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Pegloticase Side Effects

In Summary

Commonly reported side effects of pegloticase include: infusion related reaction, nausea, urticaria, bruise, and ecchymoses. Other side effects include: anaphylaxis, chest pain, nasopharyngitis, and vomiting. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to pegloticase: intravenous solution

Along with its needed effects, pegloticase 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
  • Chest pain or discomfort
  • cough
  • difficult or labored breathing
  • difficulty with swallowing
  • dizziness
  • facial swelling
  • fast heartbeat
  • fever or chills
  • flushing or redness of the skin
  • gout flare
  • headache
  • hives or welts, itching, or skin rash
  • nausea or vomiting
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • redness of the skin
  • tightness in the chest
  • unusual tiredness or weakness
  • unusually warm skin
Rare
  • Decreased urine output
  • dilated neck veins
  • extreme fatigue
  • irregular breathing
  • irregular heartbeat
  • swelling of the face, fingers, feet, or lower legs
  • weight gain

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
  • Bruise
  • contusion
  • difficulty having a bowel movement (stool)
  • large, flat, blue, or purplish patches in the skin
  • muscle aches
  • sore throat
  • stuffy or runny nose
Less common
  • Vomiting

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]

Immunologic

Very common (10% or more): Anti-pegloticase antibodies (up to 92%)[Ref]

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]

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]

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]

Cardiovascular

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

Respiratory

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

Hypersensitivity

The 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.[Ref]

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

References

1. "Product Information. Krystexxa (pegloticase)." Savient Pharmaceuticals, East Brunswick, NJ.

Some side effects of pegloticase may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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