Krystexxa (pegloticase)
Last reviewed · Source: First Databank (FDB) drug data
Overview
Pegloticase is a pegylated biosynthetic (recombinant DNA origin) modified mammalian urate oxidase (uricase) enzyme.
Pegloticase is a biosynthetic (recombinant DNA origin) modified mammalian (porcine-like) urate oxidase (uricase, urate hydroxylase) enzyme that is covalently bound to monoethoxypolyethylene glycol (PEG). The urate oxidase protein is prepared using recombinant DNA technology and a genetically modified strain of Escherichia coli. Pegloticase is a uric acid-specific enzyme that catalyzes the oxidation of uric acid to allantoin, thereby lowering serum uric acid concentrations.
Allantoin is an inert, water-soluble purine metabolite that is readily eliminated, mainly by renal excretion. Maintaining the serum urate concentration below the saturation point for monosodium urate (e.g., maintaining concentrations at 6 mg/dL or less) may prevent crystal formation and promote resolution of existing tophaceous crystal deposits, thus preventing long-term joint, bone, cartilage, and tissue destruction. A single dose of pegloticase rapidly suppresses plasma uric acid and generally maintains concentrations below 6 mg/dL for more than 12 days.
USES: Pegloticase is used to treat gout which has not responded to the usual treatments. It works by lowering high levels of uric acid in your body. Increased uric acid in your body can cause gout.
Generic name: pegloticase
Pronunciation: (peg-LOE-ti-kase)
Reference product & biosimilars
No reference, biosimilar or interchangeable associated with this drug.
Today’s intelligence on Krystexxa
Indications
The following indications are listed for Krystexxa:
- Prevention Of Acute Gout Attack
Also known as: Acute Gout Attack Prophylaxis, Prevention Of Acute Gout Flare.
Dosing
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 dosing information is available for this tab.
Drug interactions
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.
Contraindications
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.
There are no contraindication contraindications for this drug.
There are no severe contraindications for this drug.
There are no moderate contraindications for this drug.
Adverse reactions
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.
There are no severe adverse reactions for this drug.
There are no less severe adverse reactions for this drug.
Precautions
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.
ICD codes
No ICD codes are available for this drug.
Formulary status
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Last reviewed · Source: First Databank (FDB) drug data
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