美国FDA核准5天疗程的地西他滨处方用于治疗骨髓发育不良症候群
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   美国食品药物管理局（FDA）的核准5天疗程的地西他滨（商品名Dacogen，卫材制药公司），注射剂处方，用于治疗骨髓发育不良症候群（骨髓增生异常综合征，MDS）的病患;地西他滨是唯一获得核准用于此种处方的低甲基试剂（hypomethylating剂）。

   MDS的是一种可能致命的骨髓疾病，会影响功能性血球的生产，而且，会随着时间恶化成急性骨髓性白血症（急性骨髓性白血病），美国每年有约1.00万到1.5万例新诊断案例。

   相较于原本核准的处方：以15mg/m2剂量，连续静脉输注3小时以上，每疗程3天，每6周治疗一次，新核准的西他门诊病患剂量：以20-mg/m2剂量，连续静脉输注1小时以上，每疗程5天，每4周治疗一次，新核准的处方可以减少输注时间。

   美国FDA的核准是根据3个开放标签，单一群组，多中心研究的资料，研究对象是有任何法国 - 美国 - 英国亚型的MDS的病患。
   根据国际工作小组2000年版准则的结果显示，病患达到的整体反应率为16％（完全缓解有15％;部分缓解有1％），达到反应时间的中位数为162天，反应期间之中位数为443天。

   严重副作用主要是嗜中性白血球减少症（37％），血小板过低（24％）以及贫血（22％）。
   FDA的建议，病患需至少治疗4个疗程;若欲达到完全缓解或部分缓解可能需要更多疗程。在开始治疗前，应进行肝指数以及血清肌酸酐检查，每次疗程开始前应进行至少一次的全血球计数以及血小板计数，以监测反应和毒性。

   在第1次和第2次疗程时，比较会发生骨髓抑制以及嗜中性白血球减少症恶化，这可能不代表MDS的恶化，当出现骨髓抑制时，需将后续的西他疗程延后到恢复为止（绝对嗜中性白血球数量达≧1000/μL;血小板数量达≧50,000 /μ）。

Prescription Drugs

Dacogen

Generic name: Decitabine

What is Dacogen?

Dacogen is used for the treatment of myelodysplastic syndromes (MDS). MDS occurs when the bone marrow production of blood cells is disrupted, such as in refractory anemia (RA).

What is the most important information I should know about Dacogen?

Pregnant women should not begin treatment with Dacogen; this drug may cause developmental problems during the pregnancy. Also, men taking Dacogen should not father a child during or 2 months after treatment.

Who should not take Dacogen?

Do not take Dacogen if you are allergic to decitabine.

What should I tell my doctor before I take the first dose of Dacogen?

Tell your doctor about all prescription, over-the-counter, and herbal medications you are taking to prevent a possible interaction with Dacogen. Also, talk to your doctor about your complete medical history, especially if you have kidney or liver problems, are pregnant, or planning to become pregnant.

What is the usual dosage?

The information below is based on the dosage guidelines your doctor uses. Depending on your condition and medical history, your doctor may prescribe a different regimen. Do not change the dosage or stop taking your medication without your doctor's approval.

Adults: The first treatment cycle with Dacogen is 15 milligrams (mg)/m² by continuous IV for 3 hours, every 8 hours for 3 days. This cycle may be repeated every 6 weeks for a minimum of 4 cycles. However, a complete or partial response may take longer than 4 cycles. Treatment may be continued as long as the patient continues to benefit. You may be given an anti-nausea medication before beginning therapy with Dacogen.

How should I take Dacogen?

Dacogen will be administered to you in a hospital setting.

What should I avoid while taking Dacogen?

While being treated with Dacogen, avoid pregnancy, nursing, or fathering a child. The effects of Dacogen on an unborn baby are hazardous to its development. For men, avoid fathering a child while receiving treatment with Dacogen and for 2 months afterward.

What are the possible side effects of Dacogen?

Side effects cannot be anticipated. If any develop or change in intensity, tell your doctor as soon as possible. Only your doctor can determine if it is safe for you to continue taking this drug.

Side effects may include: neutropenia (low amount of neutrophils, a type of white blood cell), thrombocytopenia (low amount of platelets), anemia (low amount of hemoglobin, a molecule inside a red blood cell), constipation, cough, diarrhea, fever, increase in blood sugar level, nausea, purple-colored blotches on the skin, fatigue

Can I receive Dacogen if I am pregnant or breastfeeding?

Do not begin treatment with Dacogen if you are pregnant, plan to become pregnant, or nursing. Dacogen may cause developmental problems in your unborn child, and may pass into breast milk.

Also, if you are male, do not father a child while on Dacogen or for 2 months after finishing treatment with this drug. Developmental problems may occur during the pregnancy.

What should I do if I miss a dose of Dacogen?

Dacogen will be administered to you in a hospital setting. Do not miss any appointments, or call your doctor if you think you might.

How should I store Dacogen?

Dacogen will be administered to you in a hospital setting.