• Fibril indications
• Uses of Fibril in details
• Fibril description
• Fibril dosage
• Fibril interactions
• Fibril side effects
• Fibril contraindications

What is Fibril?

Fibril (Fibril) helps reduce cholesterol and triglycerides (fatty acids) in the blood. High levels of these types of fat in the blood are associated with an increased risk of atherosclerosis (clogged arteries).

Fibril is used to treat high cholesterol and high triglyceride levels.

Fibril may also be used for purposes not listed in this medication guide.

Fibril indications

Primary Hypercholesterolemia or Mixed Dyslipidemia

Fibril are indicated as adjunctive therapy to diet to reduce elevated low-density lipoprotein cholesterol (LDL-C), total cholesterol (total-c), Triglycerides (TG) and apolopoprotein B (Apo B), and to increase high-density lipoprotein cholesterol (HDL-C) in adult patients with primary hypercholesterolemia or mixed dyslipidemia.

Severe Hypertriglyceridemia

Fibril are also indicated as adjunctive therapy to diet for treatment of adult patients with severe hypertriglyceridemia. Improving glycemic control in diabetic patients showing fasting chylomicronemia will usually obviate the need for pharmacologic intervention.

Markedly elevated levels of serum triglycerides (e.g. > 2,000 mg/dL) may increase the risk of developing pancreatitis. The effect of Fibril therapy on reducing this risk has not been adequately studied.

Important Limitations of Use

Fibril at a dose equivalent to 150 mg was not shown to reduce coronary heart disease morbidity and mortality in 2 large, randomized controlled trials of patients with type 2 diabetes mellitus.

How should I use Fibril?

Use Fibril as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Some brands of Fibril should be taken with food. Some brands may be taken with or without food. Ask your pharmacist if you should take your brand of Fibril with food.
• Swallow Fibril whole. Do not open, crush, dissolve, or chew before swallowing. If you cannot swallow Fibril whole, tell your doctor. You may need a different medicine.
• Take Fibril with a full glass of water (8 oz [240 mL]).
• If you also take a bile acid-binding resin (eg, cholestyramine), do not take it within 4 to 6 hours before or 1 hour after taking Fibril. Check with your doctor if you have any questions.
• Take Fibril on a regular schedule to get the most benefit from it.
• Taking Fibril at the same time each day will help you remember to take it.
• Continue to take Fibril even if you feel well. Do not miss any doses.
• If you miss a dose of Fibril, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Fibril.

Uses of Fibril in details

Use: Labeled Indications

Hypercholesterolemia or mixed dyslipidemia: Adjunctive therapy to diet for the reduction of low-density lipoprotein cholesterol (LDL-C), total cholesterol (total-C), triglycerides, and apolipoprotein B (apo B), and to increase high-density lipoprotein cholesterol (HDL-C) in adults with primary hypercholesterolemia or mixed dyslipidemia (Fredrickson types IIa and IIb). Use lipid-altering agents in addition to a diet restricted in saturated fat and cholesterol when response to diet and nonpharmacological interventions alone has been inadequate.

Note: While FDA-approved for hypercholesterolemia, Fibril is not a first- or second-line choice; other agents may be more suitable (ACC/AHA [Stone 2013]). In addition, use is not recommended to lower LDL-C or raise HDL-C in the absence of hypertriglyceridemia.

Hypertriglyceridemia: Adjunctive therapy to diet for treatment of adult patients with severe hypertriglyceridemia (Fredrickson types IV and V hyperlipidemia).

Off Label Uses

Primary biliary cholangitis

Data from a single-center, retrospective cohort study support the use of Fibril (in combination with ursodiol) in patients with primary biliary cholangitis (PBC) who have had an incomplete biochemical response to ursodiol monotherapy and showed significant improvement in alkaline phosphatase, a reduction in hepatic decompensation, and transplant-free survival improvement.

Fibril description

Each film-coated tablet contains Fenofibrate BP 160 mg. It also contains the following excipients: Pregelatinized starch maize, povidone, sodium lauryl sulphate, microcrystalline cellulose, crospovidone, anhydrous colloidal silica, sodium stearyl fumarate, purified water and opadry AMB OY-B-28920.

Fibril is a lipid-regulating agent. The empirical formula is C₂₀H₂₁O₄Cl and the molecular weight is 360.83. Fibril is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester.

Fibril dosage

Fibril Dosage

Generic name: Fibril 160mg

Dosage form: tablet

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

​The dose of Fibril is 160 mg once daily.

​Patients should be placed on an appropriate lipid-lowering diet before receiving Fibril and should continue this diet during treatment with Fibril.

​Lipid levels should be monitored periodically. Therapy should be withdrawn in patients who do not have an adequate response after two months of treatment.

​Fibril tablets can be given without regard to meals. Patients should be advised to swallow Fibril tablets whole. Do not crush, break, dissolve, or chew tablets.

