Afinitor Generic Name: Everolimus
Afinitor is used for:
Treating advanced kidney cancer 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
- you have severe liver problems
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 are allergic to sirolimus or temsirolimus
- 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, a history of lung or breathing problems, or any type of infection
- if you have a history of mild or moderate liver problems
- if you have recently received or will be receiving a live vaccine (eg, measles, mumps), or if you will be in close contact with anyone who has received a live vaccine
Some MEDICINES MAY INTERACT with Afinitor . Tell your health care provider if you are taking any other medicines, especially any of the following:
- Anticoagulants (eg, warfarin) because the risk of severe bleeding may be increased
- Aprepitant, azole antifungals (eg, itraconazole, ketoconazole), calcium channel blockers (eg, diltiazem, verapamil), HIV protease inhibitors (eg, ritonavir), macrolide antibiotics (eg, clarithromycin, erythromycin), nefazodone, non-nucleoside reverse transcriptase inhibitor (NNRTI) (eg, delavirdine), P-glycoprotein, telithromycin, or voriconazole because they may increase the risk of Afinitor 's side effects
- Barbiturates (eg, phenobarbital), carbamazepine, dexamethasone, hydantoins (eg, phenytoin), rifabutin, rifampicin, rifampin, 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.
- Swallow Afinitor whole. Do not break, crush, or chew before swallowing.
- Take Afinitor with a full glass of water (8 oz/240 mL).
- Do not eat grapefruit or drink grapefruit juice while you use Afinitor .
- Taking Afinitor at the same time each day will help you to remember.
- 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. Use 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 .
- 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.
- Non-infectious 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 use Afinitor and for 2 months after you stop using it. If you have questions about effective birth control, talk with your doctor.
- Men who use Afinitor should always use effective birth control when having sex with a woman who may become pregnant. Do this for as long as you use Afinitor and for 2 months after you stop using it. If you have questions about effective birth control, talk with your doctor.
- Lab tests, including kidney function, 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 not be used in CHILDREN; safety and effectiveness in children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: Afinitor may cause harm to the fetus. Do not become pregnant while you are using it and for 2 months after you stop Afinitor . If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using 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:
Cough; diarrhea; dry skin, pain, swelling, or soreness of the mouth or tongue; fingernail or toenail changes; headache; itching; loss of appetite; nausea; nosebleed; stomach pain or upset; taste changes; trouble sleeping; vomiting; tiredness or weakness; 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); arm or leg pain; bloody stools; chest pain; decreased, difficult, or painful urination; dry mouth or increased thirst; fast or irregular heartbeat; fever, chills, or persistent sore throat; new or worsening cough; numbness or tingling; 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; 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. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch .
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), 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.
- 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.
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.
- Afinitor Prescribing Information (FDA)
- Afinitor Advanced Consumer (Micromedex) - Includes Dosage Information
- Afinitor Consumer Overview
- Everolimus Professional Patient Advice (Wolters Kluwer)