CARBAGLU (carglumic acid)

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