AFINITOR is a prescription medicine used to treat advanced hormone receptor-positive, HER2-negative breast cancer, along with the medicine exemestane, in postmenopausal women who have already received certain other medicines for their cancer.

Management of Mouth Sores While Taking AFINITOR

Mouth sores are the most common side effect of AFINITOR^® (everolimus) Tablets. They can appear as early as within 2 weeks of treatment or at any time during treatment. Your doctor may prescribe alcohol-free dexamethasone oral solution to reduce the likelihood of mouth sores occurring, or reduce the severity if they do occur.

Important Safety Information

Patients should not take AFINITOR if they are allergic to AFINITOR or to any of its ingredients. Patients should tell their health care provider before taking AFINITOR if they are allergic to sirolimus (Rapamune^®) or temsirolimus (Torisel^®).

AFINITOR can cause serious side effects, such as lung or breathing problems, infections, or kidney failure. Some of these side effects can be severe and can even lead to death. Your health care team may have ways to help manage side effects that do occur. It’s important to talk with your doctor or nurse about side effects you experience and the best ways to manage them. Serious side effects include:

Lung or Breathing Problems: Patients should tell their health care provider right away if they have any of these symptoms: new or worsening cough, shortness of breath, chest pain, difficulty breathing, or wheezing. 

Infections: AFINITOR may make patients more likely to develop an infection, such as pneumonia, or a bacterial, fungal, or viral infection. Viral infections may include reactivation of hepatitis B in people who have had hepatitis B in the past. Patients may need to be treated as soon as possible. Patients should tell their health care provider right away if they have a temperature of 100.5°F or above, have chills, or do not feel well. Symptoms of hepatitis B or infection may include the following: fever, chills, skin rash, joint pain and inflammation, tiredness, loss of appetite, nausea, pale stools or dark urine, yellowing of the skin, or pain in the upper right side of the stomach.

Angioedema: Patients who take an angiotensin-converting enzyme (ACE) inhibitor medicine during treatment with AFINITOR are at a possible increased risk for a type of allergic reaction called angioedema. Talk with your health care provider before taking AFINITOR if you are not sure if you take an ACE inhibitor medicine. Get medical help right away if you have trouble breathing or develop swelling of your tongue, mouth, or throat during treatment with AFINITOR.

Kidney Failure: Patients taking AFINITOR may develop kidney failure. Patients should have tests to check their kidney function before and during their treatment with AFINITOR.

Delayed Wound Healing: AFINITOR can cause incisions to heal slowly or not heal well. Call your health care provider right away if your incision is red, warm, or painful; if you have blood, fluid, or pus in your incision; if your incision opens up; or if your incision swells.

Before taking AFINITOR, tell your health care provider about all your medical conditions, including if you:

• Have or have had kidney problems
• Have or have had liver problems
• Have diabetes or high blood sugar
• Have high blood cholesterol levels
• Have any infections
• Previously had hepatitis B
• Are scheduled to receive any vaccinations. You should not receive a live vaccine or be around people who have recently received a live vaccine during your treatment with AFINITOR. If you are not sure about the type of vaccine, ask your health care provider
• Have other medical conditions
• Are pregnant, could become pregnant, or have a partner who could become pregnant. AFINITOR can cause harm to your unborn baby. If you are a woman who is able to become pregnant, you should use effective birth control while using AFINITOR and for 8 weeks after your last dose. Talk to your health care provider about birth control options while taking AFINITOR
• Are breastfeeding or plan to breastfeed. Do not breastfeed during treatment and for 2 weeks after your last dose
• Are about to have surgery, if you have had a recent surgery, or if you have an unhealed wound

Tell your health care provider about all of the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Using AFINITOR with certain other medicines can cause serious side effects. Keep a list of medicines you take and show it to your health care provider when you get a new medicine. Especially tell your health care provider if you take St John’s wort (Hypericum perforatum), medicines that weaken your immune system (your body’s ability to fight infections and other problems), or medicines for:

• Fungal infections
• Bacterial infections
• Tuberculosis
• Seizures
• HIV-AIDS
• Heart conditions or high blood pressure

If you are taking any medicines for the conditions listed above, your health care provider might need to prescribe a different medicine or your dose of AFINITOR may need to be changed. Tell your health care provider before you start taking any new medicine.

Common Side Effects

The most common side effect of AFINITOR in treating advanced hormone receptor-positive, HER2-negative breast cancer was mouth ulcers and sores (67%). When you start treatment with AFINITOR, your health care provider may tell you to also start a prescription mouthwash to reduce the likelihood of getting mouth ulcers or sores and to reduce their severity. Follow your health care provider’s instructions on how to use this prescription mouthwash. Tell your health care provider if you have pain, discomfort, or open sores in your mouth. Your health care provider may tell you to re-start this mouthwash or to use a special mouthwash or mouth gel that does not contain alcohol, hydrogen peroxide, iodine, or thyme.

Other common side effects of AFINITOR include:

• Infections (50%)
• Rash (39%)
• Feeling tired (36%)
• Diarrhea (33%)
• Loss of appetite (30%)
• Nausea (29%), vomiting (17%)
• Weight loss (25%)
• Cough (24%), shortness of breath (21%)
• Abnormal taste (22%)
• Headache (21%)
• Pain in arms and legs (9%), back (14%), joints (20%)
• Swelling of arms, hands, feet, ankles, face, or other parts of the body (19%)
• Nose bleeds (17%)
• Fever (15%)
• Constipation (14%)
• High blood glucose (14%)
• Difficulty sleeping (13%)
• Feeling weak (13%)
• Itching (13%)
• Dry mouth (11%)
• Hair loss (10%)

Other side effects that may occur with AFINITOR:

• Absence of menstrual periods (menstruation). You may miss 1 or more menstrual periods. Tell your health care provider if this happens
• AFINITOR may affect fertility in females and males, and may affect your ability to become pregnant if you are female or your ability to father a child if you are male. Talk to your health care provider if this is a concern for you

Tell your health care provider if you have any side effect that bothers you or does not go away.

These are not all the possible side effects of AFINITOR. For more information, ask your health care provider or pharmacist.
Call your doctor for medical advice about side effects.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.