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USES and IMPORTANT SAFETY INFORMATION You Should Know About NIASPAN^® (niacin extended-release) tablets⁶

Uses

NIASPAN^® (niacin extended-release) tablets are a prescription medication used along with diet when a low-cholesterol diet and exercise alone are not enough.

• NIASPAN raises HDL (“good”) cholesterol and lowers LDL (“bad”) cholesterol and triglycerides in people with abnormal cholesterol levels.
• NIASPAN is also used to lower the risk of heart attack in people who have had a heart attack and have high cholesterol.
• In people with coronary artery disease and high cholesterol levels, NIASPAN, when used with a bile acid-binding resin (another cholesterol medicine), can slow down or lessen the buildup of plaque (fatty deposits) in your arteries.

Taking NIASPAN with another cholesterol-lowering medicine (simvastatin) does not reduce heart attacks or strokes more than taking simvastatin alone.

Important Safety Information

• NIASPAN is not for people with liver problems, stomach ulcers, serious bleeding problems, or those allergic to any product ingredient.
• Severe liver damage has occurred when switching to a long-acting niacin (NIASPAN) from immediate-release niacin. Do not switch between forms of niacin without talking to your healthcare provider.
• Tell your healthcare provider about any unexplained muscle pain, tenderness, or weakness, as this could be a sign of a serious side effect. This risk increases when NIASPAN is taken, particularly in the elderly, diabetics, and those with kidney or thyroid problems.
• NIASPAN should be used with caution if you consume large amounts of alcohol and/or have a past history of liver disease.
• Your healthcare provider should do blood tests before and during treatment to check liver enzyme levels, as these can increase with treatment.
• NIASPAN can cause an increase in blood sugar levels. If you have diabetes, check your blood sugar levels more frequently during the first few months or with NIASPAN dose changes.
• Tell your healthcare provider if you have kidney problems or a history of gout. NIASPAN can cause an increase in uric acid levels.
• The most common side effects with NIASPAN are flushing, diarrhea, nausea, vomiting, increased cough, and itching.
• Flushing (warmth, redness, itching, and/or tingling of the skin) is a common side effect of NIASPAN therapy. It may vary in severity and is more likely to happen when starting NIASPAN or during dose increases. Flushing may get better after several weeks of consistent NIASPAN use. Talk to your doctor about how the symptoms of flushing are different from symptoms of a heart attack. By dosing at bedtime, flushing will likely occur during sleep. If awakened by flushing, get up slowly, especially if feeling dizzy or faint, or taking blood pressure medications.
• If you are taking another cholesterol medication called a bile acid-binding resin (e.g., colestipol, cholestyramine) along with NIASPAN, take these medicines at least 4 to 6 hours apart.
• Some medicines should not be taken with NIASPAN. Tell your healthcare provider about all the medicines you take, including aspirin, any cholesterol medication, blood pressure medication, blood thinner medication, or any products containing niacin or nicotinamide.

For more information, talk with your healthcare provider.

Reference: 1. Mayo Clinic. High cholesterol. https://www.mayoclinic.org/diseases-conditions/high-blood-cholesterol/diagnosis-treatment/drc-20350806. Accessed January 29, 2020. 2. US Department of Health and Human Services. National Institutes of Health, National Heart, Lung, and Blood Institute. Your Guide to Lowering Your Cholesterol With TLC. NIH publication No. 06-5235. https://www.nhlbi.nih.gov/files/docs/public/heart/chol_tlc.pdf. Published December 2005. Accessed January 29, 2020. 3. Cleveland Clinic. Triglycerides & heart health. https://my.clevelandclinic.org/health/articles/17583-triglycerides--heart-health. Reviewed October 2015. Accessed January 29, 2020. 4. Texas Heart Institute. 14 simple ways to reduce saturated fat. https://www.texasheart.org/heart-health/heart-information-center/topics/14-simple-ways-to-reduce-saturated-fat/. Accessed January 29, 2020. 5. Eat Right. American Academy of Nutrition and Dietetics. The basics of the nutrition facts label. http://www.eatright.org/resource/food/nutrition/nutrition-facts-and-food-labels/the-basics-of-the-nutrition-facts-panel. Reviewed August 2017. Accessed January 29, 2020. 6. NIASPAN [package insert]. North Chicago, IL: AbbVie Inc.

Please see the full Prescribing Information for NIASPAN and discuss it with your healthcare provider.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

If you are having difficulty paying for your medicine, AbbVie may be able to help. Visit AbbVie.com/myAbbVieAssist to learn more.

If you have any questions about AbbVie’s NIASPAN.com website that have not been answered, click here. This website and the information contained herein is intended for use by U.S. residents only, is provided for informational purposes only, and is not intended to replace a discussion with a healthcare provider. All decisions regarding patient care must be made with a healthcare provider and take into consideration the unique characteristics of each patient.