Sapropterin
Generic name: sapropterin [ SAP-roe-TER-in ]
Brand name: Kuvan
Dosage forms: oral powder for reconstitution (100 mg; 500 mg); oral tablet, soluble (100 mg)
Drug class:Miscellaneous metabolic agents
What is sapropterin?
Phenylketonuria (PKU) is a disorder in which the body cannot break down phenylalanine. Elevated phenylalanine levels can cause problems with thinking and behavior.
Sapropterin is used to lower blood levels of phenylalanine in people with a certain type of PKU.
Sapropterin may also be used for purposes not listed in this medication guide.
Warnings
Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.
Before taking this medicine
You should not use sapropterin if you are allergic to it.
Tell your doctor if you have ever had:
stomach ulcer or bleeding; or
little or no appetite, or if you are malnourished.
It is not known whether sapropterin will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.
If you are pregnant, your name may be listed on a pregnancy registry to track the effects of sapropterin on the baby.
It is not known whether sapropterin passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breastfeeding.
Sapropterin is not approved for use by anyone younger than 1 month old.
How should I take sapropterin?
Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.
Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.
Sapropterin can cause phenylalanine levels to get too low in children younger than 7 years old who use this medicine.
Older children may be able to use sapropterin for a longer period of time than younger children. Follow your doctor's dosing instructions very carefully.
Take the medicine with food at the same time each day.
You may swallow the tablet whole or dissolve it in 4 to 8 ounces of water or apple juice.
It will take a few minutes for the tablet to dissolve, and you may see small pieces in the liquid. These pieces are safe for you to swallow.
Stir the mixture and then drink all of it within 15 minutes after the tablet dissolves.
To get the entire dose, add a little more water to the same glass, swirl gently and drink right away.
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