Fenofibric acid tablets

Fenofibric acid modifies lipids by activating peroxisome proliferator-activated receptor a (PPARa). Through this mechanism, fenofibric acid activates lipoprotein lipase and reduces the production of ApoCIII (lipoprotein lipase inhibitor), thereby increasing fat decomposition and eliminating triglyceride-rich particles in plasma. The reduction of TG causes changes in the size and composition of LDL, from small dense particles to large buoyant particles. These larger particles have a greater affinity for cholesterol receptors and are rapidly degraded. The activation of PPARa also induces increased synthesis of HDL-C, ApoAI and AII. Fenofibrate can also reduce serum uric acid levels in patients with hyperuricemia and normal people by increasing the urinary excretion of uric acid.

The main ingredient of this product is fenofibric acid. Chemical name: 2-[4-(4-chlorobenzoyl)phenoxy]-2-methylpropionic acid Structural formula: Molecular formula: C17H15ClO4 Molecular weight: 318.75

This product is white or off-white tablets.

On the basis of controlled diet: 1. Used to reduce triglyceride (TG) levels in patients with severe hypertriglyceridemia (500 mg/dL). 2. Used to treat adult patients with primary hypercholesterolemia or mixed dyslipidemia. In a large-scale randomized controlled clinical trial conducted on patients with type 2 diabetes, fenofibrate equivalent to 105 mg of fenofibric acid did not show an effect on reducing the incidence and mortality of coronary heart disease in patients.

It is generally considered that patients should follow an appropriate low-fat diet before receiving fenofibric acid treatment, and continue to control their diet during treatment. This product does not need to be taken with meals. Blood lipids should be monitored regularly during treatment with this product. It is recommended that patients swallow the entire fenofibric acid tablet. Do not crush, dissolve or chew it. If the maximum recommended daily dose of 105 mg is not adequately effective after 2 months of treatment, treatment with this product should be stopped. If the blood lipid level is significantly lower than the target range, the dose of this product should be considered to be reduced. The initial dose for severe hypertriglyceridemia is 35~105mg/day. Give individualized dosing according to the patient's efficacy response, re-test blood lipids every 4~8 weeks, and adjust the dose if necessary. The maximum dose is 105mg/time, once a day. The dose for primary hypercholesterolemia and mixed dyslipidemia is 105mg/day. Patients with renal impairment For patients with mild and moderate renal impairment, the initial dose is 35mg/day, once a day, and whether to increase the dose is determined based on renal function evaluation and blood lipid levels. Patients with severe renal impairment are prohibited from using fenofibric acid. Elderly patients The dosage of elderly patients should be selected according to their renal function.

The following serious adverse reactions are described below and are listed in the instructions for other items: mortality and coronary heart disease morbidity (see [Precautions]) Hepatotoxicity (see [Precautions]) Pancreatitis (see [Precautions]) Allergic reactions (see [Precautions]) Venous thromboembolic disease (see [Precautions]) Clinical trial experience Because the conditions for conducting clinical trials vary greatly, the adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with the incidence in the clinical trials of another drug, and may not reflect the incidence observed in practice. In double-blind, placebo-controlled trials, adverse reactions reported by ≥2% of fenofibrate-treated patients (and greater than placebo) are listed in Table 1. 5% of patients in the fenofibrate group discontinued due to adverse reactions and 3% in the placebo group. In double-blind trials, the most common event, increased liver function tests, led to discontinuation of 1.6% of patients in the fenofibrate treatment group. Table 1 Adverse Reactions Reported in ≥ 2% of Patients Treated with Fenofibrate in Double-blind, Placebo-controlled Trials Physical System Adverse Reactions Fenofibrate 1 (N=439) Placebo (N=365) Generalized abdominal pain 4.6% 4.4% Back pain 3.4% 2.5% Headache 3.2% 2.7% Digestive System Abnormal liver function test 7.5% 21.4% Nausea 2.3% 1.9% Constipation 2.1% 1.4% Metabolism and Nutritional Disorders ALT increased 3.0% 1.6% CPK increased 3.0% 1.4% AST increased 3.4% 0.5% Respiratory System Respiratory disorders 6.2% 5.5% Rhinitis 2.3% 1.1% 1 Fenofibric acid is the active metabolite of fenofibrate; the dose of fenofibrate is equivalent to 105 mg fenofibric acid; 2 There is a significant difference compared with the placebo group. In controlled trials, the incidence of urticaria was 1.1% vs. 0% in patients taking fenofibrate and placebo, respectively, and the incidence of rash was 1.4% vs. 0.8%, respectively. Liver Enzyme Elevations In a pooled analysis of 10 placebo-controlled trials, the incidence of ALT elevations to 3 times the upper limit of normal was 5.3% in patients taking fenofibrate and 1.1% in patients taking placebo. In an 8-week study, the incidence of ALT or AST elevations ≥ 3 times the upper limit of normal was 13% in patients receiving equivalent doses of fenofibric acid 35 to 105 mg once daily and 0% in patients receiving equivalent doses of fenofibric acid 35 mg or less or placebo once daily. Postmarketing Experience The following adverse reactions have been identified with fenofibrate after approval. Because these adverse reactions are reported voluntarily from a population of uncertain size, their incidence cannot be reliably estimated or a causal relationship to drug exposure established: myalgia, rhabdomyolysis, pancreatitis, muscle cramps, acute renal failure, hepatitis, cirrhosis, total bilirubin increased, anemia, headache, arthralgia, hemoglobin decreased, hematocrit decreased, leukocytopenia, fatigue, severely decreased high-density lipoprotein cholesterol level, and interstitial lung disease. Photosensitivity reactions to fenofibrate occur days to months after the initial reaction; in some of these cases, patients reported prior photosensitivity reactions to ketoprofen.

