FIBRICOR (Page 6 of 7)

14.2 Primary Hypercholesterolemia (Heterozygous Familial and Nonfamilial) and Mixed Dyslipidemia

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).

Table 5. Mean Percent Change in Lipid Parameters at End of Fenofibrate Treatment *
Treatment Group Total-C LDL-C HDL-C TG
*
Duration of study treatment was 3 to 6 months.
p = < 0.05 vs. Placebo
Pooled Cohort
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%
Placebo (n=285) -0.4% -2.2% +0.7% +7.7%
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%
Placebo (n=141) +0.2% -2.2% +2.6% +11.7%
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%
Placebo (n=116) -3.0% -6.6% +2.3% +0.9%

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.

16 HOW SUPPLIED/STORAGE AND HANDLING

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.

17 PATIENT COUNSELING INFORMATION

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

Revised: 12/2020

Reference ID: 4433499

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