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默克公司新型复方降固醇药物Liptruzet获美FDA批准
5月3日，默克（美国和加拿大称为默沙东）公司对外披露：美国FDA已批准其Liptruzet（ezetimibe-atorvastatin，依折麦布-阿托伐他汀）片剂作为原发性或混合性高脂血症患者饮食控制不足以控制升高的低密度脂蛋白（LDL）胆固醇场合辅助治疗用药。Liptruzet片剂内含依泽替米贝，一种有效的降低低密度脂蛋白胆固醇药物，和目前在美国最广泛的处方他汀类药物之一阿托伐他汀。Liptruzet每日一次治疗，通过依泽替米贝抑制消化道胆固醇的吸收和通过阿托伐他汀在肝脏中抑制胆固醇的生产奏效。
Liptruzet对于心血管疾病的发病率和死亡率不比阿托伐他汀已经建立的数据有增加。
有相当比例的患者经过治疗无法使LDL胆固醇降低到建议的水平，结合健康的饮食，Liptruzet可以是一种新的有效的降脂治疗选择，能帮助解决这个问题，两种药物组合提供作用互补可使LDL比单独阿托伐他汀治疗进一步下降。
Liptruzet于5月6日在美国上市。
LIPTRUZET Rx 依折麦布阿托伐他汀钙片
LIPTRUZET tab(依泽替米贝/阿托伐他汀复方片)阿托伐他汀/依折麦布复方片
包装问题被召回
http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=Expand+Index&w=05142014&lang=eng
LIPTRUZET Rx
Generic Name and Formulations:
Ezetimibe/atorvastatin; 10mg/10mg, 10mg/20mg, 10mg/40mg, 10mg/80mg; tabs.
Company:
Merck & Co., Inc.
Indications for LIPTRUZET:
To reduce elevated total-C, LDL-C, Apo B, TG, and non-HDL-C, and to increase HDL-C in primary (heterozygous familial and non-familial) or mixed hyperlipidemia. To reduce elevated total-C and LDL-C in homozygous familial hypercholesterolemia (HoFH), as an adjunct to other lipid-lowering treatments (eg, LDL apheresis) or if such treatments are unavailable. Limitations of use: No incremental benefit on cardiovascular morbidity/mortality over and above that demonstrated for atorvastatin has been established. Not studied in Fredrickson type I, III, IV, and V dyslipidemias.
Adult Dose for LIPTRUZET:
Swallow whole. Usual range: 10mg/10mg to 10mg/80mg. Initially 10mg/10mg or 10mg/20mg; for LDL-C reduction >55%: may start at 10mg/40mg; monitor lipids within ≥2wks and adjust dose as needed. HoFH: 10mg/40mg or 10mg/80mg. Concomitant bile acid sequestrants: give Liptruzet dose either ≥2hrs before or ≥4hrs after bile acid sequestrant administration. Concomitant lopinavir/ritonavir: use lowest dose. Concomitant clarithromycin, itraconazole, saquinavir/ritonavir, darunavir/ritonavir, fosamprenavir, or fosamprenavir/ritonavir: max 10mg/20mg. Concomitant nelfinavir or boceprevir: max 10mg/40mg.
Children's Dose for LIPTRUZET:
Not established.
Pharmacological Class:
Cholesterol absorption inhibitor + HMG-CoA reductase inhibitor.
Contraindications:
Active liver disease. Unexplained persistent elevated hepatic transaminases. Pregnancy (Category X). Nursing mothers.
Warnings/Precautions:
Increased risk of myopathy/rhabdomyolysis (with high doses). Discontinue if elevated CPK (>10 X ULN) levels occur or myopathy is diagnosed or suspected; withhold if a predisposition in renal failure secondary to rhabdomyolysis develops. Monitor liver function prior to starting therapy and repeat as clinically indicated. History of liver disease or renal impairment; monitor closely. Substantial alcohol consumption. Elderly.
Interactions:
See Adult dose. Avoid with concomitant cyclosporine, tipranavir/ritonavir, telaprevir, gemfibrozil. Potentiated by strong CYP3A4 inhibitors, grapefruit juice (>1.2L/day). Caution with lopinavir/ritonavir, colchicine, fenofibrates, niacin ≥1g/day; consider dose reduction of Liptruzet. May increase serum levels of digoxin (monitor), oral contraceptives. May be antagonized by cholestyramine, CYP3A4 inducers (eg, efavirenz, rifampin); coadminister rifampin simultaneously. Monitor oral anticoagulants. Caution with drugs that decrease levels or activity of endogenous steroid hormones (eg, ketoconazole, spironolactone, cimetidine).
Adverse Reactions:
Increased ALT/AST, musculoskeletal pain, arthralgia, abdominal pain, nausea; increased in HbA1c or fasting serum glucose; myopathy, rhabdomyolysis; rare: immune-mediated necrotizing myopathy.
How Supplied:
Tabs—30, 90
Liptruzet (ezetimibe and atorvastatin) Tablets, 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg, and 10 mg/80 mg
Company: Merck Sharp & Dohme Corp.
Application No.: 200153
Approval Date: 05/03/2013
Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance.
Approval Letter(s) (PDF)
Summary Review (PDF)
Officer/Employee List (PDF)
Printed Labeling (PDF)
Medical Review(s) (PDF)
Chemistry Review(s) (PDF)
Pharmacology Review(s) (PDF)
Proprietary Name Review(s) (PDF)
Clinical Pharmacology Biopharmaceutics Review(s) (PDF)
Statistical Review (PDF)
Other Action Letter(s) (PDF)
Other Review(s) (PDF)
Administrative Document(s) & Correspondence (PDF) |
