药品信息:
--------------------------------------------------------------- 详细处方信息以本药内容附件PDF文件(201271001040411.PDF)的“原文Priscribing Information”为准 --------------------------------------------------------------- 部分中文Firazyr处方资料(仅供参考)
FDA批准新药Firazyr(艾替班特注射剂) 2011年8月25日,Shire医药公司宣布,美国FDA批准新药Firazyr(艾替班特注射剂)上市,用于治疗18岁以上患者遗传性血管水肿的急性发作(HAE)。Firazyr是治疗HAE的罕见药。缓激肽,被认为是HAE症状(包括局部红肿、发炎、疼痛)的“元凶”。Firazyr的有效成分—艾替班特,是一种有效的和选择性缓激肽B2受体拮抗剂,通过抑制缓激肽起作用。Firazyr的有效性和安全性是通过三项双盲的、随机的、临床对照试验来验证的,实验结果显示具有良好的疗效。Firazyr常见的不良反应包括:注射部位不适(包括发红和肿胀)、转氨酶增高、发热、头晕和红疹。
FDA批准急性遗传性血管水肿药物Firazyr Shire公司宣布,美国食品和药物管理局(FDA)已授予用于18岁及以上成年人的遗传性血管水肿(HAE)急性发作治疗药Firazyr(艾替班特注射液)上市许可。 “到现在为止,HAE患者仍面临着快速得到急性治疗的挑战,如需要前往医生办公室或医院进行治疗。”宾夕法尼亚州Hershey医学中心医学及儿科学教授Timothy Craig说,“Firazyr可在室温下携带和储存,并可由患者自己注射。” HAE是一种使人衰弱的罕见的遗传性疾病,具有反复发作的特点,有时会损毁面容并经常有疼痛的急性肿胀发作,这在某些情况下可危及生命。这种肿胀发作可能会影响身体的任何部分,但最常发生在面部、胃肠道、四肢或生殖器。由于窒息的危险,喉部肿胀的发作可能是致命的。 在欧盟和美国,Firazyr已获得孤儿药地位,用于治疗急性HAE。Firazyr装于可在室温(高达77华氏度)下储存的一种预装注射器中,这使其对于HAE发作的紧急治疗是便携的和易使用的。Firazyr的活性成分--艾替班特是一种强有力的和选择性的缓激肽B2受体拮抗剂。它代表了治疗HAE发作的一种新型的,靶向的,皮下给药的方法。通过抑制被认为与HAE的栓塞局部肿胀、炎症、疼痛的症状有关的缓激肽的影响,Firazyr可治疗急性HAE发作的临床症状。
Firazyr:icatibant What is Firazyr? Firazyr is a solution for injection that contains the active substance icatibant.
What is Firazyr used for? Firazyr is used to treat the symptoms of attacks of hereditary angioedema in adults. Patients with angioedema have attacks of swelling that can occur anywhere in the body, such as in the face or limbs, or around the gut, causing discomfort and pain. Firazyr is used in patients whose angioedema is linked to naturally low levels of a protein called ‘C1 esterase inhibitor’.
Because the number of patients who have angioedema is low, the disease is considered ‘rare’, and Firazyr was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 17 February 2003.
The medicine can only be obtained with a prescription.
How is Firazyr used? Firazyr is given as a slow injection under the skin, preferably in the abdomen (tummy). The recommended dose of Firazyr is one injection. If symptoms continue or come back, a second injection can be given after six hours. If needed, treatment can be repeated for a third time after an additional six hours. No more than three injections should be given in any 24-hour period.
The doctor may decide that the patient or their caregiver can administer the medicine themselves, after they have been properly trained by a healthcare professional.
How does Firazyr work? Patients with hereditary angioedema have high levels of a substance called ‘bradykinin’, which is involved in causing inflammation and swelling. The active substance in Firazyr, icatibant, blocks the receptors that bradykinin normally attaches itself to. This blocks the activity of bradykinin, helping to relieve the symptoms of the disease.
How has Firazyr been studied? Firazyr has been studied in two main studies in patients with angioedema of the skin or the abdomen. The first study compared Firazyr with tranexamic acid (another medicine for hereditary angioedema) in 74 patients, and the second study compared Firazyr with placebo (a dummy treatment) in 56 patients. The main measure of effectiveness was how long it took until the patient’s symptoms were relieved.
What benefit has Firazyr shown during the studies? Firazyr was more effective than tranexamic acid and placebo in relieving the symptoms of the disease. In both studies, the time it took for the patient’s symptoms to improve was shorter for patients taking Firazyr than for those taking tranexamic acid or placebo. Patients experienced relief an average of 2.0 to 2.5 hours after receiving Firazyr, compared with 12.0 hours for tranexamic acid in one study and 4.6 hours for placebo in the other study.
What is the risk associated with Firazyr? The most common side effects with Firazyr (seen in more than 1 patient in 10) are erythema (redness), swelling,, burning, itching and pain at injection sites. For the full list of all side effects reported with Firazyr, see the package leaflet.
Firazyr should not be used in people who may be hypersensitive (allergic) to icatibant or to any of the other ingredients.
Why has Firazyr been approved? The CHMP decided that Firazyr’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Other information about Firazyr The European Commission granted a marketing authorisation valid throughout the European Union for Firazyr to Shire Orphan Therapies GmbH on 11 July 2008. The marketing authorisation is valid for five years, after which it can be renewed.
For more information about treatment with Firazyr, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
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