KUVAN is the first and only prescription medication to lower blood Phe levels

If you or someone you care for is affected by phenylketonuria (PKU), you know that controlling phenylalanine (Phe) through dietary management can be difficult. Now there’s a medication that can help!

KUVAN is the first and only prescription medication for PKU. Along with a Phe-restricted diet, KUVAN may help you lower your blood Phe levels more than the use of diet alone. Learn more about this exciting treatment option by following the links below.

• About PKU
  PKU is a genetic condition in which the body can’t break down a certain type of amino acid found in food called phenylalanine, or Phe. This causes the level of Phe to rise in the blood, which can result in lower intelligence and behavioral problems. Find the latest information regarding the dangers of elevated Phe and what can be done to lower Phe.
• About KUVAN
  KUVAN is the first and only prescription medication to lower blood Phe levels in patients with BH4-responsive PKU. Read about the unique way that KUVAN works and more.
• PKU and You
  Here, you’ll find PKU management information specifically designed with you in mind. Whether you are the parent of a child with PKU, a teenager, or an adult, you’ll find tips that will help you overcome some of the challenges of PKU.
• Insurance Help
  BioMarin Patient and Physician Support (BPPS) is a service that will work with you and your PKU clinic to help you research insurance options so that each patient who is prescribed KUVAN will have access to it. This section will help you get answers to your questions about insurance and payment issues.
• FAQs
  Frequently asked questions (FAQs) about KUVAN are provided here as a resource, including questions about services available to patients.
• Links
  A list of links to useful online resources with the information you need to help make PKU management more manageable!

Ask your healthcare professional if KUVAN should be a part of your PKU management plan!

Next: About PKU

 

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.