- It is used to treat hereditary tyrosinemia type 1 (HT-1).
- 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.
This drug may interact with other drugs or health problems.
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.
- Have your child’s blood work checked often. Talk with your child’s doctor.
- Have your child’s urine checked as you have been told by the doctor.
- Get your child an eye exam as you have been told by the doctor.
- Nitisinone must be used with a special diet that is low in tyrosine and phenylalanine.
- Have your child follow the diet plan your child’s doctor told you about.
If your child is pregnant or breast-feeding a baby:
- Talk with the doctor if your child is pregnant, becomes pregnant, or is breast-feeding a baby. You will need to talk about the benefits and risks to your child and the baby.
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 liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
- Change in skin on hands or feet.
- Change in eyesight, eye pain, or very bad eye irritation.
- Eye is bothered by bright light.
- Feeling confused.
- Fever or chills.
- Sore throat.
- Any unexplained bruising or bleeding.
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:
- Upset stomach.
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.
- 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 on an empty stomach. Give 1 hour before or 2 hours after meals.
- Capsules may be opened and contents mixed with a small amount of water, formula, or applesauce.
- If mixed, have your child swallow the mixed drug right away. Do not store for use at a later time.
- Give this drug with or without food.
- If your child cannot swallow this drug whole, you may dissolve it in room temperature water in an oral syringe. If your child can swallow soft foods, the tablets can be crushed and mixed with applesauce. Do not mix with other liquids or foods. Follow how to mix as you have been told by your child’s doctor or read the package insert.
- Wash your hands before use.
- If dissolved in water, give within 24 hours of adding water to the tablets. If mixed in applesauce, give within 2 hours of mixing. Do not store for future use.
- If the adapter has not been put in the bottle when you get it, follow how to prepare the bottle as you have been told or read the package insert.
- Give this drug with or without food.
- Shake well before use.
- Measure liquid doses carefully. Use the measuring device that comes with this drug. If there is none, ask the pharmacist for a device to measure this drug.
- 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 in a refrigerator. Do not freeze.
- Store in the original container at room temperature.
- Keep lid tightly closed.
- Store in a dry place. Do not store in a bathroom.
- If you have mixed this drug with water or in applesauce, keep it at room temperature and out of sunlight.
- If the adapter has not been put in the bottle when you get it, store in a refrigerator until you need to prepare the bottle.
- Do not freeze.
- After the adapter has been put in the bottle, store at room temperature.
- Throw away any unused part 60 days after the adapter was put in the bottle. You or your pharmacist will need to write the date to throw away on the bottle label.
- 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.