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M-FEBUXOSTAT is a brand name for Febuxostat, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ................................................................................ 3 CONTRAINDICATIONS ..................................................................................................... 3 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
Adverse Drug Reaction Overview The following adverse drug reactions are described elsewhere in the product monograph: • Cardiovascular Death (see WARNINGS AND PRECAUTIONS, Cardiovascular and CLINICAL TRIALS). • Serious Skin Reactions (see WARNINGS AND PRECAUTIONS, Skin).
1%). The most frequently reported ADR in the long- term open label extension studies with Febuxostat 80 mg was liver function abnormalities. The overall incidence of adverse reactions did not increase during long-term studies. 9% of allopurinol- treated subjects.
Clinical Trial Adverse Drug Reactions Because clinical trials are conducted under very specific conditions the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse drug reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. In clinical studies, patients received febuxostat in doses ranging from 10 mg to 300 mg. The total exposure to febuxostat 80 mg in randomized controlled studies and long-term extension studies was greater than 2300 patient-years.
For febuxostat 80 mg, 1377 subjects were treated for 6 months, 674 patients were treated for 1 year and 515 patients were treated for 2 years. In the CARES study, a total of 3098 patients were treated with febuxostat 40 mg or up-titrated to 80 mg daily; of these, 2155 patients were treated for ≥1 year and 1539 were treated for ≥2 years.
In three randomized, controlled clinical studies which were 6 to 12 months in duration, the following adverse reactions were reported by the treating physician as related to study drug. 5% higher than placebo. 6% * Of the subjects who received allopurinol, 10 received 100 mg, 145 received 200 mg and 1122 received 300 mg based on level of renal impairment.
5% greater than placebo. Adverse drug reactions (other than cardiovascular events) reported in the CARES Cardiovascular Outcome Study were consistent with those reported in previous Phase 3 clinical trials. For analysis of the cardiovascular events see CLINICAL TRIALS, Use in Patients with Gout and a History of Major Cardiovascular Disease [CARES Cardiovascular Outcomes Trial].
Less Common Clinical Trial Adverse Drug Reactions (<1%) In clinical studies the following causally related adverse reactions occurred in less than 1% of subjects treated with 80 mg of febuxostat. This list also includes adverse reactions which occurred in at least one subject treated with doses ranging from 40 mg to 240 mg of febuxostat.
Serious Warnings and Precautions • Patients with gout and established cardiovascular (CV) disease treated with M- FEBUXOSTAT had a higher rate of CV death compared to those treated with allopurinol in a CV outcomes study (See WARNING AND PRECAUTIONS, Cardiovascular).
• Consider the risks and benefits of M-FEBUXOSTAT when deciding to prescribe or continue patients on M-FEBUXOSTAT. M-FEBUXOSTAT should only be used in patients who have an inadequate response or intolerance to allopurinol, or for whom treatment with allopurinol is inappropriate (See INDICATIONS).
General • Gout Flare M-FEBUXOSTAT treatment should not be started until an acute attack of gout has completely subsided. After initiation of M-FEBUXOSTAT therapy, an increase in gout flares is frequently observed. In order to reduce the likelihood of gout flares when M-FEBUXOSTAT is initiated, concurrent flare prophylactic treatment with drugs such as a non-steroidal anti-inflammatory drug (NSAID) or colchicine is recommended.
Flare prophylactic therapy may be beneficial for up to six months (see CLINICAL TRIALS). If a gout flare occurs during M- FEBUXOSTAT treatment, M-FEBUXOSTAT should not be discontinued. The gout flare should be managed concurrently, as appropriate for the individual patient.
, malignant disease and its treatment, Lesch-Nyhan syndrome). No studies have been conducted in these populations. Febuxostat has not been studied in organ transplant recipients. The use of M-FEBUXOSTAT in these patients with secondary hyperuricemia is not recommended.
73]. 21]. Febuxostat was similar to allopurinol for nonfatal MI, nonfatal stroke and unstable angina with urgent coronary revascularization (see CLINICAL TRIALS). 53)]. A potential increased risk of cardiac failure has also been reported in patients with pre-existing cardiovascular disease and/or risk factors for cardiovascular disease.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Blood and Lymphatic System Disorders: anemia, idiopathic thrombocytopenic purpura, leukocytosis/leukopenia, neutropenia, pancytopenia, splenomegaly, thrombocytopenia. Cardiac Disorders: angina pectoris, atrial fibrillation/flutter, cardiac murmur, ECG abnormal, palpitations, sinus bradycardia, tachycardia.
