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

primary hyperlipidemia or mixed dyslipidemia.

Limitations of Use: Doses of LIVALO greater than 4 mg once daily were associated with an increased risk for severe myopathy in premarketing clinical studies. Do not exceed 4 mg once daily dosing of LIVALO. The effect of LIVALO on cardiovascular morbidity and mortality has not been determined. LIVALO has not been studied in patients with severe renal impairment (glomerular filtration rate < 30 mL/min/1.73 m2) not on hemodialysis. LIVALO should not be used in this patient population. LIVALO has not been studied with the protease inhibitor combination lopinavir/ritonavir. LIVALO should not be used with this combination of protease inhibitors. LIVALO has not been studied in Fredrickson Type I, III, and V dyslipidemias.

General Dosing Information: The dose range for LIVALO is 1 to 4 mg orally once daily at any time of the day with or without food. The recommended starting dose is 2 mg and the maximum dose is 4 mg. The starting dose and maintenance doses of LIVALO should be individualized according to patient characteristics, such as goal of therapy and response. After initiation or upon titration of LIVALO, lipid levels should be analyzed after 4 weeks and the dosage adjusted accordingly.

Dosage in Patients with Renal Impairment: Patients with moderate renal impairment (glomerular filtration rate 30 to < 60 mL/min/1.73 m2) and end -stage renal disease receiving hemodialysis should receive a starting dose of LIVALO 1 mg once daily and a maximum dose of LIVALO 2 mg once daily. LIVALO should not be used in patients with severe renal impairment (glomerular filtration rate < 30 mL/min/1.73 m2) In patients taking erythromycin, a dose of LIVALO 1 mg once daily should not be exceeded. In patients taking rifampin, a dose of LIVALO 2 mg once daily should not be exceeded.

CONTRAINDICATIONS

The use of LIVALO is contrai
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SOURCE Eli Lilly and Company
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