Severe renal impairment, including patients on dialysis; patients with active liver disease, including primary biliary cirrhosis and patients with unexplained persistent liver function abnormalities; patients with gallbladder disease; patients with known hypersensitivity to fenofibric acid or fenofibrate; breastfeeding women.

Precautions for children: The efficacy and safety of fenofibric acid for children have not been established. Precautions for pregnancy and lactation: There is insufficient data on the use of this product in pregnant women. Animal experimental results show that this product has no teratogenic effect. At doses within the maternal toxicity range, embryotoxicity has been shown. The potential risks of human use are not yet clear. Therefore, during pregnancy, this product can only be used after careful benefit/risk assessment. During lactation, it is not clear whether fenofibric acid choline and/or its metabolites will enter breast milk. At present, the risk of this product to breastfeeding infants cannot be ruled out. Therefore, this product is contraindicated during lactation. Fertility There is no clinical data on the effect of this product on fertility. In animal experiments, it was observed that the effect of fenofibrate on fertility is reversible. Precautions for the elderly: Fenofibric acid is mainly excreted through the kidneys, and patients with renal impairment are at greater risk of adverse reactions. Fenofibric acid exposure is not affected by age. Since the incidence of renal impairment in elderly patients is higher, the dose should be adjusted according to the renal function of elderly patients. No dose adjustment is required for elderly patients with normal renal function. Renal function monitoring should be considered in elderly patients while taking this product.

Coumarin anticoagulants It has been found that the anticoagulant effect of coumarin increases with the prolongation of PT/INR. Coumarin anticoagulants and fenofibric acid should be used with caution. To prevent bleeding complications, the dose of anticoagulants should be reduced to maintain the PT/INR at the expected level. Frequent PT/INR measurements are recommended before the PT/INR is determined to be stable (see [Precautions]). Bile acid binding resins Since bile acid binding resins can bind to concomitant drugs, patients should take fenofibric acid at least 1 hour before or 4 to 6 hours after taking bile acid binding resins to avoid hindering its absorption. Immunosuppressants such as cyclosporine and tacrolimus can reduce serum creatinine clearance and increase serum creatinine, resulting in nephrotoxicity. Because the main excretion route of fibrates (including fenofibric acid) is renal excretion, drug interactions may lead to the risk of worsening renal function. The benefits and risks of using fenofibric acid with immunosuppressants and other potentially nephrotoxic drugs should be carefully considered, and the lowest effective dose should be used and renal function should be monitored. Colchicine Concomitant use of fenofibrate and colchicine has been reported to cause myopathy, including events of rhabdomyolysis, and caution should be exercised when prescribing fenofibrate and colchicine.

Keep in a dark place and sealed tightly, store at a temperature not exceeding 30℃.

35 mg

24 months.

Changchun HaiYue Pharmaceutical Limited By Share Ltd.

• Founded in:

  1992-09-12

• Address:

  No. 5555, Shuangying Road, Shuangyang Economic Development Zone, Shuangyang District, Changchun City

• Tax NO.:

  912201016059030427

• Registered Funds:

  226.1666 million yuan

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