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Otezla

新药编辑:新特药 更新时间:2015-02-04

  近日,美国FDA批准Otezla (apremilast)用于治疗活跃型银屑病性关节炎(PsA)成人患者。大多数人先出现银屑病,而后被诊断患有PsA。关节疼痛、僵硬和肿胀是PsA的主要体征和症状。目前被批准用于PsA的药物有糖皮质激素、肿瘤坏死因子(TNF)阻断剂及白介素-12/白介素-23抑制剂。
  “缓解疼痛和炎症,改善身体机能是活跃型银屑病性关节炎患者重要的治疗目标,”FDA药物评价与研究中心药物评价II办公室主任、医学博士、公共卫生学硕士Curtis Rosebraugh说。“Otezla为遭受这种疾病困扰的患者提供了一种新的治疗选择。”
  Otezla是一种磷酸二酯酶-4(PDE-4)抑制剂,其安全性及有效性基于三项由1493名活跃型银屑病性关节炎患者参与的3期临床试验。Otezla治疗患者与安慰剂患者相比,其PsA体征及症状显示有改善。
  Otezla治疗患者应定期让卫生保健专业人员监测其体重。如果出现无法解释或临床上明显的体重减轻,应对体重减轻进行评价,并应考虑中止治疗。Otezla治疗患者与安慰剂患者相比,抑郁症风险有所增加。
  在临床试验中,Otezla用药患者最常见的副作用有腹泻、恶心和头痛。Otezla由位于新泽西班州Summit的塞尔基因公司生产。
  请参阅Otezla部份处方资料
  Otezla(apremilast)片获美国FDA批准为口服使用
  美国初始批准:2014
  适应证和用途
  Otezla,一种磷酸二酯酶-4(PDE-4)的抑制剂,是适用于为治疗有活动性银屑病关节炎的成年患者。
  剂量和给药方法
  (1)为减低胃肠道症状,按照以下给药时间表点滴调整至推荐剂量30mg每天2次。
  1)第1天:早晨10mg
  2)第2天:早晨10mg和傍晚10mg
  3)第3天:早晨10mg和傍晚20mg
  4)第4天:早晨20mg和傍晚20mg
  5)第5天:早晨20mg和傍晚30mg
  6)第6天和其后:30mg每天2次
  (2)在严重肾受损中的剂量:
  1)推荐剂量是30 mg每天1次
  2)对初始剂量的点滴调整,利用表1中列出仅是早晨时间表和跳过下午剂量。
  剂型和规格
  片:10mg,20mg,30mg
  禁忌证
  已知对apremilast或制剂中任何赋形剂超敏性。
  警告和注意事项
  (1)抑郁:忠告患者,其护理人员,和家属警戒抑郁,自杀想法或其他情绪变化和如果这类变化发生时联系其卫生保健提供者。有抑郁和/或自杀想法或行为史患者中小心权衡用Otezla治疗的风险和获益。
  (2)体重减轻 :定期监视体重,如发生不能解释或临床意义体重减轻,评价体重减轻和考虑终止Otezla。
  (3)药物相互作用:不建议食用强细胞色素P450酶诱导剂(如利福平[rifampin],苯巴比妥[phenobarbital],卡马西平[carbamazepine],苯妥英[phenytoin])因为可能发生丧失疗效。
  不良反应
  最常见不良反应(≥ 5%)是腹泻,恶心和头痛。
  特殊人群中使用
  严重肾受损:曾观察到增加Otezla全身暴露,建议减低剂量至30 mg每天1次。

