KUVAN is the first and only prescription medication to lower blood Phe levels

KUVAN.com is your online resource for comprehensive information about this exciting PKU treatment option. To learn more about KUVAN and how it can be used to lower blood Phe levels in your PKU patients, follow the links below.

  • About PKU
    The latest information regarding the dangers of elevated Phe and current treatment practices.
  • About KUVAN
    KUVAN is the first and only prescription medication to lower blood Phe levels in patients with BH4-responsive PKU.1 Read about the unique way that KUVAN works, its efficacy, safety, dosing and administration, and more.
  • Nutrition and Diet
    Information and tools to make dietary management easier for your patients with PKU.
  • Insurance Support
    Information about payment and insurance issues.
  • Patient Education
    Educational tools for PKU management and KUVAN treatment that you can download and share with your patients.
  • Links
    A list of helpful online resources with PKU information for both your patients and your practice.

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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