设为首页 加入收藏

TOP

VPRIV (velaglucerase alfa for injection), for intravenous
2015-10-17 10:02:26 来源: 作者: 【 】 浏览:380次 评论:0
  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use VPRIV safely and effectively. See full prescribing information for VPRIV.

    VPRIV® (velaglucerase alfa for injection), for intravenous use
    Initial U.S. Approval: 2010
    RECENT MAJOR CHANGES
    • Dosage and Administration (2.3)
    • Warnings and Precautions (5.1)
    4/2015
    4/2015
    INDICATIONS AND USAGE

    VPRIV is a hydrolytic lysosomal glucocerebroside-specific enzyme indicated for long-term enzyme replacement therapy (ERT) for patients with type 1 Gaucher disease (1)
    DOSAGE AND ADMINISTRATION

    • Recommended Starting Dose in Adults and Pediatric Patients 4 Years of Age or Older:
      • Patients Naïve to Enzyme Replacement Therapy: 60 Units/kg (2.1)
      • Patients being treated with stable imiglucerase dosages for Gaucher disease: Can switch to VPRIV at previous imiglucerase dose two weeks after last imiglucerase dose (2.2).
    • Determine number of vials to be reconstituted based on patient's actual weight and prescribed dose (2.3)
    • Supplied VPRIV lyophilized powder must be reconstituted with Sterile Water for Injection (2.3)
    • Reconstituted VPRIV solution must be diluted in 100 mL of 0.9% sodium chloride solution prior to intravenous infusion (2.3)
    • Administer the diluted VPRIV solution through an in-line low protein-binding 0.2μm filter (2.4)
    DOSAGE FORMS AND STRENGTHS
    • Lyophilized powder to be reconstituted and diluted for infusion (3).
    • Available in 400 Units single-use vials (3).

    CONTRAINDICATIONS

    None (4)
    WARNINGS AND PRECAUTIONS

    Hypersensitivity Reactions Including Anaphylaxis:

    • Hypersensitivity reactions including anaphylaxis have occurred.(5.1)
    • Ensure that personnel administering product are adequately trained in cardiopulmonary resuscitative measures, and have ready access to emergency medical services (5.1)
    • Consider slowing infusion rate, treatment with antihistamines, antipyretics and/or corticosteroids, and/or stopping treatment if a hypersensitivity reaction occurs during an infusion. Consider pre-treatment with antihistamines and/or corticosteroids in patients with prior reactions (
  • Tags: 责任编辑:admin
    】【打印繁体】【投稿】【收藏】 【推荐】【举报】【评论】 【关闭】 【返回顶部
    分享到QQ空间
    分享到: 
    上一篇ALDURAZYME(laronidase) Solution.. 下一篇DEXILANT (dexlansoprazole) dela..

    相关栏目

    最新文章

    图片主题

    热门文章

    推荐文章

    相关文章

    广告位