Livalo
Generic Name: pitavastatin
Date of Approval: August 3, 2009
Company: Kowa Pharmaceuticals America, Inc.
Treatment for: High Cholesterol
FDA Approves Livalo
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 Feedback for Livalo
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The U.S. Food and Drug Administration (FDA) has approved Livalo (pitavastatin), a potent HMG-CoA reductase inhibitor (statin), for the primary treatment of hypercholesterolemia and combined dyslipidemia.
Livalo is a fully synthetic and highly potent statin engineered in Japan. Livalo differs from other, currently available statins in the U.S. in that it has a unique cyclopropyl group on the base structure. This cyclopropyl group contributes to a more effective inhibition of the HMG-CoA reductase enzyme to inhibit cholesterol production, and potentially affords greater low-density lipoprotein cholesterol (LDL-C) clearance and reduction of plasma cholesterol. Importantly, pitavastatin is only minimally metabolized by the liver through the cytochrome P450 pathway, through which many other medications are metabolized.
In pivotal Phase III trials, Livalo effectively reduced LDL-C and improved other parameters of lipid metabolism in special patient populations, including the elderly, patients with diabetes and patients at higher cardiovascular risk. The overall safety and tolerability of Livalo are consistent with other commonly prescribed statins.
Highlights Of Livalo Prescribing Information
These highlights do not include all the information needed to use Livalo safely and effectively. See full prescribing information for Livalo.
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)
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.
- 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 yet on hemodialysis. Livalo should not be used in 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
Dosage and Administration
- Livalo can be taken with or without food, at any time of day (2.1) Dose Range: 1 mg to 4 mg once daily
- Primary hyperlipidemia and mixed dyslipidemia: Starting dose 2 mg. When lowering of LDL-C is insufficient, the dosage may be increased to a maximum of 4 mg per day.
- Moderate renal impairment (glomerular filtration rate 30 < 60 mL/min/1.73 m2) and end-stage renal disease on hemodialysis: Starting dose of 1 mg once daily and maximum dose of 2 mg once daily
Dosage Forms and Strengths
- Tablets: 1 mg, 2 mg, and 4 mg
Contraindications
- 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
Warnings and Precautions
- 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
Livalo Side Effects
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 1-800FDA-1088 or www.fda.gov/medwatch.
Drug Interactions
- Lopinavir/Ritonavir: This combination should not be used with Livalo
- 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
Use In Specific Populations
- 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 renal impairment and patients receiving hemodialysis. Patients with severe renal impairment not receiving hemodialysis have not been studied. Livalo should not be used in this patient population
Patient Counseling Information for Livalo
The patient should be informed of the following:
- Dosing Time
Livalo can be taken at any time of the day with or without food. - Muscle Pain
Patients should be advised to promptly notify their physician of any unexplained muscle pain, tenderness, or weakness. They should discuss all medication, both prescription and over the counter, with their physician. - Pregnancy
Women of childbearing age should use an effective method of birth control to prevent pregnancy while using Livalo. Discuss future pregnancy plans with your healthcare professional, and discuss when to stop Livalo if you are trying to conceive. If you are pregnant, stop taking Livalo and call your healthcare professional. - Breastfeeding
Women who are breastfeeding should not use Livalo. If you have a lipid disorder and are breastfeeding, stop taking Livalo and consult with your healthcare professional. - Liver Enzymes
It is recommended that liver enzymes be checked before and at 12 weeks following both the initiation of therapy and any elevation of dose, and periodically (e.g., semiannually) thereafter.
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