中文药名: 干扰素β-1a干扰素注射剂

药品名称
通用名：干扰素β-1a
品牌名称:Avonex的预充式注射器，利比
β-1a是一种蛋白质，叫做β-1a干扰素,是天然存在于人体。它帮助人体抵抗病毒感染。

生产厂家
Biogen Inc.

适应症
用于治疗复发型多发性硬化症，以减缓病人的身体残疾。这种药物将不能治愈硬化症，只会降低复发的频率。β-1a干扰素也可用于治疗生殖器疣。

注意事项
在使用干扰素β-1a时，告诉医生，您对任何药物的过敏史，并且如果您有肝病，甲状腺疾病，癫痫或其他癫痫症，心脏病，胸痛（心绞痛），充血性心力衰竭，心脏节律紊乱，或抑郁症，自杀行为等等。
其它问题的存在，可能会影响使用干扰素β-1α.一定要告诉医生是否有任何其他的医疗问题，特别是：酗酒,较高的肝酶浓度称为谷丙转氨酶,肝病(比如黄疸),心脏病,精神抑郁,精神障碍,癫痫症等。

禁忌
停止使用干扰素β-1a，如果对干扰素或人血白蛋白过敏;如果你有抑郁症的症状（悲伤，哭泣，对你曾经喜欢的东西失去兴趣），或者如果您有伤害自己的想法。

妊娠和母乳喂养
可能对未出生的婴儿有害，或导致流产。如果你怀孕不要使用β-1a。目前还不知道是否β-1a干扰素传递到母乳或可能损害婴儿的资料。如果你是母乳喂养婴儿，不要使用这种药物。

药物相互作用
不建议同时使用干扰素β-1a与下列药物: 轮状病毒活疫苗
使用干扰素β-1a与下列药物可能导致某些副作用增加。如果这两个药物是开在一起的，医生可能会改变剂量或服用时间: 齐多夫定

副作用
可能带来的副作用也以不同方式影响个人:
类似流感，如疼痛，发烧，发冷，出汗，头痛，疲劳和恶心
疼痛注射部位的反应，炎症或脓肿
疼痛，肌肉和关节
皮疹或皮肤发痒的反应
腹泻
食欲不振
睡眠困难（失眠）
抑郁症
脱发（斑秃）
干扰血液的组成部分
不规律月经
头晕
甲状腺过度活跃
混乱
癫痫发作（抽搐）
肝脏炎症（肝炎）

【原产地英文商品名】AVONEX ADMIN PACK 30mcg/vial/kit 4kit/box
【原产地英文药品名】INTERFERON BETA-1A/ALBUMIN HUMAN
【中文参考商品译名】AVONEX ADMIN PACK 30微克/瓶/套 4套/盒
【中文参考药品译名】干扰素β-1a/人血白蛋白
【生产厂家中文参考译名】BIOGEN
【生产厂家英文名】BIOGEN

Avonex (interferon beta 1a)
Description
Avonex is a medication manufactured by a biotechnological process from one of the naturally-occurring interferons (a type of protein). It is made up of exactly the same amino acids (major components of proteins) as the interferon beta found in the human body. In controlled clinical trials in relapsing MS, those taking the medication had a reduced risk of disability progression, experienced fewer exacerbations, and showed a reduction in number and size of active lesions in the brain (as shown on MRI) when compared with the group taking a placebo. In a subsequent study of patients who had experienced a single demyelinating event in the optic nerve, spinal cord, or brainstem, and had lesions typical of MS on brain MRI, Avonex significantly delayed the time to a second exacerbation, and thus to a clinically definite diagnosis of MS.

Approval by the U.S. Food and Drug Administration (FDA)
Avonex is approved by the U.S. Food and Drug Administration (FDA) for the treatment of patients with relapsing forms of MS to slow the accumulation of physical disability and decrease the frequency of clinical exacerbations. Patients with MS in whom efficacy has been demonstrated include those who have experienced a first clinical episode and have MRI features consistent with MS.

Proper Usage
Avonex is given as a once-a-week intramuscular (IM) injection, usually in the large muscles of the thigh, upper arm, or hip.

You and your care partner will be instructed in safe and proper IM injection procedures. If you are unable to self-inject, and have no family member or friend available to do the injections, your physician or nurse will administer the injections. Do not attempt to inject yourself until you are sure that you understand the procedures.

Avonex comes in two different forms—as a liquid in a pre-filled syringe and as a powder in a single-use vial.

