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Antara is a brand name for Fenofibrate. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 1 INDICATIONS AND USAGE Antara is indicated as adjunctive therapy to diet: To reduce triglyceride (TG) levels in adults with severe hypertriglyceridemia (TG greater than or equal to 500 mg/dL). To reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia when use of recommended…
Verbatim from this product's FDA label. Tap a section to expand.
2 ). 2 ). 2 ). Assess TG when clinically appropriate, as early as 4 to 8 weeks after initiating Antara. 2 ). 3 ). 4 ). 1 Prior to Initiation of Antara Assess lipid levels before initiating therapy. , diabetes mellitus, hypothyroidism, or medications) of high triglyceride levels and manage as appropriate.
Patients should be placed on an appropriate lipid-lowering diet before receiving Antara and should continue this diet during treatment with Antara. In patients with diabetes and fasting chylomicronemia, improve glycemic control prior to considering starting Antara.
2 Recommended Dosage and Administration • Severe hypertriglyceridemia : ○ The recommended dosage of Antara is 30 mg or 90 mg orally once daily. ○ Dosage should be individualized according to patient response, and should be adjusted if necessary following repeat lipid determinations at 4 to 8 week intervals.
• Primary hyperlipidemia : ○ The recommended dosage of Antara is 90 mg orally once daily. • Administer Antara as a single dose at any time of day, with or without food. • Advise patients to swallow Antara capsules whole. Do not crush, break, dissolve, or chew capsules.
• Assess TG when clinically appropriate, as early as 4 to 8 weeks after initiating Antara. Discontinue Antara in patients who do not have an adequate response after two months of treatment. • If a dose is missed, advise patients not to take an extra dose.
Resume treatment with the next dose. • Advise patients to take Antara at least 1 hour before or 4 hours to 6 hours after a bile acid binding resin to avoid impeding its absorption. 4 )]. 73m 2 ), and increased only after evaluation of the effects on renal function and TG levels at this dose.
3 ) ].
1 ). To report SUSPECTED ADVERSE REACTIONS, contact Lupin Pharmaceuticals, Inc. gov/medwatch . 1 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 rates observed in clinical practice.
The Safety of Antara has been established in adults with hypertriglyceridemia or primary hyperlipidemia based on adequate and well-controlled trials of other formulations of fenofibrate, referenced below as "fenofibrate" [see Clinical Studies ( 14 )].
3 )]. Adverse events reported by 2% or more of patients treated with fenofibrate (and greater than placebo) during double-blind, placebo-controlled trials are listed in Table 1. Adverse reactions led to discontinuation of treatment in 5% of patients treated with fenofibrate and in 3% treated with placebo.
6% of patients in double-blind trials. 1 vs. 4 vs. 8% of fenofibrate and placebo patients, respectively, in controlled trials. 1% of patients treated with 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 dosages comparable to 60 mg to 90 mg Antara daily and was 0% in those receiving dosages comparable to 30 mg or less Antara daily or placebo.
2 Postmarketing Experience The following adverse reactions have been identified during post approval use of fenofibrate. Because these reactions 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.
Blood Disorders:
Anemia Gastrointestinal Disorders: Pancreatitis General Disorder: Asthenia Hepatobiliary Disorders: Increased total bilirubin, hepatitis, cirrhosis Immune System Disorders: Anaphylaxis, angioedema Lipid Disorders: Severely depressed HDL-cholesterol levels Musculoskeletal Disorders: Myalgia, muscle spasms, rhabdomyolysis, arthralgia Renal and Urinary Disorders: Acute renal failure Respiratory Disorders: Interstitial lung disease Skin and Subcutaneous Tissue Disorders: Photosensitivity reactions.
5 WARNINGS AND PRECAUTIONS Hepatotoxicity : Serious drug-induced liver injury, including liver transplantation and death, has been reported with Antara. Monitor patient's liver function, including serum ALT, AST, and total bilirubin, at baseline and periodically for the duration of therapy.
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Myopathy and rhabdomyolysis :
Have been reported in patients taking fenofibrate. Risks are increased during co-administration with a statin, particularly in elderly patients and patients with diabetes, renal failure, or uncontrolled hypothyroidism. Discontinue Antara if markedly elevated CK levels occur or if myopathy is either diagnosed or suspected.
