LIVALO Dosage & Rx Info | Uses, Side Effects

Livalo Generic Name & Formulations

Legal Class

General Description

Pitavastatin 1mg, 2mg, 4mg; tabs.

Pharmacological Class

HMG-CoA reductase inhibitor.

How Supplied

Tabs—90

Manufacturer

Kowa Pharmaceuticals America, Inc.

Generic Availability

YES

Mechanism of Action

Pitavastatin inhibits 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase, blocking the rate-limiting step in the biosynthetic pathway for cholesterol. As a result, the expression of LDL-receptors followed by the uptake of LDL from blood to liver is accelerated and then plasma total cholesterol decreases.

Livalo Indications

Indications

Adjunct to diet to reduce LDL-C: in adults with primary hyperlipidemia; or in adults and children with heterozygous familial hypercholesterolemia (HeFH).

Livalo Dosage and Administration

Adults and Children

<8yrs: not established. ≥8yrs: Initially 2mg once daily; may increase after 4 weeks to max 4mg once daily. If patient requires a high-intensity statin or is unable to achieve the LDL-C goal with 4mg daily, prescribe alternative LDL-C-lowering treatment. Moderate to severe renal impairment (eGFR <60mL/min/1.73m², or ESRD with hemodialysis): 1mg once daily; max 2mg once daily. Concomitant erythromycin: max 1mg once daily. Concomitant rifampin: max 2mg once daily.

Livalo Contraindications

Contraindications

Concomitant cyclosporine. Acute liver failure or decompensated cirrhosis.

Livalo Boxed Warnings

Not Applicable

Livalo Warnings/Precautions

Warnings/Precautions

Discontinue if myopathy or markedly elevated CK levels occur; suspend if a predisposition to development of renal failure secondary to rhabdomyolysis develops. Risk factors for myopathy (eg, renal impairment, uncontrolled hypothyroidism, age ≥65yrs, concomitant certain drugs including other lipid-lowering therapies). Immune-mediated necrotizing myopathy; discontinue if suspected. Monitor liver function prior to initiation and repeat as clinically indicated. Discontinue if serious liver injury with clinical symptoms and/or hyperbilirubinemia or jaundice occurs. Substantial alcohol ingestion. Advise females of reproductive potential to use effective contraception during treatment. Pregnancy: discontinue when recognized. Nursing mothers: not recommended.

Livalo Pharmacokinetics

Absorption

Peak plasma concentrations occurred at about 1 hour. Absolute bioavailability: 51%.

Distribution

Volume of distribution: ~148 L. >99% plasma protein bound.

Metabolism

Hepatic glucuronidation, CYP450 (minimal) including CYP2C9 and CYP2C8.

Elimination

Fecal (79%), renal (15%). Half-life: ~12 hours.

Livalo Interactions

Interactions

Potentiated by cyclosporine (see Contraindications), erythromycin, and rifampin (see Adults and Children). Avoid gemfibrozil. Increased risk of myopathy with concomitant fibrates, colchicine, niacin (≥1g/day); consider risk vs benefit.

Livalo Adverse Reactions

Adverse Reactions

Myalgia, back/extremity pain, diarrhea, constipation, elevated creatine phosphokinase, transaminases, alkaline phosphatase, bilirubin; myopathy, rhabdomyolysis with renal dysfunction, hypersensitivity reactions, increases HbA1c and fasting serum glucose levels; rare: fatal/non-fatal hepatic failure.

Livalo Clinical Trials

See Literature

Livalo Note