The common side effects include:
• hot flashes
• injection site pain, redness, and swelling, especially with the first dose
• weight gain
• increase in some liver enzymes
• tiredness
• hypertension
• back and joint pain
• chills
• urinary tract infection
• decreased sex drive and trouble with erectile function (impotence)
These are not all the possible side effects. For more information, ask your healthcare provider or pharmacist.
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
General information about the safe and effective use of degarelix.
Medicines are sometimes prescribed for conditions that are not mentioned in the patient leaflet. Do not use degarelix for a condition for which it was not prescribed. Do not give degarelix to other people, even if they have the same symptoms that you have. It may harm them.
This patient information leaflet summarizes the most important information about degarelix. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about degarelix that is written for health professionals.
For more information, call 1-888-FERRING (1-888-337-7464)
What are the ingredients in degarelix?
Active ingredient: degarelix (as acetate)
Inactive ingredient: mannitol
FDA核准： Fludarabine Phosphate 与 Degarelix
美国食品药物管理局(FDA)核准degarelix注射剂两种新剂量，用于治疗末期前列腺癌。
【Degarelix核准用于治疗末期前列腺癌】
2008年12月24日，FDA核准degarelix (Ferring药厂) 80-mg和120-mg注射剂，用于治疗末期前列腺癌病患。Degarelix是新的促性腺激素释放荷尔蒙受体拮抗剂，可逆性结合到脑垂体促性腺激素释放荷尔蒙受体，减少睪固酮之释出。
Degarelix之核准是根据一个开放标籤、多中心随机平行小组研究，对象是前列腺癌病患(N = 620)；随机指派接受两种degarelix剂量之一或者leuprolide，为期一年：degarelix开始剂量240 mg、之后每月剂量160 mg、皮下给药，degarelix开始剂量240 mg、之后每月剂量80 mg、皮下给药，或者每月leuprolide 7.5 mg肌肉注射给药。
研究的初级目标是检视degarelix 在12个月治疗期间，达到维持睪固酮抑制到去势程度(≦ 50 ng/dL)的效果。结果显示，平均去势率：degarelix 240/160-mg组为98.3% (95%信心区间94.8% - 99.4%) ，degarelix 240/80-mg组为 97.2% (95%信心区间93.5% - 98.8%) ，leuprolide 7.5-mg组为 96.4% (95%信心区间92.5% - 98.2%)。degarelix组没有测得睪固酮波，96%病患在初次degarelix剂量之后3天达到去势，leuprolide组是0%。
以degarelix治疗的1,325名病患中，最常见的不良反应包括暂时性注射位置反应、热潮红、体重增加、转胺酶与珈玛麩胺酸转胜酵素（gamma-glutamyltransferase）值增加。
Degarelix 的疗效应以週期性监测血清前列腺特定抗原值来监控，此外，长期雄性素去除疗法会延长QT 间隔。对于先天QT间隔长的病患、电解质异常病患、或者先天性心衰竭与服用IA类 (例如quinidine procainamide)或第三类(例如amiodarone) 抗心律不整药物者，医师应考量长期雄性素去除疗法之治疗利益与风险。
Degarelix只可以皮下给药。建议剂量是开始剂量240 mg、分开以120 mg给予，接著是每28天给予一次80mg维持剂量
Degarelix approved for advanced prostate cancer
Date Posted: December 29, 2008
Degarelix (injectable gonadotropin-releasing hormone (GnRH) receptor antagonist, from Ferring Pharmaceuticals) has been approved by the FDA for treatment of hormonally-sensitive advanced prostate cancer. This approval was based on results from a Phase III, 12-month, randomized, open-label, parallel-group clinical trial comparing degarelix with monthly leuprolide in patients with histologically confirmed prostate cancer. The study showed degarelix to be at least as effective as leuprolide in achieving and maintaining castrate levels of testosterone.
前列腺癌新药degarelix在III期临床中表现良好
有专家表示，III期临床试验结果显示，Fer |
