Kuvan (sapropterin dihydrochloride)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
5 WARNINGS AND PRECAUTIONS
- 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.
- 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.