CARBAGLU Patient Support Programs

The Recordati Rare Diseases CARBAGLU® (carglumic acid) Support Program, administered by Accredo, is available to assist you and your patients with:

  • Copay Support Program

    Offering a $0 copay for qualified commercially insured patients

  • General inquiries

    Answering general questions about access to CARBAGLU.

  • Prior authorizations

    Facilitating the prior authorization process by determining requirements, coordinating paperwork, and following up on the final decision.

  • Patient Assistance Program (PAP)

    Assisting qualified uninsured and underinsured patients to gain access to CARBAGLU.

  • Benefits investigation

    Determining whether the patient’s insurance will cover CARBAGLU.

Contact the Recordati Rare Diseases CARBAGLU Support Program for assistance:

Phone: 1-888-454-8860 Fax: 1-888-454-8488

Online Resources

Whether your patients are newly diagnosed or have been living with NAGS deficiency for some time, they or their caregivers are likely to have
many questions and concerns. The resources below are appropriate for your practice as well as your patients.

  • Organic Acidemia Association - logo

    The mission of the Organic Acidemia Association is to find improved treatments and a cure for propionic acidemia (PA) and methylmalonic acidemia (MMA) by funding research and providing information and support to families and medical professionals. Services and programs for families include educational materials, family matching to enable families to talk to each other, and an email group.

  • Propionic Acidemia Foundation - logo

    The mission of the Propionic Acidemia Foundation is to find improved treatments and a cure for propionic acidemia (PA) by funding research and providing information and support to families and medical professionals. Services and programs for families include educational materials, family matching to enable families to talk to each other, and an email group.

  • The National Urea Cycle Disorders Foundation (NUCDF) is dedicated to the identification, treatment, and cure of urea cycle disorders. NUCDF provides information and education for families and physicians. NUCDF offers two support programs for families: a mentor program, which matches newly diagnosed families with a mentor from the UCD community; and a networking program, which enables UCD patients and families to communicate with each other.

  • Genetic and Rare Diseases Information Center (GARD) of the National Institutes of Health provides information for individuals with genetic and rare diseases, their families, and others.

  • The National Organization for Rare Disorders (NORD) is dedicated to helping people with rare diseases. NORD provides information and resources for families, as well as ways to connect with others and get involved in the rare diseases community.

  • The Urea Cycle Disorders Consortium, part of the Rare Diseases Clinical Research Network founded by the National Institutes of Health, enables a large-scale collaborative effort to develop new research-based strategies and methods for diagnosis, treatment, and prevention of illness and disability resulting from urea cycle disorders. The consortium provides ways for patients to join with physicians and researchers through participation in research studies.

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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