LIPOFEN® is a registered trademark of Cipher Pharmaceuticals Inc.
and licensed by Kowa Pharmaceuticals America, Inc.
LIP-2016-001 November 2016LIP-2016-002 November 2016
About LIVALO® (pitavastatin) tablets
LIVALO is an HMG-CoA (3-hydroxy-3-methyl-glutaryl-co-enzyme A) reductase inhibitor (statin) developed in Japan and indicated as an adjunctive therapy to diet to reduce elevated total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B) and triglycerides (TG), and to increase high-density lipoprotein cholesterol (HDL-C) in adult patients with primary hyperlipidemia or mixed dyslipidemia. LIVALO is only minimally metabolized by the liver’s cytochrome P450 enzyme system, which may help reduce its potential for drug-drug interactions mediated by this system.
The efficacy of LIVALO has been evaluated against atorvastatin, simvastatin and pravastatin in patients with primary hyperlipidemia or mixed dyslipidemia. Since its launch in Japan (2003), South Korea (2005), Thailand (2008), China (2009) and the United States (2010), LIVALO has been successfully used to manage cholesterol levels for a range of patients, including the elderly, patients with diabetes and those whose treatment is complicated by concurrent disease and multiple drug regimens.
Important Safety Information for LIVALO® (pitavastatin) tablets
Who should NOT take LIVALO?
LIVALO is not right for everyone. Do not take LIVALO if:
•You have a known allergy to LIVALO or any of its ingredients.
•You have active liver problems, including some abnormal liver test results.
•You are nursing, pregnant or may become pregnant, as it may harm the baby.
•You are currently taking cyclosporine or gemfibrozil.
What is the most important information I should know and talk to my doctor about?
•Call your healthcare provider or get help right away if you experience any symptoms of an allergic reaction, such as rash, itching, or hives.
•Muscle problems may be an early sign of rare, serious conditions. Tell your doctor right away if you have any unexplained muscle pain, weakness, or tenderness, particularly if accompanied by malaise or fever, or if these muscle signs or symptoms persist after discontinuing LIVALO.
•Serious liver problems have been reported rarely in patients taking statins, including LIVALO. Your doctor should do liver tests before you start, and if you have symptoms of liver problems while you are taking LIVALO. Tell your healthcare provider right away if you feel more tired than usual, have a loss of appetite, upper belly pain, dark-colored urine, or yellowing of the skin or eyes.
•Tell your doctor about all your medical conditions and medications you take including nonprescription medicines, vitamins, or herbal supplements.
•Increases in blood sugar levels have been reported with statins, including LIVALO.
•Tell your doctor about your alcohol use.
What are the most common side effects of LIVALO?
The most common side effects of LIVALO in clinical studies were:
•Pain in the legs or arms
This is not a complete list of side effects. Talk to your healthcare provider for more information. You are encouraged to report negative side effects of all drugs to the FDA.
Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
How should I store and take LIVALO?
•Store LIVALO tablets at room temperature, in a dry place, and out of the reach of children.
•LIVALO can be taken at any time of day, with or without food.
•Swallow the tablet whole. Do not split, crush, dissolve, or chew.
Other important information I should know about LIVALO.
•LIVALO has not been studied to evaluate its effect on reducing heart-related disease or death.
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