Hyperlipoproteinemias:

Indications for: ANTARA

Adjunct to diet when response to nondrug therapy is inadequate in hypertriglyceridemia, and to reduce elevated total-C, LDL-C, apo B, and TG, and to increase HDL-C, in primary hypercholesterolemia and mixed dyslipidemia.

Limitations of Use:

Fenofibrate was not shown to reduce coronary heart disease morbidity and mortality in patients with type 2 diabetes.

Adult Dosage:

Swallow whole. Take without regard to food. Hypertriglyceridemia: 30–90mg/day, adjust at 4–8 week intervals; max 90mg/day. Hypercholesterolemia, dyslipidemia: 90mg/day. Renal impairment (mild-to-moderate): initially 30mg/day; (severe): avoid. Elderly: select dose based on renal function. Discontinue if inadequate response after 2 months on max dose.

Children Dosage:

Not established.

ANTARA Contraindications:

Severe renal impairment including on dialysis. Hepatic disease. Primary biliary cirrhosis. Unexplained persistent liver function abnormalities. Gallbladder disease. Nursing mothers.

ANTARA Warnings/Precautions:

Monitor CBCs for first year; monitor liver function; discontinue if ALT (SGPT) levels >3×ULN persist. Discontinue if markedly elevated CPK levels, myopathy, gallstones, hypersensitivity reactions (acute and delayed), or paradoxical decreases in HDL-C occur. Renal impairment (monitor). Elderly. Pregnancy (Cat.C). Nursing mothers: not recommended.

ANTARA Classification:

Fibrate.

ANTARA Interactions:

Avoid statins. Potentiates oral anticoagulants (reduce anticoagulant dose and monitor PT/INR). Allow at least 1hr before or 4–6hrs after bile acid sequestrants. Caution with colchicine, immunosuppressants (eg, cyclosporine, tacrolimus), other nephrotoxic drugs.

Adverse Reactions:

Abnormal LFTs, elevated CPK, respiratory or GI effects, myopathy, cholelithiasis, pancreatitis, increased serum creatinine, hypersensitivity reactions (may be severe), rash; rare: rhabdomyolysis, transient hematologic changes, blood dyscrasias.

How Supplied:

Caps 30mg—30; 90mg—30, 90, 100