Sign up for Lipofen® To Go, a mobile refill reminder program that offers you additional savings on your next prescription. Plus, get health tips delivered to your mobile phone.
What is Lipofen®?
Lipofen® (fenofibrate capsules) is a prescription medication that can help you manage elevated triglycerides or cholesterol when diet alone isn't working. Lipofen® is available in 2 prescription dosages: 50 mg and 150 mg. Although your doctor may have recommended a heart-healthy diet and exercise for the management of high cholesterol or triglycerides, you may find that you're just not reaching your goal with diet and exercise alone. If that's the case, ask your doctor if prescription Lipofen® is right for you.
How can Lipofen® help?
- Lipofen® can help you reach your lipid goals when diet alone isn't enough
- Fenofibrate has been proven to provide triglyceride reductions of up to 36%1
- It may also reduce "bad" cholesterol (LDL-C) by up to 31% and increase "good" cholesterol (HDL-C) by up to 15%1
When should I take Lipofen®?
- Lipofen® is taken once-daily and uses the unique, patented Lidose® technology delivery system2
- Because Lipofen® is more effectively absorbed in your body when taken with food, it's recommended that you take Lipofen® with a meal, such as breakfast or dinner
Indications
Lipofen® is indicated as adjunctive therapy to diet to reduce elevated LDL-C, total-C, triglycerides (TG), and Apo B, and to increase
HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidemia (Fredrickson Types IIa and IIb).
Lipid-altering agents should be used in addition to a diet restricted in saturated fat and cholesterol when response to diet and non-pharmacological intervention alone has been inadequate.
Lipofen® is also indicated as adjunctive therapy to diet for treatment of adult patients with hypertriglyceridemia (Fredrickson Types IV and V hyperlipidemia). Improving glycemic control in diabetic patients showing fasting chylomicronemia will usually reduce fasting triglycerides and eliminate chylomicronemia thereby obviating the need for pharmacologic intervention.
Important Safety Information
The effect of Lipofen® therapy on reducing the risk of pancreatitis in patients with elevated serum TG has not been adequately studied.
Drug therapy is not indicated for patients with Type I hyperlipoproteinemia.
The use of drugs should be considered only when reasonable attempts have been made to obtain satisfactory results with non-drug methods. If the decision is made to use drugs, the patient should be instructed that this does not reduce the importance of adhering to diet.
Lipofen® is contraindicated in patients with hypersensitivity to fenofibrate, hepatitis or severe renal dysfunction, including primary biliary cirrhosis, unexplained persistent liver function abnormality, and preexisting gallbladder disease.
Fenofibrate at doses equivalent to 100 mg to 150 mg Lipofen® per day has been associated with increases in serum transaminases. Regular periodic monitoring of liver functions, including serum ALT (SGPT) should be performed for the duration of therapy with Lipofen®, and therapy discontinued if enzyme levels persist >3 times the normal limit.
Fenofibrate may increase cholesterol excretion into the bile, leading to cholelithiasis. If cholelithiasis is confirmed, therapy with Lipofen® should be discontinued.
Caution should be exercised when anticoagulants are given in conjunction with Lipofen® because of a potential increase in coumarin-type anticoagulant effects. To prevent bleeding complications, frequent prothrombin time/INR determinations and appropriate dosage adjustments are advisable.
The combined use of Lipofen® and HMG-CoA reductase inhibitors should be avoided unless the benefit of further alterations in lipid levels is likely to outweigh the increased risk of this drug combination.
The effect of fenofibrate on coronary heart disease morbidity and mortality and non-cardiovascular mortality has not been established.
Lipofen® may occasionally be associated with myopathy or rhabdomyolysis, usually in patients with impaired renal function. Patients should be advised to report promptly unexplained muscle pain, tenderness or weakness. Lipofen® should be discontinued if markedly elevated CPK levels occur or myopathy is diagnosed.
Other precautions include pancreatitis, hypersensitivity reactions, and hematologic changes.
In clinical trials, the most common adverse events were abnormal liver function tests, respiratory disorder, abdominal pain, back pain, and headache.
References: 1. Lipofen® [prescribing information]. Montgomery, AL: Kowa Pharmaceuticals America, Inc; 2008. 2. Data on file. Lipofen® patent review.
July 20, 2007. Kowa Pharmaceuticals America, Inc.
