País: Taiwan
Idioma: xinès
Font: 衛生福利部食品藥物管理署 (Ministry of Health and Welfare, Food And Drug Administration)
Ofatumumab
台灣諾華股份有限公司 台北市中山區民生東路三段2號8樓 (01516589)
L01XC10
注射劑
Ofatumumab (1013004200) MG
盒裝
菌 疫
限由醫師使用
LONZA BIOLOGICS, INC. 101 INTERNATIONAL DRIVE PEASE INTERNATIONAL TRADEPORT PORTSMOUTH, NEW HAMPSHIRE, U.S. 03801 US
ofatumumab
治療對含fludarabine治療無效的CD20陽性慢性淋巴球性白血病(CLL)患者
註銷日期: 2018/10/19; 註銷理由: 自請註銷; 有效日期: 2019/09/01; 英文品名: Arzerra concentrate for solution for Infusion
已註銷
2014-09-01
1 ARZERRA ® CONCENTRATE FOR SOLUTION FOR INFUSION OFATUMUMAB 20MG/ML WARNING: HEPATITIS B VIRUS REACTIVATION AND PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY ● HEPATITIS B VIRUS (HBV) REACTIVATION CAN OCCUR IN PATIENTS RECEIVING CD20-DIRECTED CYTOLYTIC ANTIBODIES, INCLUDING ARZERRA ® , IN SOME CASES RESULTING IN FULMINANT HEPATITIS, HEPATIC FAILURE, AND DEATH _[SEE WARNINGS AND PRECAUTIONS (5.2)]_. ● PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY (PML) RESULTING IN DEATH CAN OCCUR IN PATIENTS RECEIVING CD20-DIRECTED CYTOLYTIC ANTIBODIES, INCLUDING ARZERRA _[SEE _ _WARNINGS AND PRECAUTIONS (5.4)]_. 1 INDICATIONS AND USAGE ARZERRA is indicated for the treatment of CD20 positive patients with CLL refractory to fludarabine. _[see Clinical Studies (14)]_ . 2 DOSAGE AND ADMINISTRATION Arzerra is only administered by the physicians. 2.1 RECOMMENDED DOSAGE REGIMEN Dilute and administer as an intravenous infusion according to the following schedules. Do not administer as an intravenous push or bolus or as a subcutaneous injection. Premedicate before each infusion _[see Dosage and Administration (2.4)]_ . Refractory CLL : The recommended dosage and schedule is 12 doses administered as follows: 300 mg initial dose (Dose 1), followed 1 week later by 2,000 mg weekly for 7 doses (Doses 2 through 8), followed 4-5 weeks later by 2,000 mg every 4 weeks for 4 doses (Doses 9 through 12). 2.2 ADMINISTRATION Administer ARZERRA in an environment where facilities to adequately monitor and treat infusion reactions are available _[see Warnings and Precautions (5.1)]_ . Prepare all doses in 1,000 mL of 0.9% Sodium Chloride Injection, USP _[see Dosage and _ _Administration (2.5)]_ . Dose 1 (300-mg dose): Initiate infusion at a rate of 3.6 mg/hour (12 mL/hour). Dose 2 (2,000-mg dose): Initiate infusion at a rate of 24 mg/hour (12 mL/hour). Doses 3 through 12 (2,000-mg doses): Initiate infusion at a rate of 50 mg/hour (25 mL/hour). 2 In the absence of an infusion-related adverse event, the rate of infusion Llegiu el document complet