everolimus (Afinitor)

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

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

What is everolimus (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.

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.

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

What should I discuss with my healthcare provider before taking Afinitor?

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.

• If you are a woman, do not use Afinitor if you are pregnant. You may need to have a negative pregnancy test before starting this treatment. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 8 weeks after your last dose.
• If you are a man, use effective birth control if your sex partner is able to get pregnant. 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 can harm an unborn baby.

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.

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.

Surgical incisions or other wounds may take longer to heal while you are taking Afinitor. You may need to stop taking this medicine for 1 week before and 2 weeks after a surgery. Follow your doctor's instructions.

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?

What should I avoid while taking Afinitor?

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.

What are the possible side effects of Afinitor?

• 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).