诺华公司拟于2009年秋季在美国市场推出Extavia。患者除了可通过处方获得Extavia外,诺华公司还将为患者提供支持服务,其中包括开通护理咨询热线,一对一药物注射培训,以及医保报销指导服务。此外,生产厂家将提供自动注射器,以便于患者自行注射Extavia。
据诺华公司召开的新闻发布会宣称,研究表明,β-1b重组干扰素治疗可使MS的年复发率降低34% (P =0.0001),服用Extavia的患者中未出现复发的人数几乎为安慰剂对照组的2倍(31% 对 16%, P =0.007)。另外,β-1b重组干扰素可延缓病程的进展。在研究中,在经历过单次神经系统疾病发作且病程≥ 24h的患者中有近75%在2年之后未进展至有临床表现的MS。
Legal Classification:
Rx
Adults:
≥18 years: initially 0.0625mg SC every other day; increase by 25% every 2 weeks to target dose of 0.25mg SC every other day.
Children:
<18 years: not recommended.
Precaution(s):
Depression. Suicidal ideation. Monitor CBC, differential, platelets, chemistries, liver function (at 1, 3, and 6 months then periodically). Thyroid disorders. Elderly. Pregnancy (Cat. C; may be abortifacient). Nursing mothers: not recommended.
Adverse Reaction(s):
Lymphopenia, neutropenia, leukoprnia, lymphadenopathy, headache, insomnia, incoordination, hypertension, dyspnea, abdominal pain, increased liver enzymes, rash, skin disorder, hypertonia, myalgia, urinary urgency, metrorrhagia, impotence, asthenia, flu-like symptoms, pain, peripheral edema, chest pain, malaise, injection site reactions/necrosis (suspend therapy if multiple lesions occur); anaphylaxis.
How Supplied:
Single-use vials—15 (w. prefilled diluent syringe, supplies)
Last Updated:
10/29/2009 |