There is no AB-rated therapeutic equivalent for TRILIPIX¹

TRILIPIX is the first and only fibrate with an FDA-approved indication for use in combination with a statin

Combination Indication:

TRILIPIX is indicated as an adjunct to diet in combination with a statin to reduce TG and increase HDL-C in patients with mixed dyslipidemia and CHD or a CHD risk equivalent who are on optimal statin therapy to achieve their LDL-C goal.

Important Limitations of Use:

No incremental benefit of TRILIPIX on cardiovascular morbidity and mortality over and above that demonstrated for statin monotherapy has been established. Fenofibrate at a dose equivalent to 135 mg of TRILIPIX was not shown to reduce coronary heart disease morbidity and mortality in 2 large trials of patients with type 2 diabetes mellitus.

Safety Information:

TRILIPIX is contraindicated in patients with severe renal impairment, active liver disease, gallbladder disease, and in nursing mothers. TRILIPIX is associated with myopathy, rhabdomyolysis, increases in serum transaminases and serum creatinine levels, and risk of cholelithiasis. The risks for myopathy and rhabdomyolysis are increased when fibrates are co-administered with a statin. TRILIPIX may increase the effects of oral coumarin anticoagulants. Pancreatitis, hypersensitivity reactions, hematological changes, and venothromboembolic events have also been reported with fibrates.

DAW Laws by State²

Find your state's Dispense as Written language to ensure that your patients get the TRILIPIX you prescribe
Select your state’s two-letter postal abbreviation: FIND
	Prescriber's signature on appropriate line of two-line prescription Handwrite Brand Necessary Prescriber must expressly indicate that Substitution is Not Allowed Handwrite Brand Necessary Handwrite or indicate orally Do Not Substitute or similar words or initial box labeled Do Not Substitute Handwrite Dispense As Written or initial the Dispense as Written box Handwrite Dispense As Written or DAW or Brand Medically Necessary Handwrite Brand Necessary or Brand Medically Necessary Prescriber must expressly indicate in some manner Dispense As Written Prescriber must expressly indicate in some manner Dispense As Written Handwrite Brand Necessary or Brand Medically Necessary Handwrite Brand Necessary or Brand Medically Necessary Check the Brand Only box Prescriber must indicate May Not Substitute by marking the designated box Prescriber's signature on appropriate line of two-line prescription Prescriber must expressly indicate that Substitution is Not Allowed Prescriber's signature on appropriate line of two-line prescription or must expressly indicate that Substitution is Not Allowed Prescriber must expressly indicate in some manner Do Not Substitute. Must handwrite Brand Medically Necessary on Rx for Medicaid patients. Check the appropriate box on the prescription to prevent drug product substitution Prescriber must expressly indicate in some manner Dispense As Written and check the appropriate box on the prescription to prevent drug product substitution Prescriber must expressly indicate Substitution is Not Allowed and must handwrite Brand Medically Necessary on Rx for Medicaid patients Prescriber must expressly indicate No Substitution Handwrite DAW or Dispense As Written Handwrite DAW or Dispense As Written unless the Rx is transmitted electronically in accordance with the Code of Federal Regulations, Title 42, Section 423 Prescriber's signature on appropriate line of two-line prescription Prescriber's signature on appropriate line of two-line prescription Prescriber must expressly indicate in some manner Dispense As Written Prescriber must expressly indicate in some manner Dispense As Written Handwrite Dispense as Written Handwrite or communicate in another manner Medically Necessary Prescriber's signature on appropriate line of two-line prescription Handwrite No Substitution or No Sub Prescriber must indicate Dispense As Written in the designated box and handwrite Brand Medically Necessary on Rx for Medicaid patients Prescriber's signature on appropriate line of two-line prescription or must expressly indicate in some manner Dispense As Written Handwrite Brand Necessary Handwrite DAW or Dispense as Written Prescriber should expressly indicate in some manner Dispense As Written or Substitution is Not Allowed Handwrite, verbalize, or electronically communicate No Substitution Handwrite Brand Necessary or Brand Medically Necessary Handwrite Brand Necessary or Brand Medically Necessary or patient may request in writing Brand Name be Dispensed Prescriber's signature on appropriate line of two-line prescription Handwrite Brand Necessary Handwrite Dispense As Written, DAW, Brand Medically Necessary, No Generic, or similar phrase Handwrite Brand Necessary or Brand Medically Necessary Prescriber must expressly indicate in some manner Dispense As Written or check the Do Not Substitute box Handwrite Brand Necessary or No Substitution or Dispense As Written or DAW Indicate Brand Medically Necessary Prescriber's signature on appropriate line of two-line prescription Handwrite Brand Medically Necessary or Medically Necessary Prescriber must expressly indicate in some manner Dispense as Written Prescriber must expressly indicate that Substitution is Not Allowed

