Your healthcare provider will prescribe the dose of AFINITOR® (everolimus) Tablets or AFINITOR DISPERZTM (everolimus tablets for oral suspension) that is right for you.
Take AFINITOR or AFINITOR DISPERZ exactly as your healthcare provider tells you. Your healthcare provider may change your dose of AFINITOR or AFINITOR DISPERZ if needed.
Use scissors to open the blister pack.
Swallow AFINITOR tablets whole with a glass of water. Do not take any tablet that is broken or crushed.
Take AFINITOR or AFINITOR DISPERZ one time each day at about the same time.
Take AFINITOR or AFINITOR DISPERZ the same way each time, either with food or without food.
If you take too much AFINITOR or AFINITOR DISPERZ contact your healthcare provider or go to the nearest hospital emergency department right away. Take the pack of AFINITOR or AFINITOR DISPERZ with you.
If you miss a dose of AFINITOR or AFINITOR DISPERZ, you may still take it up to 6 hours after the time you normally take it. If it is more than 6 hours after you normally take your AFINITOR or AFINITOR DISPERZ, skip the dose for that day. The next day, take AFINITOR or AFINITOR DISPERZ at your usual time . Do not take 2 doses to make up for the one that you missed. If you are not sure about what to do, call your healthcare provider.
You should have blood tests before you start AFINITOR or AFINITOR DISPERZ and as needed during your treatment. These will include tests to check your blood cell count, kidney and liver function, cholesterol, and blood sugar levels.
You will also need to have blood tests regularly to measure how much medicine is in your blood. This will help your healthcare provider decide how much AFINITOR or AFINITOR DISPERZ you need to take.
What should I avoid while taking AFINITOR or AFINITOR DISPERZ?
You should not drink grapefruit juice or eat grapefruit during your treatment with AFINITOR or AFINITOR DISPERZ. It may make the amount of AFINITOR in your blood increase to a harmful level.
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AFINITOR can cause serious side effects, including lung or breathing problems, infections, and kidney failure, which can lead to death. Mouth ulcers and mouth sores are common side effects, occurring in up to 86% of patients taking AFINITOR. AFINITOR can affect blood cell counts, kidney and liver function, and blood sugar and cholesterol levels. Regular blood tests should be performed before starting AFINITOR and as needed during treatment to check blood cell count, kidney and liver function, blood sugar and cholesterol levels, and how much AFINITOR is in the blood.
Please see additional Important Safety Information.
Please see full Prescribing Information for AFINITOR, including Patient Information.
AFINITOR and AFINITOR DISPERZ are prescription medicines used to treat adults and children with a genetic condition called tuberous sclerosis complex (TSC) who have a brain tumor called subependymal giant cell astrocytoma (SEGA) when the tumor cannot be removed completely by surgery.
The effectiveness of AFINITOR is based on change in SEGA size. Improvement in disease-related symptoms or overall survival has not been shown.
Patients should not take AFINITOR or AFINITOR DISPERZ if they are allergic to AFINITOR or AFINITOR DISPERZ or to any of its ingredients. Patients should tell their healthcare provider before taking AFINITOR or AFINITOR DISPERZ if they are allergic to sirolimus (Rapamune®) or temsirolimus (Torisel®).
AFINITOR or AFINITOR DISPERZ can cause serious side effects, which can even lead to death. If patients experience these side effects, they may need to stop taking AFINITOR or AFINITOR DISPERZ for a while or use a lower dose. Patients should follow their healthcare provider's instructions. Serious side effects include:
Lung or Breathing Problems: In some patients, lung or breathing problems may be severe and can even lead to death. Patients should tell their healthcare 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 or AFINITOR DISPERZ 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. In some people these infections may be severe and can even lead to death. Patients may need to be treated as soon as possible. Patients should tell their healthcare provider right away if they 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, or pain in the upper right side of the stomach.
Kidney Failure: Patients taking AFINITOR or AFINITOR DISPERZ may develop kidney failure. In some people this may be severe and can even lead to death. Patients should have tests to check their kidney function before and during their treatment with AFINITOR or AFINITOR DISPERZ.
Before taking AFINITOR or AFINITOR DISPERZ, tell your healthcare provider about all your medical conditions, including if you:
Tell your healthcare provider about all of the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Using AFINITOR or AFINITOR DISPERZ with certain other medicines can cause serious side effects. Keep a list of medicines you take and show it to your healthcare provider when you get a new medicine. Be sure to tell your healthcare 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:
If you are taking any medicines for the conditions listed above, your healthcare provider might need to prescribe a different medicine or your dose of AFINITOR or AFINITOR DISPERZ may need to be changed. Tell your healthcare provider before you start taking any new medicine.
Common Side Effects: Common side effects include mouth ulcers. AFINITOR or AFINITOR DISPERZ can cause mouth ulcers and sores. Tell your healthcare provider if you have pain, discomfort, or open sores in your mouth. Your healthcare provider may tell you to use a special mouthwash or gel that does not contain alcohol, peroxide, iodine, or thyme.
Other common side effects include:
Tell your healthcare 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 healthcare 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.
Please see full Prescribing Information for AFINITOR including Patient Information.
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