处 方 药：是
生产厂家中文参考译名:United Therapeutics Corporation
生产厂家英文名:United Therapeutics Corporation
原产地英文商品名:Unituxin Injection 17.5mg/5mL/vial
Unituxin (dinutuximab Injection)获美国FDA批准对高风险神经母细胞瘤第一个治疗
美国FDA药品评价和研究中心血液学和肿瘤产品室主任Richard Pazdur，M.D.说：“Unituxin 标记第一个批准为一种治疗目标特异性地针对有高风险神经母细胞瘤患者的治疗，”“Unituxin满足提供一种治疗选择延长有高风险神经母细胞瘤儿童活存至关重要的选择。”
公司：United Therapeutics Corporation
Unituxin是一种GD2-结合单克隆抗体适用与粒细胞 – 巨噬细胞集落刺激因子(GM-CSF)，白介素-2(IL-2)，和13-顺 – 视黄酸(RA)联用，为一线多药，多模式治疗前实现至少部分缓解反应有高风险神经母细胞瘤儿童患者的治疗。
17.5mg/m2/day作为一个历时10 to 20小时稀释的静脉输注连续4天共至5个疗程。
最常见不良药物反应(≥ 25%)是疼痛，发热，血小板减少，淋巴细胞减少，输注反应，低血压，低钠血症，谷丙转氨酶增加，贫血，呕吐，腹泻，低钾血症，毛细血管渗漏综合征，中性粒细胞减少，荨麻疹，低白蛋白血症，谷草转氨酶增加，和低钙血症。最常见严重不良反应(≥ 5%)是感染，输注反应，低钾血症，低血压，疼痛，发热，和毛细血管渗漏综合征。
Unituxin (dinutuximab) is a chimeric monoclonal antibody.
Unituxin is specifically indicated for use in combination with granulocyte-macrophage colonystimulating factor (GM-CSF), interleukin-2 (IL-2) and 13-cis-retinoic acid (RA), for the treatment of pediatric patients with high-risk neuroblastoma who achieve at least a partial response to prior first-line multiagent, multimodality therapy.
Unituxin is supplied as a solution for intravenous infusion. The recommended dose of Unituxin is 17.5mg/m2/day administered as an intravenous infusion over 10 to 20 hours for 4 consecutive days for a maximum of 5 cycles. Unituxin should be initiated at an infusion rate of 0.875 mg/m2 /hour for 30minutes. The infusion rate can be gradually increased as tolerated to a maximum rate of 1.75mg/m2/hour. Follow dose modification instructions (see drug label) for adverse reactions.
GD2-binding monoclonal antibody.
Dinutuximab 3.5mg/mL; solution for IV infusion after dilution; preservative-free.
United Therapeutics Corp
In combination with granulocyte-macrophage colony-stimulating factor, interleukin-2 (IL-2) and 13-cis-retinoic acid (RA), for the treatment of children with high-risk neuroblastoma who achieve at least a partial response to prior first-line multiagent, multimodality therapy.
Dinutuximab binds to cell surface GD2 and induces cell lysis of GD2-expressing cells through antibody-dependent cell-mediated cytotoxicity and complement-dependent cytotoxicity.
The safety and efficacy of Unituxin was eva luated in a randomized, open-label, multicenter trial conducted in pediatric patients with high-risk neuroblastoma.
Patients were randomized between Day 50 and Day 77 post-autologous stem cell transplantation. Patients randomized to the Unituxin/RA arm (n=113) received up to five cycles of dinutuximab in combination with GM-CSF or IL-2 plus RA, followed by one cycle of RA alone. Patients randomized to the RA arm (n=113) received six cycles of RA. Dinutuximab was administered at a dose of 17.5mg/m2/day on four consecutive days. Patients in both treatment arms received six cycles of RA at a dose of 160mg/m2/day orally (for patients weighing >12kg) or 5.33mg/kg/day (for patients weighing ≤12kg) in two divided doses for 14 consecutive days.
The major efficacy outcome measure was investigator-assessed event-free survival (EFS), defined as the time from randomization to the first occurrence of relapse, progressive disease, secondary malignancy, or death. There were 33 (29%) events in the Unituxin/RA arm vs. 50 (44%) in the RA arm (HR 0.57; [95% CI: 0.37, 0.89]; P= 0.01). Overall survival (OS) was also eva luated. After observing improvement in EFS based on the seventh interim analysis, termination of accrual was recommended.
For more clinical trial data, see full labeling.
Confirm adequate hematologic, respiratory, hepatic, and renal function prior to each course. Hydrate and premedicate with antihistamines, analgesics (eg, IV opioids), and antipyretics prior to each dose: see full labeling. Give via IV infusion over 10–20 hours for 4 consecutive days; max 5 cycles. Initial rate: 0.875mg/m2/hr for 30mins; may gradually increase as tolerated up to max 1.75mg/m2/hr. Cycles 1, 3, and 5 (24-day cycle): 17.5mg/m2/day on Days 4–7. Cycles 2 and 4 (32-day cycle): 17.5mg/m2/day on Days 8–11. Dose modifications: see full labeling.
Risk of serious infusion reactions; monitor during and at least 4 hours after completion of each infusion; interrupt or discontinue if severe or prolonged infusion reactions occur. Have resuscitative medications and equipment available. Risk of neuropathy. Permanently discontinue if life-threatening infusion reactions, Grade 3 pain unresponsive to max supportive measures, Grade 4 sensory neuropathy or Grade 3 sensory neuropathy that interferes with daily activities for more than 2 weeks, Grade 2 peripheral motor neuropathy, recurrent signs of eye disorders or vision loss, signs of atypical hemolytic uremic syndrome occurs. Interrupt or discontinue if severe capillary leak syndrome, symptomatic hypotension, systolic BP less than lower limit of normal for age or decreased by >15% compared to baseline develops. Monitor for systemic infection; temporarily discontinue until resolves. Monitor BP, peripheral blood counts during therapy, and serum electrolytes daily. Renal or hepatic impairment. Pregnancy; avoid. Use effective contraception during therapy and for at least 2 months after last dose. Nursing mothers: not recommended.
Pain, pyrexia, infusion reactions, hypotension, hyponatremia, hypokalemia, hypocalcemia, hypoalbuminemia, increased ALT/AST, vomiting, diarrhea, capillary leak syndrome, urticaria, infections, bone marrow suppression (eg, thrombocytopenia, anemia, neutropenia, lymphopenia).
Single-use vial (5mL)—1
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