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CARBAGLU is the first FDA-approved medication indicated for adult and pediatric patients as:

  • Adjunctive therapy to standard of care for the treatment of acute hyperammonemia due to N-acetylgutamate synthase (NAGS) deficiency.
  • Maintenance therapy for the treatment of chronic hyperammonemia due to N-acetylgutamate synthase (NAGS) deficiency.
  • Adjunctive therapy to standard of care for the treatment of acute hyperammonemia due to propionic acidemia (PA) or methylmalonic acidemia (MMA).
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Acute Hyperammonemia due to Propionic Acidemia (PA) and Methylmalonic Acidemia (MMA)

Clinicians must act quickly to normalize acute high plasma ammonia levels.

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Hyperammonemia due to
NAGS deficiency

Clinicians must act quickly to normalize high acute plasma ammonia levels. Maintenance therapy can treat chronic hyperammonemia due to NAGS deficiency.

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Video Library


The library includes expert videos presenting undiagnosed urea cycle disorders as a cause of hyperammonemia (HA), the causes and detection of HA due to metabolic disorders, and videos showing how CARBAGLU works to treat HA due to PA, MMA, and NAGSD.

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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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