Important Safety Information
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 health care 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 that 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 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 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 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 or AFINITOR DISPERZ are at a possible increased risk for a type of allergic reaction called angioedema. Talk with your health care 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 or AFINITOR DISPERZ.
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™.
Delayed Wound Healing: AFINITOR or 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.
- 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 or AFINITOR DISPERZ™. If you are not sure about the type of vaccine, ask your health care provider
- Have other medical conditions
- Are pregnant or could become pregnant. AFINITOR or AFINITOR DISPERZ™ can cause harm to your unborn baby. You should use effective birth control while using AFINITOR or AFINITOR DISPERZ™ and for 8 weeks after stopping treatment. Talk to your health care provider about birth control options while taking AFINITOR or AFINITOR DISPERZ™
- Are breastfeeding or plan to breastfeed. You and your health care provider should decide if you will take AFINITOR or AFINITOR DISPERZ™ or breastfeed. You should not do both
Tell your health care provider about all of the medicines you take, including prescription and nonprescription 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 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
- 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 or AFINITOR DISPERZ™ 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 or AFINITOR DISPERZ™ 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:
- Nausea and vomiting
- Diarrhea and constipation
- Swelling of your hands, arms, legs, and feet
- Joint pain
- Skin problems (such as rash, acne, or dry skin)
- Feeling tired
- Anxiety, aggression, and other abnormal behaviors
- Absence of menstrual periods (menstruation). You may miss one or more menstrual periods. Tell your health care provider if this happens
- Low red blood cells, white blood cells, or platelets
- Increased blood cholesterol levels and certain other blood levels
- Increased blood sugar levels
- Decreased blood phosphate levels
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 or AFINITOR DISPERZ™. 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 registered trademarks of their respective owners and are not trademarks or register marks of Novartis.
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.
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