- It is used to treat phenylketonuria (PKU).
- 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.
- Tell dentists, surgeons, and other doctors that you use this drug.
- Have blood work checked as you have been told by the doctor. Talk with the 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.
- 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.
- Loose stools (diarrhea).
- Runny nose.
- Stuffy nose.
- Sore throat.
- Throwing up.
- 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.
- 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.
- 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.
- 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.
If you have any questions or concerns, talk with a member of your healthcare team. You can reach them Monday through Friday from 9:00 am to 5:00 pm at ____________________. After 5:00 pm, during the weekend, and on holidays, please call____________________. If there’s no number listed, or you’re not sure, call 212-639-2000.