CARBAGLU (carglumic acid)
SELF ADMINISTRATION - ORAL
Indications for Prior Authorization:
- Indicated for the treatment of acute hyperammonemia due to the deficiency of hepatic N-acetylglutamate synthase
Patients must meet the following criteria for the indication(s) above:
- Diagnosis of hyperammonemia due to the deficiency of hepatic N-acetylglutamate synthase confirmed by enzyme analysis or DNA mutation analysis
- Patients may be approved for a three month trial pending the results of the analysis
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
Dosing:
- Carglumic acid 100 mg/Kg/day to 250 mg/Kg/day round to the nearest 100 mg dose
Approval:
One year
Last review date: December 2, 2013