Fibre200 mg

Fibre is a fibric acid derivative (fibrate) used as an adjunct to diet for the management of lipid disorders. Its evidence-based uses include:

Established / FDA-approved uses

• Primary hypercholesterolemia and mixed dyslipidemia (Fredrickson Types IIa and IIb) — used together with diet to reduce elevated LDL cholesterol, total cholesterol, triglycerides, and apolipoprotein B, and to increase HDL cholesterol in adult patients who have not responded adequately to diet alone.
• Severe hypertriglyceridemia (Fredrickson Types IV and V) — used as an adjunct to diet in adult patients with very high triglyceride levels who are at risk of pancreatitis and have not responded adequately to dietary measures.

Guideline-supported / adjunct use

• May be used in combination with a statin in selected high-risk patients with mixed dyslipidemia when triglycerides remain elevated despite statin therapy, but this combination requires careful monitoring for muscle toxicity (see Precautions).

Fibre has not been shown to reduce coronary heart disease morbidity or mortality in controlled clinical trials, and it is not indicated to prevent cardiovascular events on its own.

Fibre is an oral lipid-regulating agent belonging to the fibric acid derivative (fibrate) class. It works primarily by activating a nuclear receptor that regulates lipid and lipoprotein metabolism, leading to reductions in triglycerides and LDL cholesterol along with an increase in HDL cholesterol.

It is available in Bangladesh and internationally as capsules and tablets in various micronized and non-micronized formulations, taken once daily, typically with a meal to improve absorption.

Fibre belongs to the fibric acid derivative (fibrate) class of lipid-regulating agents, a group of antihyperlipidemic drugs distinct from statins, bile acid sequestrants, and niacin.

Fenofibrate is a prodrug that is rapidly hydrolyzed by esterases to its active form, fenofibric acid. Fenofibric acid activates peroxisome proliferator-activated receptor alpha (PPAR-α), which increases lipolysis and elimination of triglyceride-rich particles from plasma by activating lipoprotein lipase and reducing production of apolipoprotein C-III. Activation of PPAR-α also induces synthesis of apolipoproteins A-I and A-II, raising HDL cholesterol.

Overall, therapy with Fenofibrate reduces total cholesterol, LDL cholesterol, triglycerides, and apolipoprotein B, while increasing HDL cholesterol. Peak plasma concentrations of fenofibric acid occur several hours after an oral dose; absorption is enhanced when taken with food. Fenofibric acid is highly protein-bound, metabolized mainly by glucuronidation, and eliminated primarily in urine, with an elimination half-life of approximately 20 hours.

Statins (HMG-CoA reductase inhibitors)

Concomitant use of Fibre with a statin increases the risk of myopathy and rhabdomyolysis. This combination should be reserved for patients in whom the benefit is judged to outweigh the risk, and only under close medical supervision with monitoring for muscle pain, tenderness, or weakness.

Oral anticoagulants (e.g., warfarin)

Fibre can potentiate the anticoagulant effect of warfarin and other coumarin-type anticoagulants, prolonging prothrombin time/INR and increasing bleeding risk. The anticoagulant dose should be reduced and INR monitored more frequently when Fibre is started, adjusted, or stopped.

Cyclosporine and other nephrotoxic drugs

Co-administration with cyclosporine or tacrolimus may increase the risk of renal function deterioration; the lowest effective doses of both drugs should be used, with renal function monitored closely.

Bile acid-binding resins

Resins such as cholestyramine can bind Fibre and reduce its absorption; if co-administered, doses should be separated by at least 1 hour before or 4–6 hours after the resin.

Colchicine

Combined use has been associated with reports of myopathy, including rhabdomyolysis; caution is advised, particularly in elderly patients or those with renal impairment.

Like most medicines, Fibre can cause side effects in some patients, though not everyone experiences them.

Common

• Headache
• Nausea, abdominal pain, diarrhoea, or other mild gastrointestinal upset
• Back pain
• Mild elevations in liver enzymes
• Respiratory symptoms (e.g., upper respiratory infection-like symptoms in trials)

Less common but clinically important

• Myopathy and, rarely, rhabdomyolysis (muscle pain, tenderness, or weakness with elevated creatine kinase) — see Precautions.
• Elevated serum creatinine (usually reversible after stopping the drug).
• Gallstones (cholelithiasis) — see Contraindications/Precautions.
• Pancreatitis (uncommon).
• Hepatotoxicity, including significant transaminase elevation.
• Hypersensitivity reactions, including skin rash.
• Decreased haemoglobin, haematocrit, or white blood cell count (usually mild and stabilizes with continued therapy).

Pregnancy: There are insufficient data on the use of Fibre in pregnant women to establish safety. Fibre should be used during pregnancy only if the potential benefit clearly justifies the potential risk to the fetus, and only under a physician's guidance.

Lactation: It is not known whether Fibre or its metabolites pass into human breast milk; because of the potential for serious adverse reactions in a nursing infant, a decision should be made to discontinue nursing or discontinue Fibre, taking into account the importance of the drug to the mother. Many product labels consider breastfeeding a contraindication to use (see Contraindications). Always consult a physician before use during pregnancy or breastfeeding.

Myopathy and rhabdomyolysis

Fibre can cause muscle injury, including rare rhabdomyolysis with acute kidney injury. Risk is higher in elderly patients, those with diabetes, renal impairment, hypothyroidism, or when combined with a statin or colchicine. Patients should be advised to report unexplained muscle pain, tenderness, or weakness, particularly if accompanied by fever or malaise; therapy should be discontinued if myopathy is suspected or creatine kinase is markedly elevated.

Hepatotoxicity

Dose-related increases in liver transaminases can occur. Liver function should be monitored periodically, and Fibre discontinued if enzyme elevations persist (greater than 3 times the upper limit of normal) or if signs of liver injury develop.

Gallstones

Fibre increases cholesterol excretion into the bile, which may increase the risk of gallstone formation. If gallstones are suspected, gallbladder studies are indicated; if gallstones are found, Fibre should be discontinued.

Renal function

Reversible increases in serum creatinine may occur. Renal function should be monitored, especially in patients with pre-existing renal impairment; treatment should be interrupted if renal function meaningfully deteriorates.

Pancreatitis

Pancreatitis has been reported, including in patients with severe hypertriglyceridemia during treatment; consider this if unexplained abdominal pain develops.

Hematologic effects

Mild decreases in haemoglobin, haematocrit, and white cell count have been observed; periodic blood counts are advisable during the first year of therapy.

There is no specific antidote for Fibre overdose. In case of suspected overdose, seek immediate medical attention or contact a poison control center right away. Treatment is supportive and symptomatic, and may include general measures to reduce further drug absorption if the overdose is recent and the patient presents promptly to a healthcare facility; Fibre is not removed by hemodialysis. Do not attempt to manage a suspected overdose at home.

Store at room temperature (below 30°C), away from light and moisture. Keep out of reach of children.

Elderly patients

Dose selection should be cautious, generally starting at the lower end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function and concomitant disease or other drug therapy in this population. Elderly patients are also at higher risk of myopathy.

Renal impairment

Use the lowest available dose in mild-to-moderate impairment and monitor closely; avoid use in severe renal impairment/dialysis (see Contraindications).

Hepatic impairment

Not systematically studied; avoid in active liver disease and monitor liver enzymes during use.

Pediatric use

Safety and efficacy of Fibre have not been established in patients under 18 years of age; it is not recommended for use in children.

Safety and efficacy of Fibre have not been established in children and adolescents under 18 years of age. Fibre is not recommended for pediatric use outside of specialist care for rare, severe inherited lipid disorders, and only under close physician supervision.