Find your state's Dispense as Written language to ensure that your patients get the TRILIPIX you prescribe

Select your state’s two-letter postal abbreviation: FIND

Prescriber's signature on appropriate line of two-line prescription

Handwrite Brand Necessary

Prescriber must expressly indicate that Substitution is Not Allowed

Handwrite Brand Necessary

Handwrite or indicate orally Do Not Substitute or similar words or initial box labeled Do Not Substitute

Handwrite Dispense As Written or initial the Dispense as Written box

Handwrite Dispense As Written or DAW or Brand Medically Necessary

Handwrite Brand Necessary or Brand Medically Necessary

Prescriber must expressly indicate in some manner Dispense As Written

Handwrite Brand Necessary or Brand Medically Necessary

Check the Brand Only box

Prescriber must indicate May Not Substitute by marking the designated box

Prescriber's signature on appropriate line of two-line prescription

Prescriber must expressly indicate that Substitution is Not Allowed

Prescriber's signature on appropriate line of two-line prescription or must expressly indicate that Substitution is Not Allowed

Prescriber must expressly indicate in some manner Do Not Substitute. Must handwrite Brand Medically Necessary on Rx for Medicaid patients.

Check the appropriate box on the prescription to prevent drug product substitution

Prescriber must expressly indicate in some manner Dispense As Written and check the appropriate box on the prescription to prevent drug product substitution

Prescriber must expressly indicate Substitution is Not Allowed and must handwrite Brand Medically Necessary on Rx for Medicaid patients

Prescriber must expressly indicate No Substitution

Handwrite DAW or Dispense As Written

Handwrite DAW or Dispense As Written unless the Rx is transmitted electronically in accordance with the Code of Federal Regulations, Title 42, Section 423

Prescriber's signature on appropriate line of two-line prescription

Prescriber must expressly indicate in some manner Dispense As Written

Handwrite Dispense as Written

Handwrite or communicate in another manner Medically Necessary

Prescriber's signature on appropriate line of two-line prescription

Handwrite No Substitution or No Sub

Prescriber must indicate Dispense As Written in the designated box and handwrite Brand Medically Necessary on Rx for Medicaid patients

Prescriber's signature on appropriate line of two-line prescription or must expressly indicate in some manner Dispense As Written

Handwrite Brand Necessary

Handwrite DAW or Dispense as Written

Prescriber should expressly indicate in some manner Dispense As Written or Substitution is Not Allowed

Handwrite, verbalize, or electronically communicate No Substitution

Handwrite Brand Necessary or Brand Medically Necessary

Handwrite Brand Necessary or Brand Medically Necessary or patient may request in writing Brand Name be Dispensed

Prescriber's signature on appropriate line of two-line prescription

Handwrite Brand Necessary

Handwrite Dispense As Written, DAW, Brand Medically Necessary, No Generic, or similar phrase

Handwrite Brand Necessary or Brand Medically Necessary

Prescriber must expressly indicate in some manner Dispense As Written or check the Do Not Substitute box

Handwrite Brand Necessary or No Substitution or Dispense As Written or DAW

Indicate Brand Medically Necessary

Prescriber's signature on appropriate line of two-line prescription

Handwrite Brand Medically Necessary or Medically Necessary

Prescriber must expressly indicate in some manner Dispense as Written

Prescriber must expressly indicate that Substitution is Not Allowed

TRILIPIX
STUDY RESULTS

12-Week Studies
(combo therapy) Hypertriglyceridemia
(monotherapy)

DOSING

Available in 2 strengths for convenient, once-daily dosing.

