No dose adjustment is necessary in patients with mild or moderate hepatic impairment (Child-Pugh Class A or B). Febuxostat is a non-purine xanthine oxidase (XO) inhibitor.4 In early 2008, febuxostat was granted marketing authorization by the European Commission for the treatment of chronic hyperuricemia and gout.5 In the following year, the FDA for approved febuxostat for use in the chronic management of hyperuricemia in adult patients with gout who have an inadequate response or intolerance to allopurinol.10 Gout is a form of arthritis that is caused by the accumulation of uric acid crystal in or around a joint, leading to inflammation and further deposition of uric acid crystal deposition in bones, joints, tissues, and other organs in the long term. Keep using this medicine even if this happens. The agency has also approved colchicine as an oral solution for prophylaxis of gout flares in adults. URL of this page: https://medlineplus.gov/druginfo/meds/a609020.html. Febuxostat tablets can be taken with antacids. [, Tsuda H, Kawada N, Kaimori JY, Kitamura H, Moriyama T, Rakugi H, Takahara S, Isaka Y: Febuxostat suppressed renal ischemia-reperfusion injury via reduced oxidative stress. Gandhi PK, Gentry WM, Bottorff MB: Cardiovascular thromboembolic events associated with febuxostat: investigation of cases from the FDA adverse event reporting system database. J Clin Pharmacol. Eye Disorders: vision blurred. Ask your healthcare professional how you should dispose of any medicine you do not use. Antacids such as magnesium hydroxide and aluminum hydroxide delay absorption by approximately 1 hour, but the extent of absorption is not affected. Mean Cmax and AUC values for three active metabolites increased up to two and four-fold, respectively. The excretion of Abemaciclib can be decreased when combined with Febuxostat. No studies have been conducted in patients with severe hepatic impairment (Child-Pugh Class C); caution should be exercised in those patients [see Use in Specific Populations (8.7)]. Gout patients with established cardiovascular (CV) disease treated with febuxostat tablets had a higher rate of CV death compared to those treated with allopurinol in a CV outcomes study [see Warnings and Precautions (5.1)]. Nausea may occur. Febuxostat is contraindicated in patients being treated with azathioprine or mercaptopurine [see Contraindications (4)]. Infections and Infestations: herpes zoster. Feel free to get in touch with us and send a message. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, except as may be authorized by the applicable terms of use. Interestingly, the pharmacokinetic parameters of febuxostat are unaffected in mild or moderate hepatic dysfunction, based on data from phase I trials in eight Child-Pugh class A and B patients [335]. Int J Hematol. Febuxostat is a newly introduced nonpurine xanthine oxidase inhibitor used for the treatment of gout. The recommended starting dosage of febuxostat tablets is 40 mg once daily. What side effects can this medication cause? Febuxostat 80 mg was superior to allopurinol in lowering serum uric acid to less than 6 mg/dL at the final visit. Arthritis and rheumatism. No studies have been conducted in patients with severe hepatic impairment (Child-Pugh Class C); therefore, caution should be exercised in these patients [see Clinical Pharmacology (12.3)]. It is suggested for patients with severe gout until total crystal dissolution and resolution of gout, according to EULAR (European Alliance of Associations for Rheumatology) guidelines. nitrile, 1,3-thiazolemonocarboxylic acid (, M04AA Preparations inhibiting uric acid production, Drugs causing inadvertant photosensitivity, Preparations Inhibiting Uric Acid Production, Adenine Phosphoribosyl Transferase Deficiency, Predicted MS/MS Spectrum - 10V, Positive (Annotated), Predicted MS/MS Spectrum - 20V, Positive (Annotated), Predicted MS/MS Spectrum - 40V, Positive (Annotated), Predicted MS/MS Spectrum - 10V, Negative (Annotated), Predicted MS/MS Spectrum - 20V, Negative (Annotated), Predicted MS/MS Spectrum - 40V, Negative (Annotated), LC-MS/MS Spectrum - LC-ESI-qTof , Positive, splash10-03xr-0292000000-d8e012f875d1014fe351, ATP-binding cassette sub-family G member 2. The apparent mean terminal elimination half-life (t) of febuxostat was approximately 5 to 8 hours. The increases were not considered clinically significant. Febuxostat should only be used in patients who have an inadequate response to a maximally titrated dose of allopurinol, who are intolerant to allopurinol, or for whom treatment with allopurinol is not advisable . A serum uric acid level of less than 6 mg/dL is the goal of antihyperuricemic therapy and has been established as appropriate for the treatment of gout. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Febuxostat has not been studied in end stage renal impairment patients who are on dialysis. 30 Tablets (8.8). Do not take a double dose to make up for a missed one. Use with caution in patients with severe hepatic impairment (Child-Pugh class C); has not been studied. Renal: hematuria, nephrolithiasis, pollakiuria, proteinuria, renal failure, renal insufficiency, urgency, incontinence, Reproductive: breast pain, erectile dysfunction, gynecomastia, Respiratory: bronchitis, cough, dyspnea, epistaxis, nasal dryness, paranasal sinus hypersecretion, pharyngeal edema, respiratory tract congestion, sneezing, throat irritation, upper respiratory tract infection, Skin and Subcutaneous Tissue: alopecia, angioedema, dermatitis, dermographism, ecchymosis, eczema, hair color changes, hair growth abnormal, hyperhidrosis, peeling skin, petechiae, photosensitivity, pruritus, purpura, skin discoloration/altered pigmentation, skin lesion, skin odor abnormal, urticaria, Vascular: flushing, hot flush, hypertension, hypotension, Altered Laboratory Parameters: activated partial thromboplastin