Administration of a single dose of pegloticase results in rapid and sustained reduction of plasma urate levels in patients with gout (7, 8). https://profreg.medscape.com/px/getpracticeprofile.do?method=getProfessionalProfile&urlCache=aHR0cHM6Ly9yZWZlcmVuY2UubWVkc2NhcGUuY29tL2RydWcva3J5c3RleHhhLXBlZ2xvdGljYXNlLTk5OTYwMQ==
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No structural abnormalities were observed on animal reproduction studies, when pegloticase administered by subcutaneous injection to pregnant rats and rabbits during period of organogenesis at doses up to 50 and 75 times, respectively, the maximum recommended human dose (MRHD); decreases in mean fetal and pup body weights were observed at approximately 50 and 75 times MRHD, respectively No dose adjustment is needed for patients 65 years of age and older. and formulary information changes. The active substance is pegloticase, a recombinant uricase of chimeric mammalian origin produced in E. coli to which monomethoxy poly (ethylene glycol) (mPEG) has been covalently attached.
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KRYSTEXXA ® (pegloticase) is indicated for the treatment of chronic gout in adult 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 …
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In September 2010, pegloticase (Krystexxa; Savient Pharmaceuticals), a recombinant urate oxidase conjugated to polyethylene glycol (PEG), was approved by … Dose response study.....34 2.5.2. Since infusion reactions can occur after completion of infusion, observation of patients for approximately an hour post-infusion should be considered.
2010
In clinical trials, pegloticase use resulted in plasma concentrations as low as 0.5 to 1 mg/dL within 24 hours of an initial dose.
In the present study we demonstrated that multiple doses of pegloticase administered every 2 or 4 weeks effectively controlled urate levels over 12–14 weeks in most patients with treatment‐failure gout. Do not administer as an intravenous push or bolus.
Controlled studies in pregnant women show no evidence of fetal risk.Recombinant, pegylated uric acid specific enzyme; achieves its therapeutic effect by catalyzing oxidation of uric acid to allantoin, thereby lowering serum uric acid levelsPremedicate with antihistamines and corticosteroidsMonitor serum uric acid levels prior to infusions and consider discontinuing treatment if levels increase to >6 mg/dL (especially if 2 consecutive levels > 6 mg/dL observed)Administer IV infusion over at least 2 hr via gravity feed or volumetric infusion pumpStore refrigerated in original carton (do not freeze)Adding plans allows you to compare formulary status to other drugs in the same class.To view formulary information first create a list of plans.
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The pegloticase admixture should only be administered by intravenous infusion over no less than 120 minutes via gravity feed, syringe-type pump, or infusion pump.
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2001
The maximum dose that has been administered as a single intravenous dose is 12 mg as uricase protein. informational and educational purposes only.
Pegloticase at similar to and higher than the maximum recommended human dose (MRHD) on a plasma AUC basis [at intravenous (IV) doses of ≥ 0.4 mg/kg in dogs] caused cytoplasmic vacuoles in multiple organs, and edema and histiocyte infiltration in the aortic outflow tract in dogs. This website also contains material copyrighted by 3rd parties. 389965-overview
In the pivotal trials, all patients received pre-infusion medications before each pegloticase dose, including intravenous (IV) hydrocortisone.
See videos to help answer your questions.The ACR is accepting applications for mini curriculums, which are educational activities or curriculums to enhance the ACR Core Curriculum Outline.Glucose-6-phosphate dehydrogenase (G6PD) deficiency.
If an infusion reaction occurs during the administration of pegloticase, the infusion may be slowed, or stopped and restarted at a slower rate, at the discretion of the attending health care professional. 329958-overview
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