英文药名: Vidaza(Azacitidine Injection)

中文药名: 维达扎(阿扎胞苷注射液)

药品介绍：

FDA近日宣布批准阿扎胞苷(azacitidine，Vidaza)注射剂，该药是第一个骨髓增生异常综合征（MDS）的有效治疗药，它获得了FDA授予的罕见药、快速审批及优先审查资格。
MDS是由于骨髓功能异常，而不能生成足够的正常血细胞的一组综合征，可由化疗和不明原因引起。MDS的某些分型可发展为急性骨髓性白血病（AML），后者是一种以白细胞异常增生为特点的血癌。
据估计，在美国每年大约有7000到12000个MDS新增病例。尽管该病可发生在任何年龄段的人，但是60以上的人发病率最高。典型的症状有虚弱、乏力、感染、出血及发热。MDS患者需要输红细胞及血小板治疗，还要应用抗生素来抵抗感染。
Vidaza通过恢复正常血细胞的生长和骨髓细胞的分化而起作用。共有268位患者参与的一个随机、对照及两个非随机试验证明了Vidaza治疗各种分型MDS的安全性及有效性。其中有15%的患者在三个试验中都对该药全部反应或部分反应。全部反应或部分反应是以血细胞计数和骨髓中未成熟细胞的百分率为测量标准的，应答的患者无须输血。

在临床试验中出现的最常见不良反应有恶心、贫血、血小板减少症、腹泻、乏力、注射部位反应以及便秘。

Vidaza由Pharmion公司经销。

美国首次批准：2004
 
适应症及用法
VIDAZA是一种核苷代谢抑制剂表示为以下FAB骨髓增生异常综合征（MDS）亚型：难治性贫血（RA）或难治性贫血伴环形铁粒幼细胞（RARS）（若伴有中性粒细胞减少或血小板减少症或需要输血）治疗的患者，难治性贫血伴原始细胞过多（RAEB），转化中的原始细胞过多难治性贫血（RAEB-T）和慢性粒细胞白血病（CMMoL）。
 
【用法用量】
建议起始剂量为第一个治疗周期，所有患者，无论基线血液学值，VIDAZA为75 mg/m2管理的皮下（SC）注射或静脉（IV）输注7天，每天。事先投予恶心和呕吐。
重复周期每4周。 2个周期后，可能会增加剂量至100静脉如果没有有利的影响被认为是和无毒性以外的恶心和呕吐的发生。患者应被视为最低为4〜6个周期。完全或部分反应可能需要额外的治疗周期。
只要继续治疗的患者将继续受益。
应监测患者的血液学反应，肾毒性，适当的延迟或减少剂量。
 
剂型和优势
100毫克单次使用小瓶中的冻干的粉末。
 
禁忌
晚期恶性肝肿瘤。
过敏的阿扎胞苷或甘露糖醇。
 
警告和注意事项
贫血，中性粒细胞减少和血小板减少。执行完整的血球计数（CBC）前，每个治疗周期，需要监测反应和毒性。
肝毒性：严重的已经存在的肝损伤的患者谨慎使用。
肾功能异常。监视肾功能不全患者的毒性，因为阿扎胞苷和它的代谢产物主要是由肾脏排出体外。
监测肝以及血清肌酸酐开始治疗前，每个周期。
，VIDAZA可能导致对孕妇胎儿造成伤害时。有生育能力的妇女应被告知对胎儿的潜在危险。
男性应尽量不要向孩子的父亲是在接受VIDAZA。
 
不良反应
最常见的不良反应（> 30％）的SC路线是：恶心，贫血，血小板减少，呕吐，发热，白细胞减少症，腹泻，注射部位红斑，便秘，嗜中性白血球减少症和瘀斑。最常见的不良反应还包括通过静脉途径瘀斑，寒战，乏力和低血钾。

报告疑似不良反应，Celgene公司联系1-888-423-5436或FDA在1-800-FDA-1088或www.fda.gov / medwatch。
 
药物相互作用
没有正式的临床评估已经进行了VIDAZA和其他代理的药物与药物之间的相互作用。
 
特殊人群中使用
哺乳母亲：停止药物或考虑考虑药物对母亲的重要性的护理。
由于老年患者更可能有肾功能降低，这可能是有用的监测肾功能。

日期：01/2012

Indication
VIDAZA is indicated for treatment of patients with the following French-American-British (FAB) myelodysplastic syndrome subtypes: refractory anemia (RA) or refractory anemia with ringed sideroblasts (RARS) (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anemia with excess blasts (RAEB), refractory anemia with excess blasts in transformation (RAEB-T), and chronic myelomonocytic leukemia (CMMoL).

