RAVICTI (glycerol phenylbutyrate)

RAVICTI (glycerol phenylbutyrate)

SELF ADMINISTRATION - ORAL

Indications for Prior Authorization:

• Treatment of adult and pediatric patients (> 2 years) patients with urea cycle disorders (UCD)

Patients must meet the following criteria for the indication(s) above:

• Patients symptoms cannot be managed with dietary protein restrictions and/or amino acid supplementation alone

The Following Conditions Do Not Meet the Criteria for Use as Established by the WHA P & T Committee:

• All non-FDA approved uses not listed in the approved indications
• Patient must be on protein restricted diet

Recommended Dosing:

• Initial dose in treatment naïve patient is 4.5 to 11.2 mL/m2/day in three divided doses with food

Approval:

One year