Are you a healthcare professional?

Yes   No


Your name:
Your email:
Friend's emails:
(multiple emails separated by comma)
Your message:
 
Information for Patients & Caregivers
|

What is Phenylketonuria?

Importance of Phe

Managing PKU


KUVAN

Search

Share

High Phe and PKU Symptoms

Too much Phe is toxic to the brain1

Doctors have known for a long time that too much Phe causes severe mental retardation and other problems in infants with PKU.1 Although it was thought that higher Phe was not a big problem for teens and adults, that thinking has changed. Many studies show that high Phe levels can cause problems throughout life.
In a person with PKU, Phe builds up in the blood and is NOT converted to tyrosine. If people with PKU do not take steps to lower their Phe levels, toxic levels of Phe can build up in the brain and cause damage.
KUVAN works with PAH in the body to help reduce Phe levels in the blood. KUVAN assists those with PKU by helping them stay at the target Phe level their doctor recommends.

Symptoms of high Phe levels

Lower intelligence (IQ)Being depressed
Bad moods, being cranky or irritableFeeling anxious
Feeling "foggy"Not being able to focus or pay attention2,3,4,5,6
Thinking and responding slower
Long-term studies of neurocognitive outcomes with KUVAN treatment have not been conducted. BioMarin is conducting a trial to evaluate long-term neurocognitive outcomes in PKU patients treated with KUVAN.
Phe Matters at Every Age

Indication

KUVAN® (sapropterin dihydrochloride) Tablets are 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 low-Phe 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 your diet and blood Phe levels 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.


This site is intended for use by U.S. residents only.

KUVAN® is a registered trademark of BioMarin Pharmaceutical Inc. Developed in collaboration with Asubio Pharma Co., Ltd.
©2010 BioMarin Pharmaceutical Inc. All rights reserved.