Indications

Barif tablets are indicated for the long-term management of hyperuricemia (high uric acid levels) in adult patients with gout. They are not recommended for treating asymptomatic hyperuricemia.

Pharmacology

Febuxostat, the active ingredient in Barif, is a non-purine, selective inhibitor of xanthine oxidase (XO). This enzyme is responsible for producing uric acid. By inhibiting XO, febuxostat decreases the level of uric acid in the serum. At therapeutic concentrations, it is not expected to inhibit other enzymes involved in purine and pyrimidine synthesis.

Dosage & Administration

• Starting Dose: The recommended starting dose is 40 mg once daily.
• Dose Adjustment: If the serum uric acid level is not below 6 mg/dL after 2 weeks, the dose should be increased to 80 mg once daily. If the level is still not below 6 mg/dL after another 2-4 weeks, a dose of 120 mg once daily is recommended.
• Tumor Lysis Syndrome: The recommended dose is 120 mg once daily, starting two days before cytotoxic therapy and continuing for a minimum of 7 days, or up to 9 days based on clinical judgment.
• Gout Flares: Gout flares can occur at the start of treatment. Prophylactic therapy with an NSAID or colchicine is recommended. If a flare occurs, Barif treatment should not be stopped, and the flare should be managed concurrently.
• Renal or Hepatic Impairment: No dose adjustment is needed for patients with mild to moderate renal or hepatic impairment.
• Pediatric Use: The safety and effectiveness have not been established in patients under 18 years of age.

Interaction

• Mercaptopurine/Azathioprine: Coadministration is not recommended because Barif's inhibition of XO can increase the plasma concentrations of these drugs, leading to toxicity.
• Naproxen & other glucuronidation inhibitors: Barif can be coadministered with naproxen without any dose adjustments.
• Antacids: Coadministration with antacids containing magnesium or aluminum hydroxide may delay Barif's absorption, but no dose adjustment is necessary.
• Colchicine/Indomethacin/Hydrochlorothiazide/Warfarin: Barif can be co-administered with these drugs without dose adjustments.

Contraindications

Barif is contraindicated in patients who are being treated with azathioprine, mercaptopurine, or theophylline.

Side Effects

The most common side effects are gout flares, abnormal liver function tests, diarrhea, nausea, headache, rash, and swelling (edema). These are typically mild to moderate. Rare, serious hypersensitivity reactions have been reported.

Pregnancy & Lactation

This is a Pregnancy Category C drug. There are no adequate studies in pregnant women. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether febuxostat is excreted in human milk, so caution should be exercised when administering it to a nursing woman.

Precautions & Warnings

• Gout Flare: Gout flares are common at the beginning of treatment. Prophylactic therapy with an NSAID or colchicine for up to six months may be helpful.
• Cardiovascular Events: Clinical trials have shown a higher rate of cardiovascular thromboembolic events in patients treated with febuxostat compared to allopurinol. Patients should be monitored for signs of heart attack (MI) and stroke.
• Liver Enzyme Elevation: Increases in liver enzymes have been observed, so liver function tests should be monitored periodically.

Overdose Effects

In studies, doses of up to 300 mg daily for seven days in healthy subjects did not show dose-limiting toxicities.

Therapeutic Class

Barif is classified as a drug used in gout.

Storage Conditions

Store below 30°C, away from light and moisture. Keep out of the reach of children.