July 28, 2016
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Kuvan Patient Information including How Should I Take

What should I discuss with my health care provider before taking sapropterin (Kuvan)?

Before using sapropterin, tell your doctor if you are allergic to any drugs, or if you have:

  • liver disease;
  • a history of stomach ulcer or bleeding; or
  • epilepsy or other seizure disorder.

If you have any of these conditions, you may not be able to take sapropterin, or you may need a dose adjustment or special tests during treatment.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether sapropterin passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take sapropterin (Kuvan)?

Take this medication exactly as prescribed by your doctor. Do not take it in larger amounts or for longer than recommended. Follow the directions on your prescription label.

Sapropterin is usually given once daily. Follow your doctor's instructions.

Sapropterin works best if you take it with food.

Dissolve the tablet in 4 to 8 ounces of water or apple juice. It will take about 15 minutes for the tablet to dissolve. Stir this mixture and then drink all of it right away. To make sure you get the entire dose, add a little more water or juice to the same glass, swirl gently and drink right away.

The tablet may not completely dissolve and you may see small pieces in the liquid. These pieces are safe for you to swallow.

To be sure this medication is helping your condition, your blood will need to be tested on a regular basis. Do not miss any scheduled appointments.

Sapropterin can reduce your phenylalanine blood levels within 24 hours of when you take it. However, it may take up to 30 days of using this medicine before it reaches its fullest effect in your body. For best results, keep using the medication as directed.

Sapropterin is only part of a complete program of treatment that also includes a special diet. It is very important to follow the diet plan created for you by your doctor or nutrition counselor. You should become very familiar with the list of foods you must avoid to help control your condition.

Store sapropterin at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.

Side Effects Centers

Report Problems to the Food and Drug Administration


You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

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