  2014 that the U.S. Food and Drug Administration (FDA) has approved OTEZLA® (apremilast), selective inhibitor of phosphodiesterase 4 (PDE4), for the treatment of adult patients with active psoriatic arthritis. A chronic disorder, psoriatic arthritis is characterized by pain, stiffness, swelling and tenderness of the joints, inflammation of specific ligaments and tendons, and a decrease in physical functioning. OTEZLA is the only FDA-approved oral treatment for psoriatic arthritis.
  About OTEZLA
  OTEZLA is an oral small-molecule inhibitor of phosphodiesterase 4 (PDE4) specific for cyclic adenosine monophosphate (cAMP). PDE4 inhibition results in increased intracellular cAMP levels.
  Important Safety Information
  Contraindications
  OTEZLA® (apremilast) is contraindicated in patients with a known hypersensitivity to apremilast or to any of the excipients in the formulation.
  Warnings and Precautions
  Treatment with OTEZLA is associated with an increase in adverse reactions of depression. During clinical trials, 1.0% (10/998) of patients treated with OTEZLA reported depression or depressed mood compared to 0.8% (4/495) treated with placebo and 0.3% (4/1441) of patients treated with OTEZLA discontinued treatment due to depression or depressed mood compared with none in placebo treated patients (0/495). Depression was reported as serious in 0.2% (3/1441) of patients exposed to OTEZLA, compared to none in placebo treated patients (0/495). Suicidal ideation and behavior were observed in 0.2% (3/1441) of patients on OTEZLA, compared to none on placebo (0/495). Two patients who received placebo committed suicide compared to none on OTEZLA.
  Carefully weigh the risks and benefits of treatment with OTEZLA for patients with a history of depression and/or suicidal thoughts/behavior, and of continued treatment with OTEZLA for patients with these symptoms. Patients, caregivers, and families should be advised of the need to be alert for the emergence or worsening of depression, suicidal thoughts or other mood changes, and they should contact their healthcare provider.
  Weight Decrease
  Body weight loss of 5-10% was reported in 10% of patients taking OTEZLA and in 3.3% of patients taking placebo. Monitor body weight regularly; evaluate unexplained or clinically significant weight loss, and consider discontinuation of OTEZLA.
  Drug Interactions
  Apremilast exposure is decreased when OTEZLA is co-administered with strong CYP450 inducers, such as rifampin, which may result in loss of efficacy of OTEZLA. Concomitant use of OTEZLA with CYP450 enzyme inducers (e.g., rifampin, phenobarbital, carbamazepine, phenytoin) is not recommended.
  Adverse Reactions
  Adverse reactions reported in at least 2% of patients taking OTEZLA, that occurred at a frequency at least 1% higher than that observed in patients taking placebo, for up to 16 weeks (after the initial 5-day titration), were (OTEZLA%, placebo%): diarrhea (7.7, 1.6); nausea (8.9, 3.1); headache (5.9, 2.2); upper respiratory tract infection (3.9, 1.8); vomiting (3.2, 0.4); nasopharyngitis (2.6, 1.6); upper abdominal pain (2.0, 0.2).
  Use in Specific Populations
  Pregnancy and Nursing Mothers
  OTEZLA is Pregnancy Category C; it has not been studied in pregnant women. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether apremilast or its metabolites are present in human milk. Caution should be exercised when OTEZLA is administered to a nursing woman.
  Renal Impairment
  OTEZLA dosage should be reduced in patients with severe renal impairment (creatinine clearance less than 30 mL/min); for details, see Dosage and Administration, Section 2, in the Full Prescribing Information
  Please click here for Full Prescribing Information.
  About Psoriatic Arthritis
  Psoriatic arthritis is a painful, chronic inflammatory disease characterized by pain, stiffness, swelling and tenderness of the joints, inflammation of specific ligaments and tendons, and decrease in physical functioning. It is estimated that nearly 38 million people worldwide have psoriatic arthritis. Psoriatic arthritis can impact day-to-day activities and has been reported to increase work disability. Common signs and symptoms of psoriatic arthritis include pain, stiffness, and swelling in joints. To learn more about psoriatic arthritis, go to www.discoverpsa.com. To learn more about the role of PDE4 in inflammatory diseases, go to www.discoverpde4.com.

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