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Managing Your Child's PKU
Regular Blood Tests
PKU is a lifelong (chronic) condition. That means your baby will need to have frequent blood tests throughout his or her life. Blood tests are done at a PKU clinic and at home, sometimes as often as weekly.
These blood tests measure Phe levels. Phe is an amino acid found in food. Amino acids are the building blocks of protein. Measuring Phe levels is essential for keeping PKU under control.
Learn more about Phe levels
Your doctor and dietitian use these blood tests to adjust the special milk-free formula that your baby needs during his or her early development. Later, as your child grows, these blood tests will be used to make adjustments in the Phe-free medical foods and low-Phe diet to ensure adequate Phe control and nutritional balance.
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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.