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Consumer resources

• Fibril
• Fibril (Advanced Reading)

• Other brands: Fibril, Lofibra, Lipofen, Fibril, More (1) »

Professional resources

• Fibril (FDA)
• Fenofibric Acid/Fibril (AHFS Monograph)

Related treatment guides

• Hyperlipoproteinemia
• Hyperlipoproteinemia Type IIa, Elevated LDL
• Hyperlipoproteinemia Type IIb, Elevated LDL VLDL
• Hyperlipoproteinemia Type IV, Elevated VLDL
• Hyperlipoproteinemia Type V, Elevated Chylomicrons VLDL
• More (1) »

Fibril interactions

See also:
What other drugs will affect Fibril?

Coumarin Anticoagulants

Potentiation of coumarin-type anticoagulant effect has been observed with prolongation of the PT/INR.

Caution should be exercised when Fibril is given in conjunction with coumarin anticoagulants. Fibril may potentiate the anticoagulant effect of these agents resulting in prolongation of the PT/INR. To prevent bleeding complications, frequent monitoring of PT/INR and dose adjustment of the oral anticoagulant as recommended until the PT/INR has stabilized.

Immunosuppressants

Immunosuppressant agents such as cyclosporine and tacrolimus can impair renal function and because renal excretion is the primary elimination route of fibrate drugs including Fibril, there is a risk that an interaction will lead to deterioration of renal function. When immunosuppressants and other potentially nephrotoxic agents are co-administered with Fibril, the lowest effective dose of Fibril should be employed and renal function should be monitored.

Bile-Acid Binding Resins

Since bile-acid binding resins may bind other drugs given concurrently, patients should take Fibril at least 1 hour before or 4 to 6 hours after a bile acid binding resin to avoid impeding its absorption.

Colchicine

Cases of myopathy, including rhabdomyolysis, have been reported with fenofibrates co-administered with colchicine, and caution should be exercised when prescribing Fibril with colchicine.

Fibril side effects

See also:
What are the possible side effects of Fibril?

Clinical Trials Experience

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.

Fenofibric acid is the active metabolite of Fibril. Adverse events reported by 2% or more of patients treated with Fibril and greater than placebo during double-blind, placebocontrolled trials are listed in Table 1. Adverse events led to discontinuation of treatment in 5.0% of patients treated with Fibril and in 3.0% treated with placebo. Increases in liver tests were the most frequent events, causing discontinuation of Fibril treatment in 1.6% of patients in double-blind trials.

Table 1: Adverse Events Reported by 2% or More of Patients Treated with Fibril and Greater than Placebo During the Double-Blind, Placebo-Controlled Trials

Clinical trials with Fibril did not include a placebo-control arm. However, the adverse event profile of Fibril was generally consistent with that of Fibril. The following adverse events not listed above were reported in ≥ 3% of patients taking Fibril alone:

Gastrointestinal Disorders: Diarrhea, dyspepsia

General Disorders and Administration Site Conditions: Pain

Infections and Infestations: Nasopharyngitis, sinusitis, upper respiratory tract infection

Musculoskeletal and Connective Tissue Disorders: Arthralgia, myalgia, pain in extremity

Nervous System Disorders: Dizzinesss

Postmarketing Experience

The following adverse events have been identified during postapproval use of Fibril: rhabdomyolysis, pancreatitis, renal failure, muscle spasms, acute renal failure, hepatitis, cirrhosis, anemia, asthenia, and severely depressed HDL-cholesterol levels.

Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Fibril contraindications

See also:
What is the most important information I should know about Fibril?

Hypersensitivity to Fibril or fenofibric acid or to any of the excipients of Fibril.

Severe renal impairment/insufficiency, including those receiving dialysis.

Active liver disease/dysfunction/insufficiency, including those with primary biliary cirrhosis and unexplained persistent liver function abnormalities eg, persistent elevations in serum transaminases. Pre-existing gallbladder disease.

Photoallergy or phototoxic reaction during treatment with fibrates or ketoprofen.

Chronic or acute pancreatitis with the exception of acute pancreatitis due to severe hypertriglyceridemia.

Fibril contains lecithin soya as an excipient and therefore, Fibril should not be taken with allergic to peanut or arachis oil or soya lecithin, or related products due to the risk of hypersensitivity reactions.

Use in lactation: Fibril should not be used in nursing mothers. Because of the potential for tumorigenicity seen in animal studies, a decision should be made whether to discontinue nursing or to discontinue Fibril, taking into account the importance of Fibril to the mother. There are no data on the excretion of Fibril and/or its metabolites into breast milk.

Use in children: Safety and effectiveness in pediatric patients aged <18 years have not been established.

Active ingredient matches for Fibril:

Fenofibrate in Bangladesh, Philippines, Thailand.

Gemfibrozil in Bangladesh, Philippines, Thailand.

Micronized fenofibrate in Thailand.

Ispaghula husk in India.

References

1. DailyMed. "GEMFIBROZIL: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
2. DailyMed. "FENOFIBRATE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
3. PubChem. "gemfibrozil". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology