BAVENCIO 200 mg10mL concentrate for solution for infusion

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

Avelumab

Available from:

MERCK SDN. BHD.

INN (International Name):

Avelumab

Units in package:

1 Vials

Manufactured by:

Merck Serono S.A.

Summary of Product characteristics

PAGE 1
N0113401B
1.
NAME OF THE MEDICINAL PRODUCT
BAVENCIO 200 mg/10 mL concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL of concentrate contains 20 mg of avelumab. One vial of 10 mL
contains 200 mg of avelumab.
Avelumab is a human monoclonal IgG1 antibody directed against the
immunomodulatory cell surface
ligand protein PD-L1 and produced in Chinese hamster ovary cells by
recombinant DNA technology.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion (sterile concentrate).
Clear,
colourless to slightly yellow solution.
The solution pH is in the range of 5.0 - 5.6 and the
osmolality is between 285 – 350 mOsm/Kg.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Bavencio is indicated as monotherapy for the treatment of adult
patients with metastatic Merkel
cell carcinoma (MCC).
Bavencio is indicated as monotherapy for the first-line maintenance
treatment of adult patients with
locally advanced or metastatic urothelial carcinoma (UC) whose disease
has not progressed with
first-line platinum-based induction chemotherapy..
Bavencio in combination with axitinib is indicated for the first-line
treatment of adult patients with
advanced renal cell carcinoma (RCC) (see section 5.1).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Treatment should be initiated and supervised by a physician
experienced in the treatment of cancer.
Posology
The recommended dose of Bavencio as monotherapy is 800 mg administered
intravenously over
60 minutes every 2 weeks.
Administration of Bavencio should continue according to the
recommended schedule until disease
progression or unacceptable toxicity.
The recommended dose of Bavencio in combination with axitinib is 800
mg administered intravenously
over 60 minutes every 2 weeks and axitinib 5 mg orally taken twice
daily (12 hours apart) with or
without food until disease progression or unacceptable toxicity.
For information on the posology of axitinib, please refer to the
axitinib product informat