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U.S. Department of Health and Human Services

Safety

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Kuvan (sapropterin dihydrochloride)

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)

 

April 2014

Summary View

5 WARNINGS AND PRECAUTIONS

5.3 Hypophenylalaninemia
  • In clinical trials, some patients have experienced low blood Phe levels. Children younger than 7 years treated with Kuvan doses of 20 mg/kg per day are at increased risk for low levels of blood Phe compared with patients 7 years and older [see Adverse Reactions (6.1)].

8 USE IN SPECIFIC POPULATIONS

8.4 Pediatric Use
  • Pediatric patients with PKU, ages 1 month to 16 years, have been treated with Kuvan in clinical trials [see Clinical Studies (14.1)]. The efficacy and safety of Kuvan have not been established in neonates. The safety of Kuvan has been established in children .....

17 PATIENT COUNSELLING INFORMATION

  • added .....information on the recommended starting dose for children 6 years and younger ..... and the risk of hypophenylalaninemia in children.

PATIENT INFORMATION

  • added ..... specific instructions on the administration of Kuvan to patients weighing 5 kg or less, include what liquids may be used for dissolving Kuvan and how to calculate the amount of Kuvan solution (as measured in milliliters) to be administered.