Prefilled syringe: AVONEX prefilled syringes should be refrigerated at 36-46°F (2-8°C). About 30 minutes before taking Avonex, it is recommended that you remove your syringe from the refrigerator and allow it to warm to room temperature. Do not use external heat sources such as hot water to warm your AVONEX in a prefilled syringe. Should refrigeration be unavailable, AVONEX in a prefilled syringe can be stored up to 77°F (25°C) for up to 7 days. Note that after the product is removed from the refrigerator, it must not be stored above 77°F (25°C). If your Avonex prefilled syringe has been exposed to conditions other than those recommended, do not use the product. Instead, discard your prefilled syringe and call your pharmacist.

Powder: Vials of AVONEX should be refrigerated at 36-46°F (2-8°C). Should refrigeration be unavailable, vials of AVONEX can be stored up to 77°F (25°C) for up to 7 days. Do not expose the vials of AVONEX to high or freezing temperatures. After mixing the powder, AVONEX solution should be used immediately or within 6 hours if stored in the refrigerator.

Flu-like symptoms are a fairly common side effect during the initial weeks of Avonex treatment. It is recommended that you take your Avonex injection before bedtime. Immediately before your injection, and for the 24 hours that follow the injection, patients have found that use of over the counter pain and fever reducing medications can help with this common side effect.

Warnings and Precautions
In response to post-marketing findings (events that have been reported by patients and doctors since Avonex was approved for use), the FDA has added warnings and precautions to the prescribing information for this medication:
Depression and suicide
It is recommended that individuals with a history of severe depressive disorder or other mental disorder be closely monitored while taking Avonex. The people receiving Avonex in the original clinical trial did not report an increase in depression. However, depression and suicidal thoughts are known to occur with some frequency in MS, and depression and suicidal thoughts have been reported with high doses of various interferon products. In addition, there have been post-marketing reports of depression, suicidal thoughts and/or development of new or worsening of other pre-existing psychiatric disorders, including psychosis. Some of these patients improved when they stopped the medication.
Seizures
Avonex should be used with caution in individuals with a seizure disorder. A few individuals with no prior history of seizures have experienced seizures while on Avonex. Since seizures are known to occur somewhat more frequently in people with MS than in the general population, it is not known whether these seizures were related to the MS, to the medication, or to some combination of the two.
Heart problems
People with cardiac disease should be closely monitored for a worsening of their condition. While Avonex is not known to cause cardiac problems, there have been infrequent post-marketing reports of congestive heart failure and other cardiac problems in people with no prior history and no other factors predisposing them to heart problems.
Liver problems
Avonex, like other interferon medications, can affect liver functions. In post-marketing studies, a few people have developed severe liver injury. Periodic blood tests to measure liver functions are recommended for any person taking an interferon medication.
Allergic reactions
Some people taking Avonex have developed a severe allergic reaction that interferes with breathing. An allergic reaction can occur after the first dose, or not until after several doses. Less severe reactions—including itching, skin bumps, a rash, or swelling of the mouth and tongue can also occur. Anyone who develops any kind of allergic reaction should stop the medication immediately and contact his or her physician.
Blood problems
Avonex can cause a reduction in levels of infection-fighting blood cells, red blood cells, or cells that help to form blood clots. Severe changes of this kind can lessen a person’s ability to fight infections and cause tiredness. Periodic blood tests can identify changes in levels of these important types of cells.
Prior to taking Avonex, be sure to tell your physician if you have ever had any of the following medical problems:
Depression, anxiety, or trouble sleeping
Problems with your thyroid gland
Blood problems such as bleeding or bruising easily, anemia, low white cell count
Seizures
Heart problems
Liver disease
Avonex should not be used during pregnancy or by any woman who is trying to become pregnant. Women taking Avonex should use birth control measures at all times. If you want to become pregnant while being treated with Avonex, discuss the matter with your physician. If you become pregnant while using Avonex, stop the treatment and contact your physician.

Possible Side Effects
Common side effects include flu-like symptoms (fatigue, chills, fever, muscle aches, and sweating). Most of these symptoms will tend to disappear after the initial few weeks of treatment. If they continue, become more severe, or cause you significant discomfort, be sure to talk them over with your physician.

Symptoms of depression, including ongoing sadness, anxiety, loss of interest in daily activities, irritability, low self-esteem, guilt, poor concentration, indecisiveness, confusion, and eating and sleep disturbances, should be reported promptly to your doctor.