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pegloticase
Overview
What is Krystexxa?
KRYSTEXXA (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
. 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.
KRYSTEXXA is intended for intravenous infusion.
KRYSTEXXA is a sterile, clear, colorless solution containing 8 mg/mL pegloticase in phosphate-buffered saline.
KRYSTEXXA (pegloticase) concentrations are expressed as concentrations of uricase protein. Each mL of KRYSTEXXA contains 8 mg of uricase protein (conjugated to 24 mg of 10 kDa mPEG), 2.18 mg Disodium Hydrogen Phosphate Dihydrate (NaHPO•2HO), 8.77 mg Sodium Chloride (NaCl), 0.43 mg Sodium Dihydrogen Phosphate Dihydrate (NaHPO•2HO), and Water for Injection to deliver 8 mg of pegloticase (as uricase protein).
What does Krystexxa look like?
What are the available doses of Krystexxa?
KRYSTEXXA is a clear, colorless, sterile 8 mg/mL solution of pegloticase in a 2 mL single-use vial, expressed as amounts of uricase protein. KRYSTEXXA must be diluted prior to use.
What should I talk to my health care provider before I take Krystexxa?
How should I use Krystexxa?
KRYSTEXXA® (pegloticase) is a PEGylated uric acid specific enzyme 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.
Important Limitations of Use:KRYSTEXXA is not recommended for the treatment of asymptomatic hyperuricemia.
The recommended dose and regimen of KRYSTEXXA for adult patients is 8 mg (uricase protein) given as an intravenous infusion every two weeks.
The optimal treatment duration with KRYSTEXXA has not been established.
What interacts with Krystexxa?
Sorry No Records found
What are the warnings of Krystexxa?
Sorry No Records found
What are the precautions of Krystexxa?
Sorry No Records found
What are the side effects of Krystexxa?
Sorry No records found
What should I look out for while using Krystexxa?
Glucose-6-phosphate dehydrogenase
(
G6PD
)
deficiency
See Warnings and Precautions (
)
What might happen if I take too much Krystexxa?
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.
How should I store and handle Krystexxa?
Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Do not refrigerate.Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Do not refrigerate.How Supplied Storage and HandlingProtect from light. Do not shake or freeze.Do not use beyond the expiration date stamped. NDC# 60809-801-01How Supplied Storage and HandlingProtect from light. Do not shake or freeze.Do not use beyond the expiration date stamped. NDC# 60809-801-01How Supplied Storage and HandlingProtect from light. Do not shake or freeze.Do not use beyond the expiration date stamped. NDC# 60809-801-01How Supplied Storage and HandlingProtect from light. Do not shake or freeze.Do not use beyond the expiration date stamped. NDC# 60809-801-01How Supplied Storage and HandlingProtect from light. Do not shake or freeze.Do not use beyond the expiration date stamped. NDC# 60809-801-01How Supplied Storage and HandlingProtect from light. Do not shake or freeze.Do not use beyond the expiration date stamped. NDC# 60809-801-01How Supplied Storage and HandlingProtect from light. Do not shake or freeze.Do not use beyond the expiration date stamped. NDC# 60809-801-01How Supplied Storage and HandlingProtect from light. Do not shake or freeze.Do not use beyond the expiration date stamped. NDC# 60809-801-01How Supplied Storage and HandlingProtect from light. Do not shake or freeze.Do not use beyond the expiration date stamped. NDC# 60809-801-01How Supplied Storage and HandlingProtect from light. Do not shake or freeze.Do not use beyond the expiration date stamped. NDC# 60809-801-01
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
KRYSTEXXA is a uric acid specific enzyme which is a recombinant uricase and achieves its therapeutic effect by catalyzing the oxidation of uric acid to allantoin, thereby lowering serum uric acid. Allantoin is an inert and water soluble purine metabolite. It is readily eliminated, primarily by renal excretion.
Non-Clinical Toxicology
Glucose-6-phosphate dehydrogenase(
G6PD
)
deficiency
See Warnings and Precautions (
)
Although the pressor activity of desmopressin acetate is very low compared with the antidiuretic activity, use of doses as large as 0.3 mcg/kg of desmopressin acetate with other pressor agents should be done only with careful patient monitoring. The concomitant administration of drugs that may increase the risk of water intoxication with hyponatremia, (e.g., tricyclic antidepressants, selective serotonin re-uptake inhibitors, chlorpromazine, opiate analgesics, NSAIDs, lamotrigine and carbamazepine) should be performed with caution.
Desmopressin acetate has been used with epsilon aminocaproic acid without adverse effects.
During pre-marketing controlled clinical trials, anaphylaxis was reported with a frequency of 6.5% of patients treated with KRYSTEXXA every 2 weeks, compared to none with placebo. Manifestations included wheezing, peri-oral or lingual edema, or hemodynamic instability, with or without rash or urticaria. Cases occurred in patients being pre-treated with one or more doses of an oral antihistamine, an intravenous corticosteroid and/or acetaminophen. This pre-treatment may have blunted or obscured symptoms or signs of anaphylaxis and therefore the reported frequency may be an underestimate. [ ()]
KRYSTEXXA should be administered in a healthcare setting by healthcare providers prepared to manage anaphylaxis. Patients should be pre-treated with antihistamines and corticosteroids. Anaphylaxis may occur with any infusion, including a first infusion, and generally manifests within 2 hours of the infusion. However, delayed type hypersensitivity reactions have also been reported. Patients should be closely monitored for an appropriate period of time for anaphylaxis after administration of KRYSTEXXA. Patients should be informed of the symptoms and signs of anaphylaxis and instructed to seek immediate medical care should anaphylaxis occur after discharge from the healthcare setting.
The risk of anaphylaxis is higher in patients whose uric acid level increases to above 6 mg/dL, particularly when 2 consecutive levels above 6 mg/dL are observed. Monitor serum uric acid levels prior to infusions and consider discontinuing treatment if levels increase to above 6 mg/dL. Because of the possibility that concomitant use of oral urate-lowering therapy and KRYSTEXXA may potentially blunt the rise of serum uric acid levels, it is recommended that before starting KRYSTEXXA patients discontinue oral urate-lowering medications and not institute therapy with oral urate-lowering agents while taking KRYSTEXXA.
The most commonly reported serious adverse reactions from pre-marketing controlled clinical trials were anaphylaxis, which occurred at a frequency of 6.5% in patients treated with KRYSTEXXA 8 mg every 2 weeks, compared to none with placebo; infusion reactions, which occurred at a frequency of 26% in patients treated with KRYSTEXXA 8 mg every 2 weeks, compared to 5% treated with placebo; and gout flares, which were more common during the first 3 months of treatment with KRYSTEXXA compared with placebo. All patients in pre-marketing controlled clinical trials were pre-treated with an oral antihistamine, intravenous corticosteroid and/or acetaminophen to prevent anaphylaxis and infusion reaction. Patients also received non-steroidal anti-inflammatory drugs or colchicine, or both, for at least 7 days as gout flare prophylaxis before beginning KRYSTEXXA treatment. [ (, , )]
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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