"Examining drug interactions has been an ongoing part of product development, and we are pleased that results show no clinically significant drug interaction between pitavastatin and the protease inhibitor combination darunavir/ritonavir," said Dr.
The current study was designed to assess the changes in pharmacokinetic parameters when pitavastatin 4 mg and darunavir/ritonavir 800mg/100mg were administered alone or in combination. Pitavastatin and darunavir/ritonavir were co-administered in 28 healthy, adult volunteers over a 16-day period. When co-administered with darunavir/ritonavir, pitavastatin peak exposure, as measured by Cmax, decreased by 4%, while total exposure of pitavastatin, as measured by AUC0-τ, decreased by approximately 26%. When co-administered with pitavastatin, the Cmax and AUC0-τ of darunavir increased by 6% and 3% respectively, and the Cmax and AUC0-τ of ritonavir increased by 2% and 8%, respectively. These effects were not considered to be clinically significant.1,2
A secondary objective of the study was to investigate the safety of pitavastatin and darunavir/ritonavir when each treatment was given alone or in combination. The majority of treatment emergent adverse events (TEAEs) were mild in severity, and no serious or severe adverse events were reported. Nineteen of 28 patients reported at least one TEAE, of which 10 were from the darunavir/ritonavir only group; 7 from the pitavastatin and darunavir/ritonavir group; 2 from the pitavastatin only group.1
For TEAEs occurring in > /= 2 subjects in any treatment group, the most frequently reported drug-related TEAEs were diarrhea (7.1% darunavir/ritonavir only group; 7.4% pitavastatin and darunavir/ritonavir; 3.6% pitavastatin only), headache, (10.7% darunavir/ritonavir only group; 0% pitavastatin and darunavir/ritonavir; 0% from the pitavastatin only group) and myalgia (7.1% darunavir/ritonavir only; 3.7% pitavastatin and darunavir/ritonavir group; 3.6% pitavastatin only). One subject was discontinued from the study due to maculopapular rash during treatment with darunavir/ritonavir only.1
LIVALO is a HMG-CoA reductase inhibitor indicated for patients with primary hyperlipidemia and mixed dyslipidemia as an adjunctive therapy to diet to reduce elevated total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), triglycerides (TG), and to increase high-density lipoprotein cholesterol (HDL-C).
Limitations of Use:
In addition to being launched in the U.S. in
About Primary Hyperlipidemia and Mixed Dyslipidemia
Primary hyperlipidemia is defined as an elevation of cholesterol, particularly "bad" cholesterol (LDL-C), triglycerides (TG), or both. Mixed dyslipidemia is usually characterized by an elevation of LDL-C, TG, and a decrease in the "good" cholesterol (HDL-C) in the blood.
IMPORTANT SAFETY INFORMATION FOR LIVALO® (pitavastatin) tablets
LIVALO is contraindicated in patients with a known hypersensitivity to product components, in patients with active liver disease (which may include unexplained persistent elevations in hepatic transaminase levels), in women who are pregnant or may become pregnant, in nursing mothers, or in coadministration with cyclosporine.
WARNINGS AND PRECAUTIONS
Skeletal Muscle Effects
Cases of myopathy and rhabdomyolysis with acute renal failure secondary to myoglobinuria have been reported with HMG-CoA reductase inhibitors, including LIVALO.
Liver Enzyme Abnormalities
Increases in serum transaminases have been reported with HMG-CoA reductase inhibitors, including LIVALO.
Increases in HbA1c and fasting serum glucose levels have been reported with HMG-CoA reductase inhibitors, including LIVALO.
In short-term controlled studies, the most frequent adverse reactions reported by > /=2% of patients treated with LIVALO 1 mg, 2 mg, and 4 mg, respectively, and at a rate > /= placebo were back pain (3.9%, 1.8%, 1.4% vs 2.9%), constipation (3.6%, 1.5%, 2.2% vs 1.9%), diarrhea (2.6%, 1.5%, 1.9% vs 1.9%), myalgia (1.9%, 2.8%, 3.1% vs 1.4%), and pain in extremity (2.3%, 0.6%, 0.9% vs 1.9%). This is not a complete listing of all reported adverse events.
For complete product prescribing information consult the current LIVALO (pitavastatin) tablet package insert which is available at http://www.kowapharma.com/documents/LIVALO_PI_CURRENT.pdf.
LIV-RA-0044 PS77436 2/2012
exchange rate used
Lilly, a leading innovation-driven corporation, is developing a growing portfolio of pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in
LIVALO is a registered trademark of the Kowa group of companies.
 Data on File: Yu C, Campbell S, et al. Steady-state Pharmacokinetic Interactions of Darunavir/Ritonavir with Pitavastatin in
 LIVALO [prescribing information]
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