lly once daily at the same time every day, either consistently with food or consistently without food. Inform patients that AFINITOR Tablets should be swallowed whole with a glass of water.
Inform patients to take AFINITOR DISPERZ orally once daily at the same time every day as a suspension. Refer patients to the “Instructions for Use” pamphlet for additional information regarding these procedures.
Instruct patients that if they miss a dose of AFINITOR, they may still take it up to 6 hours after the time they would normally take it. If more than 6 hours have elapsed, they should be instructed to skip the dose for that day. The next day, they should take AFINITOR at the usual time. Warn patients to not take 2 doses to make up for the one that they missed.
Manufactured by:
Novartis Pharma Stein AG
Stein, Switzerland
Distributed by:
Novartis Pharmaceuticals Corporation
East Hanover, New Jersey 07936
T2015-17
January 2015
PATIENT INFORMATION
AFINITOR® (a-fin-it-or)
(everolimus)
Tablets
AFINITOR® DISPERZ (a-fin-it-or dis-perz)
(everolimus tablets for oral suspension)
Read this Patient Information leaflet that comes with AFINITOR or AFINITOR DISPERZ before you start taking it and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment.
What is the most important information I should know about AFINITOR and AFINITOR DISPERZ?
AFINITOR and AFINITOR DISPERZ can cause serious side effects. These serious side effects include:
1. 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 healthcare provider right away if you have any of these symptoms:
• New or worsening cough
• Shortness of breath
• Chest pain
• Difficulty breathing or wheezing
2. You may be more likely to develop an infection, such as pneumonia, or a bacterial, fungal or viral infection. Viral infections may include active hepatitis B in people who have had hepatitis B in the past (reactivation). 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 healthcare 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 or dark urine
•Yellowing of the skin
•Pain in the upper right side of the stomach
3. Possible increased risk for a type of allergic reaction called angioedema, in people who take an Angiotensin-Converting Enzyme (ACE) inhibitor medicine during treatment with AFINITOR or AFINITOR DISPERZ. Talk with your healthcare provider before taking AFINITOR or 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.
4. You may develop kidney failure. In some people this ma |
