AN IMPORTANT GUIDE TO HEALTH. Very high triglycerides may. put you at risk. Fortunately, there is. a proven way. to lower them. Ask your doctor.
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1 AN IMPORTANT GUIDE TO HEALTH Very high triglycerides may put you at risk. Fortunately, there is a proven way to lower them. Ask your doctor.
2 What is LOVAZA? LOVAZA is the first and only prescription omega-3 medication clinically proven to dramatically reduce very high triglycerides ( 500 mg/dl) in adults. Why do doctors prescribe LOVAZA? Doctors prescribe LOVAZA for adult patients with very high triglycerides ( 500 mg/dl). LOVAZA is used along with a low-fat and low-cholesterol diet to lower very high triglycerides. Before taking LOVAZA, your healthcare provider should help you try to control your triglyceride level by diet, exercise, and other means. Ask your doctor why treating very high triglycerides is important. Triglycerides are one of several types of fat in your body, and the most common of them all. Triglycerides occur naturally in your bloodstream. Your body stores fat in the form of triglycerides when you eat more calories than you use during your daily activities. But when your body makes too many triglycerides, the result can contribute to hypertriglyceridemia, a clinical word that describes the presence of too much fat and cholesterol in your bloodstream. How do I know my triglycerides are high? As with cholesterol, triglyceride levels can be determined by a simple blood test. Below is a set of guidelines to help your doctor determine your triglyceride level.* The National Cholesterol Education Program (NCEP) Guidelines for triglycerides are: Triglyceride Level Classifications less than 150 mg/dl desirable 150 to 199 mg/dl borderline high 200 to 499 mg/dl high 500 mg/dl or higher very high * Triglyceride levels are measured in milligrams (mg) per deciliter (dl) of blood. Ask your doctor about the importance of treating very high triglycerides and why LOVAZA may be right for you. Treatment with LOVAZA has not been shown to prevent heart attacks or strokes. 2 Please see page 9 for important safety information.
3 Why LOVAZA? WHAT CAUSES VERY HIGH TRIGLYCERIDES? There are many different causes of very high triglyceride levels. Lifestyle issues: Being overweight Drinking too much alcohol By prescribing LOVAZA, your doctor is giving you a proven, effective, and naturally derived prescription omega-3 medication. Only LOVAZA contains 465 mg EPA and 375 mg DHA, the active fatty acids proven to lower very high triglycerides, in each 1-gram capsule (see diagram below). Dietary supplement omega-3s that you can buy without a prescription could require up to 16 capsules daily to achieve amounts of EPA and DHA similar to the prescribed dose of LOVAZA. Medical conditions: Family history of high triglycerides Diabetes Underactive thyroid (hypothyroidism) Medications: Estrogen therapy (for menopause) Thiazide diuretics (for hypertension) Beta-blockers (for hypertension) Other omega-3-acid ethyl esters 80 mg Omega-6-acid ethyl esters Other, including antioxidants 30 mg 50 mg 1 capsule = 1,000 mg 4 Please see page 9 for important safety information.
4 No other omega-3 product is like LOVAZA. It is naturally derived and highly purified through a patent-protected,* 5-step process. THE LOVAZA 5-STEP REFINEMENT PROCESS This unique purification process for LOVAZA helps to eliminate worries about cholesterol, saturated fats, and environmental toxins (that can be present in fish oil), such as mercury and PCBs. LOVAZA is the only omega-3 medicine approved by the FDA. The FDA has not approved nonprescription omega-3 products for use in treating specific conditions, like very high triglycerides unrefined Crude fish oil Early purification steps removal of: Environmental toxins Cholesterol and proteins Short-chain fatty acids Secondary purification steps: Further purification and concentration of omega-3 Late purification steps removal of: Saturated fatty acids Oxidized fatty acids Other by-products 84% EPA/DHA 90% Omega-3 LOVAZA Nonprescription omega-3 products are not substitutes for LOVAZA. How else can I manage my triglycerides? Be sure to get enough exercise and eat a healthy diet. Be sure to consult your physician before beginning any exercise program. The American Heart Association recommends minutes of exercise most days of the week. Cut down on the amount of meat, butter, cheese, and simple carbohydrates that you eat. Instead, eat more whole grains, vegetables, and fish. Ask your doctor what your target body weight should be, and how you can reach it. Your doctor may have other suggestions for a healthier lifestyle. *United States Patent and Trademark Office. United States Patent Nos. 5,945,318; 6,518,049; 5,719,302; 6,204,401 and 6,630,188. Available at 6 Please see page 9 for important safety information.
