Option Care Selected to Administer First ALS Drug Approved by the FDA

BANNOCKBURN, Ill., Sept. 6, 2017 — Option Care Enterprises, Inc., the nation’s largest independent provider of home and alternate treatment site infusion services, has signed an agreement to become a national contracted home infusion provider for ALS drug RADICAVATM (edaravone), an intravenous (IV) infusion treatment for amyotrophic lateral sclerosis (ALS). RADICAVA, the first ALS treatment option approved by the Food and Drug Administration (FDA) in more than 20 years, is now available for patient treatment in the United States.

Sometimes referred to as Lou Gehrig’s Disease, ALS is a rapidly progressive neurodegenerative condition in which the majority of patients die within two to five years of diagnosis.[*]National Institute of Neurological Disorders and Stroke. Amyotrophic Lateral Sclerosis (ALS) Information Page. https://www.ninds.nih.gov/disorders/all-disorders/amyotrophic-lateral-sclerosis-als-information-page. Accessed July 17, 2017. [*]Mehta P, Kaye W, Bryan L, et al. (2016). Prevalence of Amyotrophic Lateral Sclerosis “United States, 2012—2013. MMWR Surveill Summ; 65(No. SS-8):1—12.

“Our specialized clinical knowledge and rigorous care management support — across multiple therapy areas and patient populations — are the backbone of our expertise as the nation’s home infusion therapy leader for neuromuscular disorders like ALS,” said John Rademacher, CEO of Option Care. “This expertise is why we are a trusted partner for innovators bringing to market new therapies like RADICAVA. By partnering with manufacturers, who trust us to provide critical pharmacy services and care management support, we are able to provide unmatched home infusion services to our patients.”

Option Care’s national payer network includes contracts with more than 800 health plans, ensuring broad access to RADICAVA for patients and clinicians who rely on clinical management of home infusion therapy. Additionally, its national network of clinicians includes more than 1,800 nurses specially trained in care coordination and customized clinical management of complex conditions, including ALS.[*] Option Care data on file.

Approved by the FDA in May 2017, ALS drug RADICAVA is marketed and distributed by Mitsubishi Tanabe Pharma America, Inc.

Currently, about 12,000 to 15,000 Americans have ALS, according to the Centers for Disease Control and Prevention (CDC).4 ALS attacks and kills the nerve cells in the brain and spinal cord that control the voluntary muscles and produce movements such as chewing, walking, breathing and talking. ALS is incurable, and over time, the muscles get weaker and become paralyzed.[*] National Amyotrophic Lateral Sclerosis (ALS) Registry. https://wwwn.cdc.gov/als/whatisals.aspx. Accessed July 17, 2017.

关于 Option Care

Option Care Enterprises, Inc. (Option Care) 是全美最大和最值得信赖的家庭和备选医疗站点输液服务提供者。作为行业领导者,本公司汲取了近 40 年的临床护理经验,提供以患者为中心的治疗管理。Option Care 的标志性家庭输液+服务包括输液药物的临床管理、护理支持和护理协调。Option Care 由 1,700 多名临床从业人员(包括药剂师、护士和营养师)组成的多学科团队能够为美国各地需要接受复杂和慢性病治疗的几乎所有患者提供家庭输液服务覆盖。有关详情请访问 www.OptionCare.com。

About Mitsubishi Tanabe Pharma America, Inc.

Based in Jersey City, N.J., Mitsubishi Tanabe Pharma America (MTPA) is a wholly-owned subsidiary of Mitsubishi Tanabe Pharma Corporation’s (MTPC) 100 percent owned U.S. holding company, Mitsubishi Tanabe Pharma Holdings America, Inc. MTPA is dedicated to delivering innovative products that address the unmet medical needs of patients in the U.S. It was established by MTPC to commercialize approved pharmaceutical products in the U.S. with plans to expand its product line through collaborations with partners. For more information, please visit www.mt-pharma-america.com or follow us on Twitter at https://twitter.com/MTPharmaUS.

重要的安全信息

在您接受 RADICAVA 治疗之前,请将您的所有健康状况告知您的医疗保健服务提供者,包括以下状况:

  • have asthma.
  • 对其他药物过敏。
  • 怀孕或计划怀孕。RADICAVA 对胎儿是否有害尚不清楚。
  • 母乳喂养或计划母乳喂养。RADICAVA 是否会进入乳汁尚不清楚。您和您的医疗保健提供者应决定您要接受 RADICAVA 治疗还是进行母乳喂养。

将您服用的所有药物告知您的医疗保健服务提供者,包括处方药和非处方药、维生素和草药补充剂。

RADICAVA 可能会有哪些副作用?

  • RADICAVA 可能会引起严重的副作用,包括超敏(过敏)反应和亚硫酸盐过敏反应。
  • 接受 RADICAVA 治疗的人士曾出现过超敏反应,可能在您的输液完成后发生。
  • RADICAVA 含有亚硫酸氢钠,这种亚硫酸盐可能导致一种严重且危及生命的过敏反应。亚硫酸氢钠也可能导致某些人士出现不太严重的哮喘发作。哮喘病患者比非哮喘病患者更经常出现亚硫酸盐过敏。
  • 如果您有以下任何症状,应立即告知您的医疗保健服务提供者或前往最近的急诊室就医:荨麻疹;嘴唇、舌头或面部肿胀;昏厥;呼吸问题;喘息;吞咽困难;头晕;瘙痒;或(哮喘患者)哮喘发作。
  • Your healthcare provider will monitor you during treatment to watch for signs and symptoms of all the serious side effects.

RADICAVA 最常见的副作用包括瘀伤(挫伤)、行走困难(步履不稳)和头痛。

这些并非 RADICAVA 所有可能产生的副作用。致电您的医疗保健提供者咨询相关副作用。您可以向 Mitsubishi Tanabe Pharma America, Inc. 报告副作用:1-888-292-0058 或 FDA:1-800-FDA-1088 或访问 www.fda.gov/medwatch。

要了解更多信息,包括完整的处方信息和患者信息,请访问 www.RADICAVA.com。

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