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Brand Names: Afinitor

Generic Name: everolimus (Pronunciation: E ver OH li mus)

• What is everolimus (Afinitor)?
• What are the possible side effects of everolimus (Afinitor)?
• What is the most important information I should know about everolimus (Afinitor)?
• What should I discuss with my health care provider before taking everolimus (Afinitor)?
• How should I take everolimus (Afinitor)?
• What happens if I miss a dose (Afinitor)?
• What happens if I overdose (Afinitor)?
• What should I avoid while taking everolimus (Afinitor)?
• What other drugs will affect everolimus (Afinitor)?
• Where can I get more information?

What is everolimus (Afinitor)?

Everolimus is used to treat advanced kidney cancer.

Everolimus is usually given after sorafenib (Nexavar) or sunitinib (Sutent) have been tried without successful treatment of symptoms.

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

What are the possible side effects of everolimus (Afinitor)?

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.

Call your doctor at once if you have a serious side effect such as:

• fever, chills, cough with yellow or green mucus;
• stabbing chest pain, feeling short of breath;
• white patches or sores inside your mouth or on your lips; or
• other signs of infection such as sore throat, flu symptoms, easy bruising or bleeding (nosebleeds, bleeding gums), loss of appetite, nausea and vomiting, or unusual weakness.

Less serious side effects may include:

• tired feeling;
• headache;
• stomach pain, diarrhea;
• swelling, weight gain;
• dry skin; or
• sleep problems (insomnia);

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 is the most important information I should know about everolimus (Afinitor)?

You should not use this medication if you are allergic to everolimus or sirolimus (Rapamune).

Do not use everolimus without telling your doctor if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment.

Before taking everolimus, tell your doctor if you have a breathing disorder, such as asthma or COPD, liver disease, diabetes, or high cholesterol.

Do not receive a "live" vaccine while you are being treated with everolimus, and avoid coming into contact with anyone who has recently received a live vaccine (including measles, mumps, rubella, oral polio, chickenpox, BCG, and nasal flu vaccine).

There are many other medicines that can interact with everolimus. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

To be sure this medication is not causing harmful effects, your blood may need to be tested on a regular basis. Your kidney function may also need to be tested. Do not miss any follow-up visits to your doctor.

Call your doctor at once if you have a serious side effect such as stabbing chest pain, feeling short of breath, fever, chills, cough, sore throat, flu symptoms, easy bruising or bleeding (nosebleeds, bleeding gums), loss of appetite, nausea and vomiting, or unusual weakness.