非布司他药品说明书

Drug instructions

[Drug name] Febuxostat tablets

[Function and Indications] This product is a xanthine oxidase (XO) inhibitor, suitable for the long-term treatment of hyperuricemia with gout symptoms. This product is not recommended for the treatment of asymptomatic hyperuricemia.

[Dosage] The recommended dose is 40 mg or 80 mg, once a day; take orally.

If the blood uric acid level is still not less than 6 mg/dl (approximately 360 µmol/L) after 2 weeks, it is recommended that the dose be increased to 80 mg once a day.

Food and antacid effects do not need to be considered when administering the drug.

[Adverse reactions] Liver function damage, allergies, systemic rash, skin rash, reduced platelet count, anemia, reduced white blood cell count, increased TSH, headache, numbness in hands and feet, dizziness, and rapid heartbeat.

【Notes】

1. After starting treatment with this product for gout attacks, an increase in gout attacks may be observed.

This is caused by changing serum uric acid levels that reduce the activity of deposited urate. To prevent gout attacks while administering this product, concomitant administration of a nonsteroidal anti-inflammatory drug or colchicine is recommended.

2. Patients with cardiovascular diseases are more likely to have cardiovascular thrombotic events when taking this product than those taking allopurinol. Monitor for signs and symptoms of myocardial infarction (MI) and stroke.

3. Liver enzyme increases In randomized controlled studies, transaminase levels were observed to be higher than 3 times the upper limit of normal. No dose-response relationship was found for the increase in transaminases. Liver function laboratory analysis recommends the use of this product for treatment in February and April, and periodic treatment thereafter.

[Drug interactions]

1. Xanthine oxidase substrate drugs

Febuxostat alters the metabolism of theophylline (a substrate of XO) in humans. Therefore, caution should be used when administering febuxostat with theophylline.

XO inhibition by febuxostat may increase plasma concentrations of these drugs, resulting in toxicity. Febuxostat is therefore contraindicated in patients receiving azathioprine or mercaptopurine.

2. Cytotoxic chemotherapy drugs

Safety data on the use of febuxostat during chemotherapy with cytotoxic agents are unknown.

3. Study on drug interactions in vivo

There were no significant interactions when febuxostat was coadministered with colchicine, naproxen, indomethacin, hydrochlorothiazide, warfarin, and desipramine. Therefore, it can be used in combination with these drugs.