达雷妥尤单抗皮下注射液 | China Drugs ListDaratumumab and hyaluronidase injection (subcutaneous) | China Drugs List
本页为公开参考信息，不构成医疗建议、处方或药品供应要约。请向持证专业人士确认当前批准情况、可获得性及适用性。
其他
- 商品名
- Darzalex Faspro
- 企业
- Janssen Biotech, Inc.
- 药品类型
- 生物药Biologic
- 治疗领域
- 肿瘤科Oncology
- 公开来源记录的适应症
- 美国成人部分用途包括多发性骨髓瘤的特定联合方案，例如与硼替佐米、来那度胺和地塞米松联合，用于不适合移植的新诊断患者，以及适合移植患者的诱导/巩固治疗。单药用途列有经多线治疗或双重难治的骨髓瘤，以及高危冒烟型骨髓瘤。这些仅为部分美国适应症；所有联合方案、既往治疗限制及其他病种详见说明书。本皮下制剂与静脉达雷妥尤单抗分开记录。Selected US uses in adults include multiple myeloma in specified combinations, including bortezomib, lenalidomide and dexamethasone for newly diagnosed transplant-ineligible patients and for induction/consolidation in transplant-eligible patients. Monotherapy is listed for heavily pretreated or double-refractory myeloma and for high-risk smoldering myeloma. These are selected US indications; consult the label for all combinations, treatment-history restrictions and other conditions. This subcutaneous formulation is recorded separately from intravenous daratumumab.
- 适应症来源与口径
- 美国说明书； DailyMed更新于 2026年10月12日. 部分境外适应症；不确立中国批准范围。US label; DailyMed updated 12 October 2026. Selected overseas indications; does not establish the Chinese approved scope.
- 说明书信息局限
- 已链接境外官方处方资料；尚未核实完整的现行中国说明书。Overseas official prescribing information linked; a complete current Chinese label has not been verified.
- 中国可获得性状态
- 本次英文来源核查未独立核实中国批准详情及当前供应情况。Chinese approval details and current availability have not been independently verified in this English-source review.
- 海外状态
- 请参阅所链接的境外监管机构或厂商证据。批准及适应症因司法辖区而异；尚未确认当前供应情况。See the linked overseas regulator / manufacturer evidence. Approval and indications are jurisdiction-specific; current supply is not established.
- 医保分类
- 尚未核实Not yet verified
- 医保版本
- 中国国家医保信息待核实Chinese national insurance review pending
- 医保核查说明
- 本次新增记录尚未确定报销资格；缺少信息不代表未被纳入。No reimbursement determination was made for this addition; missing information is not proof of exclusion.
来源
- https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?audience=professional&setid=4bb241af-4299-4373-8762-2d6709515db0
- Darzalex Faspro——美国处方资料Darzalex Faspro — US prescribing information
Official prescribing information · US label; DailyMed updated 12 October 2026
已于2026年11月2日打开英文一手来源。本摘要列出部分美国适应症，并非现行中国批准范围的全集。English primary source opened on 2 November 2026. The summary lists selected US indications, not the complete current Chinese approved scope.
- FDA NDC目录——包装参考FDA NDC directory — packaging reference
Supplied report reference · Report dated 25 October 2026
保留原报告引用以便追溯。仅凭此引用不能核实中国批准、品牌身份、制剂等效性或同口径价格。WAC计价单位及包装换算须另行确认。Original report citation retained for traceability. This citation alone does not verify Chinese approval, brand identity, equivalent formulations or like-for-like prices. WAC unit and pack conversions require separate confirmation.
- 得克萨斯州卫生服务部（DSHS）——2026年度WAC报告Texas DSHS — 2026 annual WAC report
Supplied report reference · Report dated 25 October 2026
保留原报告引用以便追溯。仅凭此引用不能核实中国批准、品牌身份、制剂等效性或同口径价格。WAC计价单位及包装换算须另行确认。Original report citation retained for traceability. This citation alone does not verify Chinese approval, brand identity, equivalent formulations or like-for-like prices. WAC unit and pack conversions require separate confirmation.
- 深圳新风和睦家医院——公示价格Shenzhen New Frontier United Family Hospital — public prices
Supplied report reference · Report dated 25 October 2026
保留原报告引用以便追溯。仅凭此引用不能核实中国批准、品牌身份、制剂等效性或同口径价格。WAC计价单位及包装换算须另行确认。Original report citation retained for traceability. This citation alone does not verify Chinese approval, brand identity, equivalent formulations or like-for-like prices. WAC unit and pack conversions require separate confirmation.
证据核查日期：