BLINCYTO POWDER FOR INFUSION 35 MCGVIAL

Quốc gia: Singapore

Ngôn ngữ: Tiếng Anh

Nguồn: HSA (Health Sciences Authority)

Thành phần hoạt chất:

Blinatumomab

Sẵn có từ:

AMGEN BIOTECHNOLOGY SINGAPORE PTE LTD

Mã ATC:

L01XC19

Dạng dược phẩm:

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

Thành phần:

Blinatumomab 55.0 μg/mL

Tuyến hành chính:

INTRAVENOUS

Loại thuốc theo toa:

Prescription Only

Sản xuất bởi:

Boehringer Ingelheim Pharma GmbH & Co. KG

Tình trạng ủy quyền:

ACTIVE

Ngày ủy quyền:

2016-10-18

Đặc tính sản phẩm

1
FULL PRESCRIBING INFORMATION
BLINCYTO
® POWDER FOR INFUSION 35 MCG/VIAL
1
INDICATIONS AND USAGE
1.1 MRD-POSITIVE B-CELL PRECURSOR ALL
BLINCYTO is indicated for the treatment of B-cell precursor acute
lymphoblastic leukemia (ALL) in first
or second complete remission with minimal residual disease (MRD)
greater than or equal to 0.1% in adult
and pediatric patients.
1.2
RELAPSED OR REFRACTORY B-CELL PRECURSOR ALL
BLINCYTO is indicated for the treatment of relapsed or refractory
B-cell precursor acute lymphoblastic
leukemia (ALL) in adult and pediatric patients.
2
DOSAGE AND ADMINISTRATION
In patients with a history or presence of clinically relevant central
nervous system (CNS) pathology
_[see Warnings and Precautions (5.2)]_
, hospitalization is recommended at a minimum for the first 14 days
of the first cycle. In the second cycle, hospitalization is
recommended at a minimum for 2 days, and
clinical judgment should be based on tolerance to BLINCYTO in the
first cycle. Caution should be
exercised as cases of late occurrence of first neurological events in
the second cycle have been observed.
For all subsequent cycle starts and reinitiation (e.g., if treatment
is interrupted for 4 or more hours),
supervision by a healthcare professional or hospitalization is
recommended.
2.1
TREATMENT OF MRD-POSITIVE B-CELL PRECURSOR ALL
•
A treatment course consists of 1 cycle of BLINCYTO for induction
followed by up to 3 additional
cycles for consolidation.
•
A single cycle of treatment of BLINCYTO induction or consolidation
consists of 28 days of
continuous intravenous infusion followed by a 14-day treatment-free
interval (total 42 days).
•
See Table 1 for the recommended dose by patient weight and schedule.
Patients weighing 45 kg or
more receive a fixed-dose. For patients weighing less than 45 kg, the
dose is calculated using the
patient’s body surface area (BSA).
TABLE 1. RECOMMENDED BLINCYTO DOSE AND SCHEDULE FOR THE TREATMENT OF
MRD-POSITIVE B-CELL
PRECURSOR ALL
PATIENTS WEIGHING
PATIENTS WEIGHING
CYCLE
45 KG OR MO