Adult Dosing

Chronic gout

• 8 mg IV over 120 minutes q2 wks
• Premedicate with antihistamines and corticosteroids prior to administration to reduce the incidence of anaphylaxis and infusion reactions

Note:

• Dilute in 250 mL of 0.9% or 0.45% of sodium chloride injection

Pediatric Dosing

• Safety and effectiveness in pediatric patients have not been established

[Outline]

• Adult Dosing
• Pediatric Dosing

• Treatment of chronic gout in patients not responding to conventional therapy

• Hypersensitivity to any of the ingredients of the product
• Glucose-6-phosphate dehydrogenase (G6PD) deficiency

• Anaphylaxis and infusion reactions have been reported during and after administration of pegloticase. It can occur with any infusion, including the first infusion, within 2 hrs of infusion. Delayed type hypersensitivity reactions have also been reported
• Pegloticase should be administered by healthcare provider experienced in management of anaphylaxis and infusion reactions and in proper healthcare setting
• Premedicate the patients with antihistamines and corticosteroids and closely monitor the patients for an appropriate period of time after infusion
• Monitor serum uric acid levels prior to infusion and if uric acid level is 6 mg/dL, discontinue the treatment especially when 2 consecutive levels above 6 mg/dL are observed

Renal Dose Adjustment

• Renal impairment: No dose adjustments

Hepatic Dose Adjustment

• Hepatic impairment: Dose adjustments not defined

• Not recommended for treatment of asymtomatic hyperuricemia
• Anaphylaxis manifested as wheezing, peri-oral or lingual edema, or hemodynamic instability, rash or urticaria have been reported during and after pegloticase infusion [US Black Box Warning]
• Infusion reactions have been reported; administer slowly over no less than 120 minutes and if infusion reactions occur, slow or stop the infusion and restart at slower rate [US Black Box Warning]
• Gout flares has been observed after the initiation of pegloticase therapy. Manage it with NSAID or colchine, starting 1 week before initiation of pegloticase therapy and lasting for at least 6 months, unless medically contraindicated or not tolerated. Do not discontinue the therapy because of gout flare
• When used in patients with congestive heart failure, exacerbation of symptoms was observed, use cautiously in these patients and closely monitor
• Patients receiving re-treatment after a drug free interval of 4 weeks are at increased risk of anaphylaxis and infusion reactions due to immunogenicity. Closely monitor these patients

Cautions: Use cautiously in

• CHF
• Retreatment after drug free interval

Pregnancy Category:C

Breastfeeding: It is not known whether pegloticase is excreted in human milk, but as many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infant, manufacturer recommends not to administer the drug to nursing mothers.

• CV: Exacerbation of CHF, chest pain
• GI: Nausea, vomiting, constipation
• EENT: Nasopharyngitis
• DERM: Ecchymosis, contusion
• LOCAL: Infusion reactions
• HYPERSENSITIVITY: Anaphylaxis
• MISC: Gout flares

• Uric acid specific enzyme; catalyzes the oxidation of uric acid to allantoin, thereby lowering serum uric acid
• Metabolism: Unknown
• Excretion: Unknown
• Half-life: 10-12 days

US Trade Name(s)

• Krystexxa

US Availability

Krystexxa

• INJ: 8 mg/mL (2 mL vial)

Canadian Trade Name(s)

• N/A

Canadian Availability

• N/A

UK Trade Name(s)

• N/A

UK Availability

• N/A

Australian Trade Name(s)

• N/A

Australian Availability

• N/A

[Outline]

Endocrine/Metabolic

Antihyperuricemic Agents