doctor immediately if this rare but very serious side effect occurs: change in the amount of urine.

Everolimus can lower the body's ability to fight an infection. It can also cause very serious (rarely fatal) lung problems. Tell your doctor immediately if you develop symptoms of infection or lung problems, including fever, chills, persistent sore throat, cough, shortness of breath, chest pain.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before taking everolimus, tell your doctor or pharmacist if you are allergic to it; or to sirolimus or temsirolimus; or if you have any other allergies.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, kidney disease, any recent/current infections, diabetes, high cholesterol/triglyceride levels.

Everolimus can make you more likely to get infections or may worsen any current infections. Therefore, wash your hands well to prevent the spread of infection. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.

Do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

This medication is not recommended for use during pregnancy. It may harm an unborn baby. Consult your doctor for more details and to discuss using at least 2 reliable forms of birth control (such as condoms, birth control pills) while taking this medication and for 8 weeks after stopping treatment. If you become pregnant or think you may be pregnant, tell your doctor immediately.

It is unknown if this medication passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

See also How to Use section.

The effects of some drugs can change if you take other drugs or herbal products at the same time. This can increase your risk for serious side effects or may cause your medications not to work correctly. These drug interactions are possible, but do not always occur. Your doctor or pharmacist can often prevent or manage interactions by changing how you use your medications or by close monitoring.

To help your doctor and pharmacist give you the best care, be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products) before starting treatment with this product. While using this product, do not start, stop, or change the dosage of any other medicines you are using without your doctor's approval.

Other medications can affect the removal of everolimus from your body, which may affect how everolimus works. Examples include azole antifungals (such as ketoconazole), macrolide antibiotics (such as erythromycin), certain calcium channel blockers (such as diltiazem, verapamil), HIV protease inhibitors (such as ritonavir), rifamycins (such as rifabutin), St. John's wort, drugs used to treat seizures (such as carbamazepine, phenytoin), among others.

This document does not contain all possible drug interactions. Keep a list of all the products you use. Share this list with your doctor and pharmacist to lessen your risk for serious medication problems.

If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center.

Do not share this medication with others.

Laboratory and/or medical tests (such as blood sugar, cholesterol/triglyceride levels, complete blood count, kidney function) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

If you miss a dose, take it as soon as you remember unless it is more than 6 hours after the time you usually take the dose. In that case, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

Store at room temperature at 77 degrees F (25 degrees C) away from light and moisture. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-800-854-1166 (USA) or 1-800-668-1507 (Canada).

Information last revised April 2009 Copyright(c) 2009 First DataBank, Inc.