The following educational materials are for healthcare providers to reference with patients who are interested in KUVAN, or who are making KUVAN a part of their PKU management plan. Ask your sales representative for actual samples of the printed brochures.

  • Getting Started With KUVAN
    This brochure will help a patient understand what KUVAN is, why it was prescribed, how to take KUVAN, and how it can help in the treatment of PKU.
    Download English PDF
  • Introduction to KUVAN
    This educational brochure is relevant if the patient has no knowledge of KUVAN and has many questions that need to be answered. Ask your sales representative for a copy of this helpful educational brochure.
    Download PDF
  • BPPS Patient Brochure
    BioMarin Patient and Physician Support (BPPS) will help all PKU patients research insurance coverage and make access to KUVAN easier. Patients will receive details on what BPPS provides and how to initiate support services.
    Download PDF
  • NORD Brochure
    The National Organization for Rare Disorders (NORD) is a not-for-profit, voluntary health agency that provides financial support to patients with “orphan diseases,” including PKU, on a case-by-case basis. This brochure provides specific details about eligibility for the two PKU programs that are provided.
    Download PDF

PKU.com

Be sure to tell your patients with PKU about PKU.com —a great resource from BioMarin that provides information, tips, and management aids to make PKU management easier. At PKU.com, your patients can join our growing online community and create a free account for exclusive features and content such as discussion forums, customized recipes, a personalized message in-box, and more.

Indication

KUVAN® (sapropterin dihydrochloride) Tablets is indicated to reduce blood phenylalanine (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

Prolonged exposure to elevated blood Phe levels in PKU patients can result in severe neurologic damage. The initiation of KUVAN therapy does not eliminate the need for careful monitoring of blood Phe levels and ongoing dietary management.

Some patients receiving KUVAN can experience significant drops in blood Phe levels. Patients should be monitored closely to ensure that blood Phe levels do not fall too low.

Not all patients with PKU respond to treatment with KUVAN. Response to treatment can only be determined by a therapeutic trial of KUVAN.

KUVAN has not been studied in patients with liver or renal impairment. Patients who have these conditions should be carefully monitored when receiving KUVAN. Caution should be used with the administration of KUVAN to patients who are receiving levodopa and drugs that affect nitric oxide–mediated vasorelaxation or folate metabolism.

The most serious adverse reactions reported during KUVAN administration (regardless of relationship to treatment) were gastritis, spinal cord injury, streptococcal infection, testicular carcinoma, and urinary tract infection. Mild to moderate neutropenia was also noted. The most common adverse reactions were headache, diarrhea, abdominal pain, upper respiratory tract infection, pharyngolaryngeal pain, vomiting, and nausea.

Please read the full Prescribing Information by clicking here.

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