Avonex Pen简介
Avonex Pen是首款一次性使用、一周一次用于MS治疗的完全一体式肌肉内自动注射剂。它是专为使用AVONEX治疗的MS复发患者而设计。 Avonex Pen融合目前获批的Avonex 预装式注射器特点，并采用了较小的针头（25号，5/8英寸），比标准的Avonex 预装式注射器针头细，而且短50%。
Avonex Pen其他特点
注射器保护性针帽，注射前可隐藏针头；自动进针和给药；注射过程中可稳定Avonex Pen的直径和长度。此外，Avonex Pen还配备了安全锁，可减少注射失误，同时有一个显示窗口，用于确认药物是否完全释放。
Avonex Pen相关信息
在一项开放性，多中心3b期（70例）研究中，对Avonex Pen的疗效和安全性进行了评估。通过对患者使用Avonex Pen的关键环节的主客观评估，评价了其疗效。 　　Biogen Idec公司2月28日宣布，FDA已批准两种不同的给药新方案，用以改善接受Avonex治疗（每周一次）的复发性多发性硬化症（MS）患者的治疗体验。
FDA批准Biogen Idec的多发性硬化症药物Avonex一种更易于使用的注射笔剂型，这种注射笔使用更小的针头，当患者自行注射时，可减轻疼痛和焦虑。同时，FDA还批准了该药的一个新的给药方案，可以减少用药后的流感样症状。Avonex于1996年获得FDA批准。

Avonex Pen and New Dose Titration Regimen Available
AVONEX PEN (interferon beta-1a) 30mcg/0.5mL solution for injection by Biogen Idec The Avonex Pen (interferon beta-1a 30mcg/0.5mL solution for injection), the first IM autoinjector for chronic use in multiple sclerosis (MS), has been made available by Biogen Idec. Also, a new dose titration regimen, facilitated by the AVOSTARTGRIP titration devices, provides patients with the option to gradually increase the dose of Avonex at treatment initiation to reduce the incidence and severity of flu-like symptoms.
The AVOSTARTGRIP kit contains a set of three devices that work with the Avonex prefilled syringe to administer three titrated doses of Avonex over a three-week period: 7.5mcg, 15mcg, and 22.5mg. The full dose should be administered at week four. A titration regimen should only be considered for patients initiating Avonex therapy. Once patients have completed the titration regimen, treatment can be continued with Avonex Pen or other administration options.

FDA APPROVES AVONEX® PEN™ AND DOSE TITRATION REGIMEN
Dosing Enhancements May Improve Treatment Experience for Patients Receiving AVONEX®(interferon beta-1a) for Multiple Sclerosis
U.S. Food and Drug Administration (FDA) has approved two separate dosing innovations designed to improve the treatment experience for patients receiving once-a-week AVONEX for relapsing forms of multiple sclerosis (MS).
AVONEX PEN, the first intramuscular (IM) autoinjector approved for MS, incorporates a smaller needle and easier administration to help patients reduce anxiety about AVONEX self-injection.
A new dose titration regimen, which gradually escalates the dose of AVONEX at treatment initiation, reduces the incidence and severity of flu-like symptoms that can occur at the beginning of therapy.
“AVONEX has been an effective treatment for MS for more than 15 years, and data have shown it to have the highest adherence rate among currently marketed injectable therapies,” said Douglas E. Williams, Ph.D., Biogen Idec’s executive vice president of Research and Development. “However, anxiety around administration and the potential for flu-like symptoms can be a barrier for some patients. AVONEX PEN and the new titration regimen reflect our commitment to enhancing the Biogen Idec products that people with MS rely on today.”
AVONEX PEN (AVONEX 30mcg/0.5mL solution for injection) is an automated injection device designed to be easier to use than the currently available AVONEX Prefilled Syringe. AVONEX PEN also incorporates a substantially smaller needle, which may reduce injection anxiety and pain. AVONEX PEN was approved based on data from a Phase 3b study in which approximately nine out of 10 patients used the device successfully. Ninety-four percent of patients in the study also expressed a preference for AVONEX PEN over the AVONEX Prefilled Syringe. AVONEX PEN was approved in the European Union and Canada in 2011.
The updated prescribing information also provides physicians and patients with a regimen to titrate therapy at treatment initiation to reduce the incidence and severity of flu-like symptoms. This optional titration schedule, which can be facilitated by the new AVOSTARTGRIP™ devices, is based on data from an eight-week, randomized, healthy-volunteer study that showed a three-week titration period at treatment initiation reduced the severity of flu-like symptoms by 76 percent, as well as significantly reduced the flu-like symptom incidence, versus no titration four to six hours post-injection. After the titration period, patients may continue treatment with AVONEX PEN or other administration options.
