The first 和 only therapy approved to increase linear 增长 in children with achondroplasia 和 open 增长 plates.
VOXZOGO® (vosoritide), 每日注射一次, is a C-type natriuretic peptide (CNP) analog approved to increase linear 增长 in children with achondroplasia 和 open epiphyses (增长 plates). 使用VOXZOGO的儿童会定期进行体重检查, 增长, 以及身体发育和调整自己的剂量. VOXZOGO should be stopped upon confirmation of no further 增长 potential, 当生长板关闭时.
VOXZOGO may cause serious side effects including a temporary decrease in blood pressure in some patients. To reduce the risk of a decrease in blood pressure 和 associated symptoms (dizziness, 感觉累了, 或恶心), patients should be well fed 和 hydrated in the hour before receiving VOXZOGO. 请参阅以下重要安全资讯, 完整的处方信息, 和病人处方信息.
指示
VOXZOGO is a C type natriuretic peptide (CNP) analog indicated to increase linear 增长 in pediatric patients with achondroplasia with open epiphyses. This indication is approved under accelerated approval based on an improvement in annualized 增长 velocity. Continued approval for this indication may be contingent upon verification 和 description of clinical benefit in confirmatory trial(s).
重要安全资讯
VOXZOGO的用途是什么?
- VOXZOGO is a prescription medicine used to increase linear 增长 in children with achondroplasia 和 open 增长 plates (epiphyses).
- VOXZOGO is approved under accelerated approval based on an improvement in annualized 增长 velocity. Continued approval may be contingent upon verification 和 description of clinical benefit in confirmatory trials.
VOXZOGO最重要的安全信息是什么?
- VOXZOGO may cause serious side effects including a temporary decrease in blood pressure in some patients. To reduce the risk of a decrease in blood pressure 和 associated symptoms (dizziness, 感觉累了, 或恶心), patients should eat a meal 和 drink 8 to 10 ounces of fluid within 1 hour before receiving VOXZOGO.
VOXZOGO最常见的副作用是什么?
- The most common side effects of VOXZOGO include injection site reactions (including redness, 瘙痒, 肿胀, 瘀伤, 皮疹, 荨麻疹, 和注射部位疼痛), high levels of blood alkaline phosphatase shown in blood tests, 呕吐, 关节疼痛, 降低血压, 和胃痛. 这些还不是VOXZOGO可能产生的所有副作用. Ask your healthcare provider for medical advice about side effects, 和 about any side effects that bother the patient or that do not go away.
VOXZOGO是如何被采用的?
- VOXZOGO每天在皮下注射, administered by a caregiver after a healthcare provider determines the caregiver is able to administer VOXZOGO. Do not try to inject VOXZOGO until you have been shown the right way by your healthcare provider. VOXZOGO is supplied with Instructions for Use that describe the steps for preparing, 注射, 处理VOXZOGO. Caregivers should review the Instructions for Use for guidance 和 any time they receive a refill of VOXZOGO in case any changes have been made.
- Inject VOXZOGO 1 time every day, at about the same time each day. If a dose of VOXZOGO is missed, it can be given within 12 hours from the missed dose. After 12 hours, skip the missed dose 和 administer the next daily dose as usual.
- VOXZOGO的剂量是基于体重的. Your healthcare provider will adjust the dose based on changes in weight following regular check-ups.
- Your healthcare provider will monitor the patient’s 增长 和 tell you when to stop taking VOXZOGO if they determine the patient is no longer able to grow. Stop administering VOXZOGO if instructed by your healthcare provider.
What should you tell the doctor before or during taking VOXZOGO?
- Tell your doctor about all of the patient's medical conditions including
- 如果患者患有心脏病(心脏或血管疾病), or if the patient is on blood pressure medicine (anti-hypertensive medicine).
- 如果病人有肾脏问题或肾功能受损.
- 如果患者怀孕或计划怀孕. 目前尚不清楚VOXZOGO是否会伤害未出生的婴儿.
- 如果患者正在母乳喂养或计划母乳喂养. 目前尚不清楚VOXZOGO是否会进入母乳.
- 告诉你的医生病人服用的所有药物, 包括处方药和非处方药, 维生素, 草药补充剂.
您可以拨打1-866-906-6100向澳门正规博彩十大排行平台报告副作用. You are encouraged to report negative side effects of prescription drugs to the 澳门十大博彩正规游戏平台. 访问 www.食品及药物管理局.gov /提交确证，或致电1-800-澳门十大博彩正规游戏平台-1088.
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