Important Precautions
- This drug is indicated for use in patients presenting with hypoalbuminemia despite adequate dietary intake or in whom total dietary calories and protein (amino acids) intake is restricted due to complications including diabetes mellitus or hepatic encephalopathy, among patients with decompensated hepatic cirrhosis presenting with hypoalbuminemia as indicated by a serum albumin level of 3.5 g/dL or less with current or a history of ascites/oedema or hepatic encephalopathy. A dietetic instruction should be provided to the patient in case of dietary deficiency despite the patient being amply capable of food ingestion in the absence of diabetes mellitus and hepatic encephalopathy. If the patient is deficient in dietary intake due to development of hepatic encephalopathy, a drug containing calories and protein (amino acids) should be administered.
- This drug consists of branched-chain amino acids alone and does not contain all amino acid required for protein synthesis. Therefore, the patient taking this drug must ingest the amount of protein (amino acids) and calories required (daily protein intake, 40 g or more; and daily calorie intake, 1000 kcal or more) in the diet according to the patient’s condition. If the patient is on restricted protein intake, in particular, caution must be exercised in that the patient may not respond this drug therapy and, moreover, long-term use of this product may lead to aggravation of nutriture unless the minimum protein and calorie requirements are secured.
- If abnormal blood urea nitrogen (BUN) or blood ammonia is noted following administration of this drug, caution must be taken because it may be attributable to overdose. Caution should also be observed regarding long-term overdosage since it may give rise to aggravation of nutriture.
- If no improvement in hypoalbuminemia is attained in 2 months or longer with the use of this drug, appropriate measures should be taken such as replacement with other therapy.
Precautions on Special Populations
This product should not be administered to the following patients with markedly advanced hepatic cirrhosis since such patients may not respond to this drug therapy:
(1) Patients with stage III or more in the severity of coma due to hepatic encephalopathy
(2) Patients with a total bilirubin level of 3 mg/dL or more
(3) Patients with a markedly depressed hepatic function for protein synthesis
USE IN THE ELDERLY
This drug should be administered to elderly patients with caution since such patients often have decreased physiological functions, and metabolic disorders such as blood ammonia elevation can be more sensitive to develop during this drug therapy.
PEDIATRIC USE
The safety of this drug in children has not been established (no clinical experience).
