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Carbaglu is a brand name for Carglumic Acid. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 1. INDICATIONS AND USAGE CARBAGLU 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. ( 1.1 ) Maintenance therapy for the treatment of…
Verbatim from this product's FDA label. Tap a section to expand.
2. 2 ) The recommended dosage in adult and pediatric patients is 100 mg/kg to 250 mg/kg orally daily. Divide the daily dosage into 2 to 4 doses. 2 ) The recommended dosage in adult and pediatric patients is 10 mg/kg to 100 mg/kg orally daily.
Divide the daily dosage into 2 to 4 doses. 2 ) Closely monitor plasma ammonia and titrate dosage to maintain the ammonia level within normal range for the patient's age, taking into consideration their clinical condition. 3 g/m 2 orally daily for patients greater than 15 kg Divide the daily dosage into 2 doses.
Continue treatment until ammonia level is less than 50 micromol/L and for a maximum duration of 7 days. 4 ) See Full Prescribing Information for Instructions on Dosage Adjustment. 5 ) Disperse CARBAGLU tablets in water. Do not swallow whole or crushed.
Take immediately before meals or feedings. For additional instructions on preparation and administration orally or through a nasogastric tube or gastrostomy tube, see Full Prescribing Information. 1 Important Administration Instructions Disperse CARBAGLU tablets in water.
5) ] . 5) ] . 2 Recommended Dosage for Acute or Chronic Hyperammonemia due to NAGS Deficiency Treatment Initiation Initiate CARBAGLU treatment as soon as the diagnosis of NAGS deficiency is suspected, which may be as soon as at birth, and supervised by a healthcare provider experienced in the treatment of metabolic disorders.
Dosage for Acute Hyperammonemia due to NAGS Deficiency The recommended dosage of CARBAGLU in adult and pediatric patients for acute hyperammonemia due to NAGS deficiency is (based on actual body weight) 100 mg/kg to 250 mg/kg orally daily.
, half of a CARBAGLU tablet). During acute hyperammonemic episodes, administer CARBAGLU with other ammonia lowering therapies, such as alternate pathway medications, hemodialysis, and protein restriction. Dosage for Chronic Hyperammonemia due to NAGS Deficiency The recommended dosage of CARBAGLU in adult and pediatric patients for chronic hyperammonemia due to NAGS deficiency is (based on actual body weight) 10 mg/kg to 100 mg/kg orally daily.
, half of a CARBAGLU tablet). During maintenance therapy, the concomitant use of other ammonia lowering therapies and protein restriction may be needed based on plasma ammonia levels. Therapeutic Monitoring Closely monitor plasma ammonia levels.
6.
ADVERSE REACTIONS NAGS deficiency :
Most common adverse reactions (≥13%) are vomiting, abdominal pain, pyrexia, tonsillitis, anemia, diarrhea, ear infection, infections, nasopharyngitis, hemoglobin decreased, and headache. 1 ) PA and MMA : Most common adverse reactions (≥5%) are neutropenia, anemia, vomiting, electrolyte imbalance, decreased appetite, hypoglycemia, lethargy/stupor, encephalopathy and pancreatitis/lipase increased.
1 ) To report SUSPECTED ADVERSE REACTIONS, contact Recordati Rare Diseases Inc. gov/medwatch. 1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Acute and Chronic Hyperammonemia due to NAGS Deficiency In a retrospective case series of 23 NAGS deficiency patients treated with CARBAGLU, 17 of the 23 patients reported an adverse reaction. The most common adverse reactions (occurring in ≥ 13% of patients) were vomiting, abdominal pain, pyrexia, tonsillitis, anemia, diarrhea, ear infection, infections, nasopharyngitis, hemoglobin decreased, and headache.
Table 1 summarizes adverse reactions occurring in 2 or more patients treated with CARBAGLU.
