KUVAN tips the challenges of Phe control in your favor

KUVAN—the first and only prescription medication for phenylketonuria (PKU)—can help lower Phe levels in the blood.

KUVAN functions exactly like BH4, a substance that naturally occurs in the body. Adding more BH4 can help keep your Phe level low.
Read more about how KUVAN works.
KUVAN is proven to lower blood Phe levels in patients with PKU. KUVAN works with your Phe-restricted diet to help keep blood Phe low.
Read more about the benefits of KUVAN.
In studies, side effects in patients taking KUVAN generally occurred at a similar rate as they did in patients who received placebo (a pill without any medicine in it).
Read more about safety information for KUVAN.
As with all medications, your healthcare provider will determine if KUVAN is right for you.
Read more about taking KUVAN.
Whether you’re considering including KUVAN as part of your PKU management plan or have recently started taking it, you’re likely to have some questions.
Get answers to frequently asked questions.

Want more information about PKU?

Visit PKU.com, an informative online resource from BioMarin, the makers of KUVAN. In addition to in-depth information about PKU and how it’s managed, you can register for access to exclusive features such as discussion forums, customized recipes, a personalized message in-box, and more.

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.