亞舍拉注射劑

البلد: تايوان

اللغة: الصينية

المصدر: 衛生福利部食品藥物管理署 (Ministry of Health and Welfare, Food And Drug Administration)

العنصر النشط:

Ofatumumab

متاح من:

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)

ATC رمز:

L01XC10

الشكل الصيدلاني:

注射劑

تركيب:

Ofatumumab (1013004200) MG

الوحدات في الحزمة:

盒裝

الفئة:

菌　疫

نوع الوصفة الطبية :

限由醫師使用

المصنعة من قبل:

LONZA BIOLOGICS, INC. 101 INTERNATIONAL DRIVE PEASE INTERNATIONAL TRADEPORT PORTSMOUTH, NEW HAMPSHIRE, U.S. 03801 US

المجال العلاجي:

ofatumumab

الخصائص العلاجية:

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

ملخص المنتج:

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

الوضع إذن:

已註銷

تاريخ الترخيص:

2014-09-01

نشرة المعلومات

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