Extavia(通用名：interferon beta-1，干扰素 β-1)

适应症：多发性硬化症(Symptoms of multiple sclerosis)

生产商：诺华(Novartis)

批准日期：8月14日

该药是诺华公司第一只针对多发性硬化症的产品，该药实际上跟拜耳公司的betaseron机理一样，诺华与拜耳达成协议以自有商品名上市。多发性硬化症是一种致命性的机能丧失疾病，该药可以降低疾病发作的频率，也能延缓疾病进程，诺华将此药投入市场，更重要的是在于获取销售MS药物的经验，以为自己正处于研发阶段的FTY720打基础。
http://www.oneyao.net/article/2009/1118/15865.html

Extavia® Dosing
EXTAVIA Dose Titration
The recommended dose of EXTAVIA in patients with RRMS is 0.25 mg injected subcutaneously every other day. Gradual dose titration during initiation of EXTAVIA treatment may reduce flu-like symptoms.1 Note that this dose titration schedule is not necessary if patients are currently on interferon beta-1b. These patients can continue with EXTAVIA at the same dose they are currently on.

Generally, patients should be started at 0.0625 mg (0.25 mL) subcutaneously every other day,
and increased over a 6-week period to 0.25 mg (1 mL) every other day.1

EXTAVIA Dosing Comparability
The recommended dose of EXTAVIA is 0.25 mg injected subcutaneously every other day. This dose is comparable to Betaseron® (interferon beta-1b) 0.25 mg injected subcutaneously every other day. EXTAVIA is the exact same molecule as Betaseron, and EXTAVIA 0.25 mg was approved by the FDA based on the same registration trials as Betaseron 0.25 mg.1,2

EXTAVIA can be injected manually or with the EXTAVIA Auto-Injector II.

EXTAVIA Auto-Injector II
EXTAVIA comes with the EXTAVIA Auto-Injector II if you have requested one with your patient's prescription. This device is designed to make injection as convenient as possible for your patients. It may help them reach spots on their body that are difficult to get to with manual injection.

EXTAVIA Injection Site Rotation Journal
To provide your patients with guidance on proper injection site rotation, refer to the diagram below:

You can also download the EXTAVIA Injection Site Rotation Journal, an easy-to-use diagram of injection sites that allows patients to keep a record of when and where to inject.

Access additional patient resources.

Extavia [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corp; 2009.
Betaseron [package insert]. Montville, NJ: Bayer HealthCare Pharmaceuticals Inc; 2008.
Indication and Important Safety Information
Indication
EXTAVIA (interferon beta-1b) is indicated for the treatment of relapsing forms of multiple sclerosis to reduce the frequency of clinical exacerbations. Patients with multiple sclerosis in whom efficacy has been demonstrated include patients who have experienced a first clinical episode and have MRI features consistent with multiple sclerosis.

Important Safety Information
EXTAVIA is contraindicated in patients with a history of hypersensitivity to natural or recombinant interferon beta, albumin (human), USP, or any other component of the formulation.

EXTAVIA should be used with caution in patients with depression. Depression and suicide have been reported to occur with increased frequency in patients receiving interferon compounds, including EXTAVIA. Patients treated with EXTAVIA should be advised to immediately report any symptoms of depression and/or suicidal ideation. Consider discontinuation of EXTAVIA if depression occurs.

Injection site necrosis has been reported in 4% of patients in controlled clinical trials. Injection site reactions occurred in 78% of patients receiving EXTAVIA. Patients should be advised of the importance of rotating injection sites and the use of aseptic self-injection techniques.

Anaphylaxis has been reported as a rare complication of EXTAVIA use.

The rate of flu-like symptom complex was approximately 57%. The incidence decreased over time, with only 10% of patients reporting flu-like symptom complex at the end of the studies. Concurrent use of analgesics and/or antipyretics may help ameliorate flu-like symptoms on treatment days. Leukopenia was reported in 18% of patients. Hepatic enzyme elevations of SGPT to greater than five times baseline value were reported in 12% of patients and increases of SGOT to greater than five times baseline value were reported in 4% of patients leading to dose reduction or discontinuation of EXTAVIA in some patients. Monitoring of certain lab tests is recommended following initiation of EXTAVIA therapy, including complete blood count and liver function tests. In patients with a history of thyroid dysfunction, thyroid function tests are recommended every six months.

EXTAVIA should not be used during pregnancy unless the potential benefit justifies the potential risk to the fetus.

The most common adverse reactions (at least 2% more than placebo) with EXTAVIA were: lymphopenia (66% vs 86%), neutropenia (5% vs 13%), leukopenia (4% vs 13%), lymphadenopathy (3% vs 6%), headache (43% vs 50%), insomnia (16% vs 21%), incoordination (15% vs 17%), hypertension (4% vs 6%), dyspnea (3% vs 6%), abdominal pain (11% vs 16%), increased liver enzymes (up to 4% vs up to 12%), rash (15% vs 21%), skin disorder (8% vs 10%), hypertonia (33% vs 40%), myalgia (14% vs 23%), urinary urgency (8% vs 11%), metrorrhagia (7% vs 9%), impotence (6% vs 8%), injection site reaction (26% vs 78%), asthenia (48% vs 53%), flu-like symptom complex (37% vs 57%), pain (35% vs 42%), fever (19% vs 31%), chills (9% vs 21%), peripheral edema (10% vs 12%), chest pain (6% vs 9%), malaise (3% vs 6%), and injection site necrosis (0% vs 4%).

Extavia获准用于治疗多发性硬化症

Extavia approved for the treatment of MS

美国食品药品管理局（FDA）已经批准Extavia用于治疗复发性多发性硬化症（MS），减少其临床病情恶化次数。这项治疗同样也适用于经历过MS首次临床发作且磁共振成像（MRI）所示的特征表现与MS相符的患者。Extavia是β-1b重组干扰素的新商品名，与Betaseron属同类药品。

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。

EXTAVIA

Generic Name for EXTAVIA

Interferon beta-1b 0.3mg/vial; pwd for SC inj after reconstitution; contains albumin (human), mannitol.

Legal Classification:

Rx

Pharmacological Class for EXTAVIA

Immunomodulator.

Manufacturer of EXTAVIA

Novartis Pharmaceuticals Corp

Indications for EXTAVIA

To reduce frequency of clinical exacerbations in relapsing multiple sclerosis.

Adult dose for EXTAVIA

≥18yrs: initially 0.0625mg SC every other day; increase by 25% every 2 weeks to target dose of 0.25mg SC every other day.

Children's dosing for EXTAVIA

<18yrs: not recommended.

Warnings/Precautions for EXTAVIA

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 Reactions for EXTAVIA

Lymphopenia, neutropenia, leukopenia, 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 is EXTAVIA supplied?

Single-use vials—15 (w. prefilled diluent syringe, supplies)