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- Patient Information:
Details with Side Effects
(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:
- Skin rash
- Joint pain and inflammation
- Loss of appetite
- Pale stools or dark urine
- Yellowing of the skin
- Pain in the upper right side of the stomach
3. You may develop kidney failure. In some people this may be severe and can even lead to death. Your healthcare provider should do tests to check your kidney function before and during your treatment with AFINITOR or AFINITOR DISPERZ.
If you have any of the serious side effects listed above, you may need to stop taking AFINITOR or AFINITOR DISPERZ for a while or use a lower dose. Follow your healthcare provider's instructions.
What is AFINITOR?
AFINITOR is a prescription medicine used to treat:
- advanced hormone receptor-positive, HER2-negative breast cancer, along with the medicine exemestane, in postmenopausal women who have already received certain other medicines for their cancer.
- adults with a type of pancreatic cancer known as
pancreatic neuroendocrine tumor (PNET), that has progressed and cannot be
treated with surgery.
AFINITOR is not for use in people with carcinoid tumors that actively produce hormones.
- adults with advanced kidney cancer (renal cell carcinoma or RCC) when certain other medicines have not worked.
- people with the following types of tumors that are seen with a genetic condition called tuberous sclerosis complex (TSC):
What is AFINITOR DISPERZ?
AFINITOR DISPERZ is a prescription medicine 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.
Who should not take AFINITOR or AFINITOR DISPERZ?
Do not take AFINITOR or AFINITOR DISPERZ if you are allergic to everolimus or to any of the ingredients in AFINITOR or AFINITOR DISPERZ. See the end of this leaflet for a complete list of ingredients in AFINITOR and AFINITOR DISPERZ.
Talk to your healthcare provider before taking this medicine if you are allergic to:
- sirolimus (Rapamune®)
- temsirolimus (Torisel®)
Ask your healthcare provider if you do not know.
What should I tell my healthcare provider before taking AFINITOR or AFINITOR DISPERZ?
Before taking AFINITOR or AFINITOR DISPERZ, tell your healthcare provider about all of your medical conditions, including if you:
- 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 immunization or vaccine, ask your healthcare 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.
- Are breastfeeding or plan to breastfeed. It is not known if AFINITOR or AFINITOR DISPERZ passes into your breast milk. You and your healthcare provider should decide if you will take AFINITOR or AFINITOR DISPERZ, or breastfeed. You should not do both.
Tell your healthcare provider about all of the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.
AFINITOR or AFINITOR DISPERZ may affect the way other medicines work, and other medicines can affect how AFINITOR or AFINITOR DISPERZ work. Using AFINITOR or AFINITOR DISPERZ with other medicines can cause serious side effects.
Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine. Especially tell your healthcare provider if you take:
- St. John's Wort (Hypericum perforatum)
- Medicine for:
- Medicines that weaken your immune system (your body's ability to fight infections and other problems)
Ask your healthcare provider or pharmacist if you are not sure if your medicine is one of those taken for the conditions listed above. 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. You should also tell your healthcare provider before you start taking any new medicine.
How should I take AFINITOR or AFINITOR DISPERZ?
- Your healthcare provider will prescribe the dose of AFINITOR or AFINITOR DISPERZ that is right for you.
- Take AFINITOR or AFINITOR DISPERZ exactly as your healthcare provider tells you to.
- 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.
- If your healthcare provider prescribes AFINITOR DISPERZ for you, see the “Instructions for Use” that come with your medicine for instructions on how to prepare and take your dose.
- Each dose of AFINITOR DISPERZ must be prepared as a suspension before it is given.
- AFINITOR DISPERZ can cause harm to an unborn baby. When possible, the suspension should be prepared by an adult who is not pregnant or planning to become pregnant.
- Anyone who prepares suspensions of AFINITOR DISPERZ for another person should wear gloves to avoid possible contact with the medicine.
- 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 room 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.
- If you take AFINITOR or AFINITOR DISPERZ to treat SEGA, 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.
What are the possible side effects of AFINITOR or AFINITOR DISPERZ?
AFINITOR and AFINITOR DISPERZ can cause serious side effects.
- See “What is the most important information I should know about AFINITOR and AFINITOR DISPERZ?” for more information.
Common side effects of AFINITOR in people with advanced hormone receptor-positive, HER 2-negative breast cancer, advanced pancreatic neuroendocrine tumors, and advanced kidney cancer include:
- Mouth ulcers. AFINITOR 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 mouth gel that does not contain alcohol, peroxide, iodine, or thyme.
- Feeling weak or tired
- Cough, shortness of breath
- Diarrhea and constipation
- Rash, dry skin, and itching
- Nausea and vomiting
- Loss of appetite, weight loss
- Swelling of arms, hands, feet, ankles, face or other parts of the body
- Abnormal taste
- Dry mouth
- Inflammation of lining of the digestive system
- Nose bleeds
- Pain in arms and legs, mouth and throat, back or joints
- High blood glucose
- High blood pressure
- Difficulty sleeping
- Hair loss
- Muscle spasms
- Feeling dizzy
- Nail disorders
Common side effects of AFINITOR and AFINITOR DISPERZ in people who have SEGA or renal angiomyolipoma with TSC include:
- Mouth ulcers. AFINITOR 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 mouth gel that does not contain alcohol, peroxide iodine, or thyme.
- 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 healthcare provider if this happens.
- Low red blood cells, white blood cells or platelets
- Increased blood cholesterol level and certain other blood tests
- Increased blood sugar levels
- Decreased blood phosphate levels
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 and AFINITOR DISPERZ. For more information, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1800-FDA-1088.
How should I store AFINITOR or AFINITOR DISPERZ?
- Store AFINITOR or AFINITOR DISPERZ at room temperature, between 68°F to 77°F (20°C to 25°C).
- Keep AFINITOR or AFINITOR DISPERZ in the pack it comes in.
- Open the blister pack just before taking AFINITOR or AFINITOR DISPERZ.
- Keep AFINITOR or AFINITOR DISPERZ dry and away from light.
- Do not use AFINITOR or AFINITOR DISPERZ that is out of date or no longer needed.
Keep AFINITOR or AFINITOR DISPERZ and all medicines out of the reach of children.
General information about AFINITOR and AFINITOR DISPERZ
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use AFINITOR or AFINITOR DISPERZ for a condition for which it was not prescribed. Do not give AFINITOR or AFINITOR DISPERZ to other people, even if they have the same problem you have. It may harm them.
This leaflet summarizes the most important information about AFINITOR and AFINITOR DISPERZ. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information written for healthcare professionals.
For more information call 1-888-423-4648 or go to www.AFINITOR.com.
What are the ingredients in AFINITOR?
Active ingredient: everolimus.
Inactive ingredients: anhydrous lactose, butylated hydroxytoluene, crospovidone, hypromellose, lactose monohydrate, and magnesium stearate.
What are the ingredients in AFINITOR DISPERZ?
Active ingredient: everolimus.
Inactive ingredients: butylated hydroxytoluene, colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, mannitol, and microcrystalline cellulose.
This Patient Information has been approved by the U.S. Food and Drug Administration.
Last reviewed on RxList: 3/10/2014
This monograph has been modified to include the generic and brand name in many instances.
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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