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 详细处方信息以本药内容附件PDF文件（20096418474724.pdf）的“原文Priscribing Information”为准
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部分中文维达扎处方资料（仅供参考）

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
阿扎胞苷(Azacitidine)
英文名称：Azacitidine
英文别名：5-Azacytidine、Ladakamycin
其他名：5aza-C，拉达卡霉素(Ladakamycin),5-氮杂胞苷、5-氮杂胞嘧啶核苷、氮胞苷、氮杂胞苷。

作用机制：
嘧啶类抗代谢药，干扰核苷酸的合成，以假嘧啶形式掺入DNA和RNA中，并与之结合。

适应症：
急性非淋巴细胞性白血病。用于乳腺癌、肠癌、黑色素瘤等有一定疗效。

常用剂量：
100mg／m2，静脉推注，每8小时一次，连用5天，200mg／(m2·d)静脉持续滴注，连用5天。

注意事项：
由于药物的稳定性差，因此应该在用药前配药，配药后立即使用，配药后8小时未用则应丢弃。静脉滴注应该用新鲜林格液配制，每8小时配制一次。

毒性反应：
(1)骨髓抑制和其他血液学反应：所有的病人都会出现严重的骨髓抑制和其他血液学反应，表现为白细胞于第12~14天降至最低，偶见抑制持续超过几周。
(2)恶心呕吐和其他胃肠道反应：常见。静脉持续滴注可减轻恶心呕吐和其他胃肠道反应反应。
(3)皮肤粘膜反应：粘膜炎及皮肤红疹偶见
(4)其他反应：
1)腹泻：常见。
2)神经系统反应：肌肉疼痛、虚弱、嗜睡及昏迷，少见。
3)肝毒性：罕见，但可能严重。
4)暂时性发热：偶见。

*FDA于04年5月19日宣布批准Vidaza(商品名：维达扎；通用名：azacitidine<阿扎胞苷>)注射液为治疗骨髓增生异常综合症(Myelodysplastic Syndrome, MDS)的第一个有效药物。
FDA代理专员Lester M. Crawford博士说：“通过恢复骨髓细胞的正常生长和分化，该新药将向有此种罕见的并且在一些病例中恶化为白血病的那些患者提供一个非常需要的治疗手段。FDA将继续给予这类具有显著疗效的产品的批准以最高的优先权。”
MDS是由骨髓细胞功能异常、正常血细胞生成减少而引起的一系列疾病的总称。MDS可由治疗其它疾病的药物或放射治疗所致，也可由未知病因引起。MDS的某些类型会恶化为急性髓细胞样白血病(AML)。AML是白细胞增生过度活跃的一种癌症。
FAB（法国-美国-英国）协作组织将MDS分为5型，分别是：顽固性贫血（RA）、环形铁粒幼红细胞性难治性贫血（RARS）、原始细胞过多性难治性贫血（RAEB）、转化型原始细胞过多性难治性贫血（RAEB-T）和慢性粒单核细胞白血病（CMMoL）。
Vidaza属于罕见病治疗药。罕见病治疗药用于治疗患者人数在美国少于20万的罕见疾病或症状。《罕见病药物法》规定：获得所指定罕见病药物上市批准的首个申报者将享有该药物在美国市场上7年期的独占上市权。
据估计，美国每年有7000－12,000的MDS新病例被确诊。这种疾病在各年龄段都可能发生，但是60岁以上人群发病率最高。典型症状包括虚弱、疲劳、感染、易淤伤、出血和发热。MDS患者可能需要接受红血球和血小板的输入，以及针对感染的抗生素治疗。

Why is this medication prescribed?
Azacitidine is used to treat myelodysplastic syndrome (a group of conditions in which the bone marrow produces blood cells that are misshapen and does not produce enough healthy blood cells). Azacitidine is in a class of medications called demethylation agents. It works by helping the bone marrow to produce normal blood cells and by killing abnormal cells in the bone marrow.

How should this medicine be used?
Azacitidine comes as a powder to be mixed with water and injected subcutaneously (under the skin) or intravenously (into a vein) by a doctor or nurse in a medical office or hospital outpatient department. It is usually injected once a day for 7 days. This treatment may be repeated every 4 weeks for as long as your doctor recommends. Treatment should usually be given for at least four cycles.

Your doctor may increase your dose of azacitidine after two cycles if your condition has not improved and if you have not experienced serious side effects of the medication. Your doctor may also need to delay your treatment or reduce your dose if you experience certain side effects. Be sure to tell your doctor how you are feeling during your treatment with azacitadine.

Your doctor will give you medication to prevent nausea and vomiting before you receive each dose of azacitadine.

Other uses for this medicine
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What special precautions should I follow?
Before using azacitidine,
•tell your doctor and pharmacist if you are allergic to azacitidine, mannitol (Osmitrol, Resectisol), or any other medications.
•tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
•tell your doctor if you have a liver tumor. Your doctor may tell you not to take azacitidine.
•tell your doctor if you have or have ever had liver or kidney disease.
•tell your doctor if you are pregnant or plan to become pregnant, or if you plan to father a child. You or your partner should not become pregnant while you are using azacitidine. You should use birth control to prevent pregnancy in yourself or your partner during your treatment with azacitidine. Talk to your doctor about birth control methods that will work for you. If you or your partner become pregnant while using azacitidine, call your doctor. Azacitidine may harm the fetus.
•do not breastfeed while you are using azacitidine.
•if you are having surgery, including dental surgery, tell the doctor or dentist that you are using azacitidine.

What special dietary instructions should I follow?
Unless your doctor tells you otherwise, continue your normal diet.

What should I do if I forget a dose?
Call your doctor right away if you are unable to keep an appointment to receive a dose of azacitidine.

What side effects can this medication cause?
Azacitidine may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
•nausea
•vomiting
•diarrhea
•constipation
•sores on the mouth or tongue
•hemorrhoids
•stomach pain or tenderness
•heartburn
•loss of appetite
•weight loss
•headache
•dizziness
•weakness
•excessive tiredness
•difficulty falling asleep or staying asleep
•depression
•anxiety
•back, muscle, or joint pain
•muscle cramps
•sweating
•night sweats
•difficulty urinating or pain when urinating
•swelling of the hands, feet, ankles, or lower legs
•dry skin
•redness, pain, bruising, swelling, itching, lump, or change in the skin color in the place where the medication was injected

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:
•pale skin
•shortness of breath
•fast heartbeat
•chest pain
•cough
•unusual bruising or bleeding
•nosebleeds
•bleeding gums
•small red or purple dots on the skin
•sore throat, fever, chills, or other signs of infection
•hives
•rash
•itching
•difficulty breathing or swallowing

Azacitidine may cause other side effects. Call your doctor if you have any unusual problems while using this medication.

What storage conditions are needed for this medicine?
This medication will be stored in the medical office or hospital where you receive your treatment.

In case of emergency/overdose
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Symptoms of overdose may include:
•diarrhea
•nausea
•vomiting

What other information should I know?
Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to azacitidine.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

Brand name(s):
Vidaza®

Other name(s):
Ladakamycin

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 详细处方信息以本药内容附件PDF文件（20096418474724.pdf）的“原文Priscribing Information”为准
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