Temporarily discontinue Antara in patients experiencing an acute or serious condition at high risk of developing renal failure secondary to rhabdomyolysis. Inform patients of the risk of myopathy and rhabdomyolysis when starting or increasing the Antara dosage.
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Serum creatinine:
Increases in serum creatinine have been reported in patients on Antara. Monitor renal function in patients with renal impairment taking Antara. 4 ).
Cholelithiasis:
Fenofibrate increases cholesterol excretion into the bile, leading to risk of cholelithiasis. If cholelithiasis is suspected, gallbladder studies are indicated. 5 ).
Hypersensitivity Reactions:
Acute hypersensitivity reactions, including anaphylaxis and angioedema, and delayed hypersensitivity reactions, including severe cutaneous adverse drug reactions have been reported postmarketing. Some cases were life-threatening and required emergency treatment.
3 ) ]. 2 ) ]. 5 ) ]. Hypersensitivity to fenofibric acid, fenofibrate, or any of the excipients in Antara. 9 ) ].
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Fenofibrate in United States of America.
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This may occur in patients who report a prior photosensitivity reaction to ketoprofen.
9 ). 4 )] . Because of chemical, pharmacological, and clinical similarities between Antara, pemafibrate, clofibrate, and gemfibrozil, findings in 5 large randomized, placebo-controlled clinical trials with these other fibrate drugs may also apply to Antara.
4 )] . In the Coronary Drug Project, a large trial conducted from 1965 to 1985 in men post myocardial infarction, there was no difference in mortality or nonfatal myocardial infarction between the clofibrate group and the placebo group after 5 years of treatment (NCT00000482).
In a trial conducted by the World Health Organization (WHO) from 1965 to 1976, men without known coronary artery disease were treated with placebo or clofibrate for 5 years and followed for an additional one year. 70% vs. 01). Excess mortality was due to a 33% increase in non-cardiovascular causes, including malignancy, post-cholecystectomy complications, and pancreatitis.
The Helsinki Heart Study, conducted from 1982 to 1987, was a large (n=4,081) trial of middle-aged men without a history of coronary artery disease. 5 year open extension afterward. 64]. A secondary prevention component of the Helsinki Heart Study treated middle-aged men with gemfibrozil or placebo for 5 years.
05. 2 Hepatotoxicity Serious drug-induced liver injury (DILI), including liver transplantation and death, has been reported postmarketing with Antara. DILI has been reported within the first few weeks of treatment or after several months of therapy and in some cases has reversed with discontinuation of Antara treatment.
Patients with DILI have experienced signs and symptoms including dark urine, abnormal stool, jaundice, malaise, abdominal pain, myalgia, weight loss, pruritus, and nausea. Many patients had concurrent elevations of total bilirubin, serum alanine transaminase (ALT), and aspartate transaminase (AST).
DILI has been characterized as hepatocellular, chronic active, and cholestatic hepatitis, and cirrhosis has occurred in association with chronic active hepatitis. In clinical trials, fenofibrate at dosages comparable to 30 mg or 90 mg of Antara per day has been associated with increases in serum AST or ALT.
1 )] . Antara is contraindicated in patients with active liver disease, including those with unexplained persistent liver function abnormalities [see Contraindications ( 4 )]. Monitor patient's liver function, including serum ALT, AST, and total bilirubin, at baseline and periodically for the duration of therapy with Antara.
Discontinue Antara if signs or symptoms of liver injury develop or if elevated enzyme levels persist (ALT or AST > 3 times the upper limit of normal, or if accompanied by elevation of bilirubin). Do not restart Antara in these patients if there is no alternative explanation for the liver injury.
3 Myopathy and Rhabdomyolysis Antara may cause myopathy [muscle pain, tenderness, or weakness associated with elevated creatine kinase (CK)] and rhabdomyolysis. 6 )] . Steps to Prevent or Reduce the Risk of Myopathy and Rhabdomyolysis Data from observational studies indicate that the risk for rhabdomyolysis is increased when fibrates are co-administered with a statin.
3 ) ]. Cases of myopathy, including rhabdomyolysis, have been reported with Antara co-administered with colchicine. Consider whether the benefit of using colchicine concomitantly with Antara outweighs the increased risk of myopathy [see Drug Interactions ( 7 ) ].
