Click here for the Spanish version of the FAQs section.

It is normal for patients, as well as parents, caregivers, and healthcare professionals, to have questions about a treatment as unique as KUVAN. Click on the link below for additional details about KUVAN.

Frequently Asked Questions About KUVAN

In addition to the Overview of the Patient Support and Assistance Programs for KUVAN section, more information on these programs can be found by clicking on the links below:

Frequently Asked Questions About the BioMarin Patient and Physician Support (BPPS) Program

Frequently Asked Questions About Specialty Pharmacies

Frequently Asked Questions About the KUVAN Patient Assistance Program
(K-PAP)

Frequently Asked Questions About the National Organization for Rare Disorders (NORD)

 

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.