Capsules Features That
Patients May Appreciate*


ANTARA® Capsules are the smallest
of any fenofibrate and are easy
to identify

 

Studies show a consistent
preference for oral medications
formulated as small, distinctively
colored capsules


The Burke Study1 (N=1000)

A survey of patient preferences and perceptions.

  • Capsules preferred nearly twice as often as coated tablets (54% vs 29%)
  • Key reason: ease of swallowing.


Overgaard et al2 (N=331):

A study in which patients evaluated the appearance and ease of swallowing capsules, uncoated tablets, and coated tablets.

  • Capsule form rated the easiest to swallow.
  • Dosing form with a distinctive color preferred by patients who took >10 medications/day.
  • Difficulty of swallowing tablets increased with larger tablet size.


Capsugel Consumer Preferences Study3 (N=750)

An evaluation of changing patient preferences in dosing forms that included capsules, tablets, chewable tablets, caplets, liquid-filled capsules, and
gel-coated tablets.

  • Ease of swallowing was the #1 desired characteristic, mentioned by 74% of patients
  • Capsules were rated as "very" or "extremely" well-liked by 57% of patients.
  • Key attribute of capsules: ease of swallowing.


* Some features and benefits apply to other fenofibrates.

 

References: 1. Results of the Burke Study. 1000 patients give their opinion on the capsule. Capsugel Library. October 1982. 2. Overgaard AB, Højsted J, Hansen R, Møller-Sonnergaard J, Christup LL. Patients’ evaluation of shape, size and colour of solid dosage forms. Pharm World & Science. 2001;23(5):185-188. 3. Study of consumer preferences: solid oral dosage forms. Research by Capsugel® for OTC, Dietary Supplement, and Pharmaceutical Marketers. 2010 Capsugel.

INDICATIONS

Primary Hypercholesterolemia and Mixed Dyslipidemia: ANTARA® is indicated as adjunctive therapy to diet to reduce elevated low-density lipoprotein cholesterol (LDL-C), total cholesterol (Total-C), triglycerides (TG), and apolipoprotein B (Apo B), and to increase high-density lipoprotein cholesterol (HDL-C) in adult patients with primary hyperlipidemia or mixed dyslipidemia.

Hypertriglyceridemia: ANTARA® is also indicated as adjunctive therapy to diet for treatment of adult patients with hypertriglyceridemia. Improving glycemic control in diabetic patients showing fasting chylomicronemia will usually reduce fasting triglycerides and eliminate chylomicronemia thereby obviating the need for pharmacologic intervention. Markedly elevated levels of serum triglycerides (eg, >2,000 mg/dL) may increase the risk of developing pancreatitis. The effect of fenofibrate therapy on reducing this risk has not been adequately studied.

Important limitations of use: Fenofibrate was not shown to reduce coronary heart disease morbidity and mortality in patients with type 2 diabetes mellitus.

IMPORTANT SAFETY INFORMATION

ANTARA® is contraindicated in patients with severe renal impairment; active liver disease, including unexplained persistent liver function abnormalities; preexisting gallbladder disease; nursing mothers; and hypersensitivity to fenofibric acid, choline fenofibrate or fenofibrate.

The effect of ANTARA® on coronary heart disease morbidity and mortality and non-cardiovascular mortality has not been established.

Fibrates increase the risk for myopathy and are associated with rhabdomyolysis. The risks for myopathy and rhabdomyolysis are increased when fibrates are co-administered with a statin, particularly in the elderly and in patients with diabetes, renal failure, or hypothyroidism. The combined use of fibrates and statins should be avoided unless the benefit of further alterations in lipid levels is likely to outweigh the increased risk.

Patients should be advised to report promptly unexplained muscle pain, tenderness, or weakness. Discontinue ANTARA® if myopathy/myositis is suspected or diagnosed or if CPK levels are markedly elevated.

Fenofibrate at doses equivalent to 90 mg ANTARA® per day can increase serum transaminases. Monitor liver function regularly and discontinue treatment if enzyme levels persist above 3 times the normal limit.

Fenofibrate can reversibly elevate serum creatinine. Monitor renal function in patients with renal impairment.

Fenofibrate may lead to cholelithiasis. Discontinue ANTARA® if gallstones are found.

ANTARA® can potentiate the activity of oral anticoagulants. Monitoring and dosage adjustment of anticoagulants as needed are recommended.

Other precautions include pancreatitis, hematologic changes, hypersensitivity reactions, and venothromboembolic events.

The most common adverse reactions (>2% and ≥1% greater than placebo) are abnormal liver function tests, increased AST, increased ALT, increased CPK, and rhinitis.

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