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Afinitor

Pronunciation

Generic Name: everolimus (E-ver-OH-li-mus)
Brand Name: Afinitor

Afinitor is used for:

Treating advanced kidney cancer, a type of brain tumor (subependymal giant cell astrocytoma [SEGA]), or a type of kidney tumor in certain patients. It is also used to treat a certain type of pancreatic cancer. It is also used in combination with another medicine (exemestane) to treat a type of breast 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 or to other similar medicines (eg, sirolimus, temsirolimus)
  • you are taking atazanavir, clarithromycin, delavirdine, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, St. John's wort, telithromycin, or voriconazole
  • you are taking another doseform of Afinitor (eg, tablets for oral suspension)

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

Slideshow: Flashback: FDA Drug Approvals 2013

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), or a weakened immune system
  • if you have any type of infection (including fungal infections) or a history of persistent or recurring infection
  • if you have a history of lung or breathing problems, 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 (eg, swelling of the hands, face, lips, eyes, throat, or tongue; difficulty swallowing or breathing; unusual hoarseness)
  • Aprepitant, azole antifungals (eg, fluconazole, itraconazole, ketoconazole, voriconazole), cyclosporine, delavirdine, diltiazem, fosaprepitant, macrolide antibiotics (eg, clarithromycin, erythromycin), nefazodone, protease inhibitors (eg, amprenavir, boceprevir, fosamprenavir, ritonavir), telithromycin, or verapamil because they may increase the risk of Afinitor's side effects
  • Carbamazepine, dexamethasone, hydantoins (eg, phenytoin), phenobarbital, primidone, 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. If you cannot swallow Afinitor whole, contact your doctor.
  • 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.
  • 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.
  • Continue to take Afinitor even if you feel well. Do not miss any doses.
  • 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.
  • Do NOT change your dose or stop taking Afinitor without checking with your doctor.
  • Tell your doctor or dentist that you take Afinitor before you receive any medical or dental care, emergency care, or surgery.
  • Afinitor may affect how wounds heal. Sometimes, people with wound healing problems have needed surgery. Tell your doctor if you have a wound that is red, warm, painful, or swollen; if your wound opens up; or if there is blood, fluid, or pus in a wound.
  • 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, tongue, or throat 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, peroxide, iodine, or thyme.
  • Afinitor may lower the ability of your body to fight infection. Serious and sometimes fatal infections have happened with Afinitor. 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.
  • Women may miss one or more menstrual periods while taking Afinitor. If you miss a menstrual period, tell your doctor right away.
  • 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. Talk with your doctor about birth control options while taking Afinitor.
  • Afinitor may cause fertility problems in women and men. This may affect your ability to have children. Discuss any questions or concerns 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.
  • Use Afinitor with caution in the ELDERLY; they may be more sensitive to its effects.
  • Afinitor should be used with extreme caution in CHILDREN younger than 1 year old; 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 taking 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 mouth; dry skin; fingernail or toenail changes; hair loss; headache; joint, back, arm, or leg pain; loss of appetite; mild itching; mild sore throat; 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, throat, or tongue; unusual hoarseness); bloody stools; burning, numbness, or tingling; chest pain; decreased, difficult, or painful urination; fast or irregular heartbeat; fever, chills, or persistent sore throat; interrupted breathing while sleeping; menstrual changes; mental, mood, or behavior changes (eg, depression); new or worsening cough; pain, discomfort, or sores of the mouth, tongue, or throat; persistent dry mouth or increased thirst; redness, pain, swelling, bleeding, or blisters on the palms of your hands or soles of your feet; 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 (eg, wheezing); swelling of the arms, hands, feet, or ankles; symptoms of high blood sugar (eg, increased hunger, thirst, or urination; confusion; unusual drowsiness); symptoms of liver problems (eg, dark urine, loss of appetite, pale stools, yellowing of the skin or eyes); unusual bruising or bleeding.

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.

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 room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store in the original package away from heat, moisture, and light. Do not store in the bathroom. Do not use Afinitor if the expiration date has passed. 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 should not be used to decide whether or not to take Afinitor or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Afinitor. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Afinitor. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using Afinitor.

Issue Date: September 3, 2014
Database Edition 14.3.1.003
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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