Livact

Each sachet of Livact granules contains L-isoleucine (Livact) 952 mg, L-leucine (Livact) 1,904 mg, L-valine (Livact) 1,144 mg for a total branched-chain amino acid content of 4000 mg.

It also contains the following excipients: Povidone, polyvinyl alcohol (partly saponified), tartaric acid, saccharin sodium hydrate and flavoring agents as additives.

Improves hypoalbuminemia in patients with decompensated hepatic cirrhosis presenting with hypoalbuminemia despite adequate dietary intake.

Livact 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 complicated 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 with current or a history of ascites/edema 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.

Livact should not be administered to the following patients with markedly advanced hepatic cirrhosis since such patients may not respond to Livact therapy: Patients with stage III or more in the severity of coma due to hepatic encephalopathy.

Patients with a total bilirubin level of ≥3 mg/dL.

Patients with a markedly depressed hepatic function for protein synthesis.

Adults: Usual Dose: 1 sachet 3 times a day after meals or as prescribed by physician.

Livact consists of branched-chain amino acids alone and does not contain all amino acid required for protein synthesis. Therefore, the patient taking Livact must ingest the amount of protein (amino acids) and calories required (daily protein intake, ≥40 g; and daily calorie intake, ≥1,000 kCal) 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 Livact therapy and, moreover, long term use 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 Livact, 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 with the use of Livact, appropriate measures should be taken eg, replacement with other therapy.

Hypersensitivity to any of the contents of Livact.

Patients with congenital branched-chain amino acid metabolic abnormality. The use of Livact may be induced with convulsions or respiratory disturbances in patients with maple syrup urine disease.

There is no report to indicate the interaction with other drugs.

Among 2898 patients studied in clinical trials conducted prior to application for approval and in post-marketing drug use investigations, 249 adverse reactions were reported in 169 cases (5.8%). Major adverse reactions included sensation of abdominal bloating (18 cases, 0.6%), retching/nausea (17 cases, 0.6%), diarrhea (16 cases, 0.6%), elevation in blood urea nitrogen (15 cases, 0.5%), and increased blood ammonia (15 cases, 0.5%). (At the 4th Periodic Safety Update Reporting.)

Gastrointestinal¹: 0.1 to <5%: Abdominal distension, queasy, diarrhoea, constipation, abdominal discomfort, abdominal pain, vomiting, anorexia, heartburn, etc. <0.1%: Thirst, eructation.

Renal¹: 0.1 to <5%: Increased BUN and serum creatinine, etc.

Metabolism¹: 0.1 to <5%: Increased blood ammonia, etc.

Hepatic: 0.1 to <5%: Increased serum AST (GOT), serum ALT (GPT), total bilirubin, etc.

Skin: 0.1 to <5%: Rash, itching, etc.

Others: 0.1 to <5%: Malaise, oedema (facial, lower leg, etc.). Frequency Unknown: Redness, hot flush.

¹The dose should be reduced or administration temporarily discontinued in the event that any abnormality is observed.