Pegloticase Side Effects

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.

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
  • nausea or vomiting
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • redness of the skin
  • shortness of breath
  • skin rash
  • tightness in the chest
  • unusual tiredness or weakness
  • unusually warm skin
  • wheezing
Rare
  • Decreased urine output
  • dilated neck veins
  • extreme fatigue
  • irregular breathing
  • irregular heartbeat
  • swelling of the face, fingers, feet, or lower legs
  • troubled breathing
  • 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

Immunologic

Immunologic side effects have included anaphylaxis, which occurred at a frequency of 6.5% in patients treated with pegloticase 8 mg every 2 weeks, compared to none with placebo. Infusion reactions occurred in 26% of patients in the 2 week dosing regimen group and 41 % of patients in the 4 week dosing regimen group compared to 5% of placebo-treated patients. Manifestations of these reactions included urticaria (10.6%), dyspnea (7.1%), chest discomfort (9.5%), chest pain (9.5%), erythema (9.5%), and pruritus (9.5%). These manifestations overlap with the symptoms of anaphylaxis, but in a given patient did not occur together to satisfy the clinical criteria for diagnosing anaphylaxis. Infusion reactions are thought to result from release of various mediators, such as cytokines. Infusion reactions occurred at any time during a course of treatment with approximately 3% occurring with the first infusion, and approximately 91% occurring during the time of infusion. Some infusion reaction manifestations were reduced with slowing the rate of infusion, or stopping the infusion and restarting the infusion at a slower rate. These infusion reactions occurred with all patients being pretreated with an oral antihistamine, intravenous corticosteroid and acetaminophen.

Local

Local side effects have included infusion reactions (26%) compared to placebo (5%).

Metabolic

Metabolic side effects have included gout flares, which were more common during the first 3 months of treatment with pegloticase compared with placebo. All patients in clinical trials were pretreated with an oral antihistamine, intravenous corticosteroid and/or acetaminophen to prevent anaphylaxis and infusion reaction. Patients also received nonsteroidal anti-inflammatory drugs or colchicine, or both, for at least 7 days as gout flare prophylaxis before beginning pegloticase treatment.

Cardiovascular

Two cases of congestive heart failure exacerbation occurred during clinical trials in patients receiving treatment with pegloticase 8 mg every 2 weeks versus no cases in placebo treated patients. Four trial participants had exacerbations of preexisting congestive heart failure while receiving pegloticase 8 mg every 2 weeks during an open-label extension study. Other cardiovascular side effects have included chest pain (6%).

Gastrointestinal

Gastrointestinal side effects have included nausea (12%), constipation (6%), and vomiting (5%).

Respiratory

Respiratory side effects have included nasopharyngitis (7%).

Dermatologic

Dermatologic side effects have included contusion or ecchymosis (11%).

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