Adempas(riociguat) 片批准为口服使用,是由德国拜耳先灵制药公司研发的一种口服有效的治疗肺高压
适应证和用途
Adempas是一种可溶性鸟苷酸环化酶(sGC)刺激剂适用为有以下情况成年的治疗：
（1）手术治疗后或不手术的慢性血栓栓塞性肺高血压(CTEPH)(WHO组4)持久性/复发性CTEPH提高运动能力和WHO功能性类别。
（2）肺动脉高压(PAH)(WHO组1)提高运动能力，改善WHO功能性类别和延缓临床恶化。
剂量和给药方法
（1）开始治疗服用在1mg 1天3次。
（2）对可能不能耐受Adempas的降血压作用患者，考虑开始剂量0.5mg，1天3次。
（3）通过间隔不短于2周增加剂量0.5mg当耐受最大2.5mg 1天3次。
剂型和规格
片：0.5mg，1mg，1.5mg，2mg和2.5mg
禁忌证
（1）妊娠。
（2）与任何形式的硝酸盐或一氧化氮供体使用。
（3）与磷酸二酯酶(PDE)抑制剂使用。
警告和注意事项
（1）症状性低血压。
（2）出血。
（3）在有肺静脉闭塞病患者中如被确证肺水肿，终止治疗。
不良反应
用Adempas比安慰剂更频(≥3%)发生的不良反应是头痛，眩晕，消化不良/胃炎，恶心，腹泻，低血压，呕吐，贫血，胃食道反流，和便秘。
药物相互作用
（1）强CYP和P-gp/BCRP抑制剂：对接受强CYP和P-gp/BCRP抑制剂患者，考虑开始剂量0.5mg 1天3次。监视低血压。
（2）抗酸药：分开给药间隔至少1小时。
特殊人群中使用
（1）哺乳母亲：终止药物或哺乳。
（2）肾受损：肌酐清除率
（3）肝受损：有严重(Child Pugh C)肝受损患者建议不要使用。
（4）吸烟：如耐受可能需要剂量高于2.5mg 1天3次。停止吸烟患者可能需要减低剂量。
-------------------------------------------------------
注：以下产品不同规格和不同价格，购买以咨询为准！
-------------------------------------------------------
产地国家: 日本
原产地英文商品名:
Adempas 0.5mg  100Tablets
原产地英文药品名:
Riociquat
中文参考商品译名:
Adempas 0.5毫克 100片/盒
中文参考药品译名:
利奥西呱
生产厂家中文参考译名:
拜尔
生产厂家英文名:
Bayer
-------------------------------------------------------
产地国家: 日本
原产地英文商品名:
Adempas 1mg  100Tablets
原产地英文药品名:
Riociquat
中文参考商品译名:
Adempas 1毫克 100片/盒
中文参考药品译名:
利奥西呱
生产厂家中文参考译名:
拜尔
生产厂家英文名:
Bayer
-------------------------------------------------------
产地国家: 日本
原产地英文商品名:
Adempas 2.5mg  100Tablets
原产地英文药品名:
Riociquat
中文参考商品译名:
Adempas 2.5毫克 100片/盒
中文参考药品译名:
利奥西呱
生产厂家中文参考译名:
拜尔
生产厂家英文名:
Bayer

IMPORTANT SAFETY INFORMATION
WARNING: EMBRYO-FETAL TOXICITY
Do not administer Adempas (riociguat) tablets to a pregnant female because it may cause fetal harm.
Females of reproductive potential: Exclude pregnancy before the start of treatment, monthly during treatment, and 1 month after stopping treatment. Prevent pregnancy during treatment and for one month after stopping treatment by using acceptable methods of contraception.
For all female patients, Adempas is available only through a restricted program called the Adempas Risk Evaluation and Mitigation Strategy (REMS) Program.
Contraindications
Adempas is contraindicated in:
•Pregnancy. Adempas may cause fetal harm when administered to a pregnant woman. Adempas was consistently shown to have teratogenic effects when administered to animals. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus
•Co-administration with nitrates or nitric oxide donors (such as amyl nitrite) in any form.•Concomitant administration with phosphodiesterase (PDE) inhibitors, including specific PDE-5 inhibitors (such as sildenafil, tadalafil, or vardenafil) or nonspecific PDE inhibitors (such as dipyridamole or theophylline).
