药物名称：Krystexxa（pegloticase）
适应症：痛风
公司：Savient Pharmaceuticals
批准日期：2010年9月14日
药品类型：生物制品
简要说明：用于常规治疗无效或常规治疗无法耐受的成年痛风患者。Pegloticase于2001年被FDA指定为孤儿药。KRYSTEXXA是Savient制药公司的商标。在2009年7月初，完成了OLE试验，在2010年1月，完成了特殊程序的6个月的观察。 



HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use KRYSTEXXA safely and effectively. See full prescribing information for KRYSTEXXA
KRYSTEXXA™ (pegloticase)
Injection, for intravenous infusion
Initial U.S. Approval: 2010
Savient Pharmaceuticals, Inc.
WARNING: ANAPHYLAXIS and INFUSION REACTIONS
See full prescribing information for complete boxed warning.
Anaphylaxis and infusion reactions have been reported to occur during and after administration of KRYSTEXXA (5.1, 5.2).
KRYSTEXXA should be administered in healthcare settings and by healthcare providers prepared to manage anaphylaxis and infusion reactions.
Patients should be pre-medicated 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.
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. (1)
Important Limitations of Use:
KRYSTEXXA is not recommended for the treatment of asymptomatic hyperuricemia. (1)
DOSAGE AND ADMINISTRATION
For adult patients 8 mg given as an intravenous infusion every two weeks. (2.1)
Do not administer as an intravenous push or bolus. (2.3)
Monitor serum uric acid levels before each infusion. (2.3)
Patients should be pre-medicated with antihistamines and corticosteroids. (2.3, 5.1, 5.2)
Administer in a healthcare setting by healthcare providers prepared to manage anaphylaxis. (2.3, 5.1, 5.2)
The KRYSTEXXA admixture should only be administered by intravenous infusion over no less than 120 minutes via gravity feed, syringe-type pump, or infusion pump. (2.3)
DOSAGE FORMS AND STRENGTHS
1 mL sterile concentrate for dilution containing 8 mg of pegloticase protein, expressed in uricase protein amounts. (3)
CONTRAINDICATIONS
Glucose-6-phosphate dehydrogenase (G6PD) Deficiency: Before starting KRYSTEXXA, patients at higher risk for G6PD deficiency (e.g., those of African and Mediterranean ancestry) should be screened due to the risk of hemolysis and methemoglobinemia. (4)
WARNINGS AND PRECAUTIONS
Anaphylaxis: Anaphylaxis occurred in patients treated with KRYSTEXXA. 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. Patients should be pre-medicated with antihistamines and corticosteroids. Patients should be closely monitored for an appropriate period of time for anaphylaxis after administration of KRYSTEXXA. (5.1)
Infusion Reactions: Infusion reactions occurred in patients treated with KRYSTEXXA. KRYSTEXXA shou