Afinitor; Afinitor Disperz; Zortress
Afinitor; Afinitor Disperz
- 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. Talk with the doctor.
- In people who have had a kidney transplant, the risk of a blood clot in the 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 the doctor right away if your child has back, groin, or belly pain; is not able to pass urine; has blood in the urine, dark urine, a fever, or an upset stomach; or is throwing up.
- If your child is taking this drug with cyclosporine, your child will need a lower dose of cyclosporine. Talk with the doctor.
- This drug is not to be used if your child has had a heart transplant. More deaths were seen in people taking this drug after a heart transplant. Talk with the doctor.
- 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 your child for other reasons. Talk with the doctor.
- If your child has an allergy to this drug or any part of this drug.
- If your child is allergic to any drugs like this one or any other drugs, foods, or other substances. Tell the doctor about the allergy and what signs your child had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
- If your child has an infection.
- If your child is taking 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.
- If your child is taking another drug that has the same drug in it.
- If your child is taking St. John’s wort. Do not give St. John’s wort with this drug. This drug may not work as well.
- If your child has a rare hereditary problem of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
- Be sure your child does not breast-feed a baby while taking this drug.
All other products:
- Be sure your child does not breast-feed a baby while taking this drug and for 2 weeks after the last dose.
This is not a list of all drugs or health problems that interact with this drug.
Tell the doctor and pharmacist about all of your child’s drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for your child to take this drug with all of his/her drugs and health problems. Do not start, stop, or change the dose of any drug your child takes without checking with the doctor.
- Tell all of your child’s health care providers that your child is taking this drug. This includes your child’s doctors, nurses, pharmacists, and dentists.
- Your child may have more chance of getting an infection. Some infections have been deadly. Have your child wash hands often. Have your child stay away from people with infections, colds, or flu.
- High blood sugar has happened with this drug. This includes diabetes that is new or worse. Talk with the doctor.
- Have your child’s blood sugar checked as you have been told by your child’s doctor.
- Have blood work checked as you have been told by the doctor. Talk with the doctor.
- This drug may cause high cholesterol and triglyceride levels. Talk with the doctor.
- Avoid giving your child grapefruit and grapefruit juice.
- Talk with the doctor before your child gets any vaccines. Use with this drug may either raise the chance of very bad infection or make the vaccine not work as well.
- To prevent mouth irritation or mouth sores, follow what your child’s doctor has told you to do. If your child has mouth irritation or mouth sores, do not give your child mouth rinses that have alcohol, peroxide, iodine, or thyme in them. If you have questions, talk with the doctor.
- This drug may affect fertility. Fertility problems may lead to not being able to get pregnant or father a child. Talk with the doctor.
- If your child is of childbearing age, a pregnancy test will need to be done before starting this drug to make sure she is not pregnant.
If your child is or may be sexually active:
- Have your child use birth control to prevent pregnancy while taking this drug and for 2 months after stopping this drug.
- If your child is a male and has sex with a female who could get pregnant, they may need to protect her from pregnancy during care and for some time after care ends. Talk with the doctor.
- If your child is a male and his sex partner gets pregnant while he takes this drug or within several months after his last dose, call the doctor right away.
If your child is pregnant:
- This drug may cause harm to the unborn baby if your child takes it during pregnancy.
- If your child gets pregnant while taking this drug or within 2 months after her last dose, call the doctor right away.
- There is a chance of skin cancer. Have your child avoid lots of sun, sunlamps, and tanning beds. Use sunscreen and dress your child in clothing and eyewear that protects your child 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.
All other products:
- Make sure your child avoids 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.
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 child’s doctor or get medical help right away if your child has 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 high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
- 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 or pressure or a fast heartbeat.
- Any unexplained bruising or bleeding.
- A heartbeat that does not feel normal.
- Dizziness or passing out.
- Muscle pain or weakness.
- Period (menstrual) changes. These may include a missed period.
