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Managing PKU

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KUVAN and Low-Phe Diet

KUVAN and Low-Phe Diet

People with PKU need to keep Phe levels low. Low-Phe is good, and lower is better.*1,2

A low-Phe diet

PKU is carefully managed with a low-Phe diet in order to limit the amount of Phe in the blood. Phe is found in all protein-containing foods (eg, meat, eggs, dairy, nuts) as well as other foods that are not generally thought of as containing protein (eg, most wheat products, such as pasta and bread, some vegetables, and some fruit, such as oranges and cherries). People with PKU limit how much they eat of foods with less Phe.1,2 Phe-free formula and other supplements help people with PKU get the other amino acids they need to grow and be healthy.1

KUVAN—PKU medication

Some people can also take a medicine to help lower Phe.14 In combination with a low-Phe diet, KUVAN, the only prescription medication for PKU, can offer an additional way to help lower blood Phe levels even more.
* Lower is better until you get Phe into the normal range of 1-2 mg/dL. Going lower than 1-2 mg/dL can be unhealthy because your body needs a minimum amount of Phe. Talk with your doctor about the right target range for you.1,2
Control Starts in the Kitchen

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.


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