Table 1:
Adverse Reactions Reported in ≥ 2 Patients with NAGS deficiency Treated with CARBAGLU in the Retrospective Case Series Adverse Reaction Number of Patients (N) (%) Vomiting 6 (26) Abdominal pain 4 (17) Pyrexia 4 (17) Tonsillitis 4 (17) Anemia 3 (13) Diarrhea 3 (13) Ear infection 3 (13) Infections 3 (13) Nasopharyngitis 3 (13) Hemoglobin decreased 3 (13) Headache 3 (13) Dysgeusia 2 (9) Asthenia 2 (9) Hyperhidrosis 2 (9) Influenza 2 (9) Pneumonia 2 (9) Weight decreased 2 (9) Anorexia 2 (9) Somnolence 2 (9) Rash 2 (9) Acute Hyperammonemia due to PA and MMA In a randomized, double-blind, placebo-controlled clinical trial, 24 patients (15 with PA and 9 with MMA) experienced a total of 90 hyperammonemic episodes which were randomized 1:1 to be treated with either CARBAGLU or placebo, each in addition to standard-of-care therapy, with randomization based on each hyperammonemic episode.
4. CONTRAINDICATIONS None None. ( 4 )
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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). 4) ] . 3 Recommended Dosage for Acute Hyperammonemia due to PA or MMA Treatment Initiation Initiate CARBAGLU for the treatment of acute hyperammonemia in patients with a suspected or confirmed diagnosis of PA or MMA. , one-quarter of a CARBAGLU tablet).
Administer doses 12 hours apart. Continue CARBAGLU treatment until the patient's ammonia level is less than 50 micromol/L and for a maximum duration of 7 days. During acute hyperammonemic episodes, administer CARBAGLU with other ammonia lowering therapies, such as intravenous glucose, insulin, L-carnitine, protein restriction, and dialysis.
4) ] . 73 m 2 ). The recommended dosage of CARBAGLU in patients with moderate or severe renal impairment is shown below. , one-quarter of a CARBAGLU tablet); administer each dose 12 hours apart. , one-quarter of a CARBAGLU tablet); administer each dose 12 hours apart.
5 Preparation and Administration Overview Disperse CARBAGLU tablets in water. Do not swallow whole or crush. CARBAGLU tablets do not dissolve completely in water, and undissolved particles of the tablet may remain in the mixing container.
Take CARBAGLU immediately before meals or feedings. The CARBAGLU suspension has a slightly acidic taste. For all preparations, use in foods or liquids other than water has not been studied and is not recommended. 5 mL of water into a small cup for each CARBAGLU tablet or each ½ or ¼ CARBAGLU tablet needed for the prescribed dose.
Add the CARBAGLU tablets to the water in the cup. Carefully stir the tablet and water mixture. Swallow the mixture immediately. Pieces of the tablet may remain in the cup. Rinse the cup with additional water and swallow the mixture immediately.
Repeat as needed until no pieces of the tablet are left in the cup. 5 mL of water into a small cup for each CARBAGLU tablet or each ½ or ¼ CARBAGLU tablet needed for the prescribed dose. Add the CARBAGLU tablets to the water in the cup.
Carefully stir the tablet and water mixture. Draw up the mixture in an oral syringe and administer immediately. Pieces of the tablet may remain in the oral syringe. Refill the oral syringe with a minimum volume of water (1 mL to 2 mL) and administer immediately.
Flush the oral syringe again, as needed, until no pieces of the tablet are left in the syringe. 5 mL of water into a small cup for each CARBAGLU tablet or each ½ or ¼ CARBAGLU tablet needed for the prescribed dose. Add the CARBAGLU tablets to the water in the cup.
Carefully stir the tablet and water mixture. Draw up the mixture into a catheter-tip syringe. Administer the mixture immediately through the NG tube or G-tube. Pieces of the tablet may remain in the catheter-tip syringe or the feeding tube.
Flush immediately with 1 to 2 mL of additional water to clear the NG tube or G-tube. Flush the NG tube or G-tube again, as needed, until no pieces of the tablet are left in the syringe or the feeding tube.
7) and 12 (50 %) were males. 14 days. At least 1 adverse reaction was reported during the course of hyperammonemic episodes in 42% of hyperammonemic episodes. The most common adverse reactions (≥5%) during hyperammonemic episodes were neutropenia, anemia, vomiting, electrolyte imbalance, decreased appetite, hypoglycemia, lethargy/stupor, encephalopathy and pancreatitis/lipase increased.
Table 2 summarizes adverse reactions (≥2%) during hyperammonemic episodes in patients with PA or MMA treated with CARBAGLU or placebo. 2 Postmarketing Experience The following adverse reactions have been identified during postapproval use of CARBAGLU.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or to establish a causal relationship to drug exposure. Psychiatric disorders : mania Skin and subcutaneous tissue disorders : pruritus, rash including rash erythematous, rash maculopapular, rash pustular