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Patients should not take AFINITOR® (everolimus) Tablets 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 that can even lead to death. If patients experience these side effects, they may need to stop taking AFINITOR for a while or use a lower dose. Patients should follow their health care 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 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. 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 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. 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.
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:
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:
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: Common side effects include mouth ulcers. AFINITOR can cause mouth ulcers and sores. Tell your health care provider if you have pain, discomfort, or open sores in your mouth. Your health care provider may tell you to use a special mouthwash or gel that does not contain alcohol, hydrogen peroxide, iodine, or thyme.
Other common side effects include:
Other side effects that may occur with AFINITOR:
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.
Please see full Prescribing Information for AFINITOR, including Patient Information.
The brands listed are the trademarks or register marks of their respective owners and are not trademarks or register marks of Novartis.
Advanced Renal Cell Carcinoma (RCC)
AFINITOR is a prescription medicine used to treat adults with advanced kidney cancer (renal cell carcinoma or RCC) when certain other medicines (ie, Sutent® [sunitinib] or Nexavar® [sorafenib]) have not worked.
The brands listed are the trademarks or registered trademarks of their respective owners and are not trademarks or register marks of Novartis.
AFINITOR® (everolimus) Tablets is a prescription medicine used to treat adults with advanced kidney cancer (renal cell carcinoma or RCC) when certain other medicines (ie, Sutent® [sunitinib] or Nexavar® [sorafenib]) have not worked. AFINITOR may slow the growth and spread of kidney cancer cells and reduce blood supply to the tumor.
Patients should not take AFINITOR® (everolimus) Tablets 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... See More
AFINITOR® (everolimus) Tablets is a prescription medicine used to treat adults with advanced kidney cancer (renal cell carcinoma or RCC) when certain other medicines (ie, Sutent® [sunitinib] or Nexavar® [sorafenib]) have not worked.
As your treatment journey moves forward, your doctor may periodically perform follow-up tests. These tests will help your doctor assess how well your medicine is slowing the growth, or stopping the progression, of your cancer.
Monitoring how well your treatment is working is an important part of your continuing care. Some of the tests that your doctors use for monitoring may be the same tests that were used for initial diagnoses when your advanced kidney cancer was originally diagnosed, such as:
Laboratory tests, such as blood tests, may be used to help doctors check the number of red blood cells in your body, and to detect the presence of certain chemicals and hormones. They can also be used to check how well your liver is working.
Monitoring tests are an important way to get information about the progression of a patient's kidney cancer disease progression. Your doctor will discuss the results of these tests in context with the following assessments to let you know if they show any of the following:
Having monitoring tests from time to time is a good way to see if your current treatment medicine is working the way it should and if your condition has changed in any way. This can also help your doctors decide if it is a good time to try a different treatment option, such as another kind of medicine.