- Mood changes.
- Change in the way your child acts.
- This drug may affect how wounds heal. Sometimes, people with wound healing problems have needed surgery. Call the doctor right away if your child has a wound that is red, warm, painful, or swollen. Call the doctor right away if your child has a wound that opens up or if there is blood, fluid, or pus in a wound.
- Very bad and sometimes deadly lung problems have happened with this drug. Call the doctor right away if your child has lung or breathing problems like trouble breathing, shortness of breath, or a cough that is new or worse.
- Very bad and sometimes deadly kidney problems have happened with this drug. Call the doctor right away if your child is unable to pass urine, has blood in the urine, or has a change in the amount of urine passed.
- Change in color or size of a mole.
- A skin lump or growth.
- Swollen gland.
- Night sweats.
- A big weight loss.
- Some people treated with this drug 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 the doctor right away if your child has signs of kidney problems like change in the amount of urine passed, trouble passing urine, pain when passing urine, or blood in the urine.
- A very bad brain problem called progressive multifocal leukoencephalopathy (PML) may happen with this drug. It may cause disability or death. Tell the doctor right away if your child has signs like confusion, memory problems, low mood (depression), change in the way your child acts, change in strength on 1 side is greater than the other, trouble speaking or thinking, change in balance, or change in eyesight.
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your child’s doctor or get medical help if any of these side effects or any other side effects bother your child or do not go away:
- Feeling tired or weak.
- Not able to sleep.
- Pimples (acne).
- Dry skin.
- Upset stomach or throwing up.
- Loose stools (diarrhea).
- Mouth irritation or mouth sores.
- Change in taste.
- Not hungry.
- Weight loss.
- Dry mouth.
- Change in nails.
- Hair loss.
- Joint pain.
- Back pain.
- Pain in arms or legs.
- Muscle spasm.
- Belly pain.
- Nose or throat irritation.
These are not all of the side effects that may occur. If you have questions about side effects, call your child’s doctor. Call your child’s doctor for medical advice about side effects.
You may report side effects to your national health agency.
Give this drug as ordered by your child’s doctor. Read all information given to you. Follow all instructions closely.
- Give this drug with or without food but give it the same way each time. Always give with food or always give on an empty stomach.
- To gain the most benefit, do not miss giving your child doses.
- Keep giving this drug to your child as you have been told by your child’s doctor or other health care provider, even if your child feels well.
- Give this drug at the same time of day.
- Do not switch between different forms of this drug without first talking with the doctor.
- Give this drug with a full glass of water.
- Have your child swallow whole. Do not let your child chew, break, or crush.
- If you take cyclosporine or tacrolimus, take them at the same time as this drug.
- Give as a liquid only. Do not let your child swallow tablets whole.
- Wear gloves when touching this drug.
- Mix with water as you have been told before drinking.
- Have your child drink right after mixing. Throw away any part not used after 1 hour.
- If possible, a person who is pregnant or plans to get pregnant must not mix this drug. If you have questions, talk with the doctor.
- Give a missed dose as soon as you think about it.
- If it is close to the time for your child’s next dose, skip the missed dose and go back to your child’s normal time.
All other products:
- Give a missed dose as soon as you think about it.
- If it has been 6 hours or more since the missed dose, skip the missed dose and go back to your child’s normal time.
- Do not give 2 doses at the same time or extra doses.
- 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.
- 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.
- If your child’s symptoms or health problems do not get better or if they become worse, call your child’s doctor.
- Do not share your child’s drug with others and do not give anyone else’s drug to your child.
- Keep a list of all your child’s drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your child’s doctor.
- Talk with your child’s doctor before giving your child any new drug, including prescription or OTC, natural products, or vitamins.
- Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your child’s doctor, nurse, 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. 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.
© 2018 Wolters Kluwer Clinical Drug Information, Inc. and its affiliates and/or licensors. All rights reserved.