Feburic

Feburic

febuxostat

Manufacturer:

Astellas Pharma

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Febuxostat
Indications/Uses
Chronic hyperuricaemia in conditions where urate deposition has already occurred (including history, or presence of, tophus &/or gouty arthritis). Prevention & treatment of hyperuricaemia in adult patients undergoing chemotherapy for haematologic malignancies at intermediate to high risk of tumor lysis syndrome (TLS).
Dosage/Direction for Use
Gout 80 mg once daily. May increase dose to 120 mg once daily if serum uric acid is >6 mg/dL (357 micromol/L) after 2-4 wk. Mild hepatic impairment 80 mg. Gout flare prophylaxis At least 6 mth. TLS 120 mg once daily. Start 2 days before initiation of cytotoxic therapy & continue for min of 7 days. May be prolonged up to 9 days according to chemotherapy duration.
Administration
May be taken with or without food.
Contraindications
Special Precautions
Discontinue immediately & do not restart treatment if serious allergic/hypersensitivity reactions including SJS & acute anaphylactic reaction/shock occur/develop. Not to start treatment until acute gout attack has completely subsided. Not recommended in patients w/ ischaemic heart disease or CHF; Lesch-Nyhan syndrome; organ transplant recipients. Exacerbation &/or onset of CV disease. Increased TSH values (>5.5 uIU/mL) in patients on long-term treatment. Perform cardiac monitoring in patients undergoing chemotherapy for haematologic malignancies at intermediate to high risk of TLS. Flare prophylaxis for at least 6 mth w/ an NSAID or colchicine at treatment initiation is recommended. Patients w/ alteration of thyroid function. Monitor closely for symptoms of allergic/hypersensitivity reactions. Perform LFT prior to treatment, & periodically thereafter. Not recommended in patients concomitantly treated w/ mercaptopurine/azathioprine. Not to be taken by patients w/ galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. May affect ability to drive & use machines. Severe renal impairment (CrCl <30 mL/min). Severe hepatic impairment (Child Pugh Class C). Not to be used during pregnancy & lactation. Childn <18 yr.
Adverse Reactions
Gout flares; headache; diarrhoea, nausea; liver function abnormalities; rash; oedema. TEN, SJS, DRESS.
Drug Interactions
Increased plasma conc of mercaptopurine/azathioprine. Increased metabolism & decreased efficacy w/ potent UGT enzyme inducers. Increased AUC of CYP2D6 substrate desipramine. Delayed absorption & decreased Cmax w/ antacids containing Mg & Al hydroxide.
MIMS Class
Hyperuricemia & Gout Preparations
ATC Classification
M04AA03 - febuxostat ; Belongs to the class of preparations inhibiting uric acid production. Used in the treatment of gout.
Presentation/Packing
Form
Feburic FC tab 80 mg
Packing/Price
3 × 10's
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