IMPORTANT SAFETY INFORMATION
VIDAZA is contraindicated in patients with a known hypersensitivity to azacitidine or mannitol and in patients with advanced malignant hepatic tumors.
In Studies 1 and 2, the most commonly occurring adverse reactions by SC route were nausea (70.5%), anemia (69.5%), thrombocytopenia (65.5%), vomiting (54.1%), pyrexia (51.8%), leukopenia (48.2%), diarrhea (36.4%), injection site erythema (35.0%), constipation (33.6%), neutropenia (32.3%), and ecchymosis (30.5%). Other adverse reactions included dizziness (18.6%), chest pain (16.4%), febrile neutropenia (16.4%), myalgia (15.9%), injection site reaction (13.6%), and malaise (10.9%). In Study 3, the most common adverse reactions by IV route also included petechiae (45.8%), weakness (35.4%), rigors (35.4%), and hypokalemia (31.3%).
In Study 4, the most commonly occurring adverse reactions were thrombocytopenia (69.7%), neutropenia (65.7%), anemia (51.4%), constipation (50.3%), nausea (48.0%), injection site erythema (42.9%), and pyrexia (30.3%). The most commonly occurring Grade 3/4 adverse reactions were neutropenia (61.1%), thrombocytopenia (58.3%), leukopenia (14.9%), anemia (13.7%) and febrile neutropenia (12.6%).
Because treatment with VIDAZA is associated with anemia, neutropenia and thrombocytopenia, complete blood counts should be performed as needed to monitor response and toxicity, but at a minimum, prior to each dosing cycle.
Because azacitidine is potentially hepatotoxic in patients with severe preexisting hepatic impairment, caution is needed in patients with liver disease. In addition, azacitidine and its metabolites are substantially excreted by the kidneys and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, it may be useful to monitor renal function.
VIDAZA may cause fetal harm when administered to a pregnant woman. Women of childbearing potential should be apprised of the potential hazard to the fetus. Men should be advised not to father a child while receiving VIDAZA.
Nursing mothers should be advised to discontinue nursing or the drug, taking into consideration the importance of the drug to the mother.
Please see full Prescribing Information.

VIDAZA® is a registered trademark of and Celgene Patient Support™ is a trademark of Celgene Corporation.

Azacitidine injection

What is Azacitidine injection?

AZACITIDINE (Vidaza™) is a chemotherapy agent used to treat myelodysplastic syndromes and may be used to treat some types of leukemia. Azacitidine interferes with the growth of rapidly dividing cells, like cancer cells, and eventually causes these cells to die. Generic azacitidine injections are not available.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:
• dental disease
• infection (especially viral infections such as chickenpox or herpes)
• kidney disease
• liver disease
• an unusual reaction to Azacitidine, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should this medicine be used?

Azacitidine is given as an injection under the skin by a trained health care profesiional. It has also been given by an infusion into a vein. Azacitidine is usually administered in a hospital or clinic setting.

Contact your pediatrician or health care professional regarding the use of this medicine in children. Special care may be needed.

What drug(s) may interact with Azacitidine?

• vaccines

Talk to your prescriber or health care professional before taking any of these medicines:
• aspirin
• acetaminophen
• ibuprofen
• naproxen
• ketoprofen

Tell your prescriber or health care professional about all other medicines you are taking, including non-prescription medicines, nutritional supplements, or herbal products. Also tell your prescriber or health care professional if you are a frequent user of drinks with caffeine or alcohol, if you smoke, or if you use illegal drugs. These may affect the way your medicine works. Check with your health care professional before stopping or starting any of your medicines.

What should I watch for while taking Azacitidine?

Visit your prescriber or health care professional for checks on your progress. You will need to have regular blood checks. The side effects can continue after you finish your treatment; report side effects promptly.

Azacitidine may make you feel generally unwell. This is not uncommon because azacitidine affects good cells as well as cancer cells. Report any side effects as above, but continue your course of medicine even though you feel ill, unless your prescriber or health care professional tells you to stop.

Azacitidine may decrease your body's ability to fight infections. Call your prescriber or health care professional if you have a fever, chills, sore throat or other symptoms of a cold or flu. Do not treat these symptoms yourself. Try to avoid being around people who are sick. Azacitidine may increase your risk to bruise or bleed. Call your prescriber or health care professional if you notice any unusual bleeding. Be careful not to cut, bruise or injure yourself because you may get an infection and bleed more than usual.

Avoid taking aspirin, acetaminophen (Tylenol®), ibuprofen (Advil®), naproxen (Aleve®), or ketoprofen (Orudis® KT) products as they may mask a fever, unless instructed to by your prescriber or health care professional.

Be careful brushing and flossing your teeth or using a toothpick while receiving azacitidine because you may get an infection or bleed more easily. If you have any dental work done, tell your dentist you are receiving azacitidine.

There is a possibility that azacitidine could cause harm to an unborn child; this applies to both men and women. If you are pregnant or you or your partner are considering getting pregnant, talk to your health care provider about the risks of azacitidine therapy. Women or men whose partner may have children should use appropriate birth control methods during azacitidine therapy. Discuss possible methods of birth control with your health care provider.

If you are going to have surgery or dental work, tell your prescriber or health care professional that you are using azacitidine.

What side effects may I notice from receiving Azacitidine?

The side effects you may experience with azacitidine therapy depend upon the dose, other types of chemotherapy or radiation therapy given, and the disease being treated. Not all of these effects occur in all patients. Discuss any concerns or questions with your prescriber or health care professional.

Side effects that you should report to your prescriber or health care professional as soon as possible:
• low blood counts - azacitidine may decrease the number of white blood cells, red blood cells and platelets. You may be at increased risk for infections and bleeding.
• signs of infection - fever or chills, cough, sore throat, pain or difficulty passing urine
• signs of decreased platelets or bleeding - bruising, pinpoint red spots on the skin, black, tarry stools, blood in the urine
• signs of decreased red blood cells - unusual weakness or tiredness, fainting spells, lightheadedness
• reactions at the injection site including redness, pain, itching, or bruising

Side effects that usually do not require medical attention (report to your prescriber or health care professional if they continue or are bothersome):
• constipation
• diarrhea
• fatigue
• headache
• loss of appetite
• nausea, vomiting
• skin rash, itching
• stomach pain
• water retention

Where can I keep my medicine?
This does not apply. You will only receive this medicine in a hospital or clinic setting and will not need to store it at home.

ビダーザ注射用100 mg：1バイアル