time prolonged, creatine increased, bicarbonate decreased, sodium increased, EEG abnormal, glucose increased, cholesterol increased, triglycerides increased, amylase increased, potassium increased, TSH increased, platelet count decreased, hematocrit & hemoglobin decreased, MCV increased, RBC decreased, creatinine & blood urea increased, BUN/creatinine ratio increased, creatine phosphokinase (CPK) increased, LDH increased, PSA increased, lymphocyte count decreased, neutrophil count decreased, low-density lipoprotein (LDL) increased, prothrombin time prolonged, urinary casts, urine positive for white blood cells and protein. This information should not be interpreted without the help of a healthcare provider. Febuxostat may cause serious side effects. Before taking this medication, tell your doctor if you have heart disease, chest pain (angina), or have had a heart attack or stroke in the past since these conditions may increase your risk. If your dose is different, do not change it unless your doctor tells you to do so. Share This Section Things to know before you start febuxostat Liver problems can happen in people who take febuxostat tablets. Keep from freezing. No overdose of febuxostat was reported in clinical studies. [1][2]Due to an increased risk of cardiovascular mortality with febuxostat versus allopurinol, the FDA recently recommended limiting the use of febuxostat to patients for whom allopurinol is not efficaciousor who experience severeadverse effects with allopurinol. You may report side effects to the FDA at 1-800-FDA-1088. No dose adjustment is necessary for either febuxostat or colchicine when the two drugs are coadministered. We comply with the HONcode standard for trustworthy health information. 2009 Jun; [PubMed PMID: 19286847], Richette P,Doherty M,Pascual E,Barskova V,Becce F,Castaeda-Sanabria J,Coyfish M,Guillo S,Jansen TL,Janssens H,Liot F,Mallen C,Nuki G,Perez-Ruiz F,Pimentao J,Punzi L,Pywell T,So A,Tausche AK,Uhlig T,Zavada J,Zhang W,Tubach F,Bardin T, 2016 updated EULAR evidence-based recommendations for the management of gout. In the CARES study, liver function abnormalities and diarrhea were reported in more than 1% of patients treated with febuxostat, although not at a rate more than 0.5% greater than allopurinol. PubMed, Gout Flares See full prescribing information for complete boxed warning. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). [4], Gout is the most common form of inflammatory arthritis, characterized by painful episodes of arthritis; gout results in substantial morbidity and disability. Do not double the dose to catch up. Nervous System Disorders: altered taste, balance disorder, cerebrovascular accident, Guillain-Barr syndrome, headache, hemiparesis, hypoesthesia, hyposmia, lacunar infarction, lethargy, mental impairment, migraine, paresthesia, somnolence, transient ischemic attack, tremor. Generic name: febuxostat [fe-BUX-oh-stat] We anticipate reposting the images once we are able identify and filter out images that do not match the information provided in the drug labels. Rheumatology (Oxford). Protect from light. Limitations of Use: Study 2 (ClinicalTrials.gov identifier NCT00174915) randomized patients to: placebo, febuxostat 80 mg daily, febuxostat 120 mg daily, febuxostat 240 mg daily or allopurinol (300 mg daily for patients with a baseline serum creatinine 1.5 mg/dL or 100 mg daily for patients with a baseline serum creatinine greater than 1.5 mg/dL and 2 mg/dL). Do not let anyone else take your medication. Febuxostat is an XO inhibitor. Inform patients that gout patients with established CV disease treated with febuxostat tablets had a higher rate of CV death compared to those treated with allopurinol in a CV outcomes study. 2006 Dec; [PubMed PMID: 17132810], Schumacher HR Jr,Becker MA,Wortmann RL,Macdonald PA,Hunt B,Streit J,Lademacher C,Joseph-Ridge N, Effects of febuxostat versus allopurinol and placebo in reducing serum urate in subjects with hyperuricemia and gout: a 28-week, phase III, randomized, double-blind, parallel-group trial. For non-prescription products, read the label or package ingredients carefully. The metabolism of Febuxostat can be decreased when combined with Asciminib. The efficacy of febuxostat was demonstrated in three randomized, double-blind, controlled trials in patients with hyperuricemia and gout. Ear and Labyrinth Disorders: deafness, tinnitus, vertigo. Colchicine Consider the risks and benefits of febuxostat when deciding to prescribe or continue patients on febuxostat. It may take several months before febuxostat begins to prevent gout attacks. No dose adjustment is necessary in elderly patients. Effect of Other Drugs on Febuxostat Get medical help right away if you develop any rash. Blood and urine tests may be needed to check for unwanted effects. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location one that is up and away and out of their sight and reach. Many people using this medication do not have serious side effects. Febuxostat tablets should be used with caution in these patients. The Cmax and AUC24 of febuxostat following multiple oral doses of febuxostat in geriatric patients (65 years) were similar to those in younger patients (18 to 40 years) [see Clinical Pharmacology (12.3)]. Tell your doctor if you get any of the following signs or symptoms of liver problems: loss of appetite for several days or longer, pain, aching, or tenderness on the right side of your stomach-area, your skin or the white part of your eyes turns yellow (jaundice). For this medicine, the following should be considered: Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. (1). Take the missed dose as soon as you remember it. Taking febuxostat may increase your risk of serious or fatal heart problems. This medicine is available only with your doctor's prescription. 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