Support

Below are some helpful links. A more complete list of links can be found by clicking here.

• PKU.com
  Sponsored by BioMarin, PKU.com is your connection to basic information, tips, and aids to help with PKU management, and to the diverse online PKU community. Create a free account for exclusive features and content such as discussion forums, customized recipes, a personalized message in-box, and more.
• The California Late Treatment Project (pkulatetx.com/index.htm)
  This site provides treatment options for patients with PKU, regardless of age, with the goal of increasing the quality of life in these individuals and stopping the neurological deterioration that occurs in those not treated. The downloadable Late Treatment Protocol also has a handy list of Phe amounts found in over-the-counter and prescription medications.
• Resource Mothers Program
  (web1.tch.harvard.edu/newenglandconsortium/RMWebsite/
  RMProgram/RMProgram.htm)
  The Resource Mothers Program was designed to help women with PKU gain metabolic control before or during a pregnancy by providing social support and promoting positive outlooks on life through home visitation. The Resource Mothers Program teaches women to be empowered advocates for their children who have PKU.
• PKU Organization of Illinois (PKUIL.org)
  The PKU Organization of Illinois Web site features a broad range of PKU information, including clinics and product suppliers.
• The Mid-Atlantic Connection for PKU and Allied Disorders (Macpad.org)
  A non-profit organization that promotes better health and well-being in individuals with PKU and related metabolic disorders by providing information and facilitating the exchange of ideas within the PKU community.
• National PKU News Organization (PKUnews.org)
  This non-profit organization provides the latest PKU news and information to people affected by PKU and their families.
• University of Washington PKU Clinic (depts.washington.edu/pku)
  The University of Washington’s PKU Clinic Web site provides in-depth information on PKU and clinic insights from the Seattle PKU clinic.
• National Organization for Rare Disorders (rarediseases.org)
  This organization provides a database of reports on rare diseases. It also administers various assistance programs to help people, including uninsured patients, obtain certain medications.

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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 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.