5 The American Heart Association. For patients who need to lower very high triglycerides, the AHA recommends the use of omega-3 therapy. LOVAZA is the only prescription omega-3 medication approved by the FDA for the treatment of very high triglycerides. All other omega-3 products are dietary supplements. Dietary supplements are not FDA approved for any specific disease or medical condition. Go to these web sites for more information about triglycerides: The American Heart Association US Department of Health and Human Services The National Heart, Lung, and Blood Institute How do I take LOVAZA? The daily dose of LOVAZA is 4 capsules: take all 4 capsules at the same time, or take 2 capsules twice a day. Take LOVAZA exactly as prescribed. Do not take more than 4 capsules a day. Important information about LOVAZA. LOVAZA is used along with a low-fat and low-cholesterol diet to lower very high triglycerides ( 500 mg/dl) in adults. Talk to your healthcare provider to find out if LOVAZA is right for you. Before taking LOVAZA, your healthcare provider should help you try to control your triglyceride levels by: losing weight if you are overweight, increasing physical exercise, lowering alcohol use, treating diseases such as diabetes and low thyroid hormone levels (hypothyroidism), and adjusting other medications that may raise triglyceride levels such as certain blood pressure medications and estrogens. What should I expect to feel when I take LOVAZA? LOVAZA is generally well tolerated with a low occurrence of side effects. The most common side effects with LOVAZA are burping, infection, flu-like symptoms, upset stomach, a change in sense of taste, back pain, and skin rash. These are not all the side effects with LOVAZA. Ask your doctor or pharmacist for a complete list. Talk to your doctor immediately if you think you are experiencing any side effects. 8 Please see page 9 for important safety information.
6 Do not take LOVAZA if you are allergic to any of its ingredients. Tell your doctor about all of your medical conditions, including if you: have diabetes, have a thyroid problem called hypothyroidism, have a liver problem, have a pancreas problem, are allergic to fish, are pregnant or planning to become pregnant, or are breastfeeding. Tell your doctor about all the medicines you take, including prescription and nonprescription medicine, vitamins, and herbal supplements. Especially tell your doctor if you take medicines to reduce clotting known as anticoagulants or blood thinners. These include aspirin, warfarin, coumarin, and clopidogrel (Plavix ).* Are there any special storage requirements for LOVAZA? No. LOVAZA should be stored at room temperature, 59 to 86 F (15 to 30 C). Do not keep medicine that is out-of-date or that you no longer need. Keep LOVAZA out of the reach of children. Active Ingredients: omega-3-acid ethyl esters. Inactive ingredients: gelatin, glycerol, purified water, alphatocopherol (in partially hydrogenated vegetable oils, including soybean oil). Please read accompanying important prescribing information about LOVAZA. Is there anything else I should know about taking LOVAZA? Treatment with LOVAZA has not been shown to prevent heart attacks or strokes. Your doctor should do blood tests to check your triglyceride and cholesterol levels, and to monitor liver function during treatment with LOVAZA. LOVAZA is occasionally associated with an elevation of one of the tests doctors use to monitor the function of your liver and cholesterol levels. *PLAVIX is a registered trademark of Bristol-Myers Squibb/ Sanofi Pharmaceuticals. 10 Please see page 9 for important safety information.
7 For more detailed information about LOVAZA, ask your doctor or pharmacist or go to RLOV Reliant Pharmaceuticals, Inc. July 2007
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