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Krystexxa(聚乙二醇重组尿酸酶pegloticase)注射剂(五)
2013-10-31 15:52:08 来源: 作者: 【 】 浏览:6802次 评论:0
( 5.1 , 5.2 )]
Infusion Reactions:
Infusion reactions occurred in 26% of patients in the 2Â week dosing regimen group and 41% of patients in the 4Â week dosing regimen group, compared to 5% of placebo-treated patients. Manifestations of these reactions included urticaria (frequency of 10.6%), dyspnea (frequency of 7.1%), chest discomfort (frequency of 9.5%), chest pain (frequency of 9.5%), erythema (frequency of 9.5%), and pruritus (frequency of 9.5%). These manifestations overlap with the symptoms of anaphylaxis, but in a given patient did not occur together to satisfy the clinical criteria for diagnosing anaphylaxis. Infusion reactions are thought to result from release of various mediators, such as cytokines. Infusion reactions occurred at any time during a course of treatment with approximately 3% occurring with the first infusion, and approximately 91% occurred during the time of infusion. Some infusion reaction manifestations were reduced with slowing the rate of infusion, or stopping the infusion and restarting the infusion at a slower rate. These infusion reactions occurred with all patients being pre-treated with an oral antihistamine, intravenous corticosteroid and acetaminophen. [see Boxed Warning , Warnings and Precautions ( 5.1 , 5.2 )]
Gout Flares:
Gout flares were common in the study patients before randomization to treatment, with patients experiencing an average of 10Â flares in the preceding 18Â months prior to study entry. During the controlled treatment period with KRYSTEXXA or placebo, the frequencies of gout flares were high in all treatment groups, but more so with KRYSTEXXA treatment during the first 3Â months of treatment, which seemed to decrease in the subsequent 3Â months of treatment. The percentages of patients with any flare for the first 3Â months were 74%, 81%, and 51%, for KRYSTEXXA 8Â mg every 2Â weeks, KRYSTEXXA 8Â mg every 4Â weeks, and placebo, respectively. The percentages of patients with any flare for the subsequent 3Â months were 41%, 57%, and 67%, for KRYSTEXXA 8Â mg every 2Â weeks, KRYSTEXXA 8Â mg every 4Â weeks, and placebo, respectively. Patients received gout flare prophylaxis with colchicine and/or nonsteroidal anti-inflammatory drugs (NSAIDs) starting at least one week before receiving KRYSTEXXA. [see Warnings and Precautions ( 5.3 )]
Congestive Heart Failure:
Two cases of congestive heart failure exacerbation occurred during the trials in patients receiving treatment with KRYSTEXXA 8Â mg every 2Â weeks. No cases were reported in placebo-treated patients. Four subjects had exacerbations of pre-existing congestive heart failure while receiving KRYSTEXXA 8Â mg every 2Â weeks during the open-label extension study. [see Warnings and Precautions ( 5.4 )].
Other Adverse Reactions:
The most commonly reported adverse reactions that occurred in greater than or equal to 5% of patients treated with KRYSTEXXA 8 mg every 2 weeks are provided in Table 1.
Table 1. Adverse Reactions Occurring in 5% or More of Patients Treated with KRYSTEXXA Compared to Placebo Adverse Reaction
(Preferred Term) KRYSTEXXA
8Â mg every 2Â weeks
(N=85)
Na (%) Placebo
(N=43)
N (%)
a If the same subject in a given group had more than one occurrence in the same preferred term event category, the subject was counted only once.
b Most did not occu
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