KUVAN Tablets are taken:

  • Once a day
  • Preferably at the same time each day
  • With food

You should work with your doctor to determine when KUVAN should be taken and how many tablets are needed.

KUVAN can be mixed with 4–8 oz (1/2 to 1 cup) of water or apple juice until the tablets dissolve. Drink the mixture within 15 minutes.

  • Apple juice may help mask the taste.
  • It may take a few minutes of stirring for the tablets to completely dissolve.
    • Putting the tablets in a closed container and shaking may result in the tablets dissolving more quickly.
  • After dissolving, the liquid will appear cloudy, as in the photos below, and there may be small floating particles. This is normal and safe for you to swallow.
  • Make sure you take all of the medicine in the glass. If any undissolved medicine remains in the glass, add 1–2 oz (1/4 cup or less) of water or apple juice and drink immediately.
  • Remember, KUVAN should be used in conjunction with a Phe-restricted diet.

KUVAN being mixed in water

KUVAN dissolved in water and apple juice

Next: PKU and You

 

Indication

KUVAN® (sapropterin dihydrochloride) Tablets is approved to reduce blood Phe levels in patients with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin- (BH4-) responsive Phenylketonuria (PKU). KUVAN is to be used in conjunction with a Phe-restricted diet.

Important Safety Information

High blood Phe levels are toxic to the brain and can lead to lower intelligence and decrease in the ability to focus, remember and organize information. Any change you make to your diet may impact your blood Phe level. Follow your doctor’s instructions carefully. Your doctor and dietitian will continue to monitor and may adjust your diet throughout your treatment with KUVAN.

If you have a fever, or if you are sick, your Phe level may go up. Tell your doctor and dietitian as soon as possible so they can see if they have to adjust your treatment to help keep your blood Phe levels in the desired range.

KUVAN is a prescription medicine and should not be taken by people who are allergic to any of its ingredients. Tell your doctor if you have ever had liver or kidney problems, are nursing or pregnant or may become pregnant, have poor nutrition or are anorexic. Your doctor will decide if KUVAN is right for you. Tell your doctor about all the medicines you take.

The most common side effects reported when using KUVAN are headache, diarrhea, abdominal pain, upper respiratory tract infection (like a cold), throat pain, vomiting, and nausea.

To report SUSPECTED ADVERSE REACTIONS, contact BioMarin Pharmaceutical Inc. at 1-866-906-6100, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please read the full Patient Information by clicking here.

BIOMARIN