AFINITOR®(everolimus) tablets
- December 6, 2020
- 0
AFINITOR®
a-fin-it-or
Everolimus tablets
Chemotherapy
AFINITOR®
a-fin-it-or
Everolimus tablets
Chemotherapy
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. It is not known if AFINITOR is safe and effective in people with carcinoid tumors.
- Adults with advanced kidney cancer (renal cell carcinoma or RCC) when certain other medicines have not worked.
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people with the following types of tumors that are seen with a genetic condition called tuberous sclerosis complex (TSC):
o a kidney tumor called angiomyolipoma, when their kidney tumor does not require surgery right away.
o a brain tumor called subependymal giant cell astrocytoma (SEGA) in adults and children 3 years and older who cannot have surgery for their tumor. It is not known if AFINITOR is safe and effective in children under 3 years of age with SEGA.
It is not known if AFINITOR is safe and effective in children under 3 years of age with SEGA.
What is the most important information I should know about AFINITOR?
AFINITOR can cause serious side effects. These serious side effects include:
- 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
-
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
- Skin rash
- Joint pain and inflammation
- Tiredness
- Loss of appetite
- Nausea
- Pale stool or dark urine
- Yellowing of the skin
- Pain in your upper right side
- 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.
If you have any of the serious side effects listed above, you may need to stop taking AFINITOR for a while or use a lower dose. Follow your healthcare provider’s instructions.
How should I take AFINITOR?
- Your healthcare provider will prescribe the dose of AFINITOR that is right for you.
- Take AFINITOR exactly as your healthcare provider tells you. Your healthcare provider may change your dose of AFINITOR if needed.
- Swallow AFINITOR tablets whole with a glass of water. Do not crush AFINITOR tablets. Do not take AFINITOR tablets which are crushed or broken.
- If you cannot swallow AFINITOR tablets whole, you can stir them into a glass of water:
- Put the prescribed number of tablets into a glass that contains about 2 Tablespoons (30 mL) of water.
- Gently stir the contents until the tablets break apart and then drink the mixture right away.
- Add about 2 Tablespoons (30 mL) of water to the glass and drink all of the water. This will help to make sure that you get the full dose of AFINITOR.
- Take AFINITOR one time every day, at about the same time every day.
- Take AFINITOR the same way each time, either with food or without food.
- You may use scissors to open the blister to avoid spillage
- If you take too much AFINITOR contact your healthcare provider or go to the nearest hospital emergency department right away. Take the pack of AFINITOR with you.
- If you miss a dose of AFINITOR, 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, skip the dose for that day. The next day, take AFINITOR 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 regular blood tests before you start AFINITOR 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 to treat SEGA, you will need to have blood tests regularly to measure how much AFINITOR is in your blood. This will help your healthcare provider decide how much AFINITOR you need to take.
What are the possible side effects of AFINITOR?
AFINITOR can cause serious side effects.
- See “What is the most important information I should know about AFINITOR?”
Common side effects of AFINITOR in patients with advanced hormone receptor-positive, HER2-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 or peroxide.
- Infections
- Feeling weak or tired
- Cough, shortness of breath
- Diarrhea and constipation
- Rash, dry skin, and itching
- Nausea and vomiting
- High blood pressure
- Difficulty sleeping
- Hair loss
- Fever
- 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
- Headache
- Nose bleeds
- Pain in arms and legs, mouth and throat, back or joints
- High blood glucose
- Muscle spasms
- Feeling dizzy
- Nail disorders
- Common side effects of AFINITOR in patients who have 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 or peroxide.
- decreased platelet cell count
- numbness, tingling, pain, or weakness in the hands or feet
- Headache
- Cough
- Diarrhea
- Swelling of your hands, arms, legs, and feet
- Acne or eczema
- Nausea and vomiting
- Increased blood sugar levels
- Absence of menstrual periods (menstruation).
- ou may miss one or more menstrual periods. Tell your healthcare provider if this happens.
- Low red blood cells and white blood cells
- Decreased blood phosphate level
- Increased blood cholesterol level and certain other blood tests
- Respiratory tract infection
- Joint pain
- Common side effects of AFINITOR in patients with SEGA include:
- Infections of the respiratory tract, sinuses and ears
- 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 or peroxide.
- hair loss
- Cough
- Stuffy or runny nose
- High levels of fats in the blood (raised triglycerides)
- Diarrhea and constipation
- Vomiting
- Stomach pain
- Fever
- Seizure
- Vomiting
- Rash
- Headache
- Dizziness
- Skin problems (such as rash, acne, dry skin, or scratching of the skin)
- Change in personality
- Low white blood cells (a type of blood cell that fights infection; your healthcare provider will periodically check you for this problem)
Tell your healthcare provider if you have vomiting, diarrhea, or signs of dehydration that does not go away. ABRAXANE may cause fertility problems in males and females, which may affect your ability to have a child.
Talk to your healthcare provider if this is a concern for you. These are not all of the possible side effects of ABRAXANE. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Important Safety Information
You should not receive ABRAXANE if:
Do not take AFINITOR if you are allergic to AFINITOR or to any of its ingredients. See the end of this leaflet for a complete list of ingredients in AFINITOR. 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?
Before taking AFINITOR, 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. 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. It is not known if AFINITOR will harm your unborn baby. You should use effective birth control while using AFINITOR and for 8 weeks after stopping treatment.
- Are breast-feeding or plan to breast-feed. It is not known if AFINITOR passes into your breast milk. You and your healthcare provider should decide if you will take AFINITOR or breast-feed. You should not do both.
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Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list to show your healthcare provider and pharmacist when you get a new medicine.
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: ○ Fungal infections ○ Bacterial infections ○ Tuberculosis ○ Seizures ○ HIV-AIDS ○ Heart conditions or high blood pressure
• Medicines that suppress your immune system
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 may need to be changed. You should also tell your healthcare provider before you start taking any new medicine.
You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch.
General information about AFINITOR
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use AFINITOR for a condition for which it was not prescribed. Do not give AFINITOR 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. 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.
Other ingredient: human albumin (containing sodium caprylate and sodium acetyltryptophanate).butylated hydroxytoluene, magnesium stearate, lactose monohydrate, hypromellose, crospovidone, and lactose anhydrous.
This Patient Information has been approved by the U.S. Food and Drug Administration.
Please see full Prescribing Information for additional Important Safety Information.
