- 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.
- 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.
- If your child has high blood sugar (diabetes), you will need to watch his/her blood sugar closely.
- Your child may have more chance of getting infections. 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 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:
- If your child gets pregnant while taking this drug or within 3 months after her last dose, call the doctor right away.
- 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 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.
- Belly pain.
- Hard stools (constipation).
- Loose stools (diarrhea).
- Upset stomach.
- Joint pain.
- Pimples (acne).
- Nose or throat irritation.
- Give this drug with or without food. 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.
- Do not take cyclosporine capsules (Neoral®, Gengraf®) or oral solution (Neoral®) within 4 hours of 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 cup.
- 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.
- 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 out the tablet from the tablet pack until you are ready to give this drug to your child. Give the tablet right away after opening the blister pack. Do not store the tablet for future use.
- Store liquid (solution) at room temperature or in a refrigerator. Throw away any part not used after 15 days if stored at room temperature. Throw away any part not used after 1 month if refrigerated.
- 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.
- Check with your pharmacist about how to throw out unused drugs.
- 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.