Uses of Everolimus Tablets:

• It is used to keep the body from harming the organ after an organ transplant.
• It may be given to you for other reasons. Talk with the doctor.

What do I need to tell my doctor BEFORE I take Everolimus Tablets?

• If you are allergic to this medicine (everolimus tablets); any part of this medicine (everolimus tablets); or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have an infection.
• If you take any drugs (prescription or OTC, natural products, vitamins) that must not be taken with this medicine (everolimus tablets), like certain drugs that are used for HIV, infections, or depression. There are many drugs that must not be taken with this medicine (everolimus tablets). Your doctor or pharmacist can tell you if you are taking a drug that must not be taken with this medicine (everolimus tablets).
• If you are taking another drug that has the same drug in it.
• If you have a rare hereditary problem of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
• If you are breast-feeding. Do not breast-feed while you take this medicine (everolimus tablets).

This is not a list of all drugs or health problems that interact with this medicine (everolimus tablets).

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine (everolimus tablets) with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Everolimus Tablets?

• Tell all of your health care providers that you take this medicine (everolimus tablets). This includes your doctors, nurses, pharmacists, and dentists.
• You may have more of a chance of getting an infection. Wash hands often. Stay away from people with infections, colds, or flu. Some infections have been very bad and even deadly.
• High blood sugar has happened with this medicine (everolimus tablets). This includes diabetes that is new or worse.
• Check your blood sugar as you have been told by your doctor.
• Tell your doctor if you have signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
• This medicine may cause high cholesterol and triglyceride levels. Talk with the doctor.
• Avoid grapefruit and grapefruit juice.
• This medicine may affect how wounds heal. Sometimes, people with wound healing problems have needed surgery. Call your doctor right away if you have a wound that is red, warm, painful, or swollen. Call your doctor right away if your wound opens up or if there is blood, fluid, or pus in a wound.
• Some people have had lung problems with this medicine (everolimus tablets). Sometimes, this has been deadly. Call your doctor right away if you have signs of lung problems like shortness of breath or other trouble breathing, cough that is new or worse, or fever.
• The chance of skin cancer may be raised. Avoid lots of sun, sunlamps, and tanning beds. Use sunscreen and wear clothing and eyewear that protects you from the sun.
• In people who have had a liver transplant, the risk of a blood clot in the liver transplant may be raised. This may lead to loss of the liver or death. Most of the time, this has happened within the first 30 days after the liver transplant. Talk with the doctor.
• Some people treated with this medicine (everolimus tablets) have had very bad kidney problems caused by a certain viral infection (BK virus). In people who have had a kidney transplant, BK virus infection may cause loss of the kidney. Call your doctor right away if you have signs of kidney problems like change in the amount of urine passed, difficulty or pain when passing urine, or blood in the urine.
• If you are 65 or older, use this medicine (everolimus tablets) with care. You could have more side effects.
• This medicine may affect fertility. Fertility problems may lead to not being able to get pregnant or father a child.
• This medicine may cause harm to an unborn baby. A pregnancy test will be done before you start this medicine (everolimus tablets) to show that you are NOT pregnant.
• Women must use birth control while taking this medicine (everolimus tablets) and for some time after the last dose. Ask your doctor how long to use birth control. If you get pregnant, call your doctor right away.
• Men with a partner who may get pregnant must use birth control while taking this medicine (everolimus tablets) and for some time after the last dose. Ask your doctor how long to use birth control. If your partner gets pregnant, call the doctor right away.

How is this medicine (Everolimus Tablets) best taken?

Use this medicine (everolimus tablets) as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take with or without food but take the same way each time. Always take with food or always take on an empty stomach.
• Take with a full glass of water.
• Swallow whole. Do not chew, break, or crush.
• Keep taking this medicine (everolimus tablets) as you have been told by your doctor or other health care provider, even if you feel well.
• Take this medicine (everolimus tablets) at the same time of day.
• Talk with your doctor before getting any vaccines. Use of some vaccines with this medicine (everolimus tablets) may either raise the chance of an infection or make the vaccine not work as well.
• To prevent mouth irritation or mouth sores, follow what your doctor has told you to do. If you have mouth irritation or mouth sores, do not use mouth rinses that have alcohol, peroxide, iodine, or thyme in them. If you have questions, talk with your doctor.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• If you take cyclosporine or tacrolimus, take them at the same time as this medicine (everolimus tablets).

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
• Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
• Signs of electrolyte problems like mood changes, confusion, muscle pain or weakness, a heartbeat that does not feel normal, seizures, not hungry, or very bad upset stomach or throwing up.
• Redness or irritation of the palms of hands or soles of feet.
• A burning, numbness, or tingling feeling that is not normal.
• Flushing.
• Chest pain.
• Any unexplained bruising or bleeding.
• Fast or abnormal heartbeat.
• Dizziness or passing out.
• Seizures.
• Muscle pain or weakness.
• Period (menstrual) changes. These may include a missed period.
• Mood changes.
• Change in the way you act.
• Swelling.
• Very bad and sometimes deadly kidney problems have happened with this medicine (everolimus tablets). Call your doctor right away if you are unable to pass urine or if you have blood in the urine or a change in the amount of urine passed.
• A very bad brain problem called progressive multifocal leukoencephalopathy (PML) has happened with this medicine (everolimus tablets). It may cause disability or can be deadly. Tell your doctor right away if you have signs like confusion, memory problems, low mood (depression), change in the way you act, change in strength on 1 side is greater than the other, trouble speaking or thinking, change in balance, or change in eyesight.

What are some other side effects of Everolimus Tablets?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Pimples (acne).
• Feeling tired or weak.
• Headache.
• Trouble sleeping.
• Constipation, diarrhea, stomach pain, upset stomach, throwing up, or feeling less hungry.
• Mouth irritation or mouth sores.
• Change in taste.
• Weight loss.
• Dry mouth.
• Dry skin.
• Change in nails.
• Hair loss.
• Joint pain.
• Back pain.
• Pain in arms or legs.
• Muscle spasm.
• Nosebleed.
• Nose or throat irritation.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Everolimus Tablets?

• Store at room temperature protected from light. Store in a dry place. Do not store in a bathroom.
• Store in original container.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Consumer Information Use and Disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time this medicine (everolimus tablets) is refilled. If you have any questions about this medicine (everolimus tablets), please talk with the doctor, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Frequently asked questions

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• How long can you take Afinitor for?
• How long can you take everolimus?
• What is everolimus used for and how does it work?
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