Onbevzi

Țară: Uniunea Europeană

Limbă: engleză

Sursă: EMA (European Medicines Agency)

Ingredient activ:

bevacizumab

Disponibil de la:

Samsung Bioepis NL B.V.

Codul ATC:

L01FG01

INN (nume internaţional):

bevacizumab

Grupul Terapeutică:

Antineoplastic agents

Zonă Terapeutică:

Colorectal Neoplasms; Breast Neoplasms; Ovarian Neoplasms; Fallopian Tube Neoplasms; Peritoneal Neoplasms; Carcinoma, Non-Small-Cell Lung; Carcinoma, Renal Cell; Uterine Cervical Neoplasms

Indicații terapeutice:

Onbevzi in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum.Onbevzi in combination with paclitaxel is indicated for first-line treatment of adult patients with metastatic breast cancer. For further information as to human epidermal growth factor receptor 2 (HER2) status, please refer to section 5.1.Onbevzi in combination with capecitabine is indicated for first-line treatment of adult patients with metastatic breast cancer in whom treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate. Patients who have received taxane and anthracycline containing regimens in the adjuvant setting within the last 12 months should be excluded from treatment with Onbevzi in combination with capecitabine. For further information as to HER2 status, please refer to section 5.1.Onbevzi, in addition to platinum-based chemotherapy, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-small cell lung cancer other than predominantly squamous cell histology.Onbevzi, in combination with erlotinib, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer with Epidermal Growth Factor Receptor (EGFR) activating mutations.Onbevzi in combination with interferon alfa-2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer.Onbevzi, in combination with carboplatin and paclitaxel is indicated for the front-line treatment of adult patients with advanced (International Federation of Gynecology and Obstetrics (FIGO) stages III B, III C and IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer.Onbevzi, in combination with carboplatin and gemcitabine or in combination with carboplatin and paclitaxel, is indicated for treatment of adult patients with first recurrence of platinum-sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor targeted agents.Onbevzi, in combination with topotecan, or pegylated liposomal doxorubicin is indicated for the treatment of adult patients with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor targeted agents.Onbevzi, in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy, is indicated for the treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix.

Rezumat produs:

Revision: 4

Statutul autorizaţiei:

Authorised

Data de autorizare:

2021-01-11

Prospect

62
B. PACKAGE LEAFLET
63
PACKAGE LEAFLET: INFORMATION FOR THE USER
ONBEVZI 25 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION
bevacizumab
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, pharmacist or
nurse.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Onbevzi is and what it is used for
2.
What you need to know before you use Onbevzi
3.
How to use Onbevzi
4.
Possible side effects
5.
How to store Onbevzi
6.
Contents of the pack and other information
1.
WHAT ONBEVZI IS AND WHAT IT IS USED FOR
Onbevzi contains the active substance bevacizumab, which is a
humanised monoclonal antibody (a
type of protein that is normally made by the immune system to help
defend the body from infection
and cancer). Bevacizumab binds selectively to a protein called human
vascular endothelial growth
factor (VEGF), which is found on the lining of blood and lymph vessels
in the body. The VEGF
protein causes blood vessels to grow within tumours, these blood
vessels provide the tumour with
nutrients and oxygen. Once bevacizumab is bound to VEGF, tumour growth
is prevented by blocking
the growth of the blood vessels which provide the nutrients and oxygen
to the tumour.
Onbevzi is a medicine used for the treatment of adult patients with
advanced cancer in the large bowel,
i.e., in the colon or rectum. Onbevzi will be administered in
combination with chemotherapy treatment
containing a fluoropyrimidine medicine.
Onbevzi is also used for the treatment of adult patients with
metastatic breast cancer. When used

Caracteristicilor produsului

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
Onbevzi 25 mg/ml concentrate for solution for infusion.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of concentrate contains 25 mg of bevacizumab*.
Each 4 ml vial contains 100 mg of bevacizumab.
Each 16 ml vial contains 400 mg of bevacizumab.
For dilution and other handling recommendations, see section 6.6.
*Bevacizumab is a recombinant humanised monoclonal antibody produced
by DNA technology in Chinese
Hamster Ovary cells.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion (sterile concentrate).
Clear to slightly opalescent, colourless to pale brown liquid.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Onbevzi in combination with fluoropyrimidine-based chemotherapy is
indicated for treatment of adult
patients with metastatic carcinoma of the colon or rectum.
Onbevzi in combination with paclitaxel is indicated for first-line
treatment of adult patients with metastatic
breast cancer. For further information as to human epidermal growth
factor receptor 2 (HER2) status,
please refer to section 5.1.
Onbevzi in combination with capecitabine is indicated for first-line
treatment of adult patients with
metastatic breast cancer in whom treatment with other chemotherapy
options including taxanes or
anthracyclines is not considered appropriate. Patients who have
received taxane and
anthracyclinecontaining regimens in the adjuvant setting within the
last 12 months should be excluded
from treatment with Onbevzi in combination with capecitabine. For
further information as to HER2 status,
please refer to section 5.1.
Onbevzi, in addition to platinum-based chemotherapy, is indicated for
first-line treatment of adult patients
wi