INDICATION(S) AND SAFETY INFORMATION

CARBAGLU® (carglumic acid) tablets for oral suspension 200 mg

INDICATIONS AND USAGE

CARBAGLU® (carglumic acid) is a carbamoyl phosphate synthetase 1 (CPS 1) activator indicated in adult and pediatric patients as:

Acute and Chronic Hyperammonemia due to N-acetylglutamate Synthase (NAGS) Deficiency:

  • 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.

Acute Hyperammonemia due to Propionic Acidemia (PA) or Methylmalonic Acidemia (MMA)

  • 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: The most common adverse reactions (≥13%) are vomiting, abdominal pain, pyrexia, tonsillitis, anemia, diarrhea, ear infection, infections, nasopharyngitis, hemoglobin decreased, and headache.

PA and MMA: The 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.

Use in Special Population(s): 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.

Dosing and Administration: The recommended dosage of CARBAGLU in patients with moderate or severe renal impairment must be adjusted based upon the estimated glomerular filtration rate (eGFR). See Prescribing Information for details.

CARBAGLU® (carglumic acid) is available as 200 mg tablets for oral suspension.

For more information, please see full Prescribing Information at www.carbaglu.com/PI

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INDICATION(S) AND SAFETY INFORMATION

CARBAGLU® (carglumic acid) tablets for oral suspension 200 mg

INDICATIONS AND USAGE

CARBAGLU® (carglumic acid) is a carbamoyl phosphate synthetase 1 (CPS 1) activator indicated in adult and pediatric patients as:

Acute and Chronic Hyperammonemia due to N-acetylglutamate Synthase (NAGS) Deficiency:

  • 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.

Acute Hyperammonemia due to Propionic Acidemia (PA) or Methylmalonic Acidemia (MMA)

  • 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: The most common adverse reactions (≥13%) are vomiting, abdominal pain, pyrexia, tonsillitis, anemia, diarrhea, ear infection, infections, nasopharyngitis, hemoglobin decreased, and headache.

PA and MMA: The 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.

Use in Special Population(s): 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.

Dosing and Administration: The recommended dosage of CARBAGLU in patients with moderate or severe renal impairment must be adjusted based upon the estimated glomerular filtration rate (eGFR). See Prescribing Information for details.

CARBAGLU® (carglumic acid) is available as 200 mg tablets for oral suspension.

For more information, please see full Prescribing Information at www.carbaglu.com/PI

See LessSee More
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