Discontinue Antara if markedly elevated CK levels occur or if myopathy is either diagnosed or suspected. Muscle symptoms and CK elevations may resolve if Antara is discontinued. , sepsis; shock; severe hypovolemia; major surgery; trauma; severe metabolic, endocrine, or electrolyte disorders; or uncontrolled epilepsy).
Inform patients of the risk of myopathy and rhabdomyolysis when starting or increasing the Antara dosage. Instruct patients to promptly report any unexplained muscle pain, tenderness or weakness, particularly if accompanied by malaise or fever.
4 Increases in Serum Creatinine Increases in serum creatinine have been reported in patients on Antara. These increases tend to return to baseline following discontinuation of Antara. The clinical significance of this finding is unknown.
Monitor renal function in patients with renal impairment taking Antara. Renal monitoring should also be considered for patients taking Antara at risk for renal insufficiency such as the elderly and patients with diabetes. 3 )] . 5 Cholelithiasis Fenofibrate may increase cholesterol excretion into the bile, leading to cholelithiasis.
If cholelithiasis is suspected, gallbladder studies are indicated. Antara therapy should be discontinued if gallstones are found. Antara is contraindicated in patients with pre-existing gallbladder disease. 6 Increased Bleeding Risk with Coumarin Anticoagulants Caution should be exercised when anticoagulants are given in conjunction with Antara because of the potentiation of coumarin-type anti-coagulants in prolonging the prothrombin time/International Normalized Ratio (PT/INR).
To prevent bleeding complications, frequent monitoring of PT/INR and dosage adjustment of the anticoagulant are recommended until PT/INR has stabilized [see Drug Interactions ( 7 ) ]. 7 Pancreatitis Pancreatitis has been reported in patients taking Antara.
This occurrence may represent a failure of efficacy in patients with severe hypertriglyceridemia, a direct drug effect, or a secondary phenomenon mediated through biliary tract stone or sludge formation with obstruction of the common bile duct.
8 Hematologic Changes Mild to moderate hemoglobin, hematocrit, and white blood cell decreases have been observed in patients following initiation of Antara. However, these levels stabilize during long-term administration. Thrombocytopenia and agranulocytosis have been reported in individuals treated with Antara.
Periodic monitoring of red and white blood cell counts is recommended during the first 12 months of Antara administration. 9 Hypersensitivity Reactions Acute Hypersensitivity Anaphylaxis and angioedema have been reported postmarketing with fenofibrate.
In some cases, reactions were life-threatening and required emergency treatment. If a patient develops signs or symptoms of an acute hypersensitivity reaction, advise them to seek immediate medical attention and discontinue Antara. Antara is contraindicated in patients with a hypersensitivity to fenofibrate, fenofibric acid, or any of the ingredients in Antara.
Delayed Hypersensitivity Severe cutaneous adverse drug reactions (SCAR), including Stevens-Johnson syndrome, Toxic Epidermal Necrolysis, and Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), have been reported postmarketing, occurring days to weeks after initiation of Antara.
The cases of DRESS were associated with cutaneous reactions (such as rash or exfoliative dermatitis) and a combination of eosinophilia, fever, systemic organ involvement (renal, hepatic, or respiratory). Discontinue fenofibrate and treat patients appropriately if SCAR is suspected.
10 Venothromboembolic Disease In the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) trial, pulmonary embolus (PE) and deep vein thrombosis (DVT) were observed at higher rates in the fenofibrate than the placebo-treated group.
Of 9,795 patients enrolled in FIELD, there were 4,900 in the placebo group and 4,895 in the fenofibrate group. 022). 2% vs. 01). 3%) subjects in the placebo group. 2%) subjects in the placebo group. 11 Paradoxical Decrease in HDL Cholesterol Levels There have been postmarketing and clinical trial reports of severe decreases in HDL cholesterol levels (as low as 2 mg/dL) occurring in patients with and without diabetes initiated on fibrate therapy.
The decrease in HDL-C is mirrored by a decrease in apolipoprotein A1. This decrease has been reported to occur within 2 weeks to years after initiation of fibrate therapy. The HDL-C levels remain depressed until fibrate therapy has been withdrawn; the response to withdrawal of fibrate therapy is rapid and sustained.
The clinical significance of this decrease in HDL-C is unknown. Check HDL-C levels within the first few months after initiation of Antara. If a severely depressed HDL-C level is detected, discontinue Antara and monitor HDL-C until it has returned to baseline.
Antara should not be re-initiated.