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everolimus (Afinitor)

everolimus (Afinitor)

Pronunciation: E ver OH li mus (a FIN i tor)

Brand: Afinitor

What is the most important information I should know about Afinitor?

This medication guide provides information about the Afinitor brand of everolimus. Zortress is another brand of everolimus used to prevent organ rejection after a kidney transplant.

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You should not use this medication if you are allergic to everolimus, sirolimus (Rapamune), tacrolimus (Prograf), or temsirolimus (Torisel).

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Do not use Afinitor if you are pregnant. It could harm the unborn baby. Use effective birth control while you are using this medication and for at least 8 weeks after your treatment ends.

Before taking Afinitor, tell your doctor if you have a breathing disorder such as asthma or COPD, liver disease (or a history of hepatitis B), an active infection, diabetes or high blood sugar, or high cholesterol.

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Do not receive a "live" vaccine while using Afinitor. The vaccine may not work as well during this time, and may not fully protect you from disease.

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There are many other drugs that can interact with everolimus. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products.

While using Afinitor, you may need blood tests at your doctor's office. Visit your doctor regularly.

What is everolimus (Afinitor)?

Everolimus is a cancer medication that interferes with the growth of cancer cells and slows their spread in the body.

The Afinitor brand of everolimus is used to treat certain types of kidney cancer, breast cancer, or brain tumor. Afinitor is usually given after other cancer medications have been tried without successful treatment.

Afinitor is also used to treat non-cancerous (benign) kidney tumors, and certain types of advanced or progressive tumors of the pancreas.

This medication guide provides information about the Afinitor brand of everolimus. Zortress is another brand of everolimus used to prevent organ rejection after a kidney transplant.

Everolimus may also be used for purposes not listed in this medication guide.

What should I discuss with my health care provider before taking Afinitor?

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You should not use this medication if you are allergic to everolimus, sirolimus (Rapamune), tacrolimus (Prograf), or temsirolimus (Torisel).

To make sure you can safely take everolimus, tell your doctor if you have any of these other conditions:

  • a breathing disorder, such as asthma or COPD (chronic obstructive pulmonary disease);
  • liver disease, or a history of hepatitis B;
  • kidney disease;
  • an active infection;
  • diabetes or high blood sugar; or
  • high cholesterol.
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FDA pregnancy category D. Do not take Afinitor if you are pregnant. It could harm the unborn baby. Use effective birth control while you are taking this medication and for at least 8 weeks after your treatment ends.

Everolimus can affect fertility (your ability to have children), whether you are a man or a woman.

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It is not known whether everolimus passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are taking everolimus.

How should I take Afinitor?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results.

Everolimus should be taken at the same time each day. You may take everolimus with or without food, but take it the same way each time.

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Take this medication with a full glass (8 ounces) of water.

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Do not crush or chew an everolimus tablet. Swallow the pill whole. If you have trouble swallowing the tablet, stir it into 2 tablespoons of water until the tablet breaks apart. Stir this mixture and drink all of it right away. To make sure you get the entire dose, add a little more water to the same glass, swirl gently and drink right away.

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Everolimus can lower blood cells that help your body fight infections and help your blood to clot. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. Your blood may need to be tested often. Visit your doctor regularly.

If you have hepatitis B you may develop liver symptoms after you stop taking this medication, even months after stopping. Your doctor may want to check your liver function for several months after you stop using everolimus. Visit your doctor regularly.

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Store at room temperature in the original container, away from moisture, heat, and light. Keep each tablet in its blister pack until you are ready to take it.

What happens if I miss a dose?

If you are less than 6 hours late in taking your medicine, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

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Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking Afinitor?

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Do not receive a "live" vaccine while taking everolimus, and avoid coming into contact with anyone who has recently received a live vaccine. There is a chance that the virus could be passed on to you. Live vaccines include measles, mumps, rubella (MMR), oral polio, typhoid, chickenpox (varicella), BCG (Bacillus Calmette and Guérin), and nasal flu vaccine.

Grapefruit and grapefruit juice may interact with everolimus and lead to unwanted side effects. Discuss the use of grapefruit products with your doctor.

What are the possible side effects of Afinitor?

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Get emergency medical help if you have any of these signs of an allergic reaction: hives; chest pain, difficult breathing; swelling of your face, lips, tongue, or throat.

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Stop using Afinitor and call your doctor at once if you have a serious side effect such as:

  • new or worsening cough, wheezing, feeling short of breath;
  • stabbing chest pain, cough with yellow or green mucus;
  • seizure (convulsions);
  • white patches or sores inside your mouth or on your lips;
  • swelling, rapid weight gain, urinating less than usual or not at all;
  • fever, chills, sore throat, body aches, flu symptoms, feeling weak or tired;
  • pain or burning when you urinate;
  • pain or fullness in your ear, hearing problems;
  • pale skin, feeling light-headed, rapid heart rate, trouble concentrating;
  • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin; or
  • nausea, pain in your upper stomach, itching, joint pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of your skin or eyes).

Less serious side effects may include:

  • diarrhea, constipation, mild nausea or vomiting, weight loss;
  • dry skin, acne, mild itching or skin rash;
  • cold symptoms such as stuffy nose, sneezing, sore throat;
  • unusual taste in your mouth;
  • headache; or
  • pain in your arms and legs.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Afinitor?

Many drugs can interact with everolimus. Below is just a partial list. Tell your doctor if you are using:

  • aprepitant (Emend);
  • bosentan (Tracleer);
  • conivaptan (Vaprisol);
  • dexamethasone (Cortastat, Dexasone, Solurex, DexPak);
  • imatinib (Gleevec);
  • isoniazid (for treating tuberculosis);
  • St. John's wort;
  • an antibiotic such as clarithromycin (Biaxin), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin), rifabutin (Mycobutin), rifampin (Rifadin, Rifater, Rifamate), rifapentine (Priftin), or telithromycin (Ketek);
  • an antidepressant such as nefazodone;
  • antifungal medication such as clotrimazole (Mycelex Troche), itraconazole (Sporanox), ketoconazole (Nizoral), miconazole (Oravig), or voriconazole (Vfend);
  • a barbiturate such as butabarbital (Butisol), secobarbital (Seconal), pentobarbital (Nembutal), or phenobarbital (Solfoton);
  • heart or blood pressure medication such as amiodarone (Cordarone, Pacerone), diltiazem (Cartia, Cardizem), dronedarone (Multaq), nicardipine (Cardene), quinidine (Quin-G), or verapamil (Calan, Covera, Isoptin, Verelan);
  • HIV or AIDS medication such as atazanavir (Reyataz), delavirdine (Rescriptor), efavirenz (Atripla, Sustiva), etravirine (Intelence), fosamprenavir (Lexiva), indinavir (Crixivan), nelfinavir (Viracept), nevirapine (Viramune), saquinavir (Invirase), or ritonavir (Kaletra, Norvir);
  • medicines used to prevent organ transplant rejection, such as cyclosporine (Gengraf, Neoral, Sandimmune), sirolimus (Rapamune), or tacrolimus (Prograf).
  • medicines to treat narcolepsy, such as armodafinil (Nuvigil) or modafinil (Progivil); or
  • seizure medication such as carbamazepine (Carbatrol, Equetro, Tegretol), felbamate (Felbatol), oxcarbazepine (Trileptal), phenobarbital (Solfoton), phenytoin (Dilantin), or primidone (Mysoline).
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This list is not complete and there are many other drugs that can interact with everolimus. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.

Where can I get more information?

Your pharmacist can provide more information about everolimus (Afinitor).


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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