Livalo Adverse Reactions

In the clinical studies conducted by the time of approval, adverse reactions were found in 197 patients (22.2%) out of 886 patients. Adverse reactions in subjective and objective symptoms were seen in 50 patients (5.6%). The main symptoms were abdominal pain, rash, malaise, numbness and pruritus. Adverse reactions pertaining to clinical laboratory values were found in 167 patients (18.8%), and the main changes were elevations of γ-GTP, CK (CPK), serum ALT (GPT) and serum AST (GOT) (at the approval).
In a drug use investigation on the drug use results, adverse reactions were found in 1,210 patients (6.0%) out of 20,002 patients (at the time of 5^th periodic safety report).
Clinically significant adverse reactions: Rhabdomyolysis (frequency unknown): Rhabdomyolysis characterized by myalgia, weakness, CK (CPK) increased, blood and urinary myoglobin increased may occur. Since serious renal disorders such as acute renal failure may occur in association with rhabdomyolysis, administration of this product should be discontinued if such symptoms are observed.
Myopathy (frequency unknown): Myopathy may occur. Therefore, when extensive myalgia, muscular tenderness or marked CK (CPK) increased is observed, administration of this product should be discontinued.
Hepatic dysfunction, Jaundice (less than 0.1%): Hepatic dysfunction and/or jaundice with significant AST (GOT) and ALT (GPT) increased may occur. Regular observations such as liver function tests are required. If any abnormality is observed, discontinue the administration of this product and treat with the appropriate therapy.
Platelet count decreased (frequency unknown): Platelet count decreased may develop occasionally. Therefore, close observations such as blood tests are required. If any abnormality is observed, discontinue the administration of this product and treat with the appropriate therapy.
Interstitial pneumonia (less than 0.1%): Interstitial pneumonia may occur. Therefore, even in long-term administration, if any abnormalities such as fever, coughing, dyspnoea or relevant chest X-ray test findings are observed, discontinue the administration of this product and treat with appropriate therapies such as the administration of adrenal corticosteroid.
Other adverse reactions: See Table 3.

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