ZOLINZA（伏立诺他胶囊）
生产商：默沙东公司
初步U. S.批准：2006年
适应症
ZOLINZA是一种组蛋白去乙酰化酶（HDAC）抑制剂表示为：
渐进，持续性或复发性疾病或以下两个全身治疗皮肤T细胞淋巴瘤（CTCL）患者在治疗皮肤表现。
剂量和用法
400毫克，每天口服一次食品。
如果患者不能耐受治疗，剂量可减少到300毫克，口服，每日一次与食品。如果有必要，可进一步降低剂量为300毫克，每日一次，连续5天每星期与食物。
剂型和优势
胶囊：100毫克
禁忌
无
警告和注意事项
肺栓塞和深静脉血栓形成的报道。监察有关的症状和体征的病人。
剂量相关的血小板减少和贫血有发生，并可能需要调整剂量或停药。
肠胃不适（如恶心，呕吐和腹泻）的报告。患者可能需要止吐药，止泻药和体液和电解质更换（以防止脱水）。
已观察到高血糖。增加葡萄糖的调整饮食和/或治疗可能是必要的的。
在基线和治疗期间定期监测电解质。
监测血细胞计数和化学测试，包括电解质，血糖和血清肌酐，每2周期间的第2个月的治疗和每月一次。
ZOLINZA和其他HDAC抑制剂（如丙戊酸）同时使用，已报告有严重的血小板减少和胃肠道出血。监测血小板计数。
胎儿造成伤害发生时，一名孕妇。妇女应了解对胎儿的潜在危害。
不良反应
最常见的不良反应（发生率≥20％），腹泻，乏力，恶心，血小板减少，厌食和味觉障碍。
药物相互作用
香豆素衍生物的抗凝血药：延长凝血酶原时间和国际标准化比值已发现同时使用。仔细监测。
修订日期：10/2010
【原产地英文商品名】ZOLINZA 100mg/cap 120Caps/bottle
【原产地英文药品名】VORINOSTAT
【中文参考商品译名】ZOLINZA 100毫克/胶囊 120胶囊/瓶
【中文参考药品译名】伏立诺他
【生产厂家中文参考译名】默克
【生产厂家英文名】MERCK
Zolinza
(Zo-LEN-zah)
Generic Name: Vorinostat
Drug Type:
Zolinza is an anti-cancer ("antineoplastic" or "cytotoxic") chemotherapy drug. Zolinza is classified as an "Histone Deacetylase Inhibitor". For more detail, see How Zolinza Works below.
What Zolinza Is Used For:
Zolinza is used to treat relapsed or refractory cutaneous T-cell lymphoma (CTCL).
Note: If a drug has been approved for one use, physicians may elect to use this same drug for other problems if they believe it may be helpful.
How Zolinza Is Given:
The amount of Zolinza that you will receive depends on many factors, including your general health or other health problems, and the type of cancer or condition you have. Your doctor will determine your exact dosage and schedule.
Zolinza Side Effects:
Important things to remember about the side effects of Zolinza:
•Most people will not experience all of the Zolinza side effects listed.
•Zolinza side effects are often predictable in terms of their onset, duration, and severity.
•Zolinza side effects are almost always reversible and will go away after therapy is complete.
•There is no relationship between the presence or severity of Zolinza side effects and the effectiveness of the medication.
•Zolinza side effects may be quite manageable. There are many options to minimize or prevent them.
The following Zolinza side effects are common (occurring in greater than 30%) for patients taking Zolinza:
•Fatigue
•Diarrhea
•Nausea
•Taste changes
•Increased blood glucose level (hyperglycemia)
•Increased creatinine level (transient)
•Increased level of protein in the urine
•Low platelet count (thrombocytopenia)
These are less common side effects (occurring in about 10-29%) of patients receiving Zolinza:
•Loss of appetite (anorexia)
•Weight loss
•Muscle spasms
•Hair loss (alopecia)
•Dry mouth
•Chills
•Fever
•Vomiting
•Dizziness
•Constipation
•Low red blood cell count (anemia)
•Headache
•Itching
•Swelling in hands or feet
•Cough
•Upper respiratory infection
•Dehydration
•Shortness of breath
A rare, but serious side effect of Zolinza is blood clots, including deep vein thrombosis (DVT) and pulmonary embolus. You should seek emergency help and notify your health care provider immediately if you develop sudden chest pain and shortness of breath. Notify your health care provider within 24 hours if you notice that one leg is swollen, red, painful and/or warm to touch and the other is not.
This list includes common and less common side effects for those taking Zolinza. Zolinza side effects that are very rare -- occurring in less than about 10 percent of patients -- are not listed here. But you should always inform your health care provider if you experience any unusual symptoms.
When To Contact Your Doctor or Health Care Provider:
Contact your health care provider immediately, day or night, if you should experience any of the following symptoms:
•Chest pain
•Sudden onset of shortness of breath
•Severe bleeding
The following symptoms require medical attention, but are not an emergency. Contact your health care provider within 24 hours of noticing any of the following:
•Nausea (interferes with ability to eat and unrelieved with prescribed medication).
•Vomiting (vomiting more than 4-5 times in a 24 hour period).
