Brand Name
Krystexxa
Generic Name
Pegloticase
View Brand Information FDA approval date: September 14, 2010
Classification: Uric Acid-specific Enzyme
Form: Injection
What is Krystexxa (Pegloticase)?
KRYSTEXXA ® is indicated, for the treatment of chronic gout in adult patients refractory to conventional therapy. Gout refractory to conventional therapy occurs in patients who have failed to normalize serum uric acid and whose signs and symptoms are inadequately controlled with xanthine oxidase inhibitors at the maximum medically appropriate dose or for whom these drugs are contraindicated. KRYSTEXXA ® is a PEGylated uric acid specific enzyme indicated for the treatment of chronic gout in adult patients refractory to conventional therapy. Limitations of Use: KRYSTEXXA is not recommended for the treatment of asymptomatic hyperuricemia. Limitations of Use: KRYSTEXXA is not recommended for the treatment of asymptomatic hyperuricemia.
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Related Clinical Trials
A Phase 3, Multicenter, Double-blind, Randomized Controlled Study Evaluating the Efficacy and Safety of Pegloticase Administered by Subcutaneous Injection Compared With Pegloticase Administered by Intravenous Injection, Both Administered Concurrently With Methotrexate Weekly, in Participants With Uncontrolled Gout
Summary: The primary objective of this trial is to evaluate the effect of pegloticase 18 mg subcutaneously (SC) every two weeks with methotrexate (MTX) versus pegloticase 8 mg intravenously (IV) every two weeks with MTX on the response rate during Month 6, as measured by the sustained normalization of serum uric acid (sUA) to \< 6 mg/dL for at least 80% of the time during Month 6.
A Phase 2, Multicenter, Open-label, Efficacy and Safety Study of AR882 and XOI Co-administration in Participants With Uncontrolled Gout Who Have Previously Failed Uricase Treatment
Summary: This study will assess the effect of AR882 and XOI co-administration on sUA lowering as well as reducing tophus burden in the population that has failed uricase treatment (eg., pegloticase). Failed uricase treatment is defined as having an inherent intolerance, anaphylaxis, infusion reaction, antibody development, and/or at least one sUA level that rose to greater than 6 mg/dL while on therapy.
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Brand Information
Krystexxa (pegloticase)
WARNING: ANAPHYLAXIS and INFUSION REACTIONS, G6PD DEFICIENCY ASSOCIATED HEMOLYSIS and METHEMOGLOBINEMIA
- Anaphylaxis and infusion reactions have been reported to occur during and after administration of KRYSTEXXA. (
- Anaphylaxis may occur with any infusion, and generally manifests within 2 hours of the infusion. However, delayed hypersensitivity reactions have also been reported. (
- KRYSTEXXA 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 KRYSTEXXA. (
- 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 KRYSTEXXA. Hemolysis and methemoglobinemia have been reported with KRYSTEXXA in patients with G6PD deficiency. KRYSTEXXA is contraindicated in patients with G6PD deficiency. (
1INDICATIONS AND USAGE
KRYSTEXXA
Gout refractory to conventional therapy occurs in patients who have failed to normalize serum uric acid and whose signs and symptoms are inadequately controlled with xanthine oxidase inhibitors at the maximum medically appropriate dose or for whom these drugs are contraindicated.
2DOSAGE FORMS AND STRENGTHS
KRYSTEXXA is a clear and colorless solution, containing 8 mg of pegloticase expressed as concentrations of uricase protein available as:
- Injection: Ready-to-Use 8 mg/50 mL (0.16 mg/mL) in a single-dose vial (with hanger label)
- Injection: To-be-Diluted 8 mg/mL in a single-dose vial
3CONTRAINDICATIONS
KRYSTEXXA is contraindicated in:
- Patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency
- Patients with history of serious hypersensitivity reactions, including anaphylaxis, to KRYSTEXXA or any of its components.
4ADVERSE REACTIONS
The following serious adverse reactions are discussed in greater detail in other sections of the label:
- Anaphylaxis
- Infusion Reactions
- G6PD Deficiency Associated Hemolysis and Methemoglobinemia
- Gout Flares
- Congestive Heart Failure
4.1Clinical Trials Experience
Because clinical studies are conducted under widely varying and controlled conditions, adverse reaction rates observed in clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug, and may not predict the rates observed in a broader patient population in clinical practice.
4.2Postmarketing Experience
The following adverse reactions have been identified during postapproval use of KRYSTEXXA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship.
General disorders and administration site conditions: asthenia, malaise, peripheral swelling
5OVERDOSAGE
No reports of overdosage with KRYSTEXXA have been reported. The maximum dose that has been administered as a single intravenous dose is 12 mg as uricase protein.
Patients suspected of receiving an overdose should be monitored, and general supportive measures should be initiated as no specific antidote has been identified.
6DESCRIPTION
Pegloticase is a uric acid specific enzyme which is a PEGylated product that consists of recombinant modified mammalian urate oxidase (uricase) produced by a genetically modified strain of Escherichia coli. Uricase is covalently conjugated to monomethoxypoly (ethylene glycol) [mPEG] (10 kDa molecular weight). The cDNA coding for uricase is based on mammalian sequences. Each uricase subunit has a molecular weight of approximately 34 kDa per subunit. The average molecular weight of pegloticase (tetrameric enzyme conjugated to mPEG) is approximately 540 kDa.
Ready-to-Use KRYSTEXXA (pegloticase) injection 8 mg/50 mL (0.16 mg/mL) single-dose vial is supplied as a sterile, preservative-free, clear and colorless solution intended for intravenous infusion and does not require further dilution. Each 8 mg/50 mL (0.16 mg/mL) single-dose vial contains 50 mL of deliverable volume including 8 mg of uricase protein (conjugated to 24 mg of 10 kDa mPEG), Disodium Hydrogen Phosphate Heptahydrate (109 mg), Sodium Chloride (438.5 mg), Sodium Dihydrogen Phosphate Monohydrate (13mg), and Water for Injection to deliver 8 mg of pegloticase (as uricase protein).
To-be-Diluted KRYSTEXXA (pegloticase) injection 8 mg/mL single-dose vial is supplied as a sterile, preservative-free, clear and colorless solution intended for intravenous infusion after dilution. KRYSTEXXA (pegloticase) concentrations are expressed as concentrations of uricase protein. Each 8 mg/mL single-dose vial contains 1 mL of deliverable volume including 8 mg of uricase protein (conjugated to 24 mg of 10 kDa mPEG), Disodium Hydrogen Phosphate Dihydrate (2.18 mg), Sodium Chloride (8.77 mg), Sodium Dihydrogen Phosphate Dihydrate (0.43 mg), and Water for Injection to deliver 8 mg of pegloticase (as uricase protein).
7PATIENT COUNSELING INFORMATION
Advise patients to read the FDA-approved patient labeling (Medication Guide).
8PRINCIPAL DISPLAY PANEL - 8 mg/mL Vial Carton
NDC-75987-080-10
KRYSTEXXA
Injection
8 mg/mL
For Intravenous Infusion
Single-dose vial. Discard unused portion.
Dispense the enclosed
Rx Only
9PRINCIPAL DISPLAY PANEL - 50 mL Vial Carton
NDC-75987-058-01
KRYSTEXXA
Injection
8 mg per 50 mL (0.16 mg/mL)
For Intravenous Infusion
Ready-to-Use Presentation and
Contains 1 Single-dose vial. Discard unused portion.
Dispense the enclosed
Rx Only
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