When a patient has acute hyperammonemia due to propionic acidemia (PA) or methylmalonic acidemia (MMA)...

It's about time.

CARBAGLU is the first FDA-approved medication indicated for the adjunctive treatment of acute hyperammonemia due to PA or MMA.

Be prepared to act quickly to identify and treat acute hyperammonemia due to PA, MMA, or NAGS deficiency, Rapid progression to a hyperammonemic crisis can occur in anyone with these disorders. FDA-approved CARBAGLU, in conjunction with standard of care, can be the key to normalizing acute high plasma ammonia levels.

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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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