Some patients may be unable to afford their KUVAN co-payment. If this applies to you, BPPS can refer you to NORD. NORD is an independent non-profit agency dedicated to the treatment and cure of rare diseases. NORD has set up a fund that provides premium and co-payment assistance for patients receiving prescription medication treatment for PKU. Other costs necessary for remaining on medication, such as lab tests, may also be covered by NORD.

The NORD process

After referral to NORD by BPPS, NORD will call you and send an application packet upon request. All patients are eligible to apply for the program. There is no preset income threshold for applying to the program; however, NORD examines household income and available assets versus household and medical expenses in determining eligibility.

NORD will notify you by mail of acceptance into the program or denial. After acceptance into the program, you must remain compliant with treatment, defined as taking ≥90% of prescribed PKU medications. If for some reason access to the program is denied, NORD encourages you to resubmit your application along with additional information explaining why your case should be reconsidered.

Timing

All fully completed applications are reviewed within 10–12 business days. Eligibility for NORD assistance is guaranteed for 12 months, then you must reapply.

Contacting NORD

After referral by BPPS, you can reach NORD patient representatives by calling 1-800-999-6673 (option 3) Monday through Friday from 9 AM to 5 PM (Eastern Time) or by accessing their Web site at www.rarediseases.org.

More information about NORD

If you have more questions about NORD, please click here to see our Frequently Asked Questions About NORD section.

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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 in conjunction 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.