Gout
ICD-10 M10 · ICD-11 FA25

Gout After Urate-Lowering Therapy Failure in Patients Receiving Strong P-Glycoprotein and/or CYP3A4 Inhibitors

This protocol targets a specific clinical situation: a patient with gout who is concurrently receiving strong P-glycoprotein and/or CYP3A4 inhibitors, and whose serum uric acid could not be controlled adequately with the previous urate-lowering approach.

Clinical Situation

Concurrent Use of Strong P-gp/CYP3A4 Inhibitors

This scenario applies to patients receiving one or more of the following agents alongside gout management:

Cyclosporin Clarithromycin Ketoconazole Verapamil

Co-prescription of colchicine with these agents should be avoided. Strong P-glycoprotein and/or CYP3A4 inhibitors increase colchicine plasma concentration when co-prescribed, exposing patients to risk of serious side effects.

Previous Treatment — Target Not Reached

When the Prior Step Did Not Achieve the Serum Uric Acid Goal

The preceding treatment step — involving agents such as febuxostat, uricosurics (benzbromarone, probenecid), or combinations with allopurinol — was unable to achieve serum uric acid below 6 mg/dL (360 mmol/L), or below 5 mg/dL (300 mmol/L) for patients with severe gout where complete crystal dissolution is the aim.

Failure to reach those targets is the trigger for escalation to this protocol.

Next Therapeutic Step — Overview Only

Escalation for Refractory, Severe Tophaceous Gout

For patients with crystal-proven, severe debilitating chronic tophaceous gout and poor quality of life in whom no available drug at maximal dosage has achieved the serum uric acid target, pegloticase is indicated. The full eligibility criteria, regimen, and monitoring requirements are in the complete protocol.

Dosing, route, frequency, and the full treatment algorithm are not shown here — access the structured regimen below.

Treatment Goals

Clinical Targets

Instant Access to Structured Evidence-Based Regimens

References

DOI: 10.1136/annrheumdis-2016-209707

Colchicine should not be given to patients receiving strong P-glycoprotein and/or CYP3A4 inhibitors such as cyclosporin or clarithromycin.

Co-prescription of colchicine with strong P-glycoprotein and/or CYP3A4 inhibitors should be avoided.

A pharmacokinetic study showed that strong P-glycoprotein and/or CYP3A4 inhibitors such as cyclosporin, clarithromycin, verapamil and ketoconazole when prescribed with colchicine increased colchicine plasma concentration, thereby exposing patients to risk of serious side effects.

In patients with crystal-proven, severe debilitating chronic tophaceous gout and poor quality of life, in whom the SUA target cannot be reached with any other available drug at the maximal dosage (including combinations), pegloticase is indicated.

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