Carglumic acid
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1];
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Overview
Carglumic acid is a hyperammonemia Agent that is FDA approved for the treatment of acute hyperammonemia in patients with NAGS deficiency, maintenance therapy for chronic hyperammonemia in patients with NAGS deficiency. Common adverse reactions include abdominal pain, diarrhea, vomiting, anemia, infectious disease , headache, infection of ear , nasopharyngitis, tonsillitis, fever.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
1.1 Acute hyperammonemia in patients with NAGS deficiency Carbaglu® is indicated as an adjunctive therapy in pediatric and adult patients for the treatment of acute hyperammonemia due to the deficiency of the hepatic enzyme N-acetylglutamate synthase (NAGS). During acute hyperammonemic episodes concomitant administration of Carbaglu with other ammonia lowering therapies such as alternate pathway medications, hemodialysis, and dietary protein restriction are recommended.
1.2 Maintenance therapy for chronic hyperammonemia in patients with NAGS deficiency Carbaglu® is indicated for maintenance therapy in pediatric and adult patients for chronic hyperammonemia due to the deficiency of the hepatic enzyme N-acetylglutamate synthase (NAGS). During maintenance therapy, the concomitant use of other ammonia lowering therapies and protein restriction may be reduced or discontinued based on plasma ammonia levels.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Carglumic acid in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Carglumic acid in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
Condition1
- Dosing Information
- Dosage
Condition2
There is limited information regarding FDA-Labeled Use of Carglumic acid in pediatric patients.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
Condition1
- Developed by:
- Class of Recommendation:
- Strength of Evidence:
- Dosing Information
- Dosage
Condition2
There is limited information regarding Off-Label Guideline-Supported Use of Carglumic acid in pediatric patients.
Non–Guideline-Supported Use
Condition1
- Dosing Information
- Dosage
Condition2
There is limited information regarding Off-Label Non–Guideline-Supported Use of Carglumic acid in pediatric patients.
Contraindications
- Condition1
Warnings
- Description
Precautions
- Description
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Clinical Trial Experience of Carglumic acid in the drug label.
Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous
Postmarketing Experience
There is limited information regarding Postmarketing Experience of Carglumic acid in the drug label.
Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous
Drug Interactions
- Drug
- Description
Use in Specific Populations
Pregnancy
- Pregnancy Category
- Australian Drug Evaluation Committee (ADEC) Pregnancy Category
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Carglumic acid in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Carglumic acid during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Carglumic acid with respect to nursing mothers.
Pediatric Use
There is no FDA guidance on the use of Carglumic acid with respect to pediatric patients.
Geriatic Use
There is no FDA guidance on the use of Carglumic acid with respect to geriatric patients.
Gender
There is no FDA guidance on the use of Carglumic acid with respect to specific gender populations.
Race
There is no FDA guidance on the use of Carglumic acid with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Carglumic acid in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Carglumic acid in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Carglumic acid in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Carglumic acid in patients who are immunocompromised.
Administration and Monitoring
Administration
- Oral
- Intravenous
Monitoring
There is limited information regarding Monitoring of Carglumic acid in the drug label.
- Description
IV Compatibility
There is limited information regarding IV Compatibility of Carglumic acid in the drug label.
Overdosage
Acute Overdose
Signs and Symptoms
- Description
Management
- Description
Chronic Overdose
There is limited information regarding Chronic Overdose of Carglumic acid in the drug label.
Pharmacology
There is limited information regarding Carglumic acid Pharmacology in the drug label.
Mechanism of Action
Structure
Pharmacodynamics
There is limited information regarding Pharmacodynamics of Carglumic acid in the drug label.
Pharmacokinetics
There is limited information regarding Pharmacokinetics of Carglumic acid in the drug label.
Nonclinical Toxicology
There is limited information regarding Nonclinical Toxicology of Carglumic acid in the drug label.
Clinical Studies
There is limited information regarding Clinical Studies of Carglumic acid in the drug label.
How Supplied
Storage
There is limited information regarding Carglumic acid Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Patient Counseling Information of Carglumic acid in the drug label.
Precautions with Alcohol
- Alcohol-Carglumic acid interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
- ®[1]
Look-Alike Drug Names
- A® — B®[2]
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.
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