Krystexxa (pegloticase)

Dosage of pegloticase is expressed in terms of the amount of uricase protein.

The recommended adult dosage of pegloticase for the management of chronic gout that is refractory to conventional therapy is 8 mg (of uricase protein) given as an IV infusion every 2 weeks. The optimum duration of therapy has not been established.

Because the risk of anaphylaxis or infusion reactions is higher in patients who have lost therapeutic response to the drug, discontinuance of therapy should be considered if uric acid concentrations rise above 6 mg/dL, particularly if 2 consecutive measurements exceed 6 mg/dL. (See Sensitivity Reactions under Cautions: Warnings/Precautions.)

Pegloticase is administered by IV infusion via gravity feed, syringe pump, or infusion pump. The drug should not be administered by rapid IV injection, such as IV push or bolus.

No dosing information is available for this tab.

No formal drug interaction studies have been conducted to date.

Because antipegloticase antibodies appear to bind to the polyethylene glycol (PEG) portion of the drug, the potential exists for the antibodies to bind with other pegylated drugs. The effect of such antibodies on the efficacy of other PEG-containing drugs is not known.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

Pegloticase is contraindicated in patients with glucose-6-phosphate dehydrogenase (G-6-PD) deficiency since the drug may cause hemolysis and methemoglobinemia in these individuals. Patients at higher risk for G-6-PD deficiency (e.g., patients of African or Mediterranean ancestry) should be screened for G-6-PD deficiency before initiating pegloticase therapy.

• Glucose-6-phosphate dehydrogenase (g6Pd) deficiency
• Hemoglobin H disease
• Hemolytic anemia from pyruvate kinase and g6PD deficiencies

There are no severe contraindications for this drug.

• Chronic heart failure

Adverse effects reported in 5% or more of patients receiving pegloticase at a dosage of 8 mg (of uricase protein) every 2 weeks include gout flares, infusion reactions, nausea, contusion or ecchymosis, nasopharyngitis, constipation, chest pain, anaphylaxis, and vomiting.

More Frequent

• Anaphylaxis
• Chest discomfort
• Chest pain
• Dyspnea
• Erythema
• Hypersensitivity drug reaction
• Pruritus of skin
• Urticaria

Rare or Very Rare

• Worsening of chronic heart failure

More Frequent

• Acute gouty arthritis
• Arthralgia
• Constipation
• Ecchymosis
• Fatigue
• Nausea

Less Frequent

• Pharyngitis
• Vomiting

Rare or Very Rare

• General weakness
• Malaise
• Peripheral edema

No enhanced messaging available.

Safety and efficacy have not been established in children younger than 18 years of age.

Category C. (See Users Guide.)

It is not known whether pegloticase is distributed into milk. Because many drugs are distributed into human milk and because of the potential for serious adverse reactions to pegloticase in nursing infants, the manufacturer recommends that the drug not be used in nursing women.

No substantial differences in safety and efficacy relative to younger adults were observed, but increased sensitivity cannot be ruled out.