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 What is Carbaglu? how to use?

Carbaglu (carglumic acid) is an artificial form of liver enzyme used to treat hyperammonemia, which is a urea cycle disorder caused by a lack of certain liver enzymes. Carbaglu is usually used with other drugs to treat this lifelong disease.

What are the side effects of Carbaglu?

Common side effects of Carbaglu include:

• Vomiting
• diarrhea,
• stomachache,
• headache,
• Stuffy nose,
• sore throat,
• Ear infections
• Changes in taste,
• fever,
• infection,
• Flu symptoms
• lose weight,
• Lethargy, and
• rash

description

CARBAGLU tablets for oral suspension contain 200 mg of pyrophosphate. Active carbamic acid is the activator of carbamoyl phosphate synthase 1 (CPS 1), soluble in boiling water, slightly soluble in cold water, and almost insoluble in organic solvents.

The chemical pyroic acid is N-carbamoyl-L-glutamic acid or (190) (2S)-2-(carbamoylamino)glutaric acid with a molecular weight of 190.16.

The structural formula is:

CARBAGLU® (pyrophosphoric acid)-structure diagram

Molecular formula: C6H10N2O5

The inactive ingredients of CARBAGLU are croscarmellose sodium, hypromellose, microcrystalline cellulose, anhydrous colloidal silica, sodium lauryl sulfate, sodium stearyl fumarate.

Indications

Acute and chronic hyperammonemia caused by N-acetylglutamate synthase (NAGS) deficiency

The indications of CARBAGLU in pediatric and adult patients are:

Adjuvant treatment of the standard of care for acute hyperammonemia caused by NAGS deficiency.

Maintenance therapy is used to treat chronic hyperammonemia caused by NAGS deficiency.

Acute hyperammonemia caused by propionic acidemia (PA) or methylmalonic acidemia (MMA)

In pediatric and adult patients, CARBAGLU is designated as the standard care adjuvant therapy for the treatment of acute hyperammonemia caused by PA or MMA.

Dosage and administration

Recommended dose for acute or chronic hyperammonemia caused by NAGS deficiency

Start of treatment

Once the diagnosis of NAGS deficiency is suspected, CARBAGLU treatment should be started as soon as possible, which may be started at birth and managed by an experienced doctor and medical team with metabolic disorders.

Dose for acute hyperammonemia due to NAGS deficiency

For pediatric and adult patients with acute hyperammonemia caused by NAGS deficiency, the recommended daily dose of CARBAGLU is 100 mg/kg to 250 mg/kg.

Divide the daily dose into 2 to 4 doses and round to the nearest 100 mg (that is, half of CARBAGLU tablets).

During acute hyperammonemia episodes, CARBAGLU is used with other ammonia-lowering therapies, such as alternative route drugs, hemodialysis, and protein restriction.

Dose for chronic hyperammonemia due to NAGS deficiency

For pediatric and adult patients with chronic hyperammonemia caused by NAGS deficiency, the recommended daily dose of CARBAGLU is 10 mg/kg to 100 mg/kg.

Divide the daily dose into 2 to 4 doses and round to the nearest 100 mg (that is, half of CARBAGLU tablets).

During maintenance treatment, it may be necessary to simultaneously use other ammonia-reducing therapies and limiting protein based on plasma ammonia levels.

Treatment monitoring

Closely monitor plasma ammonia levels. Taking into account the patient's clinical conditions (such as nutritional requirements, protein intake, growth parameters, etc.), the CARBAGLU dose is titrated to maintain the plasma ammonia level within the normal range of the patient's age.

Recommended dose for acute hyperammonemia caused by PA or MMA

Start of treatment

Initiate CARBAGLU to treat acute hyperammonemia in patients with suspected or confirmed PA or MMA.

Dose of acute hyperammonemia caused by PA or MMA

In pediatric and adult patients with acute hyperammonemia caused by PA and MMA, the recommended daily dose of CARBAGLU is:

150 mg/kg/day per day for patients less than or equal to 15 kg

3.3 g/m2/day for patients over 15 kg

Divide the daily dose into 2 equal doses and round up to the next multiple of 50 mg (ie, one quarter of CARBAGLU tablets). Take it every 12 hours.

Continue CARBAGLU treatment until the patient's ammonia level is below 50 micromol/L for a maximum of 7 days.

During an acute hyperammonemia episode, CARBAGLU is used together with other ammonia-lowering therapies, such as intravenous glucose, insulin, L-carnitine, protein restriction, and dialysis.

Preparation and management

Overview

Disperse CARBAGLU tablets in water. Do not swallow whole food or crush it.

CARBAGLU tablets cannot be completely dissolved in water, and undissolved particles of the tablets may remain in the mixing container.

Take CARBAGLU immediately before eating or eating.

CARBAGLU suspension is slightly acidic.

For all preparations, its use in foods or liquids other than water has not been studied, so its use is not recommended.

Oral management

When taken orally, use CARBAGLU as follows:

For each CARBAGLU tablet or each ½ or ¼ CARBAGLU tablet required for the prescribed dose, at least 2.5 mL of water should be added to a small cup.

Add CARBAGLU tablets to the water in the cup.

Stir the mixture of tablets and water carefully.

Swallow the mixture immediately. The tablets may remain in the cup.

Rinse the cup with water and swallow the mixture immediately. Repeat as needed until there are no tablets in the cup.

Oral administration using an oral syringe

For administration by oral syringe, use CARBAGLU as follows:

For each CARBAGLU tablet or each ½ or ¼ CARBAGLU tablet required for the prescribed dose, at least 2.5 mL of water should be added to a small cup.

Add CARBAGLU tablets to the water in the cup.

Stir the mixture of tablets and water carefully.

Drain the mixture with an oral syringe and administer immediately. The tablets can be kept in the oral syringe.

Refill the oral syringe with the minimum amount of water (1 mL to 2 mL) and administer immediately.

Flush the oral syringe again as needed until there are no tablets in the syringe.

Use nasogastric tube (NG tube) or gastrostomy tube (G-Tube) for feeding tube management

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