RX ITEM-Krystexxa 8Mg/Ml Vial By Crealta Pharma (Horizon Pharma)

KRYSTEXXA- pegloticase injection, solution
Savient Pharmaceuticals, Inc.
WARNING: ANAPHYLAXIS AND INFUSION REACTIONS

Anaphylaxis and infusion reactions have been reported to occur during and after administration of KRYSTEXXA. [see Warnings and Precautions (5.1, 5.2)]
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.
KRYSTEXXA should be administered in healthcare settings and by healthcare providers prepared to manage anaphylaxis and infusion reactions.
Patients should be premedicated with antihistamines and corticosteroids.
Patients should be closely monitored for an appropriate period of time for anaphylaxis after administration of KRYSTEXXA.
Monitor serum uric acid levels prior to infusions and consider discontinuing treatment if levels increase to above 6 mg/dL, particularly when 2 consecutive levels above 6 mg/dL are observed.

1 INDICATIONS AND USAGE

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.
2 DOSAGE AND ADMINISTRATION
2.1 Dosage

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.

RX ITEM-Krystexxa 8Mg/Ml Vial By Crealta
NDC 60809-0801-01 UPC/GTIN No.3-60809-80101-8 Mfg.Part No.80101

Krystexxa 8Mg/Ml Vial By Crealta Pharma
BRAND: KRYSTEXXA NDC: 60809-0801-01,60809080101 UPC: 3-60809-80101-8,360809801018 Crealta Pharmaceuticals Llc

PEGLOTICASE INTRAVEN VIAL
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Krystexxa 8mg/ml Vial
Krystexxa 8mg/ml Vial by Crealta Pharma

Krystexxa 8mg/ml Vial
Krystexxa 8mg/ml Vial by Crealta Pharma