"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"...
Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate.
ZETIA®, administered alone, is indicated as adjunctive therapy to diet for the reduction of elevated total cholesterol (total-C), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), and nonhigh- density lipoprotein cholesterol (non-HDL-C) in patients with primary (heterozygous familial and nonfamilial) hyperlipidemia.
Combination Therapy with HMG-CoA Reductase Inhibitors (Statins)
ZETIA, administered in combination with a 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitor (statin), is indicated as adjunctive therapy to diet for the reduction of elevated total-C, LDL-C, Apo B, and non-HDL-C in patients with primary (heterozygous familial and non-familial) hyperlipidemia.
Combination Therapy with Fenofibrate
ZETIA, administered in combination with fenofibrate, is indicated as adjunctive therapy to diet for the reduction of elevated total-C, LDL-C, Apo B, and non-HDL-C in adult patients with mixed hyperlipidemia.
Homozygous Familial Hypercholesterolemia (HoFH)
The combination of ZETIA and atorvastatin or simvastatin is indicated for the reduction of elevated total-C and LDL-C levels in patients with HoFH, as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) or if such treatments are unavailable.
Limitations of Use
The effect of ZETIA on cardiovascular morbidity and mortality has not been determined.
ZETIA has not been studied in Fredrickson Type I, III, IV, and V dyslipidemias.
DOSAGE AND ADMINISTRATION
General Dosing Information
The recommended dose of ZETIA is 10 mg once daily.
ZETIA can be administered with or without food.
Concomitant Lipid-Lowering Therapy
ZETIA may be administered with a statin (in patients with primary hyperlipidemia) or with fenofibrate (in patients with mixed hyperlipidemia) for incremental effect. For convenience, the daily dose of ZETIA may be taken at the same time as the statin or fenofibrate, according to the dosing recommendations for the respective medications.
Co-Administration with Bile Acid Sequestrants
Patients with Hepatic Impairment
Patients with Renal Impairment
No dosage adjustment is necessary in patients with renal impairment [see CLINICAL PHARMACOLOGY]. When given with simvastatin in patients with moderate to severe renal impairment (estimated glomerular filtration rate < 60 mL/min/1.73 m²), doses of simvastatin exceeding 20 mg should be used with caution and close monitoring [see Use in Specific Populations].
No dosage adjustment is necessary in geriatric patients [see CLINICAL PHARMACOLOGY].
Dosage Forms And Strengths
10-mg tablets are white to off-white, capsule-shaped tablets debossed with “414” on one side.
Storage And Handling
No. 3861 — Tablets ZETIA, 10 mg, are white to off-white, capsule-shaped tablets debossed with “414” on one side. They are supplied as follows:
NDC 66582-414-31 bottles of 30
NDC 66582-414-54 bottles of 90
NDC 66582-414-74 bottles of 500
NDC 66582-414-76 bottles of 5000
NDC 66582-414-28 unit dose packages of 100.
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F). [See USP Controlled Room Temperature.] Protect from moisture.
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ 08889, USA. Revised: 06/2012This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 1/30/2013
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