fenofibric acid

REMS

To reduce triglycerides (TG) and increase high density lipoprotein-C (HDL-C) in patients with mixed dyslipidemias and CHD or a CHD risk equivalent who are on statin therapy to achieve their low-density lipoprotein-C (LDL-C) goal (TriLipix only) (in combination with a statin).
To reduce TG in patients with severe hypertriglyceridemia.
To reduce elevated LDL-C, total cholesterol, TG, and apolipoprotein B (Apo B), and increase HDL-C in patients with primary hyperlipidemia or mixed dyslipidemia.

Contraind./Precautions ⬆ ⬇

Contraindicated in:

Hypersensitivity to fenofibric acid, choline fenofibrate or fenofibrate;
Severe renal impairment (CCr <30 mL/min);
Hepatic impairment (including primary biliary cirrhosis);
Pre-existing gallbladder disease;
Lactation: Lactation.

Use Cautiously in:

Mild/moderate renal impairment (dose ↓ required for CCr 30–80 mL/min);
Concurrent use with statins in elderly patients, patients with diabetes, renal failure, or hypothyroidism (↑ risk of myopathy/rhabdomyolysis);
OB: Safety not established in pregnancy;
Pedi: Safety and effectiveness not established in children;
Geri: Consider age-related ↓ in renal function, concurrent illnesses and drug therapy in older adults.

Adv. Reactions/Side Effects ⬆ ⬇

Derm: DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS (DRESS), STEVENS-JOHNSON SYNDROME, TOXIC EPIDERMAL NECROLYSIS

GI: diarrhea, nausea, ↑liver enzymes, cholelithiasis, HEPATOTOXICITY, pancreatitis

GU: ↑serum creatinine

MS: myalgia, back pain, MYOPATHY/RHABDOMYOLYSIS

Neuro: headache

Resp: INTERSTITIAL LUNG DISEASE

Misc: HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS AND ANGIOEDEMA)

Interactions ⬆ ⬇

Drug-drug:

↑effects and risk of bleeding with warfarin; closely monitor INR.
Bile acid sequestrants may ↓ absorption and effectiveness; administer at least 1 hr before or 4–6 hr after a bile acid sequestrant.
Concurrent use with nephrotoxic drugs including cyclosporine may impair renal function and excretion, ↑ risk of adverse reactions.
Concurrent use with colchicine may ↑ risk of rhabdomyolysis

Availability ⬆ ⬇

(Generic available)

Delayed-release capsules (Fibricor generic): 105 mg
Delayed-release capsules (TriLipix): 45 mg; 135 mg

Route/Dosage ⬆ ⬇

Hypertriglyceridemia

PO (Adults ): Fibricor (generic): 105 mg once daily; TriLipix: 45–135 mg once daily.

Renal Impairment

PO (Adults ): CCr 30–89 mL/min: Fibricor (generic): Avoid use. TriLipix: 45 mg once daily initially; may titrate, if needed, up to 135 mg once daily.

Primary Hypercholesterolemia or Mixed Dyslipidemia

PO (Adults ): Fibricor (generic): 105 mg once daily; TriLipix: 135 mg once daily.

Renal Impairment

PO (Adults ): CCr 30–89 mL/min: Fibricor (generic): Avoid use. TriLipix: 45 mg once daily initially; may titrate, if needed, up to 135 mg once daily.

US Brand Names ⬆ ⬇

~~Fibricor,~~ TriLipix

Action ⬆ ⬇

Activates the peroxisome proliferator activated receptor α (PPARα), resulting in increased lipolysis and elimination of TG from plasma. Activation of PPARα also increases production of HDL-C.

Therapeutic effects:

Improvement in lipid profile with lowered TG and LDL-C, and increased HDL-C.

Classifications ⬆ ⬇

Therapeutic Classification: lipid-lowering agents

Pharmacologic Classification: fibric acid derivatives

Pharmacokinetics ⬆ ⬇

Absorption: Well absorbed following oral administration.

Distribution: Unknown.

Protein Binding: 99%.

Metabolism/Excretion: Fenofibric acid is the active metabolite of fenofibrate. Fenofibric acid is mostly metabolized by glucuronidation and the metabolites are mostly excreted by the kidneys.

Half-Life: 20 hr.

Time/Action Profile ⬆ ⬇

(effects on blood lipids)

ROUTE	ONSET	PEAK	DURATION
PO	unknown	4–5 hr‡	unknown

‡Blood levels.

Patient/Family Teaching ⬆ ⬇

Instruct patient to take medication as directed. Take missed doses as soon as remembered; if time for next dose, skip dose and take next dose at regular time. Do not double doses. Medication helps control but does not cure elevated serum TG levels. Advise patient to read Medication Guide before starting and with each Rx refill, as new information may be available.
Advise patient that this medication should be used in conjunction with diet restrictions (fat, cholesterol, carbohydrates, alcohol), exercise, and cessation of smoking.
Instruct patient to notify health care professional immediately if signs and symptoms of liver injury (jaundice, abdominal pain, nausea, malaise, dark urine, abnormal stool, pruritus), rash, unexplained muscle pain, tenderness, weakness, tiredness, fever, nausea, vomiting, or abdominal pain occurs, especially if accompanied by fever or malaise or signs and symptoms of hypersensitivity reactions (itching, hives, swollen face or throat, difficulty breathing) occur.
Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications.
Advise patient to notify health care professional of medication regimen before treatment or surgery.
Rep: Advise females of reproductive potential to notify health care professional if pregnancy is planned or suspected and to avoid breastfeeding during therapy and for 5 days after last dose.
Emphasize the importance of follow-up exams to determine effectiveness and to monitor for side effects.

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Indications ⬇