Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
Clincial Trials Experiences
PKU Clinical Studies
- In Study 7, 27 pediatric patients with PKU aged 0 to 4 years received Kuvan 10 mg/kg per day or 20 mg/kg per day. Adverse reactions were similar in type and frequency to those observed in other clinical trials, with the addition of rhinitis, which was reported in 2 subjects (7.4%).
- Based on in vitro study, there is potential for Kuvan to inhibit p-glycoprotein (P-gp) and breast cancer resistance protein (BCRP) in the gut at the therapeutic doses. Co-administration of Kuvan may increase systemic exposure to drugs that are substrates for P-gp or BCRP.
PATIENT COUNSELING INFORMATION
Patients should be advised of the following information before beginning treatment with Kuvan:
- (addition) Advise patients that Kuvan may interact with other drugs. Advise patients to report to their healthcare provider the use of any other prescription or nonprescription medication.
How should I take Kuvan?
Kuvan comes as a tablet and powder for oral solution.
- Be sure that you know what dose of Kuvan powder your doctor prescribed and whether you should use Kuvan 100 mg packets, Kuvan 500 mg packets, or both types of packets to prepare your dose. (addition)
- Open Kuvan powder packets only when you are ready to use them. (addition)
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.