Pegloticase

3
Pegloticase
Brands

DEA Class; Rx

Common Brand Names; Krystexxa

  • Enzymes, Oncology; 
  • Rheumatologics, Other

Recombinant urate oxidase enzyme; pegylated product; converts uric acid to allantoin, a benign metabolite
Used in chronic gout refractory to conventional oral therapy in combination with oral methotrexate and folic acid or folinic acid supplementation or as monotherapy when methotrexate not clinically appropriate; given as IV infusion only; high cost
Boxed warning for risk of infusion-related and hypersensitivity reactions; premedicate patients with antihistamines and corticosteroids and monitor for 1 hour after each dose

Indicated for treatment of chronic gout in adults refractory to conventional treatment

Pegloticase alone may be used in patients for whom methotrexate is contraindicated or not clinically appropriate

History of serious hypersensitivity, including anaphylaxis, to pegloticase or its components

G6PD-deficiency (increased risk of hemolysis and methemoglobinemia)

  • Gout flares (77%)
  • Infusion reactions (26%)
  • Nausea (12%)
  • Urticaria (10.6%)
  • Chest discomfort (9.5%)
  • Chest pain (9.5%)
  • Erythema (9.5%)
  • Pruritus (9.5%)
  • Nasopharyngitis (7%)
  • Anaphylaxis (5%)

Life threatening hemolytic reactions and methemoglobinemia reported with G6PD deficiency; screen patients at risk for G6PD deficiency before initiating (eg, patients of African, Mediterranean [including Southern European and Middle Eastern], and Southern Asian ancestry); do not administer to patients with G6PD deficiency

Gout flares may occur after initiating owing to changing serum uric acid levels resulting in mobilization of urate from tissue deposits; gout flare prophylaxis with an NSAID or colchicine is recommended starting at least 1 week before starting and during pegloticase treatment and for at least 6 months, unless medically contraindicated or not tolerated

Exacerbation of pre-existing CHF reported; exercise caution when using this drug in patients who have congestive heart failure and monitor patients closely following infusion

No controlled trial data are available regarding safety and efficacy of retreatment with pegloticase after stopping treatment for >4 weeks; owing to immunogenicity of pegloticase, patients receiving retreatment may be at increased risk of anaphylaxis and infusion reactions

There are no adequate and well-controlled studies in pregnant women

Not known whether drug is excreted in human milk

Adults

8 mg IV infusion every 2 weeks.

Geriatric

8 mg IV infusion every 2 weeks.

Adolescents

Safety and efficacy have not been established.

Children

Safety and efficacy have not been established.

Infants

Safety and efficacy have not been established.

Neonates

Safety and efficacy have not been established.

pegloticase 

injectable solution

  • 8mg/mL
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