KUVAN has an established safety profile

KUVAN has been tested in over 579 PKU patients aged 4–49 years for periods from 1 to 30 weeks.¹ In 2 studies lasting 6 and 10 weeks, the type and incidence of adverse events were similar in KUVAN and placebo groups.¹ In addition, BH4 has been studied for over 15 years, including a 10-year safety surveillance study.^{1,
26} Since 1992, more than 1100 subjects have been exposed to treatment with BH4.²⁶

Adverse Reactions Occurring in ≥4% of Patients in Controlled Clinical Studies With KUVAN¹

KUVAN has been shown to be well tolerated at all doses up to 20 mg/kg/day for periods from 1 to 30 weeks¹
The most common adverse reactions (≥4% of PKU patients treated with KUVAN) across all studies (n=579) were headache, diarrhea, abdominal pain, upper respiratory tract infection, pharyngolaryngeal pain, vomiting,
and nausea¹

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.

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