TRILIPIX MODIFIED RELEASE CAPSULES 45MG [SIN14375P]

Product Info

TRILIPIX MODIFIED RELEASE CAPSULES 45MG

[SIN14375P]

Indications

1. Co-administration Therapy with Statins for the Treatment of Mixed Dyslipdemia
   Trilipix is indicated as an adjunct to diet in combination with a statin to reduce triglyceride (TG) and increase HDL-C in patients with mixed dyslipidemia and coronary heart disease (CHD) or a CHD risk equivalent who are on optimal statin therapy to achieve their LDL-C goal.

   CHD risk equivalents comprise:

   • Other clinical forms of atherosclerotic disease (peripheral arterial disease, abdominal aortic aneurysm, and symptomatic carotid artery disease);

   • Diabetes;

   • Multiple risk factors that confer a 10-year risk for CHD > 20%.

2. Treatment of Severe Hypertriglyceridemia
   Trilipix is indicated as adjunctive therapy to diet to reduce TG in patients with severe hypertriglyceridemia. Improving glycemic control in diabetic patients showing fasting chylomicronemia will usually obviate the need for pharmacological intervention. Markedly elevated levels of serum triglycerides (e.g. >2,000 mg/dL) may increase the risk of developing pancreatitis. The effect of Trilipix therapy on reducing this risk has not been adequately studied.

3. Treatment of Primary Hyperlipidemia or Mixed Dyslipidemia
   Trilipix is indicated as adjunctive therapy to diet to reduce elevated LDL-C levels, total-cholesterol, TG and Apo B, and to increase HDL-C in patients with primary hyperlipidemia or mixed dyslipidemia.

   No incremental benefit of Trilipix on cardiovascular morbidity and mortality has been established over and above that demonstrated for statin monotherapy.

   Fenofibrate at a dose equivalent to 135 mg of Trilipix was not shown to reduce coronary heart disease morbidity and mortality in a large, randomized controlled trial of patients with type 2 diabetes mellitus.

Posology and method of administration
Patients should be placed on an appropriate lipid-lowering diet before receiving Trilipix as monotherapy or co-administered with a statin, and should continue this diet during treatment.
Trilipix modified release capsules can be taken without regard to meals.
Serum lipids should be monitored periodically.
The maximum dose is 135 mg once daily.

Adults

• Co-administration therapy with statins for the treatment of mixed dyslipidemia:
  Trilipix 135 mg may be co-administered with an HMG-CoA reductase inhibitor (statin) in patients with mixed dyslipidemia. For convenience, the daily dose of Trilipix may be taken at the same time as a statin, according to the dosing recommendations for each medication. Coadministration with the maximum dose of a statin has not been evaluated in clinical studies and should be avoided unless the benefits are expected to outweigh the risks.

• Severe Hypertriglyceridemia
  The initial dose of Trilipix is 45 to 135 mg once daily. Dosage should be individualized according to patient response, and should be adjusted if necessary following repeat lipid determinations at 4 to 8 week intervals. The maximum dose is 135 mg once daily.

• Primary Hyperlipidemia or Mixed Dyslipidemia
  The dose of Trilipix is 135 mg once daily.

Elderly
Dose selection for the elderly should be made on the basis of renal function.

Renal impairment
Treatment with Trilipix should be initiated at a dose of 45 mg once daily in patients with mild to moderate renal impairment (creatinine clearance 30–80ml/min) and should only be increased after evaluation of the effects on renal function and lipid levels at this dose. The use of Trilipix should be avoided in patients with severely impaired renal function.

Hepatic impairment
Patients with hepatic disease have not been studied.

Children
Trilipix is not recommended for use in children below age 18 due to a lack of data on safety and efficacy.

General Considerations for Treatment
Fenofibrate at a dose equivalent to 135mg of Trilipix was not shown to reduce coronary heart disease morbidity and mortality in a large, randomized controlled trial of patients with type 2 diabetes mellitus.

Laboratory studies should be performed to establish that lipid levels are abnormal before instituting Trilipix therapy.

Every reasonable attempt should be made to control serum lipids with non-drug methods including appropriate diet, exercise, weight loss in obese patients, and control of any medical problems such as diabetes mellitus and hypothyroidism that may be contributing to the lipid abnormalities. Medications known to exacerbate hypertriglyceridemia (beta-blockers, thiazides, estrogens) should be discontinued or changed if possible, and excessive alcohol intake should be addressed before triglyceride-lowering drug therapy is considered. If the decision is made to use lipid-altering drugs, the patient should be instructed that this does not reduce the importance of adhering to diet.

Drug therapy is not indicated for patients who have elevations of chylomicrons and plasma triglycerides, but who have normal levels of VLDL.

Contraindications
Trilipix is contraindicated in:

• patients with severe renal insufficiency (creatinine clearance < 30 ml/min), including those receiving dialysis.

• patients with active liver disease, including those with primary biliary cirrhosis and unexplained persistent liver function abnormalities.

• patients with preexisting gallbladder disease.

• Nursing mothers.

• patients with hypersensitivity to fenofibric acid, choline fenofibrate or fenofibrate (see Warnings and precautions for use – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

When Trilipix is co-administered with a statin, refer to the Contraindications section of the respective statin labeling.