BAVENCIO CONCENTRATE FOR SOLUTION FOR INFUSION 200MG10ML

Страна: Сингапур

Язык: английский

Источник: HSA (Health Sciences Authority)

Активный ингредиент:

Avelumab

Доступна с:

MERCK PTE. LTD.

код АТС:

L01XC31

Фармацевтическая форма:

INJECTION, SOLUTION, CONCENTRATE

состав:

Avelumab 200mg/10ml

Администрация маршрут:

INTRAVENOUS

Тип рецепта:

Prescription Only

Производитель:

MERCK SERONO SA (Aubonne)

Статус Авторизация:

ACTIVE

Дата Авторизация:

2019-04-25

Характеристики продукта

1
1.
NAME OF THE MEDICINAL PRODUCT
Bavencio 200 mg/10mL 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 and 350 mOsm/kg.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Bavencio is indicated as monotherapy for the treatment of patients
with metastatic Merkel cell
carcinoma (MCC).
Bavencio is indicated for the first-line maintenance treatment of
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 information.
2
_Premedication _
Patients have to be