Brand Names: U.S.
What is this drug used for?
- It is used to treat phenylketonuria (PKU).
What do I need to tell my doctor BEFORE I take this drug?
This drug may interact with other drugs or health problems.
Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this drug with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.
- If you have an allergy to sapropterin or any other part of this drug.
- If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
What are some things I need to know or do while I take this drug?
- Tell dentists, surgeons, and other doctors that you use this drug.
- Have your blood work checked often. Talk with your doctor.
- Talk with your doctor if you have a fever or you are sick. Your dose may need to be changed.
- Follow the diet plan that your doctor told you about.
- Some people have had low blood phenylalanine levels with this drug. The chance is raised in children younger than 7 years of age. Blood levels that are too low for a long time may lead to very bad health problems. Talk with the doctor.
- Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this drug while you are pregnant.
- Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.
What are some side effects that I need to call my doctor about 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 doctor or get medical help right away if you have 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 or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
- Black, tarry, or bloody stools.
- Throwing up blood or throw up that looks like coffee grounds.
- Very bad belly pain.
- Wheezing or coughing.
- Shortness of breath.
- Very upset stomach or throwing up.
- Fidgeting, moving around too much, or talking too much.
- Chest pain or pressure or passing out.
- Passing urine often.
- Swelling in the arms or legs.
What are some other side effects of this drug?
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you 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 doctor. Call your doctor for medical advice about side effects.
You may report side effects to your national health agency.
- Loose stools (diarrhea).
- Runny nose.
- Stuffy nose.
- Sore throat.
- Throwing up.
How is this drug best taken?
Use this drug as ordered by your doctor. Read and follow the dosing on the label closely.
- To gain the most benefit, do not miss doses.
- Take this drug at the same time of day.
- Take with a meal.
- This drug may be swallowed whole or mixed in water or apple juice.
- This drug may also be crushed and mixed in a small amount of soft food like applesauce or pudding.
- If mixing the tablets, mix with 1/2 to 1 cup (4 to 8 ounces) of water or apple juice. Drink within 15 minutes of mixing. It may take a few minutes for the tablets to melt. You may stir or crush the tablets to help the tablets melt faster. Rinse glass with more juice or water and drink.
- This drug may not melt all the way. You may see small pieces floating on the top of the water or apple juice. This is normal and safe to swallow.
- Empty packet in 1/2 to 1 cup (4 to 8 ounces) of water or apple juice. Mix well and drink within 30 minutes of mixing.
- This drug may also be mixed in a small amount of soft food like applesauce or pudding.
What do I do if I miss a dose?
- Take a missed dose as soon as you think about it.
- If you do not think about the missed dose until the next day, skip the missed dose and go back to your normal time.
- Do not take 2 doses on the same day.
How do I store and/or throw out this drug?
- Store at room temperature.
- Store in a dry place. Do not store in a bathroom.
- Keep all drugs out of the reach of children and pets.
- Check with your pharmacist about how to throw out unused drugs.
- Store in the original container. Do not take out the antimoisture cube or packet.
General drug facts
- If your symptoms or health problems do not get better or if they become worse, call your doctor.
- Do not share your drugs with others and do not take anyone else’s drugs.
- Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
- Talk with the doctor before starting 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 doctor, 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.
Consumer Information Use and Disclaimer
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.
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Last updated: June 24, 2014