This information from Lexicomp® explains what you need to know about this medication, including what it’s used for, how to take it, its side effects, and when to call your healthcare provider.
- Do not give this drug to your child during pregnancy. Use during pregnancy may cause birth defects or loss of the unborn baby.
- If your child is of childbearing age, a pregnancy test will be done before starting this drug and while taking it to show that your child is NOT pregnant.
- If your child may become pregnant, your child will need to use birth control for 1 month before starting this drug, during treatment, and for 1 month after the last dose. If your child only takes this drug as needed for flare-ups, your child will need to use birth control all the time. Be sure you know what type of birth control your child needs to use and when to use it. If you are not sure, talk with the doctor.
- If your child gets pregnant while taking this drug or within 1 month after the last dose, call the doctor right away.
- This drug may affect growth in children and teens in some cases. They may need regular growth checks. Talk with the doctor.
- It is used to lessen the growth of bone where it does not normally grow in people with fibrodysplasia ossificans progressive (FOP).
- If your child is allergic to this drug; any part of this drug; or any other drugs, foods, or substances. Tell the doctor about the allergy and what signs your child had.
- If the patient is a child. This drug may not be for use in all ages of children.
- If your child has any of these health problems: Kidney disease or liver disease.
- If your child is using another drug like this one. If you are not sure, ask your child’s doctor or pharmacist.
- If your child takes 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 seizures. There are many drugs that must not be taken with this drug.
If your child is or may be sexually active:
- If your child is able to get pregnant and is not using birth control.
If your child is breast-feeding a baby:
- Be sure your child does not breast-feed a baby while taking this drug and for 1 month after stopping this drug.
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 to give this drug with all of your child’s other 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.
- Lowered night eyesight may happen. This may be sudden. This may clear up after your child stops the drug but sometimes it may not go away. Have your child use care when doing tasks that call for clear eyesight.
- Have your child’s blood work and other lab tests checked as you have been told by your child’s doctor. This includes X-rays of the spine.
- Be sure the capsules are not touched by someone who is pregnant or able to get pregnant.
- Your child may get sunburned more easily. Avoid lots of sun, sunlamps, and tanning beds. Use sunscreen and dress your child in clothing and eyewear that protects from the sun.
- It is common to have dry eyes with this drug. Artificial tears, lubricant eye gels, or other products may be used to prevent or treat dry eyes. If you have questions, talk with the doctor or pharmacist.
- Avoid giving your child grapefruit and grapefruit juice.
- Avoid giving your child other sources of vitamin A.
- Be sure your child does not donate blood while taking this drug or for 1 week after stopping.
- If your child’s weight changes, talk with the doctor. The dose of this drug may need to be changed.
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 skin infection like oozing, heat, swelling, redness, or pain.
- New or worse behavior or mood changes like depression or thoughts of suicide.
- Swelling in the arms or legs.
- Change in nails.
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:
- Dry eyes.
- Dry mouth.
- Upset stomach.
- Back, muscle, or joint pain.
- Pain in arms or legs.
- Feeling tired or weak.
- It is common to have skin irritation with this drug. This includes dry skin; dry, scaly, or chapped lips; hair loss; itching; redness of the skin; rash; skin peeling; and eczema. This may also raise the risk of skin infections. Ask the doctor or pharmacist for ways to prevent or treat skin irritation. Call the doctor if any of these effects are severe, bother your child, or do not go away.
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 food.
- Give this drug at the same time of day.
- Have your child swallow whole. Do not let your child chew or crush.
- If needed, you may open the capsule and sprinkle the contents on 1 teaspoon (5 mL) of soft food like applesauce, low-fat yogurt, or warm oatmeal. Do not mix with grapefruit, pomelo, or juices that have these fruits in them. Have your child swallow the mixture within 1 hour after mixing. Protect the mixture from sunlight; do not store for future use.
- Wear gloves to handle this drug.
- If you open the capsule, use paper towels and a sealable container (like a sealable bag) to collect and throw away any waste.
- 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 on the same day.
- Store at room temperature in a dry place. Do not store in a bathroom.
- Store in the outer carton to 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.
- 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.
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