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GlaxoSmithKline Obtains Exclusive U.S. OTC Marketing Rights to MEVACOR(R) (lovastatin) from Merck & Co., Inc.
Date:11/26/2007

ibitors

Nefazodone

Gemfibrozil Do not exceed 20 mg lovastatin daily

Other fibrates

Lipid-lowering doses

(Greater Than or Equal To 1 g/day)

of niacin

Cyclosporine

Danazol

Amiodarone Do not exceed 40 mg lovastatin daily

Verapamil

Grapefruit juice Avoid large quantities of grapefruit

juice (>1 quart daily)

Liver Dysfunction

Persistent increases (to more than 3 times the upper limit of normal) in serum transaminases occurred in 1.9% of adult patients who received lovastatin for at least one year in early clinical trials (see ADVERSE REACTIONS). When the drug was interrupted or discontinued in these patients, the transaminase levels usually fell slowly to pretreatment levels. The increases usually appeared 3 to 12 months after the start of therapy with lovastatin, and were not associated with jaundice or other clinical signs or symptoms. There was no evidence of hypersensitivity. In the EXCEL study (see CLINICAL PHARMACOLOGY, Clinical Studies), the incidence of persistent increases in serum transaminases over 48 weeks was 0.1% for placebo, 0.1% at 20 mg/day, 0.9% at 40 mg/day, and 1.5% at 80 mg/day in patients on lovastatin. However, in post- marketing experience with MEVACOR, symptomatic liver disease has been reported rarely at all dosages (see ADVERSE REACTIONS).

In AFCAPS/TexCAPS, the number of participants with consecutive elevations of either alanine aminotransferase (ALT) or aspartate aminotransferase (AST) (> 3 times the upper limit of normal), over a median of 5.1 years of follow- up, was not significantly different between the MEVACOR and placebo groups (18 [0.6%] vs. 11 [0.3%]). The starting dose of MEVACOR was 20 mg/day; 50% of the MEVACOR treated participants were titrated to 40 mg/day at Week 18. Of the 18 participants on MEVACOR with consecutive elevati
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SOURCE GlaxoSmithKline
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