Dosage form:

tablet 0.25 , 0.75 mg    

• This drug may raise the chance of very bad and sometimes deadly infections. Talk with the doctor.
• This drug may raise the chance of getting cancer like lymphoma or skin cancer. Call your doctor right away if you have a change in color or size of a mole, a skin lump or growth, a big weight loss, night sweats, or swollen glands.
• In people who have had a kidney transplant, the risk of a blood clot in your kidney transplant may be raised. This may lead to loss of the kidney. Most of the time, this has happened within the first 30 days after the kidney transplant. Call your doctor right away if you have back, groin, or belly pain; are not able to pass urine; have blood in your urine, dark urine, a fever, or an upset stomach; or you are throwing up.
• If you are taking this drug with cyclosporine, you will need a lower dose of cyclosporine. Talk with your doctor.
• This drug is not to be used if you have had a heart transplant. More deaths were seen in people taking this drug after a heart transplant. Talk with your doctor.

What is this drug used for?

• It is used to treat cancer.
• It is used to treat certain kinds of kidney cysts.
• It is used to keep the body from harming the organ after an organ transplant.
• It is used to help control certain kinds of seizures.
• It may be given to you for other reasons. Talk with the doctor.

What do I need to tell my doctor BEFORE I take this drug?

• If you are allergic to this drug; any part of this drug; 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 been told that your body has problems with certain sugars (lactose, glucose, galactose). Some products have lactose.
• If you take any drugs (prescription or OTC, natural products, vitamins) that must not be taken with this drug, like certain drugs that are used for HIV, infections, or depression. There are many drugs that must not be taken with this drug. Your doctor or pharmacist can tell you if you are taking a drug that must not be taken with this drug.
• If you are breast-feeding. Do not breast-feed while you take this drug. You may also need to avoid breast-feeding for some time after your last dose. Talk with your doctor to see if you need to avoid breast-feeding after your last dose.

This is not a list of all drugs or health problems that interact with this drug. 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 drug 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 this drug?

Tell all of your health care providers that you take this drug. 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 drug. 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 drug may cause high cholesterol and triglyceride levels. Talk with the doctor.
• Avoid grapefruit and grapefruit juice.
• Very bad and sometimes deadly kidney problems have happened with this drug. 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.
• Some people have had lung problems with this drug. 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.
• If you are 65 or older, use this drug with care. You could have more side effects.
• This drug may affect fertility. Fertility problems may lead to not being able to get pregnant or father a child.
• A pregnancy test will be done before you start this drug to show that you are NOT pregnant.
• Women must use birth control while taking this drug 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 drug 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.
• 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.
• Avoid being near anyone who has had a recent live vaccine. There are many types of live vaccines. Ask your doctor or pharmacist if you are not sure.

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 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.
• Mood changes.
• Swelling.
• A very bad brain problem called progressive multifocal leukoencephalopathy (PML) may happen with this drug. 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 this drug?

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.

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.

 

How do I store and/or throw out this drug?

• 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.