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Lilly, Kowa and Kowa Pharmaceuticals America Announce Co-Promotion and Licensing Agreement
Date:12/23/2009

ors, LIVALO should be used with caution in patients who consume substantial quantities of alcohol. Active liver disease, which may include unexplained persistent transaminase elevations, is a contraindication to the use of LIVALO.

ADVERSE REACTIONS:

The following serious adverse reactions are discussed in greater detail in the full prescribing information:

  • rhabdomyolysis (a serious muscle disorder) with myoglobinuria (a laboratory test result), and acute renal (kidney) failure and myopathy including myositis (muscular pains), and
  • liver enzyme abnormalities (a laboratory test result).

In controlled clinical trials of up to 12 weeks duration adverse reactions were infrequent, the common adverse reactions, including their MedDRA and common names, reported by 2% or more of treated patients are: back pain, constipation or diarrhea, myalgia (muscular pain), and pain in the extremities (pain in arms or legs). Other adverse reactions reported from clinical studies were arthralgia (joint pain), headache, influenza (the flu), and nasopharyngitis (common cold). The following laboratory abnormalities have also been reported: elevated creatine phosphokinase, transaminases, alkaline phosphatase, bilirubin, and glucose.

In controlled clinical studies and their open-label extensions, 3.9% (1 mg), 3.3% (2 mg), and 3.7% (4 mg) of pitavastatin-treated patients were discontinued due to adverse reactions. The most common adverse reactions that led to treatment discontinuation were: elevated creatine phosphokinase (0.6% on 4 mg) and myalgia (0.5% on 4 mg).

DRUG INTERACTIONS:

As with other statin medications there is a chance of certain drug interactions while taking LIVALO. Caution is advised. The physician should consult the full prescribing information regarding suggested dose reductions or avoidance of LIVALO therapy when coadminstration of any of the following is being
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SOURCE Eli Lilly and Company
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