制造商：
诺华制药公司
药理分类：
免疫调节剂
活性成分（补）：
干扰素β- 1b 0.3mg/vial;为SC已经来到重组后的密码;含有白蛋白（人），甘露醇。
指示（补）：
为了减少复发的多发性硬化症（MS）的临床发作的频率。
药理作用：
干扰素β- 1b干扰素是一类我有不同的免疫调节作用。其作用机制治疗多发性硬化症患者不明。
临床试验：
研究1是一个为期两年的并行设计研究中，患者的复发型多发性硬化症或随机与干扰素β- 1b在剂量为0.05mg或0.25mg隔日，或安慰剂治疗。主要的结果措施是每名患者病情加重和发作频率无患者比例。为在干扰素β- 1b 0.25mg治疗组患者病情恶化率分别为0.9年，比1.31的安慰剂。在急性发作无患者的比例为25对干扰素β- 1b 0.25mg组％，而16％的安慰剂。
研究2和3进行了评估多发性硬化症患者继发进步对这种药物的效果。这两项研究入选患者的病情恶化了谁的证据，也包括在研究二前两年有两个复发患者。在研究2例随机分为干扰素β- 1b 0.25mg或安慰剂;在研究3患者给予干扰素β- 1b 0.25mg，干扰素β- 1b 0.16mg/m2，或安慰剂，连续3年每一天。主要措施是发展成果的残疾，作为一个在Kurtzke扩展残疾状态量表1点增加（EDSS）的，或在得分为0.5分，与基线EDSS评分≥6例增加定义。在研究二，时间在EDSS评分进展是在干扰素β- 1b治疗组更长的时间。在研究3，进展率差异不显着治疗组。多重分析病人未能找出其中的一个子集与干扰素β- 1b治疗与残疾恶化相关的延迟。这两项研究显示，2和3在与干扰素β- 1b治疗相关的复发率显着下降。
法律分类：
接收
成人：
≥18岁：最初0.0625mg资深大律师，隔日; 25％，每2周增加至目标剂量0.25mg供应链每隔一天。
儿童：
<18年：不推荐。
警告/注意事项：
抑郁症。自杀意念。央行监测，鉴别，血小板，化学，肝功能（1，3，6个月然后定期）。甲状腺疾病。老人。妊娠（目录℃;可能流产）。哺乳母亲：不推荐。
不良反应（补）：
淋巴细胞，中性粒细胞减少，leukoprnia，淋巴结肿大，头痛，失眠，动作不协调，高血压，呼吸困难，腹痛，肝酶升高，皮疹，皮肤疾病，增高，肌肉痛，尿急，崩漏，阳痿，疲乏无力，类似感冒的症状，疼痛，周围水肿，胸痛，全身乏力，注射部位反应/坏死（暂停治疗如果有多个病灶发生）;过敏反应。
如何提供：
单用小瓶- 15（瓦特预充式注射器稀释剂，物资）
最后更新：
二○○九年十月二十九日
EXTAVIA
Manufacturer:
Novartis Pharmaceuticals Corp
Pharmacological Class:
Immunomodulator
Active Ingredient(s):
Interferon beta-1b 0.3mg/vial; pwd for SC inj after reconstitution; contains albumin (human), mannitol.
Indication(s):
To reduce frequency of clinical exacerbations in relapsing multiple sclerosis (MS).
Pharmacology:
Interferon beta-1b is a Type I interferon that has various immunomodulatory effects. Its mechanism of action in treating patients with MS is unknown.
Clinical Trials:
Study 1 was a two-year, parallel design study in which patients with relapsing-remitting MS were randomized to treatment with either interferon beta-1b, dosed at 0.05mg or 0.25mg every other day, or placebo. The primary outcome measures were the frequency of exacerbations per patient and the proportion of exacerbation-free patients. The annual exacerbation rate for the patients in the interferon beta-1b 0.25mg treatment group was 0.9, compared to 1.31 for placebo. The proportion of exacerbation-free patients was 25% for the interferon beta-1b 0.25mg group, compared to 16% for placebo.
Studies 2 and 3 were conducted to assess the effect of this drug in patients with secondary progressive MS. Both studies enrolled patients who had evidence of disability progression, and Study 2 also included patients with two relapses within the previous two years. Patients in Study 2 were randomized to either interferon beta-1b 0.25mg or placebo; patients in Study 3 were given interferon beta-1b 0.25mg, interferon beta-1b 0.16mg/m2, or placebo, every other day for 3 years. The primary outcome measure was progression of disability, defined as a 1 point increase in the Kurtzke expanded disability status scale (EDSS), or a 0.5 point increase in the score for patients with baseline EDSS ≥6. In Study 2, time to progression in EDSS was longer in the interferon beta-1b treatment group. In Study 3, the rates of progression did not differ significantly between treatment groups. Multiple analyses failed to identify a patient subset where treatment with interferon beta-1b was associated with delayed progression of disability. Both Studies 2 and 3 showed a statistically significant decrease in the incidence of relapses associated with interferon beta-1b treatment.
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.
Warnings/Precautions:
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)