Understanding Side Effects

AFINITOR DISPERZ 

WHAT ARE THE MOST SERIOUS SIDE EFFECTS?

AFINITOR DISPERZ® (everolimus tablets for oral suspension) can cause serious side effects. These serious side effects include:

 

  • You may develop lung or breathing problems. In some people lung or breathing problems may be severe and can even lead to death. Tell your health care provider right away if you have any of these symptoms: new or worsening cough, shortness of breath, chest pain, difficulty breathing, or wheezing
  • You may be 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. In some people these infections may be severe and can even lead to death. You may need to be treated as soon as possible. Tell your health care provider right away if you have a temperature of 100.5˚F or above, 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, dark urine, yellowing of the skin, pain in the upper right side of the stomach
  • Severe allergic reactions. Severe allergic reactions can happen in people who take AFINITOR DISPERZ. Call your health care provider or get medical help right away if you get signs and symptoms of a severe allergic reaction including: rash, itching, hives, flushing, trouble breathing or swallowing, chest pain, or dizziness

  • Possible increased risk for a type of allergic reaction called angioedema (swelling under the skin), in people who take an angiotensin-converting enzyme (ACE) inhibitor medicine during treatment with AFINITOR DISPERZ. Talk with your health care provider before taking AFINITOR DISPERZ 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 DISPERZ 
  • You may develop kidney failure. In some people this may be severe and can even lead to death. Your health care provider should do tests to check your kidney function before and during your treatment with AFINITOR DISPERZ 
  • You may experience delayed wound healing. AFINITOR DISPERZ 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
  • Increased blood sugar and fat (cholesterol and triglyceride) levels in the blood. Your health care provider should do blood tests to check your fasting blood sugar, cholesterol, and triglyceride levels in your blood before you start and during treatment with AFINITOR DISPERZ
  • Decreased blood cell counts. AFINITOR DISPERZ can cause you to have decreased red blood cells, white blood cells, and platelets. Your health care provider should do blood tests to check your blood cell counts before you start and during treatment with AFINITOR DISPERZ

 

If you have any of the serious side effects listed above, you may need to stop taking AFINITOR DISPERZ, for a while or use a lower dose. Follow your doctor’s instructions. 

COMMON SIDE EFFECTS

The most common side effects of AFINITOR DISPERZ:

 

  • Mouth ulcers: AFINITOR DISPERZ can cause mouth ulcers and sores. When you start treatment with AFINITOR DISPERZ, 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 restart this mouthwash or to use a special mouthwash or gel that does not contain alcohol, hydrogen peroxide, iodine, or thyme

 

  • Respiratory tract infection

 

Other side effects that may occur with AFINITOR DISPERZ:

 

  • Absence of menstrual periods (menstruation). Women may miss 1 or more menstrual periods. Tell your health care provider if this happens
  • Fertility may be affected in women and may affect the ability to become pregnant. Talk to your health care provider if this is a concern for you
  • Fertility may be affected in men and may affect the ability to father a child. 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 DISPERZ. For more information, ask your health care provider or pharmacist. Call your doctor for medical advice about side effects.

TIPS ABOUT COMMON SIDE EFFECTS OF AFINITOR DISPERZ

With AFINITOR DISPERZ, you may have side effects. That’s why it is important to have frequent conversations with your doctor. You can make a management plan in case of side effects.

 

Some people experience many side effects, while others have few. It can be helpful to keep track of your experience by writing it down in a journal.

 

  • AFINITOR DISPERZ works differently than treatments you may have had in the past, and it may cause side effects that you are not familiar with
  • Tell your doctor if you have any side effect that bothers you or does not go away 
  • Your doctor or nurse may tell you to temporarily stop treatment until your symptoms improve, and then adjust your dose accordingly
  • Your doctor may offer some suggestions about proper oral care and what foods to avoid


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.