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Krystexxa Side Effects

Generic name: pegloticase

Medically reviewed by Drugs.com. Last updated on Apr 26, 2023.

Note: This document contains side effect information about pegloticase. Some dosage forms listed on this page may not apply to the brand name Krystexxa.

Applies to pegloticase: intravenous solution.

Warning

Intravenous route (Solution)

Anaphylaxis and infusion reactions have been reported to occur during and after administration of pegloticase. Anaphylaxis may occur with any infusion, and generally manifests within 2 hours of the infusion. Pegloticase should be administered in healthcare settings and by healthcare providers prepared to manage anaphylaxis and infusion reactions. Premedicate with antihistamines and corticosteroids and closely monitor for anaphylaxis for an appropriate period of time after administration of pegloticase. Monitor serum uric acid levels prior to each infusion and discontinue treatment if levels increase to above 6 mg/dL, particularly when 2 consecutive levels above 6 mg/dL are observed. Screen patients at risk for G6PD deficiency prior to starting pegloticase Hemolysis and methemoglobinemia have been reported with pegloticase in patients with G6PD deficiency. Pegloticase is contraindicated in patients with G6PD deficiency.

Serious side effects of Krystexxa

Along with its needed effects, pegloticase (the active ingredient contained in Krystexxa) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking pegloticase:

More common

Rare

Other side effects of Krystexxa

Some side effects of pegloticase may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Incidence not known

For Healthcare Professionals

Applies to pegloticase: intravenous solution.

General

The most commonly reported adverse reactions included gout flares, infusion reactions, nausea, contusion, and ecchymosis.[Ref]

Hematologic

Life-threatening glucose-6-phosphate dehydrogenase (G6PD) deficiency associated hemolysis and methemoglobinemia have been reported in patients treated with this drug.

Frequency not reported: Glucose-6-phosphate dehydrogenase (G6PD) deficiency associated hemolysis and methemoglobinemia

Hypersensitivity

Common (1% to 10%): Anaphylaxis[Ref]

Diagnostic criteria for anaphylaxis included skin or mucosal tissue involvement, and either airway compromise, and/or reduced blood pressure with or without associated symptoms, and a temporal relationship with the injection as well as no other identifiable cause. In clinical trials, 6.5% (n=8) patients receiving this drug every 2-weeks and 4.8% (n=6) of patients receiving this drug every 4 weeks experienced anaphylaxis. All patients had been pretreated with oral antihistamine, IV corticosteroid, and/or acetaminophen. There were no instances in placebo patients. For those experiencing anaphylaxis, manifestations included wheezing, peri-oral or lingual edema, or hemodynamic instability with or without rash or urticaria. Pre-treatment may have blunted or obscured symptoms, and therefore frequency may be an underestimate.[Ref]

Local

Infusion reactions occurred in 26% of patients receiving this drug every 2-weeks and 41% of patients receiving this drug every 4 weeks. Manifestations have included urticaria, dyspnea, chest discomfort, chest pain, erythema, and pruritus. These symptoms overlap with those that constitute anaphylaxis, but in the individual patient did not satisfy the clinical criteria for anaphylaxis. Infusion reactions are thought to result from the release of various mediators, such as cytokines. They may occur at any time during the course of treatment with approximately 3% occurring with the first infusion and 91% occurring during the time of infusion. Some infusion reactions improved with the slowing of the infusion rate.[Ref]

Very common (10% or more): Infusion reactions (up to 26%)[Ref]

Other

Postmarketing reports: Asthenia, malaise

Metabolic

Very common (10% or more): Gout flares (up to 77%)[Ref]

An increase in gout flares is frequently observed upon initiation of anti-hyperuricemic therapy due to changing serum uric acid levels resulting from mobilization of urate from tissue deposits. During clinical trials, the frequency of gout flares was 74%, 81%, and 51% for patients receiving 8 mg every 2 weeks, 8 mg every 4 weeks, and placebo, respectively. In the subsequent 3 months, the frequencies were 41%, 57%, and 67%, respectively. Patients were receiving gout flare prophylaxis with colchicine and/or a NSAID.[Ref]

Cardiovascular

Common (1% to 10%): Chest discomfort, chest pain

Postmarketing reports: Peripheral swelling[Ref]

During clinical trials, 2 cases of congestive heart failure (CHF) exacerbation were reported among patients receiving 8 mg every 2 weeks. During the open-label extension study while patients continued to receive 8 mg every 2 weeks, 4 patients reported CHF exacerbation.[Ref]

Immunologic

Very common (10% or more): Anti-pegloticase (the active ingredient contained in Krystexxa) antibodies (up to 92%)[Ref]

Gastrointestinal

Very common (10% or more): Nausea (up to 12%)

Common (1% to 10%): Constipation, vomiting[Ref]

Dermatologic

Contusions were generally not reported on the day of infusion; most were thought to be related to other factors such as concomitant medications relevant to contusion or ecchymosis, type 1 diabetes mellitus.[Ref]

Very common (10% or more): Contusion (up to 11%), ecchymosis (up to 11%), urticaria (up to 10.8%)

Common (1% to 10%): Erythema, pruritus[Ref]

Respiratory

Common (1% to 10%): Dyspnea, nasopharyngitis[Ref]

References

1. Product Information. Krystexxa (pegloticase). Savient Pharmaceuticals. 2010.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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