"June 10, 2015 -- A new class of medications can lower "bad" LDL cholesterol to unheard-of levels, and it may be on the horizon.
The new class is called PCSK9 inhibitors. An FDA advisory panel on Tuesday recommended that the agency approve t"...
Drug therapy should be one component of multiple-risk-factor intervention in individuals who require modifications of their lipid profile. Lipid-altering agents should be used in addition to a diet restricted in saturated fat and cholesterol only when the response to diet and other nonpharmacological measures has been inadequate.
Primary Hyperlipidemia and Mixed Dyslipidemia
LIVALO® is indicated 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 HDL-C in adult patients with primary hyperlipidemia or mixed dyslipidemia.
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.
The effect of LIVALO on cardiovascular morbidity and mortality has not been determined.
LIVALO has not been studied in Fredrickson Type I, III, and V dyslipidemias.
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 [see DRUG INTERACTIONS].
Use with Rifampin
In patients taking rifampin, a dose of LIVALO 2 mg once daily should not be exceeded [see DRUG INTERACTIONS].
Dosage Forms And Strengths
1 mg: Round white film-coated tablet. Debossed “KC” on one side and “1” on the other side of the tablet.
2 mg: Round white film-coated tablet. Debossed “KC” on one side and “2” on the other side of the tablet.
4 mg: Round white film-coated tablet. Debossed “KC” on one side and “4” on the other side of the tablet.
Storage And Handling
LIVALO tablets for oral administration are provided as white, film-coated tablets that contain 1 mg, 2 mg, or 4 mg of pitavastatin. Each tablet has “KC” debossed on one side and a code number specific to the tablet strength on the other.
LIVALO (pitavastatin) Tablets are supplied as;
NDC 0002-4770-90 : 1 mg. Round white film-coated tablet debossed “KC” on one face and “1” on the reverse; HDPE bottles of 90 tablets
NDC 0002-4771-90 : 2 mg. Round white film-coated tablet debossed “KC” on one face and “2” on the reverse; HDPE bottles of 90 tablets
NDC 0002-4772-90 : 4 mg. Round white film-coated tablet debossed “KC” on one face and “4” on the reverse; HDPE bottles of 90 tablets
Store at room temperature between 15°C and 30°C (59° to 86° F) [see USP]. Protect from light.
Manufactured under license from: Kowa Company Limited., Tokyo 103-8433 Japan. Product of Japan. Manufactured into tablets by: Patheon, Inc. Cincinnati, OH 45237 USA or by Kowa Company, LTD Nagoya, 462-0024 Japan. Marketed by: Kowa Pharmaceuticals America, Inc. Montgomery, AL 36117 USA. and Lilly USA, LLC. Indianapolis, IN 46285 USA. To request additional information or if you have questions concerning LIVALO please phone Kowa Pharmaceuticals America, Inc. at 877-8-LIVALO (877-854-8256) or fax your inquiry to 800-689-0244. Revised: February 2012This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 3/13/2012
Additional Livalo Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Tips to keep it under control.