Generic Name: Everolimus Tablets (Zortress) (E ver OH li mus)
Brand Name: Zortress
- This medicine may raise the chance of very bad and sometimes deadly infections. Talk with the doctor.
- This medicine 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 medicine (everolimus tablets) with cyclosporine, you will need a lower dose of cyclosporine. Talk with your doctor.
- This medicine is not to be used if you have had a heart transplant. More deaths were seen in people taking this medicine after a heart transplant. Talk with your doctor.
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 have an allergy to everolimus, temsirolimus, sirolimus, or any other part of this medicine (everolimus tablets).
- If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
- If you have an infection.
- If you take any drugs (prescription or OTC, natural products, vitamins) that must not be taken with this medicine, 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.
- If you are taking another drug that has the same drug in it.
- If you are taking St. John's wort. Do not take St. John's wort with this medicine (everolimus tablets). This medicine may not work as well.
- 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.
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 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.
- 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.
- Have blood work checked as you have been told by the doctor. Talk with the doctor.
- Avoid grapefruit and grapefruit juice.
- Talk with your doctor before getting any vaccines. Use with this medicine 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.
- 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.
- Very bad and sometimes deadly lung problems have happened with this medicine (everolimus tablets). Call your doctor right away if you have lung or breathing problems like trouble breathing, shortness of breath, or a cough that is new or worse.
- If you are 65 or older, use this medicine with care. You could have more side effects.
- If you are a man and have sex with a female who could get pregnant, you may need to protect her from pregnancy during care and for some time after care ends. Talk with your doctor.
- This medicine may affect sperm in men. This may affect being able to father a child. Talk with the doctor.
- This medicine may cause harm to the unborn baby if you take it while you are pregnant.
- Use birth control that you can trust during care and for 2 months after care ends.
- If you get pregnant while taking this medicine (everolimus tablets) or within 2 months after your last dose, call your doctor right away.
- This medicine may raise the chance of high blood sugar (diabetes). Talk with the doctor.
- There is a chance of skin cancer. Avoid 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 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.
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. Always take with food or always take on an empty stomach.
- To gain the most benefit, do not miss doses.
- Keep taking this medicine 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.
- Do not switch between different forms of this medicine without first talking with the doctor.
- Take with a full glass of water.
- Swallow whole. Do not chew, break, or crush.
- 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 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.
- Redness or irritation of the palms of hands or soles of feet.
- A burning, numbness, or tingling feeling that is not normal.
- Chest pain.
- Any unexplained bruising or bleeding.
- A fast heartbeat.
- A heartbeat that does not feel normal.
- Very bad dizziness or passing out.
- Muscle pain or weakness.
- Period (menstrual) changes. These may include a missed period.
- Mood changes.
- Change in the way you act.
- Very bad and sometimes deadly kidney problems have happened with this medicine. 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.
- Not able to sleep.
- Upset stomach or throwing up.
- Loose stools (diarrhea).
- Hard stools (constipation).
- Mouth irritation or mouth sores.
- Change in taste.
- Not hungry.
- Weight loss.
- Dry mouth.
- Dry skin.
- Change in nails.
- Hair loss.
- Joint pain.
- Back pain.
- Pain in arms or legs.
- Muscle spasm.
- Belly pain.
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-FDA-1088. You may also report side effects at http://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 in the original container at room temperature.
- Protect from light.
- Store in a dry place. Do not store in a bathroom.
- Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
- Check with your pharmacist about how to throw out unused drugs.
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.
- Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
- Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
- This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time this medicine 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.
This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine (everolimus tablets). It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine (everolimus tablets).
Review Date: December 6, 2017
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