Treating hyperammonemia due to NAGS deficiency

Be prepared to act quickly to diagnose this serious, rare genetic disorder that can present suddenly in neonates and suddenly or chronically in individuals with late-onset NAGS deficiency (NAGSD). Rapid progression to a hyperammonemic crisis can occur in anyone with the disorder. Prescribe your patients an FDA-approved proven treatment that can be the key to normalizing high blood ammonia levels.

Review CARBAGLU® (carglumic acid) clinical data

You and your patients can learn more about the urea cycle, NAGS deficiency, and the importance of normalizing high blood ammonia levels.

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Diagnosing hyperammonemia due to NAGSD

Hyperammonemic crises can result in serious neurological complications and death. Clinicians must act quickly to diagnose and treat.1

Identify symptoms and review diagnostic tests

CARBAGLU clinical results

CARBAGLU has been shown to normalize high blood ammonia levels.

Review clinical data

References

  1. Cartagena A, Prasad AN, Rupar CA, Strong M, Tuchman M, Ah Mew N, Prasad C. Recurrent encephalopathy: NAGS (N-acetylglutamate synthase) deficiency in adults. Can J Neurol Sci. 2013;40:3-9.

Indications and Usage

Carbaglu® (carglumic acid) is a Carbamoyl Phosphate Synthetase 1 (CPS 1) activator indicated in pediatric and adult patients as:

  • Adjunctive therapy for the treatment of acute hyperammonemia due to the deficiency of the hepatic enzyme N-acetylglutamate synthase (NAGS).
  • Maintenance therapy for the treatment of chronic hyperammonemia due to the deficiency of the hepatic enzyme N-acetylglutamate synthase (NAGS).

Important Safety Information

  • Hyperammonemia: Monitor plasma ammonia level during treatment. Prolonged exposure to elevated plasma ammonia level can result in brain injury or death. Prompt use of all therapies necessary to reduce plasma ammonia level is essential.
  • Most common adverse reactions (>9%) are: vomiting, abdominal pain, pyrexia, tonsillitis, anemia, diarrhea, ear infection, infections, nasopharyngitis, hemoglobin decreased, and headache.
  • To report SUSPECTED ADVERSE REACTIONS, contact Recordati Rare Diseases Inc. at 1-888-575-8344, or FDA at 1‑800-FDA-1088 or www.fda.gov/medwatch.
  • If CARBAGLU is administered during pregnancy, health care providers should report CARBAGLU exposure to the pregnancy pharmacovigilance program by calling 1-888-575-8344.
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