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

Some people receiving a pegloticase injection have had a reaction to the infusion (when the medicine is injected into the vein). Infusion reactions may also occur after the injection is given. Tell your caregiver right away if you feel itchy, nervous, light-headed, short of breath, or have a fast heartbeat, chest discomfort, or redness of your skin during the injection.

Get emergency medical help if you have any of these signs of an allergic reaction while taking pegloticase: hives; wheezing, difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

• chest pain; or

• flushing (warmth, redness, or tingly feeling).

Less serious side effects of pegloticase may include:

• new gout flares;

• nausea, vomiting, constipation;

• easy bruising; or

• stuffy nose, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

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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