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.

Watch Video

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) tablets for oral suspension 200mg is a carbamoyl phosphate synthetase 1 (CPS 1) activator indicated in pediatric and adult patients as:

  • Adjunctive therapy to standard of care for the treatment of acute hyperammonemia due to N-acetylglutamate synthase (NAGS) deficiency.
  • Maintenance therapy for the treatment of chronic hyperammonemia due to N-acetylglutamate synthase (NAGS) deficiency.
  • Adjunctive therapy to standard of care for the treatment of acute hyperammonemia due to propionic acidemia (PA) or methylmalonic acidemia (MMA).

Important Safety Information

  • Contraindications: None.
  • NAGS deficiency: Most common adverse reactions (≥13%) are: vomiting, abdominal pain, pyrexia, tonsillitis, anemia, diarrhea, ear infection, infections, nasopharyngitis, hemoglobin decreased, and headache.
  • PA and MMA: Most common adverse reactions (≥5%) are neutropenia, anemia, vomiting, electrolyte imbalance, decreased appetite, hypoglycemia, lethargy/stupor, encephalopathy and pancreatitis/lipase increased.
  • 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 to women with NAGS deficiency, health care providers should report CARBAGLU exposure to the pregnancy pharmacovigilance program by calling 1-888-575-8344.
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