Go to Dosing

PATIENT SAVINGS

Eligible patients receive special savings on their TRILIPIX prescription

Savings Offer

Important Safety Information and Indications for TRILIPIX^®

Important Safety Information for TRILIPIX

TRILIPIX is contraindicated in patients with severe renal impairment; active liver disease, including those with unexplained persistent liver function abnormalities; gallbladder disease; in nursing mothers; and in patients with hypersensitivity to fenofibric acid or fenofibrate.
Fibrate and statin monotherapy increase the risk of myositis or myopathy and have been associated with rhabdomyolysis. The risks for myopathy and rhabdomyolysis are increased when fibrates are coadministered with a statin, particularly in the elderly and in patients with diabetes, renal failure, or hypothyroidism.
Tell patients to promptly report unexplained muscle pain, tenderness, or weakness. If markedly elevated CPK levels occur or myopathy/myositis is diagnosed, TRILIPIX and statin therapy should be discontinued.
TRILIPIX can cause reversible elevations in serum creatinine. Monitor renal function periodically in patients with or at risk for renal insufficiency.
TRILIPIX can increase serum transaminases. Monitor liver function tests regularly, and discontinue therapy if enzyme levels persist above 3 times the upper limit of normal.
TRILIPIX may lead to cholelithiasis. If cholelithiasis is confirmed, TRILIPIX should be discontinued.
TRILIPIX may increase the effects of oral coumarin anticoagulants. Monitoring and dosage adjustment of the anticoagulant are recommended.
Pancreatitis, hypersensitivity reactions, hematological changes, and venothromboembolic events have been reported with the use of fibrates.
The effect of TRILIPIX on coronary heart disease morbidity and mortality and non-cardiovascular mortality has not been established.
Co-administration with the maximum dose of a statin has not been evaluated and should be avoided unless the benefits are expected to outweigh the risks.
Adverse events reported by ≥4% of patients receiving TRILIPIX alone or co-administered with a statin in controlled clinical trials were dyspepsia, nausea, nasopharyngitis, upper respiratory tract infection, arthralgia, back pain, pain in extremity, dizziness, and headache.

Indications for TRILIPIX^® (fenofibric acid) delayed-release capsules

Every reasonable attempt should be made to control serum lipids with diet, other disease-state management, and other non-drug methods before and during treatment with TRILIPIX.
TRILIPIX is indicated as an adjunct to diet in combination with a statin to reduce TG and increase HDL-C in patients with mixed dyslipidemia and CHD or a CHD risk equivalent who are on optimal statin therapy to achieve their LDL-C goal.
TRILIPIX is indicated as an adjunct to diet to reduce TG in patients with severe hypertriglyceridemia. Improving glycemic control in diabetics with fasting chylomicronemia will usually obviate the need for drug therapy. The effect of TRILIPIX on pancreatitis risk reduction in patients with markedly elevated serum TG has not been adequately studied.
TRILIPIX is indicated as an adjunct to diet to reduce LDL-C, Total-C, TG, and Apo B and to increase HDL-C in patients with primary hyperlipidemia or mixed dyslipidemia.
Important Limitations of Use: No incremental benefit of TRILIPIX on cardiovascular morbidity and mortality over and above that demonstrated for statin monotherapy has been established. Fenofibrate at a dose equivalent to 135 mg of TRILIPIX was not shown to reduce coronary heart disease morbidity and mortality in 2 large trials of patients with type 2 diabetes mellitus.

Please see full Prescribing Information for TRILIPIX.

References:

1. Drugs@FDA [database online]. US Food and Drug Administration. Available at: http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm. Accessed October 19, 2011.

2. National Association of Boards of Pharmacy. Drug Product Selection Laws. In: Survey of Pharmacy Law - 2011. Mount Prospect, IL: National Association of Boards of Pharmacy; 2010: 63-66.

There is no AB-rated therapeutic equivalent for TRILIPIX1

TRILIPIX is the first and only fibrate with an FDA-approved indication for use in combination with a statin

Combination Indication:

Important Limitations of Use:

Safety Information:

DAW Laws by State2

TRILIPIX STUDY RESULTS

DOSING

PATIENT SAVINGS

Important Safety Information and Indications for TRILIPIX®

Important Safety Information for TRILIPIX

Indications for TRILIPIX® (fenofibric acid) delayed-release capsules

There is no AB-rated therapeutic equivalent for TRILIPIX¹

DAW Laws by State²

TRILIPIX
STUDY RESULTS

Important Safety Information and Indications for TRILIPIX^®

Indications for TRILIPIX^® (fenofibric acid) delayed-release capsules