everolimus (Afinitor)

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

Brand: Afinitor, Afinitor Disperz

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

Afinitor can cause serious and sometimes fatal side effects. Call your doctor right away if you have: signs of infection --fever, chills, skin rash, joint pain, tiredness; lung problems --cough, chest pain, wheezing, shortness of breath; kidney problems --swelling, little or no urination; or liver problems --loss of appetite, dark urine, yellowing of your skin or eyes, or upper stomach pain.

If you have ever had hepatitis B, Afinitor can cause this condition to come back or get worse.

You may be more likely to have an allergic reaction if you take an "ACE inhibitor" heart or blood pressure medication while you are taking Afinitor. Tell your doctor about all your current medicines and any you start or stop using.

What is everolimus (Afinitor)?

Everolimus is a cancer medicine 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 also used to treat certain types of advanced or progressive tumors of the stomach, intestines, or pancreas.

Afinitor is also used to treat certain non-cancerous (benign) tumors of the brain or kidney in people with a certain genetic condition called tuberous sclerosis complex.

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 healthcare provider before taking Afinitor?

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

To make sure Afinitor is safe for you, tell your doctor if you have ever had:

  • an active or chronic infection;
  • liver disease, especially hepatitis B;
  • kidney disease;
  • diabetes or high blood sugar;
  • high cholesterol;
  • if you are scheduled to receive any vaccine; or
  • high blood pressure.

Afinitor can harm an unborn baby. Use effective birth control to prevent pregnancy while you are using this medicine, whether you are a man or a woman. Afinitor use by either parent may cause birth defects.

If you are a woman, keep using birth control for at least 8 weeks after your last dose of Afinitor. If you are a man, keep using birth control for at least 4 weeks after your last dose. Tell your doctor right away if a pregnancy occurs while either the mother or the father is using Afinitor.

This medicine may affect fertility (ability to have children) in both men and women. However, it is important to use birth control to prevent pregnancy because Afinitor may harm the baby if a pregnancy does occur.

It is not known whether Afinitor passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine and for at least 2 weeks after your last dose.

How should I take Afinitor?

Follow all directions on your prescription label. Your doctor may occasionally change your dose. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Take Afinitor at the same time each day. You may take the medicine with or without food, but take it the same way each time.

Take the Afinitor regular tablet with a full glass of water. Do not crush, chew, or break the tablet. Swallow the pill whole.

Do not take an Afinitor regular tablet together with an Afinitor dispersible tablet. Use only one form of this medicine.

Do not swallow the dispersible tablet (Afinitor Disperz) whole. Place it into about 2 tablespoons of water and allow the tablet to disperse in the liquid for at least 3 minutes. Stir gently and drink this mixture right away. The dispersed tablet may also be taken with an oral syringe. Wear latex gloves while handling the Afinitor Disperz tablet.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Afinitor 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.

If you have ever had hepatitis B, Afinitor can cause this condition to come back or get worse. You will need frequent blood tests to check your liver function during treatment and for several months after you stop using this medicine.

If you need surgery, tell the surgeon ahead of time that you are using Afinitor. Your surgical incisions or other wounds may take longer to heal while you are taking this medicine.

Store at room temperature in the original container, away from moisture, heat, and light. Keep unused dispersible tablets in the foil blister pack.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If you are more than 6 hours late, skip the missed dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

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

What should I avoid while taking Afinitor?

If you develop mouth sores or ulcers, avoid using mouthwashes or applying medicines that contain alcohol, peroxide, iodine, or thyme. Your doctor may prescribe a steroid mouthwash if your mouth sores are severe.

Do not receive a "live" vaccine while using Afinitor, 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), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

This medicine can pass into body fluids (urine, feces, vomit). Caregivers should wear rubber gloves while cleaning up a patient's body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.

Grapefruit and grapefruit juice may interact with Afinitor and lead to unwanted side effects. Avoid the use of grapefruit products while taking Afinitor.

What are the possible side effects of Afinitor?

Get emergency medical help if you have signs of an allergic reaction: hives; chest pain, difficult breathing; swelling of your face, lips, tongue, or throat. You may be more likely to have some of these symptoms if you also take an "ACE inhibitor" heart or blood pressure medication.

Stop using Afinitor and call your doctor at once if you have:

  • blisters or ulcers in your mouth, red or swollen gums, trouble swallowing;
  • lung problems --new or worsening cough, chest pain, wheezing, feeling short of breath;
  • signs of infection --fever, chills, tiredness, joint pain, skin rash;
  • kidney problems --little or no urination; swelling in your feet or ankles;
  • liver problems --nausea, loss of appetite, stomach pain (upper right side), dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • low blood cell counts --flu-like symptoms, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath;
  • any wound that will not heal; or
  • a surgical incision that is red, warm, swollen, painful, bleeding, or oozing pus.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common side effects may include:

  • infections, cough, breathing problems, nosebleeds;
  • painful mouth sores, taste problems, dry mouth;
  • nausea, vomiting, diarrhea, constipation;
  • loss of appetite, weight loss, feeling weak or tired;
  • pain or swelling anywhere in your body;
  • dry skin, rash, acne, hair loss, problems with your nails;
  • missed menstrual periods;
  • sleep problems (insomnia), unusual changes in mood or behavior;
  • dizziness, headache; or
  • high blood sugar --increased thirst or urination, hunger, fruity breath odor, blurred vision.

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 Afinitor. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any you start or stop using, especially:

  • an antibiotic or antifungal medicine;
  • heart or blood pressure medication;
  • medicine to treat hepatitis C, or HIV/AIDS;
  • seizure medicine;
  • St. John's wort;
  • tuberculosis medication; or
  • drugs that weaken the immune system, such as cancer medicine, steroids, and medicines to prevent organ transplant rejection.

This list is not complete and many other drugs can interact with Afinitor. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines 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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