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. Continue reading for a comprehensive list of adverse effects.
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 Pegloticase
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, discomfort, or tightness
- cough
- difficult or labored breathing
- difficulty in moving
- 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
- joint pain
- muscle pain or stiffness
- nausea or vomiting
- pain in the arms or legs
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- redness of the skin
- 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
Other side effects of Pegloticase
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
- sore throat
- stuffy or runny nose
Incidence not known
- Lack or loss of strength
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 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]
