The effects of fenofibrate at doses equivalent to 105 mg of FIBRICOR were assessed from four randomized, placebo-controlled, double-blind, parallel-group studies including patients with the following mean baseline lipid values: Total-C 306.9 mg/dL; LDL-C 213.8 mg/dL; HDL-C 52.3 mg/dL; and triglycerides 191.0 mg/dL. Fenofibrate therapy lowered LDL-C, Total-C, and the LDL-C/HDL-C ratio. Fenofibrate therapy also lowered triglycerides and raised HDL-C (see Table 5).
|Mean baseline lipid values (n=646)||306.9 mg/dL||213.8 mg/dL||52.3 mg/dL||191.0 mg/dL|
|All FEN (n=361)||-18.7%†||-20.6%†||+11.0%†||-28.9%†|
|Baseline LDL-C >160 mg/dL and TG <150 mg/dL (Type IIa)|
|Mean baseline lipid values (n=334)||307.7 mg/dL||227.7 mg/dL||58.1 mg/dL||101.7 mg/dL|
|All FEN (n=193)||-22.4%†||-31.4%†||+9.8%†||-23.5%†|
|Baseline LDL-C >160 mg/dL and TG ≥150 mg/dL (Type IIb)|
|Mean baseline lipid values (n=242)||312.8 mg/dL||219.8 mg/dL||46.7 mg/dL||231.9 mg/dL|
|All FEN (n=126)||-16.8%†||-20.1%†||+14.6%†||-35.9%†|
In a subset of the subjects, measurement of Apo B was conducted. Fenofibrate treatment significantly reduced Apo B from baseline to endpoint as compared with placebo (-25.1% vs. 2.4%, p < 0.0001, n=213 and 143 respectively).
The effect of FIBRICOR on cardiovascular morbidity and mortality has not been determined.
FIBRICOR® (fenofibric acid) Tablets 35 mg, are white, round tablets, debossed “AR 787” on one side and blank on the other side.
|Bottles of 30||NDC 71511-501-30|
FIBRICOR® (fenofibric acid) Tablets 105 mg, are white, modified oval tablets, debossed “AR 788” on one side and blank on the other side.
|Bottles of 30||NDC 71511-502-30|
Store at USP controlled room temperature 20-25ºC (68-77ºF); excursions permitted to 15-30ºC (59-86ºF)
DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.
Patients should be advised:
- of the potential benefits and risks of FIBRICOR.
- not to use FIBRICOR if there is a known hypersensitivity to fenofibrate or fenofibric acid.
- that if they are taking coumarin anticoagulants, FIBRICOR may increase their anticoagulant effect, and increased monitoring may be necessary.
- of medications that should not be taken in combination with FIBRICOR.
- to continue to follow an appropriate lipid-modifying diet while taking FIBRICOR.
- to take FIBRICOR once daily, without regard to food, at the prescribed dose, swallowing each tablet whole.
- to inform their physician of all medications, supplements, and herbal preparations they are taking and any change to their medical condition. Patients should also be advised to inform their physicians prescribing a new medication that they are taking FIBRICOR.
- to inform their physician of any muscle pain, tenderness, or weakness; onset of abdominal pain; or any other new symptoms.
- to return to their physician’s office for routine monitoring.
- not to breastfeed during treatment with FIBRICOR and for 5 days after the final dose.
TriCor® is a registered trademark of Abbott Laboratories.
FIBRICOR® is a registered U.S. trademark of Athena Bioscience LLC
U.S. Patent Nos. 7,569,612; 7,741,373; 7,741,374; and 7,915,247.
|Manufactured for:||Athena Bioscience LLC|
|Athens, GA 30601|
Reference ID: 4433499
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