PEGLOTICASE INJ,SOLN

Clinical Criteria Summary

Exclusion Criteria:
G6PD deficiency (screen high-risk patients of African or Mediterranean descent)
Concurrent use of other urate-lowering therapies (allopurinol, febuxostat, probenecid, etc.) due to risk of masking loss of efficacy/antibody development and increased infusion reaction/anaphylaxis risk
Inclusion Criteria (New Patients):
≥3 gout flares in the past 18 months AND baseline serum uric acid concentration (SUAc) >8 mg/dl
AND (≥1 tophi affecting physical function/QoL OR chronic gouty arthritis with documented joint damage)
Failure to reduce SUAc <6 ml/dl despite adequate trial of maximally tolerated allopurinol (up to 800 mg/day) and febuxostat (up to 80 mg/day) for ≥3 months at highest tolerated dose, with >80% adherence confirmed; OR documented contraindication/inability to tolerate both agents
Reversible causes of gout considered/treated (alcohol use, purine-rich foods, obesity, diuretics, niacin, low-dose salicylates, tacrolimus, cyclosporine)
Prescribed by VA Rheumatologist or locally designated physician trained on infusion reactions and pegloticase-specific issues

SUAc must be <6 mg/dl prior to each scheduled infusion
Discontinue treatment if SUAc >6 mg/dl on more than one occasion during therapy
Exercise caution for significant increases between infusions (e.g., 2.0 mg/dl to 5.5 mg/dl) as it may indicate antibody development
Consider switching back to allopurinol or febuxostat maintenance therapy if individual treatment goals are met (improved QoL, reduced flares/mobility issues/tophi/pain, no longer need surgery for tophi) and no contraindications exist

Recommended dose: 8 mg IV infusion every 2 weeks
Gout flare prophylaxis (colchicine or NSAIDs) initiated ≥1 week prior to first infusion and continued ≥6 months unless contraindicated/intolerant
Preparation: Withdraw 1 ml into sterile syringe, inject into 250 ml bag of 0.9% sodium chloride injection, USP or 0.45% sodium chloride injection, USP. Do not mix with other drugs. Invert to mix; do not shake. Stable for 4 hours refrigerated or at room temperature (protect from light). Allow to reach room temperature prior to infusion; never use artificial heating
Administration: Never administer as IV push or bolus. Infuse over ≥120 minutes via gravity feed, syringe-type pump, or infusion pump

Pre-treat with antihistamine and corticosteroid prior to each infusion to minimize anaphylaxis/infusion reaction risk (e.g., oral antihistamine evening prior & just before infusion; IV hydrocortisone 200 mg and acetaminophen 1000 mg immediately prior)
Administer in a healthcare setting by providers prepared to manage anaphylaxis and infusion reactions
Observe patients for an appropriate period post-infusion (≥1 hour recommended due to risk of delayed hypersensitivity)
If infusion reaction occurs: slow/stop and restart at slower rate per physician discretion

Limited to FDA indication: adult patients with symptomatic gout refractory to conventional treatment; not indicated for rapid debulking in non-refractory patients or tumor lysis syndrome
Monitor SUAc prior to each infusion; discontinue if >6 mg/dl, especially with two consecutive levels >6 mg/dl
Re-treatment/restarting after >4 weeks off therapy lacks data and carries increased anaphylaxis/infusion reaction risk requiring closer monitoring
Not recommended for nursing mothers due to unknown excretion in human milk and potential for serious adverse events in the infant
Biweekly corticosteroid premedication may alter glucose control in diabetic patients; monitor closely
Monitor cardiovascular safety post-marketing due to reported ischemic cardiovascular events, heart failure, cardiac arrhythmias, and death

Download CFU PDF