Warnings and Precautions
Embryo-Fetal Toxicity. Adempas may cause fetal harm when administered during pregnancy and is contraindicated for use in women who are pregnant. In females of reproductive potential, exclude pregnancy prior to initiation of therapy, advise use of acceptable contraception and obtain monthly pregnancy tests. For females, Adempas is only available through a restricted program under the Adempas REMS Program.
Adempas REMS Program.  Females can only receive Adempas through the Adempas REMS Program, a restricted distribution program.
Important requirements of the Adempas REMS program include the following:
•Prescribers must be certified with the program by enrolling and completing training.
•All females, regardless of reproductive potential, must enroll in the Adempas REMS Program prior to initiating Adempas. Male patients are not enrolled in the Adempas REMS Program.
•Female patients of reproductive potential must comply with the pregnancy testing and contraception requirements.
•Pharmacies must be certified with the program and must only dispense to patients who are authorized to receive Adempas.
Further information, including a list of certified pharmacies, is available at www.AdempasREMS.com or 1-855-4ADEMPAS.
Hypotension. Adempas reduces blood pressure. Consider the potential for symptomatic hypotension or ischemia in patients with hypovolemia, severe left ventricular outflow obstruction, resting hypotension, autonomic dysfunction, or concomitant treatment with antihypertensives or strong CYP and P-gp/BCRP inhibitors. Consider a dose reduction if patient develops signs or symptoms of hypotension.
Bleeding.  In the placebo-controlled clinical trials program, serious bleeding occurred in 2.4% of patients taking Adempas compared to 0% of placebo patients. Serious hemoptysis occurred in 5 (1%) patients taking Adempas compared to 0 placebo patients, including one event with fatal outcome. Serious hemorrhagic events also included 2 patients with vaginal hemorrhage, 2 with catheter site hemorrhage, and 1 each with subdural hematoma, hematemesis, and intra-abdominal hemorrhage.
Pulmonary Veno-Occlusive Disease. Pulmonary vasodilators may significantly worsen the cardiovascular status of patients with pulmonary veno-occlusive disease (PVOD). Therefore, administration of Adempas to such patients is not recommended. Should signs of pulmonary edema occur, the possibility of associated PVOD should be considered and if confirmed, discontinue treatment with Adempas.
Most Common Adverse Reactions
The most common adverse reactions occurring more frequently (≥3%) on Adempas than placebo were headache (27% vs. 18%), dyspepsia/gastritis (21% vs. 8%), dizziness (20% vs. 13%), nausea (14% vs. 11%), diarrhea (12% vs. 8%), hypotension (10% vs. 4%), vomiting (10% vs. 7%), anemia (7% vs. 2%), gastroesophageal reflux disease (5% vs. 2%), and constipation (5% vs. 1%).
Other events that were seen more frequently in Adempas compared to placebo and potentially related to treatment were: palpitations, nasal congestion, epistaxis, dysphagia, abdominal distension and peripheral edema.
For important risk and use information, please see the full Prescribing Information, including Boxed Warning, at www.adempas-us.com.
About Bayer HealthCare Pharmaceuticals Inc.
Bayer HealthCare Pharmaceuticals Inc. is the U.S.-based pharmaceuticals business of Bayer HealthCare LLC, a subsidiary of Bayer AG. Bayer HealthCare is one of the world’s leading, innovative companies in the healthcare and medical products industry, and combines the activities of the Animal Health, Consumer Care, Medical Care, and Pharmaceuticals divisions. As a specialty pharmaceutical company, Bayer HealthCare provides products for General Medicine, Hematology, Neurology, Oncology and Women’s Healthcare. The company’s aim is to discover and manufacture products that will improve human health worldwide by diagnosing, preventing and treating diseases.
Bayer® and the Bayer Cross® and Adempas® are registered trademarks of Bayer. 
Intended for U.S. media only
全球制药巨头拜耳公司近日已得到日本卫生当局的批准，可以用药物riociguat对患有反复出现的肺部疾病或慢性血栓栓塞肺动脉高压的患者进行治疗。
据报道，该药隶属于Adempas品牌，它于2011年9月在日本已成为罕见药物。拜耳全球药物开发总裁凯末尔·马利克（Kemal Malik）当地时间1月17日在一项陈述中表示：“Riociguat已达成了巨大的临床改善：它能够用于治疗不可手术的，或是病情顽固反复发作的慢性血栓栓塞性肺高压患者。”
据悉，该药在2013年9月至11月已在美国、加拿大和瑞士获得批准