Ear and Labyrinth Disorders: deafness, tinnitus, vertigo. Eye Disorders: cataract, vision blurred. Gastrointestinal Disorders: abdominal distention, abdominal pain, colitis, constipation, diarrhea, dry mouth, dyspepsia, esophageal stenosis, flatulence, frequent stools, gastritis, gastroenteritis, gastroesophageal reflux disease, gastrointestinal discomfort, gingival pain, hematemesis, hematochezia, hyperchlorhydria, mouth ulceration, pancreatitis, peptic ulcer, rectal hemorrhage, vomiting.
General Disorders and Administration Site Conditions: asthenia, chest pain/discomfort, edema, fatigue, feeling abnormal, gait disturbance, influenza-like symptoms, mass, pain, thirst. Hepatobiliary Disorders: cholelithiasis/cholecystitis, hepatic steatosis, hepatitis, hepatomegaly.
Immune System Disorder: hypersensitivity. Infections and Infestations: cellulitis, herpes zoster, sinusitis, tinea pedis. Injury, Poisoning and Procedural Complications: contusion. Page 9 of 32 Metabolism and Nutrition Disorders: anorexia, appetite decreased/increased, cow’s milk intolerance, dehydration, diabetes mellitus, dyslipidemia, gout, hypercholesterolemia, hyperglycemia, hyperlipidemia, hypertriglyceridemia, hypokalemia, weight decreased/increased.
Musculoskeletal and Connective Tissue Disorders: arthralgia, arthritis, bunion, bursitis, costochondritis, gouty tophus, joint stiffness, joint swelling, muscle spasms/twitching/tightness/weakness, musculoskeletal pain/stiffness, myalgia.
Neoplasms Benign, Malignant and Unspecified: malignant melanoma, myelodysplastic syndrome. Nervous System Disorders: altered taste, amnesia, balance disorder, burning sensation, cerebrovascular […]
Treatment with febuxostat is not recommended in patients with ischemic heart disease or congestive heart failure. Monitor for signs and symptoms of myocardial infarction (MI), stroke and cardiac failure. Consider the risks and benefits of M-FEBUXOSTAT when deciding to prescribe or continue patients on M-FEBUXOSTAT.
Patients should be informed about the symptoms of serious CV events and the steps to take if they occur. Gastrointestinal M-FEBUXOSTAT tablets contain lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactase malabsorption should not take M- FEBUXOSTAT.
Hepatic/Biliary/Pancreatic There have been postmarketing reports of fatal and non-fatal hepatic failure in patients taking Febuxostat, although the reports contain insufficient information necessary to establish the probable cause.
During randomized controlled studies, transaminase elevations greater than three times the upper limit of normal (ULN) were observed (AST: 2%, 2% and ALT: 3%, 2% in Febuxostat and allopurinol-treated patients, respectively). No dose-effect relationship for these transaminase elevations was noted.
Laboratory assessment of liver function is recommended prior to the initiation of M-FEBUXOSTAT therapy and periodically thereafter (see ADVERSE REACTIONS, Abnormal Hematologic and Clinical Chemistry Findings). Obtain a liver test panel (serum alanine aminotransferase [ALT], aspartate aminotransferase [AST], alkaline phosphatase, and total bilirubin) as a baseline before initiating M-FEBUXOSTAT.
Measure liver tests promptly in patients who report symptoms that may indicate liver injury, including fatigue, anorexia, right upper abdominal discomfort, dark urine or jaundice. In this clinical context, if the patient is found to have abnormal liver tests (ALT greater than three times the upper limit of the reference range), M-FEBUXOSTAT treatment should be interrupted and investigation done to establish the probable cause.
M-FEBUXOSTAT should not be restarted in these patients without another explanation for the liver test abnormalities. Patients who have serum ALT greater than three times the reference range with serum total bilirubin greater than two times the reference range without alternative etiologies are at risk for severe drug- induced liver injury and should not be restarted on M-FEBUXOSTAT.
For patients with lesser elevations of serum ALT or bilirubin and with an alternate probable cause, treatment with M- FEBUXOSTAT can be used with caution. Hypersensitivity See Skin. Page 6 of 32 Skin Serious skin and hypersensitivity reactions, including Stevens-Johnson Syndrome, DRESS and Toxic Epidermal Necrolysis have been reported in patients taking febuxostat.
Many of these patients had reported previous similar skin reactions to allopurinol. M-FEBUXOSTAT should be used with caution in […]