目前，白介素-2融合毒素(Ontak)已经被美国FDA批准用于治疗皮肤性T细胞白血病及卵巢癌的患者。
研究人员最近声明，通过静脉注射药物白介素-2融合毒素(Ontak)可以消除抑制身体对癌症的自然免疫应答的有害细胞，从而达到有效治疗卵巢癌和皮肤性T细胞白血病的目的，这是一种新颖的卵巢癌以及皮肤性T细胞白血病治疗方法。

最初美国批准：1999

卫材公司

适应症
ontak是1 CD25导向毒素的持续或复发的皮肤T细胞淋巴瘤的恶性细胞表达IL-2受体CD25表达组件患者的治疗表示。
 
剂量和用法
Premedicate与抗组胺药和对乙酰氨基酚之前每个Ontak输液。
管理在9或18微克/公斤/天静脉滴注超过30至60分钟，连续5天8个周期，每21天。
 
剂型和优势
在单次使用小瓶含有150微克/毫升（2毫升300微克）的解决方案。
 
禁忌
没有。

注意事项：
输液反应：立即停止和永久停止Ontak严重的输液反应。监测后输液的病人。
毛细管渗漏综合征：显示器的重量，水肿，血压和血清白蛋白水平。
丧失视力及色觉：监视视力及色觉。
实验室检查：监控每个疗程开始前血清白蛋白水平。直到血清白蛋白水平至少3.0克/升，拖延的Ontak管理。

不良反应
最常见的不良反应（≥20％），发热，恶心，乏力，寒战，呕吐，腹泻，头痛，血管神经性水肿，咳嗽，呼吸困难，皮肤瘙痒。
 
在特殊人群中使用
怀孕：没有人或动物的数据。如果确实需要，只能使用。
哺乳母亲：停止药物或哺乳，考虑药物对母亲的重要性。

日期：08/2011

ONTAK® (denileukin difitox) is indicated for the treatment of patients with persistent or recurrent cutaneous T-cell lymphoma whose malignant cells express the CD25 component of the IL–2 receptor.

Important Safety Information

The following adverse reactions have been reported: Serious and fatal infusion reactions. Administer ONTAK® in a facility equipped and staffed for cardiopulmonary resuscitation. Immediately stop and permanently discontinue ONTAK® for serious infusion reactions. Capillary leak syndrome resulting in death. Monitor weight, edema, blood pressure and serum albumin levels prior to and during ONTAK® treatment. Loss of visual acuity and color vision.

Infusion Reactions
Infusion reactions, defined as symptoms occurring within 24 hours of infusion and resolving within 48 hours of the last infusion in that course, were reported in 70.5% of 234 ONTAK®-treated patients across 3 clinical studies. Serious infusion reactions were reported in 8.1% of patients. There have been post-marketing reports of infusion reactions resulting in death. For patients completing at least 4 courses of ONTAK® treatment in a placebo-controlled trial, the incidence of infusion reactions was lower in the third and fourth cycles as compared to the first and second cycles of ONTAK®.

Capillary leak syndrome
Capillary leak syndrome was defined as the occurrence of at least 2 of the following 3 symptoms (hypotension, edema, serum albumin < 3.0 g/dL) at any time during ONTAK® therapy. These symptoms were not required to occur simultaneously to be characterized as capillary leak syndrome. As defined, capillary leak syndrome was reported in 32.5% (76/234) of ONTAK®-treated patients in clinical studies; one-third required hospitalization or medical intervention to prevent hospitalization. There are post-marketing reports of capillary leak syndrome resulting in death. The onset of symptoms in patients with capillary leak syndrome may be delayed, occurring up to 2 weeks following infusion. Symptoms may persist or worsen after the cessation of ONTAK®.

Regularly assess patients for weight gain, new onset or worsening edema and hypotension (including orthostatic changes). Monitor serum albumin levels prior to each course of therapy and more often as clinically indicated. Withhold ONTAK® for serum albumin levels less than 3 g/dL.

Visual loss
Loss of visual acuity, usually with loss of color vision, with or without retinal pigment mottling has been reported following administration of ONTAK®. Recovery was reported in some of the affected patients; however, most patients reported persistent visual impairment.

Hepatobilary Disorders
Increase in ALT/AST from baseline occurred in 84% of ONTAK®-treated patients. The majority of these elevations occurred during either the first or second cycle, resolved without medical intervention, and did not require discontinuation of ONTAK®.

Pregnancy and Lactation
ONTAK® should be given to a pregnant woman only if clearly needed and should not be used in women who are nursing.

Most Common Adverse Reactions
In clinical studies (n=234), the most common adverse reactions in ONTAK®-treated patients (≥20%) were pyrexia, nausea, fatigue, rigors, vomiting, diarrhea, headache, peripheral edema, cough, dyspnea and pruritus. The most common serious adverse reactions were capillary leak syndrome (11.1%), infusion reactions (8.1%), and visual changes including loss of visual acuity (4%). ONTAK® was discontinued in 28.2% of patients due to adverse reactions.
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原产地英文商品名:
ONTAK 150MCG/ML 2ML/VIAL 6VIALS/BOX
原产地英文药品名:
DENILEUKIN DIFTITOX
中文参考商品译名:
ONTAK 150微克/毫升 2毫升/瓶 6瓶/盒
中文参考药品译名:
地尼白介素2
生产厂家中文参考译名:
Seragen
生产厂家英文名:
Seragen
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原产地英文商品名:
ONTAK 300MCG/ML 2ML/VIAL 6VIALS/BOX
原产地英文药品名:
DENILEUKIN DIFTITOX
中文参考商品译名:
ONTAK 300微克/毫升 2毫升/瓶 6瓶/盒
中文参考药品译名:
地尼白介素2
生产厂家中文参考译名:
Seragen
生产厂家英文名:
Seragen