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LIVALO (pitavastatin) Tablet, Film Coated for Oral use
Initial U.S. Approval: 2009

LIVALO (pitavastatin) is an inhibitor of HMG-CoA reductase. It is a synthetic lipid-lowering agent for oral administration.

The chemical name for pitavastatin is (+)monocalcium bis{(3R, 5S, 6E)-7-[2-cyclopropyl-4-(4-fluorophenyl)-3-quinolyl]-3,5-dihydroxy-6-heptenoate}.

Pitavastatin is odorless and occurs as white to pale-yellow powder. It is freely soluble in pyridine, chloroform, dilute hydrochloric acid, and tetrahydrofuran, soluble in ethylene glycol, sparingly soluble in octanol, slightly soluble in methanol, very slightly soluble in water or ethanol, and practically insoluble in acetonitrile or diethyl ether. Pitavastatin is hygroscopic and slightly unstable in light.

Each film-coated tablet of LIVALO contains 1.045 mg, 2.09 mg, or 4.18 mg of pitavastatin calcium, which is equivalent to 1 mg, 2 mg, or 4 mg, respectively of free base and the following inactive ingredients: lactose monohydrate, low substituted hydroxypropylcellulose, hypromellose, magnesium aluminometasilicate, magnesium stearate, and film coating containing the following inactive ingredients: hypromellose, titanium dioxide, triethyl citrate, and colloidal anhydrous silica.

Clinical pharmacology

Mechanism of Action
Pitavastatin competitively inhibits HMG-CoA reductase, which is a rate-determining enzyme involved with biosynthesis of cholesterol, in a manner of competition with the substrate so that it inhibits cholesterol synthesis in the liver. As a result, the expression of LDL-receptors followed by the uptake of LDL from blood to liver is accelerated and then the plasma TC decreases. Further, the sustained inhibition of cholesterol synthesis in the liver decreases levels of very low density lipoproteins.

In a randomized, double-blind, placebo-controlled, 4-way parallel, active-comparator study with moxifloxacin in 174 healthy participants, LIVALO was not associated with clinically meaningful prolongation of the QTc interval or heart rate at daily doses up to 16 mg (4 times the recommended maximum daily dose).

Indications and usage 


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)



--Known hypersensitivity to product components
--Active liver disease, which may include unexplained persistent elevations in hepatic transaminase levels
--Women who are pregnant or may become pregnant
--Nursing mothers
--Co-administration with cyclosporine



--Skeletal muscle effects (e.g., myopathy and rhabdomyolysis): Risks increase in a dose-dependent manner, with advanced age (>65), renal impairment, inadequately treated hypothyroidism, and combination use with fibrates. Advise patients to promptly report unexplained muscle pain, tenderness, or weakness, and discontinue LIVALO if signs or symptoms appear.

--Liver enzymes abnormalities and monitoring: Persistent elevations in hepatic transaminases can occur. Monitor liver enzymes before and during treatment.


--Erythromycin: Combination increases pitavastatin exposure. Limit LIVALO to 1 mg once daily -
--Rifampin: Combination increases pitavastatin exposure. Limit LIVALO to 2 mg once daily -
--Fibrates: Use with fibrate products may increase the risk of adverse skeletal muscle effects-


--Pediatric use: Safety and effectiveness have not been established.
--Renal impairment: Limitation of a starting dose of LIVALO 1 mg once daily and a maximum dose of LIVALO 2 mg once daily for patients with moderate and severe renal impairment as well as patients receiving hemodialysis

Adverse reactions

The most frequent adverse reactions (rate >/=2.0% in at least one marketed dose) were myalgia, back pain, diarrhea, constipation and pain in extremity.

To report SUSPECTED ADVERSE REACTIONS, contact Kowa Pharmaceuticals America, Inc. at 1-877-334-3464 or FDA at 1-800-FDA-1088 or

Dosage and administration 

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 and severe renal impairment (glomerular filtration rate 30 – 59 mL/min/1.73 m2 and 15 – 29 mL/min/1.73 m2 not receiving hemodialysis, respectively) as well as 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.

Use with Erythromycin:
In patients taking erythromycin, a dose of LIVALO 1 mg once daily should not be exceeded.

Use with Rifampin:
In patients taking rifampin, a dose of LIVALO 2 mg once daily should not be exceeded

How supplied


Tablets: 1 mg, 2 mg, and 4 mg


Package Insert data: 
LIVALO is a trademark of the Kowa group of companies.
© Kowa Pharmaceuticals America, Inc. (2009)

Manufactured under license from: Kowa Company, Limited Tokyo 103-8433 Japan
Product of Japan
Manufactured into tablets by: Patheon, Inc. Cincinnati, OH 45237 USA
Marketed by: Kowa Pharmaceuticals America, Inc. Montgomery, AL 36117 USA
and Lilly USA, LLC. Indianapolis, IN 46285 USA

Revised: 08/2011


National Institutes of Health, U.S. National Library of Medicine, DailyMed Database.
Provides access to the latest drug monographs submitted to the Food and Drug Administration (FDA). Please review the latest applicable package insert for additional information and possible updates.  A local search option of this data can be found here.

LIVALO® (pitavastatin) Tablet