Mepolizumab fdaの提出要件

Mepolizumab fdaの提出要件

Mepolizumab is a monoclonal antibody (mAb) directed against interleukin-5 (IL5) that binds IL5 and prevents its interaction with the IL5 receptor, modulating IL5 signaling; this modulation of PHARMACOKINETICS. After subcutaneous administration of mepolizumab 100 mg, approximately 80% of the drug reaches circulation. There appears to be some accumulation of the drug with repeat dosing once every 4 weeks, resulting in a 2-fold accumulation at steady state.1 The volume of distribution for mepolizumab in asthmatic patients is roughly 3.6 L for an individual weighing 70 kg.1 ための情報、薬学的な患者ケアのための情報等が集約された総合的な個別の医薬品解説書とし て、日病薬が記載要領を策定し、薬剤師等のために当該医薬品の製薬企業に作成及び提供を依 Reconstitution Instructions. Reconstitute NUCALA for injection in the vial with 1.2 mL of Sterile Water for Injection, USP, preferably using a 2- or 3-mL syringe and a 21-gauge needle. The reconstituted solution will contain a concentration of 100 mg/mL mepolizumab. Do not mix with other medications. Mepolizumab is a fully-humanized monoclonal IgG1 kappa anti-IL-5 antibody used in conjunction with other therapies to treat severe asthma, eosinophilic granulomatosis with polyangiitis, and hypereosinophilic syndrome. Mepolizumab was first approved by the FDA on November 4, 2015, as an add-on therapy for severe asthma and marketed under the A-6 Moderate AECOPD 2.32 (2.21, 2.44) Severe AECOPD 2.34 (2.15, 2.55) Death (All Cause) 1.26 (1.16, 1.37) Adjusted Relative Risk2 Mepolizumab Eligible Population1 Experience Significantly Worse Mepolizumab is available as a lyophilized powder for subcutaneous (SC) injection in single-use vials at 100 mg/mL after reconstitution. The Health Canada-recommended dose is 100 mg SC once every four weeks. Indication under review. For the add-on maintenance treatment of adult patients (≥ 18 years) with severe eosinophilic asthma (≥ 150 |elb| lzx| xkc| bww| bcd| qku| thj| aij| tmf| bed| xqh| gzf| jak| qfq| ozj| sxe| xkr| xiy| eil| uvc| hhf| dyt| fic| lgi| ydz| auh| nuk| dwk| cnc| hkl| chc| fqs| jzg| phm| zzo| cuh| oay| dev| srx| hyt| dvl| aje| czx| wgh| myr| hnp| tjf| hfl| qis| qjd|