“Enhancements to improve the administration of AVONEX have helped thousands of patients around the world, and we will make AVONEX PEN and the AVOSTARTGRIP kit available to patients in the United States as soon as possible,” continued Dr. Williams.
About AVONEX PEN
AVONEX PEN is the first single-use, once-a-week, fully integrated IM autoinjector for MS. It is designed for use with AVONEX treatment in patients with relapsing forms of MS. AVONEX PEN integrates the currently approved AVONEX Prefilled Syringe and incorporates a smaller needle (25 gauge, 5/8 inch), which is thinner and 50 percent shorter than the standard AVONEX Prefilled Syringe needle.
Additional features of AVONEX PEN include: a protective injector shield that conceals the needle prior to injection; automated needle insertion and medication delivery; and a diameter and length designed to stabilize AVONEX PEN during the injection procedure. In addition, AVONEX PEN incorporates a safety lock, which helps prevent injection error and a display window that confirms complete delivery of the medication.
The efficacy and safety of AVONEX PEN was evaluated in an open-label, multicenter, Phase 3b study (n=70). Efficacy was assessed through objective and subjective assessments of key aspects of patients’ use of AVONEX PEN.
About Titration
The AVONEX label provides physicians and patients with a clinically-supported schedule for gradually escalating the dose of AVONEX at the start of therapy, which has been shown to reduce the incidence and severity of flu-like symptoms that can occur with AVONEX treatment. In an eight-week, healthy-volunteer, randomized, Phase 1 study (n=234), a three-week titration period at the initiation of AVONEX treatment reduced the incidence (Odds Ratio: 0.18) of flu-like symptoms versus no titration four to six hours post-injection. It also reduced the severity of flu-like symptoms by 76 percent versus no titration four to six hours post-injection.
Titration with AVONEX can be facilitated by the AVOSTARTGRIP kit, a set of three devices that work with the AVONEX Prefilled Syringe to administer three titrated doses of AVONEX over a three-week period: 7.5mcg, 15mcg and 22.5mcg. The full dose should be administered at week four.
A titration regimen should only be considered for patients initiating AVONEX therapy. Once patients have completed the titration regimen, treatment can be continued with AVONEX PEN or other administration options.
About AVONEX
AVONEX is one of the most prescribed treatments for relapsing forms of MS worldwide and has been approved for use in the United States for more than 15 years. AVONEX is indicated 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 patients who have experienced a first clinical episode and have MRI features consistent with MS.
AVONEX should be used with caution in patients with depression or other mood disorders and in patients with seizure disorders. AVONEX should not be used by pregnant women. Patients should also be monitored for signs of hepatic injury. Rare cases of anaphylaxis have been reported. Patients with cardiac disease should be closely monitored. Routine periodic blood chemistry and hematology tests are recommended during treatment with AVONEX.
The most common side effects associated with AVONEX treatment are flu-like symptoms, including chills, fever, myalgia, and asthenia.
FDA批准Biogen Idec的多发性硬化症药物Avonex一种更易于使用的注射笔剂型
Biogen Idec公司2月28日宣布，FDA已批准两种不同的给药新方案，用以改善接受Avonex治疗（每周一次）的复发性多发性硬化症（MS）患者的治疗体验。
Avonex Pen是首个被批准用于治疗MS的自动肌肉注射器，采用了较小的针头，给药更加容易，有助于缓解患者自我注射的焦虑症状。新型滴定剂量方案是开始治疗后逐渐增加Avonex剂量，这样可降低治疗初期流感样症状的发生率和严重程度。
Biogen Idec公司研发执行副总裁Douglas E. Williams博士说，“Avonex有效治疗MS已经超过15年，有数据表明，目前上市的注射药物中，该药的依从性最好。” “然而，给药时的焦虑及可能出现的流感样症状限制了某些患者的使用。
Avonex Pen（Avonex 30mcg/0.5mL注射液）是一个自动注射装置，比目前的Avonex 预装式注射器更容易使用。 Avonex Pen还采用了小针头，这可能会降低注射的焦虑和痛苦。
Avonex Pen此次得以获批，是基于3b期的研究数据，研究显示，10例患者中有9例成功使用了该设备。研究中94％的患者称与使用Avonex 预装式注射器相比，更偏好用Avonex Pen。2011年Avonex Pen在欧盟和加拿大被批准使用。
最新的处方信息也给医生和患者提供了一种治疗初期的滴定方案，可以减少流感样症状的发病率和严重程度。一项为期8周的随机、健康志愿者研究数据表明，与注射后4到6小时未进行滴定相比，治疗开始后进行3周滴定治疗可使流感样症状严重程度下降76％，同时可显著降低流感样症状的发病率。根据上述研究，制定了这种可选的滴定时间表，可通过新型AVOSTARTGRIP™装置对其顺利实施。滴定治疗期结束后，患者可继续使用Avonex Pen治疗或其他治疗。