Bavencio

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

avelumab

Saatavilla:

Merck Europe B.V.

ATC-koodi:

L01FF04

INN (Kansainvälinen yleisnimi):

avelumab

Terapeuttinen ryhmä:

Other antineoplastic agents, Monoclonal antibodies

Terapeuttinen alue:

Neuroendocrine Tumors

Käyttöaiheet:

Bavencio is indicated as monotherapy for the treatment of adult patients with metastatic Merkel cell carcinoma (MCC).Bavencio in combination with axitinib is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC).Bavencio is indicated as monotherapy for the first‑line maintenance treatment of adult patients with locally advanced or metastatic urothelial carcinoma (UC) who are progression-free following platinum‑based chemotherapy.

Tuoteyhteenveto:

Revision: 16

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2017-09-18

Pakkausseloste

42
B. PACKAGE LEAFLET
43
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
BAVENCIO 20 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION
avelumab
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor.
•
If you get any side effects, talk to your doctor. This includes any
possible side effects not listed
in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Bavencio is and what it is used for
2.
What you need to know before you use Bavencio
3.
How to use Bavencio
4.
Possible side effects
5.
How to store Bavencio
6.
Contents of the pack and other information
1.
WHAT BAVENCIO IS AND WHAT IT IS USED FOR
Bavencio contains the active substance avelumab, a monoclonal antibody
(a type of protein) that
attaches to a specific target in the body called PD-L1.
PD-L1 is found on the surface of certain tumour cells, and helps
protect them from the immune system
(the body’s natural defences). Bavencio binds to PD-L1, and blocks
this protective effect, allowing the
immune system to attack the tumour cells.
Bavencio is used in adults to treat:
•
Merkel cell carcinoma (MCC)
, A RARE TYPE OF SKIN CANCER
, when it is metastatic (has spread to
other parts of the body).
•
Urothelial carcinoma (UC),
A CANCER THAT ORIGINATES IN THE URINARY TRACT
, when it is advanced
or metastatic (has spread beyond the urinary bladder or to other parts
of the body). Bavencio is
used as maintenance treatment if the tumour has not grown after so
called platinum-based
chemotherapy as the first treatment.
•
Renal cell carcinoma (RCC)
, A TYPE OF KIDNEY CANCER
, when it is advanced (has spread beyond
the kidney or to other parts of the body).
For rena

Valmisteyhteenveto

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions.
See section 4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
Bavencio 20 mg/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 and 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) who are
progression-free following
platinum-based 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
intravenous