- This drug may raise the chance of very bad and sometimes deadly infections. Talk with the doctor.
- Call your child’s doctor right away if your child has any signs of infection like fever, chills, flu-like signs, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or a wound that will not heal.
- This drug may raise the chance of getting cancer like lymphoma or skin cancer. Call your child’s doctor right away if your child has a change in color or size of a mole, a skin lump or growth, a big weight loss, night sweats, or swollen glands.
- This drug is not for use in people who have had liver or lung transplants. Very bad and sometimes deadly problems have happened in these people. Talk with the doctor.
- It is used to keep the body from turning down the kidney after a kidney transplant.
- It is used to treat a lung disease called lymphangioleiomyomatosis (LAM).
- 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 is taking any of these drugs: Clarithromycin, erythromycin, itraconazole, ketoconazole, rifabutin, rifampin, telithromycin, or voriconazole.
If your child is breast-feeding a baby:
- Talk with the doctor if your child is breast-feeding a baby or plans to breast-feed a baby.
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.
- Do not switch between different forms of this drug without first talking with the doctor.
- High blood pressure has happened with this drug. Have your child’s blood pressure checked as you have been told by the doctor.
- This drug may cause high cholesterol and triglyceride levels. Talk with the doctor.
- Have blood work checked as you have been told by the doctor. Talk with the doctor.
- Have your child’s urine checked as you have been told by the doctor.
- 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.
- Your child may have more chance of getting infections. Have your child wash hands often. Avoid crowds and people with infections, colds, or flu.
- Your child may bleed more easily. Make sure your child is careful and avoids injury. Be sure your child has a soft toothbrush.
- 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.
- Talk with the doctor before your child gets any vaccines. Use of some vaccines with this drug may either raise the chance of very bad infection or make the vaccine not work as well.
- Avoid giving your child grapefruit and grapefruit juice.
- 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.
If your child is or may be sexually active:
- Have your child use birth control to prevent pregnancy before care begins, during care, and for 3 months after care ends.
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 3 months after her last dose, call the doctor 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 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 high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
- Signs of low potassium levels like muscle pain or weakness, muscle cramps, or a heartbeat that does not feel normal.
- 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.
- Swelling, warmth, numbness, change of color, or pain in a leg or arm.
- Chest pain or pressure or a fast heartbeat.
- Coughing up blood.
- Feeling very tired or weak.
- Skin wound that will not heal.
- Swelling in the arms or legs.
- Any unexplained bruising or bleeding.
- 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.
- 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.
- 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.
- Very bad and sometimes deadly blood problems like thrombotic thrombocytopenic purpura/hemolytic uremic syndrome (TTP/HUS) have happened with this drug in some people. Call your child’s doctor right away if your child feels very tired or weak or has any bruising or bleeding; dark urine or yellow skin or eyes; pale skin; change in the amount of urine passed; change in eyesight; change in strength on 1 side is greater than the other, trouble speaking or thinking, or change in balance; or fever.
- Very bad and sometimes deadly liver problems have happened with this drug. Call your child’s doctor right away if your child has 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.
If your child has menstrual periods:
- Period (menstrual) changes.
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:
- Belly pain.
- Upset stomach.
- Joint pain.
- Pimples (acne).
- 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.
- If your child is taking cyclosporine, give it to your child at least 4 hours before giving this drug.
- Have your child swallow whole. Do not let your child chew, break, or crush.
- If your child has trouble swallowing, talk with the doctor.
- Put 1/4 cup of water or orange juice into a glass or plastic container. Do not mix with other liquids.
- Measure this drug in the oral dose syringe. Empty drug from syringe into cup. Mix well and have your child drink.
- Fill container again with 1/2 cup of water or orange juice. Mix well and have your child drink.
- After mixing, give your child’s dose right away. Do not store for future use.
- Throw syringe away after use. Do not use the same syringe more than one time.
- If you get this drug on the skin, wash it off right away with soap and water.
- If this drug gets in the eyes, rinse with cool water.
- 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.
- Do not give 2 doses at the same time or extra doses.
- Store at room temperature.
- Store in a dry place. Do not store in a bathroom.
- Do not take this drug out of the blister pack until you are ready to give this drug to your child. Give this drug right away after opening the blister pack. Do not store the removed drug for future use.
- Store in a refrigerator. Do not freeze.
- After opening, throw away any part not used after 1 month.
- This drug may also be stored at room temperature. If stored at room temperature, throw away any part not used after 15 days.
- Liquid (solution) may look hazy when refrigerated. Bring to room temperature and shake gently until haze goes away.
- Liquid (solution) in a syringe may be stored at room temperature or in a refrigerator for up to 24 hours.
- Protect from light.
- 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.
© 2019 Wolters Kluwer Clinical Drug Information, Inc. and its affiliates and/or licensors. All rights reserved.