Pegloticase
Pegloticase is a biologic medication used to treat chronic gout in adult patients who have not responded adequately to conventional uric acid-lowering therapies. Administered via intravenous infusion, it contains a recombinant enzyme that rapidly lowers serum uric acid levels. This treatment is typically reserved for patients with severe, refractory gout.
Pegloticase is an IV biologic therapy for chronic gout that works by converting uric acid into an easily excreted form.
This medication carries a boxed (black box) warning — the strongest type of FDA warning. Review the full prescribing information before use.
Key facts at a glance
- ATC
- M04AX02
- RxNorm
- 1011650
- Generic
- Pegloticase
- Class
- atc-m04
- Brands
- Krystexxa
- Availability
- rx
- Lactation
- unknown
- Routes
- —
- Forms
- injection
- Regions
- US, EU, CN, JP
- Monitoring
- —
This page is for informational purposes only.
Do not use this information to diagnose yourself or to replace a physician's advice. Always consult a qualified healthcare provider before starting, stopping, or changing any medication. If you believe you are experiencing a medical emergency, call your local emergency number immediately.
Dosage and administration
- Usual dose
- 8mg every 2 weeks
- Maximum
- consult physician
- Frequency
- every 2 weeks
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- safety and efficacy not established
- Maximum
- consult physician
- Frequency
- not established
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 8mg every 2 weeks
- Maximum
- consult physician
- Frequency
- every 2 weeks
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
Overdose information
Special Populations
8 groupspregnancy
first trimesteravoid if possible
avoid use during pregnancy unless benefits outweigh risks
regular fetal monitoring
Use of this medication in this population requires careful consideration of risks and benefits.
pregnancy
second trimesteravoid if possible
avoid use during pregnancy unless benefits outweigh risks
regular fetal monitoring
Use of this medication in this population requires careful consideration of risks and benefits.
pregnancy
third trimesteravoid if possible
avoid use during pregnancy unless benefits outweigh risks
regular fetal monitoring
Use of this medication in this population requires careful consideration of risks and benefits.
lactation
not applicablediscontinue breastfeeding or avoid
not recommended during lactation, excretion in breast milk unknown
monitor infant for adverse effects
pediatric_age
not applicablenot applicable
not indicated for use in pediatric patients, safety and efficacy not established
not applicable
Use of this medication in this population requires careful consideration of risks and benefits.
geriatric
not applicableno specific adjustment
use with caution, start at low end of dosing range, monitor for infusion reactions
monitor renal function and for infusion reactions
Use with caution and monitor for adverse effects.
renal_impairment
moderate to severeno specific dosage adjustment required
use with caution, no dose adjustment needed but monitor closely
monitor renal function regularly
Use with caution and monitor for adverse effects.
hepatic_impairment
mild to moderateno specific adjustment
use with caution, limited clinical data available
monitor liver function tests
Use with caution and monitor for adverse effects.
Statistics and clinical data
FDA approval year
Initial FDA approval for Krystexxa
Enzyme replacement therapy for uric acid metabolism
Indication
For patients with gout who have failed conventional therapy
Mechanism of action
Converts uric acid to allantoin for excretion
Chronic gout in adult patients with inadequate response to or intolerance of conventional urate-lowering therapies, such as xanthine oxidase inhibitors.
Contains a recombinant uricase enzyme that catalyzes the oxidation of uric acid to allantoin, a water-soluble metabolite that is readily eliminated by the kidneys.
Requires IV infusion every 2 weeks; infusion reactions may occur; G6PD deficiency must be ruled out before treatment due to risk of hemolysis; periodic monitoring of serum uric acid levels is recommended.
Contraindications
Conditions and patient states where this medication should be avoided or used with caution.
Do not use (1)
Known allergy to this medication or its components
Use caution (1)
Consult healthcare provider for benefits vs risks assessment
Official drug label
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This information is for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment.
This content is for general informational and educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the guidance of a qualified healthcare provider with any questions you have about a medical condition, and never disregard professional medical advice or delay seeking it because of something you read here.
If you think you may have a medical emergency, call your local emergency number or go to the nearest emergency department immediately.
Medically reviewed by WellAlly Editorial Team Last reviewed July 26, 2026. · Read our editorial policy