IMPORTANT NOTICE: FILTRATION REQUIRED FOR AMMONUL

FREQUENTLY ASKED QUESTIONS

In September 2008, Ucyclyd Pharma, Inc. (Ucyclyd) detected particulate matter in its AMMONUL (sodium phenylacetate and sodium benzoate) Injection 10%/10% product. Due to the possibility that this particulate matter may impact the safe use of this product and to ensure optimal patient care, you are instructed to use the Millex^® Durapore GV 33 mm Sterile Syringe Filter (0.22 µm) during the admixture process when injecting AMMONUL into the 10% dextrose IV bag. Please note that this particulate matter may not be readily seen on visual inspection, so this filter must be employed in all cases regardless of whether particulate matter is seen in the vial. This filter was chosen because it is made from the same materials as the validated cartridge filters used in the processing of the drug product and it is rated to remove particles 0.22 µm and larger. Testing has confirmed the removal of this specific particulate matter when using this filter to admix AMMONUL.

AMMONUL (sodium phenylacetate and sodium benzoate) Injection 10%/10% is the only FDA-approved drug for the adjunctive treatment of acute hyperammonemia and associated encephalopathy in patients with urea cycle disorders (UCDs). Left untreated, UCDs can cause dangerously heightened levels of ammonia in the bloodstream (hyperammonemia) resulting in brain damage, coma, and/or death.

Indication and Usage
AMMONUL Injection 10%/10% is indicated as adjunctive therapy for the treatment of acute hyperammonemia and associated encephalopathy in patients with deficiencies in enzymes of the urea cycle.

In acute neonatal hyperammonemic coma, in moderate to severe episodes of hyperammonemic encephalopathy, and in episodes of hyperammonemia which fail to respond to an initial course of AMMONUL therapy, hemodialysis is the most rapid and effective technique for removing ammonia. In such cases, the concomitant administration of AMMONUL can help prevent the re-accumulation of ammonia by increasing waste nitrogen excretion.

Treatment of hyperammonemia also requires caloric supplementation and restriction of dietary protein; intravenous arginine is an essential component of therapy for patients with CPS, OTC, ASS, or ASL deficiency.

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