•Diarrhea (4-6 episodes in a 24-hour period).
•Unusual bleeding or bruising
•Black or tarry stools, or blood in your stools.
•Blood in the urine.
• ain or burning with urination.
•Extreme fatigue (unable to carry on self-care activities).
•Swelling, redness and/or pain in one leg or arm and not the other
•Unable to eat or drink for 24 hours or have signs of dehydration: tiredness, thirst, dry mouth, dark and decreased amount of urine, or dizziness (particularly with standing).
Always inform your health care provider if you experience any unusual symptoms.
Zolinza Precautions:
•Before starting Zolinza treatment, make sure you tell your doctor about any other medications you are taking (including prescription, over-the-counter, vitamins, herbal remedies, etc.).
•Do not receive any kind of immunization or vaccination without your doctor’s approval while taking Zolinza.
•Inform your health care professional if you are pregnant or may be pregnant prior to starting Zolinza. Pregnancy category D (zolinza may be hazardous to the fetus. Women who are pregnant or become pregnant must be advised of the potential hazard to the fetus.)
•For both men and women: Do not conceive a child (get pregnant) while taking Zolinza. Discuss with your doctor when you may safely become pregnant or conceive a child after therapy.
•Do not breast feed while taking Zolinza.
Zolinza Self-Care Tips:
•Drink at least two to three quarts of fluid every 24 hours, unless you are instructed otherwise.
•You may be at risk of infection so try to avoid crowds or people with colds, and report fever or any other signs of infection immediately to your health care provider.
•Wash your hands often.
•Use an electric razor and a soft toothbrush to minimize bleeding.
•Avoid contact sports or activities that could cause injury.
•To reduce nausea, take anti-nausea medications as prescribed by your doctor, and eat small
Zolinza胶囊(vorinostat)-获FDA批准用于治疗皮肤癌的新药
日前，美国食品药品管理局（FDA）批准了一种治疗皮肤癌新药Zolinza胶囊(vorinostat)。用于治疗皮肤T细胞淋巴瘤（CTCL），该药可用于皮肤癌持续恶化、其他药物治疗期间或以后复发。该药由美国默克公司生产。
皮肤T细胞淋巴瘤（CTCL）发病率较低，全美每年每100万人中约有3人诊断为CTCL。多数CTCL患者为男性，平均年龄50岁。根据相关法规，FDA按照罕见病治疗药物审批程序批准Zolinza，目的在于激励制药公司投资开发每年影响约20万美国人的罕见性疾病。
Zolinza的安全性和有效性的证据来自两项临床试验，其中包括对接受其他药物治疗后又复发的107名CTCL患者。按皮肤损伤评分等级的改善确定的标准分析，接受Zolinza治疗的30％患者有所改善，疗效平均持续168天。最常见的严重不良反应为肺栓塞、脱水、深度静脉血栓和贫血。常见的不良反应有胃肠症状（包括腹泻，恶心，食欲减退，呕吐和便秘）；疲惫，寒战和味觉障碍。动物实验结果显示，孕妇禁用该药。
Zolinza的副作用药品不良反应
Zolinza（Vorinostat）是用于治疗一种名为皮肤T细胞淋巴瘤的疾病的处方药。患此病的患者如使用其他药物治疗后症状恶化并未好转，或者又复发的时候可选用Zolinza进行治疗。Zolinza还未进行在18岁以下儿童身上的应用研究。以下列举的是使用Zolinza疗法可能面临的主要风险及副作用。列表中的内容并不能完全列举，如果患者在使用中出现以下任何症状请立即告知医生：
1.腿部出现血块凝集（深静脉血栓形成）
2.一条腿出现突然肿胀
3.腿部出现疼痛或触痛，且只有在站立或行走时才能感觉到这种疼痛
4.局部出现发热，且肿胀部位的皮肤出现发红或颜色改变
5.血液凝块游走至肺部（肺栓塞）
6.突然发作的尖锐胸痛
7.脉搏急促
8.气短
9.晕厥
10.咳出血性分泌物
11.焦躁不安
12.多汗
13.脱水，这可能发生在患者出现恶心、呕吐或腹泻后没能及时补液的情况
14.全血细胞计数降低：患者的医生应定期为患者做血液检测以检查血细胞计数
15.红细胞降低。红细胞降低可能让患者容易疲倦或感觉疲劳。患者可能出现苍白，气短
16.血小板降低。血小板降低可能导致皮下的异常出血或容易碰伤，这种情况出现时应立即告知医生
17.高血糖。如果患者本身有高血糖或糖尿病，应在医生指导下时常监测血糖。如果患者血糖高于正常应立即告知医生
18.心电图异常。心电图（又叫EKG）是用于记录心脏心电活动的方式。医生应定期检查患者的血电解质及心电图。
Zolinza最常见的副作用还包括：肠胃问题（如腹泻、恶心、呕吐、纳差，便秘和体重降低），疲乏，头晕，头痛，口干及味觉异常，肌肉疼痛，脱发，寒战，发热，上呼吸道感染，咳嗽，血肌酐升高，以及足部、踝部或腿部的肿胀或搔痒。
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