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详细处方信息以本药内容附件PDF文件（201942221225217.pdf）的“原文Priscribing Information”为准
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部分中文Cablivi处方资料（仅供参考）

【英文名称】Cablivi

【适用证】

Cablivi适用于治疗出现获得性血栓性血小板减少性紫癜（aTTP）发作的成人，并结合血浆置换和免疫抑制。

【用法用量】

使用Cablivi治疗应由具有血栓性微血管病患者管理经验的医生发起和监督。

剂量学：

第一剂：

在血浆交换之前静脉注射10mg的capslacizumab。

后续剂量： 在每次血浆交换完成后每日皮下施用10mg的caplacizumab，持续每日血浆交换处理，然后在停止每日血浆交换处理后每日皮下注射10mg的caplacizumab 30天。

如果在此期间结束时有证据表明未解决的免疫疾病，建议优化免疫抑制方案，并继续每日皮下注射10 mg caplacizumab，直至出现潜在免疫疾病的迹象（例如持续正常化） ADAMTS13活动水平）。

在临床开发计划中，每天给予caplacizumab长达65天。没有关于用caplacizumab再治疗的数据。

错过剂量：

如果错过了一剂Cablivi，可以在12小时内给药。如果已经给药剂量超过12小时，则不应给药错过的剂量，并且应按照通常的给药方案给予下一剂量。

【药物形式】

用于注射溶液的粉末和溶剂。

白色冻干粉末。

溶剂是透明无色液体。

【禁忌】

对活性物质或6.1节中列出的任何赋形剂过敏。

【Therapeutic indications】

Cablivi is indicated for the treatment of adults experiencing an episode of acquired thrombotic thrombocytopenic purpura (aTTP), in conjunction with plasma exchange and immunosuppression.

【Posology and method of administration】

Treatment with Cablivi should be initiated and supervised by physicians experienced in the management of patients with thrombotic microangiopathies.

Posology

First dose：

Intravenous injection of 10 mg of caplacizumab prior to plasma exchange.

Subsequent doses：

Daily subcutaneous administration of 10 mg of caplacizumab after completion of each plasma exchange for the duration of daily plasma exchange treatment, followed by daily subcutaneous injection of 10 mg of caplacizumab for 30 days after stopping daily plasma exchange treatment.

If at the end of this period there is evidence of unresolved immunological disease, it is recommended to optimise the immunosupression regimen and continue daily subcutaneous administration of 10 mg of caplacizumab until the signs of underlying immunological disease are resolved (e.g. sustained normalisation of ADAMTS13 activity level).

In the clinical development program, caplacizumab has been administered daily for up to 65 days. No data on re-treatment with caplacizumab are available.

Missed dose：

If a dose of Cablivi is missed, it can be administered within 12 hours. If more than 12 hours have passed since the dose was to have been given, the missed dose should NOT be administered and the next dose should be administered per the usual dosing schedule.

【Contraindications】

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

【PHARMACEUTICAL FORM】

Powder and solvent for solution for injection.

White lyophilised powder.

The solvent is a clear, colourless liquid.

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详细处方信息以本药内容附件PDF文件（201942221225217.pdf）的“原文Priscribing Information”为准
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