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everolimus (Afinitor)

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

Brand: Afinitor, Afinitor Disperz

Afinitor

slide 1 of 2, Afinitor,

5 mg, oval, white, imprinted with 5, NVR

 Image of Afinitor
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Afinitor

slide 2 of 2, Afinitor,

10 mg, oval, white, imprinted with UHE, NVR

 Image of Afinitor
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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 types of seizures or non-cancerous (benign) tumors of the brain or kidney in people with a 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).

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.

Both men and women using this medicine should use effective birth control to prevent pregnancy. Afinitor can harm an unborn baby or cause birth defects if the mother or father is using this medicine.

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.

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 and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

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.

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

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Afinitor can increase your risk of bleeding or infection by changing the way your immune system works. You will need frequent medical tests.

If you've ever had hepatitis B, using Afinitor can cause this virus to become active or get worse. You may need frequent liver function tests while using this medicine and for several months after you stop.

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?

Use the medicine as soon as you can, but skip the missed dose if you are more than 6 hours late for the dose. Do not use two doses at one time.

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?

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), and zoster (shingles).

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

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.

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.

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;
  • 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:

  • fever, cough, infections, feeling weak or tired;
  • mouth sores;
  • nausea, loss of appetite;
  • swelling anywhere in your body;
  • rash;
  • missed menstrual periods;
  • headache; or
  • high blood sugar --increased thirst, increased urination, dry mouth, fruity breath odor.

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?

Tell your doctor about all your current medicines. Many drugs can affect Afinitor, 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 may affect Afinitor. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

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.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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