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第一种也是唯一一种被批准用于增加5岁及以上软骨发育不全儿童开放性生长板线性生长的疗法.

VOXZOGO™ (vosoritide), a once-daily injection, 是c型利钠肽(CNP)的类似物,被批准用于增加5岁及以上软骨发育不全患者或骨骺开放的儿童的线性生长(生长板). Children on VOXZOGO have regular check ups to measure weight, growth, and physical development and adjust their dose. 在确认没有进一步增长潜力时,应停止使用VOXZOGO, when growth plates are closed.

VOXZOGO可能会导致严重的副作用,包括在一些患者中暂时降低血压. 降低血压下降和相关症状(头晕)的风险, feeling tired, or nausea), 患者应在接受VOXZOGO治疗前一小时内进食充足并补充水分. Please see below for Important Safety Information, full Prescribing Information, and Patient Prescribing Information.


Molecule
阶段(临床前,1期,2期,3期,BLA/NDA/MAA,批准)

Indication

VOXZOGO™是一种处方药,用于增加5岁及以上有开放骨生长板(骨骺)的软骨发育不全儿童的线性生长。. 这一指标是根据年化生长速度的改善在加速审批下批准的. 该适应症的继续批准可能取决于验证性试验中临床益处的验证和描述。.

Important Safety Information

What is VOXZOGO used for?

  • VOXZOGO是一种处方药,用于增加5岁及以上有开放生长板(骨骺)的软骨发育不全儿童的线性生长。.
  • 目前尚不清楚VOXZOGO对5岁以下软骨发育不全儿童是否安全有效.
  • VOXZOGO是基于年化增长速度的提高而加速批准的. 继续批准可能取决于验证性试验中临床疗效的验证和描述.

What is the most important safety information about VOXZOGO?

  • VOXZOGO可能会导致严重的副作用,包括在一些患者中暂时降低血压. 降低血压下降和相关症状(头晕)的风险, feeling tired, or nausea), 患者应在接受VOXZOGO治疗前1小时内吃一顿饭并喝8至10盎司的液体.

What are the most common side effects of VOXZOGO?

  • VOXZOGO最常见的副作用包括注射部位反应(包括发红), itching, swelling, bruising, rash, hives, and injection site pain), vomiting, joint pain, decreased blood pressure, and stomach ache. These are not all the possible side effects of VOXZOGO. 询问你的医疗保健提供者关于副作用的医疗建议, 以及任何困扰病人或无法消除的副作用.

How is VOXZOGO taken?

  • VOXZOGO is taken daily as an injection given under the skin, 在医疗保健提供者确定护理人员能够管理VOXZOGO后,由护理人员管理. 在您的医疗保健提供者向您展示正确的方法之前,不要尝试注射VOXZOGO. VOXZOGO提供了使用说明,描述了准备步骤, injecting, and disposing VOXZOGO. 护理人员应查阅使用说明以获得指导,并在收到补充的VOXZOGO时以防有任何更改.
  • Inject VOXZOGO 1 time every day, at about the same time each day. 如果漏服了一剂VOXZOGO,可以在漏服剂量后的12小时内给予. 12小时后,跳过错过的剂量,并像往常一样服用下一剂量.
  • The dose of VOXZOGO is based on body weight. 您的医疗保健提供者将根据定期检查后的体重变化调整剂量.
  • 您的医疗保健提供者将监测患者的生长情况,如果他们确定患者不再能够生长,则告诉您何时停止服用VOXZOGO. 如果您的医疗保健提供者指示停止使用VOXZOGO.

What should you tell your doctor before or during taking VOXZOGO?

  • 告诉你的医生病人的所有病情,包括
    • If the patient has heart disease (cardiac or vascular disease), 或者患者正在服用降压药(抗高血压药).
    • If the patient has kidney problems or renal impairment.
    • If the patient is pregnant or plans to become pregnant. It is not known if VOXZOGO will harm the unborn baby.
    • If the patient is breastfeeding or plans to breastfeed. It is not known if VOXZOGO passes into breast milk.
  • Tell your doctor about all of the medicines the patient takes, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

You may report side effects to 威廉希尔最新网址 at 1-866-906-6100. 威廉希尔最新网址鼓励你向沙巴体育足球网址报告处方药的负面副作用. Visit www.fda.gov/medwatch, or call 1-800-沙巴体育足球网址-1088.

Please see additional safety information in the full Prescribing Information and Patient Prescribing Information.


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