Ogivri

Țară: Uniunea Europeană

Limbă: engleză

Sursă: EMA (European Medicines Agency)

Ingredient activ:

trastuzumab

Disponibil de la:

Biosimilar Collaborations Ireland Limited

Codul ATC:

L01XC03

INN (nume internaţional):

trastuzumab

Grupul Terapeutică:

Antineoplastic agents

Zonă Terapeutică:

Stomach Neoplasms; Breast Neoplasms

Indicații terapeutice:

Breast cancerMetastatic breast cancerOgivri is indicated for the treatment of adult patients with HER2 positive metastatic breast cancer (MBC):as monotherapy for the treatment of those patients who have received at least two chemotherapy regimens for their metastatic disease. Prior chemotherapy must have included at least an anthracycline and a taxane unless patients are unsuitable for these treatments. Hormone receptor positive patients must also have failed hormonal therapy, unless patients are unsuitable for these treatmentsin combination with paclitaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease and for whom an anthracycline is not suitablein combination with docetaxel for the treatment of those patients who have not received chemotherapy for their metastatic diseasein combination with an aromatase inhibitor for the treatment of postmenopausal patients with hormone-receptor positive MBC, not previously treated with trastuzumab.Early breast cancer                     Ogivri is indicated for the treatment of adult patients with HER2 positive early breast cancer (EBC):following surgery, chemotherapy (neoadjuvant or adjuvant) and radiotherapy (if applicable)following adjuvant chemotherapy with doxorubicin and cyclophosphamide, in combination with paclitaxel or docetaxelin combination with adjuvant chemotherapy consisting of docetaxel and carboplatin.in combination with neoadjuvant chemotherapy followed by adjuvant Ogivri therapy, for locally advanced (including inflammatory) disease or tumours > 2 cm in diameter.Ogivri should only be used in patients with metastatic or EBC whose tumours have either HER2 overexpression or HER2 gene amplification as determined by an accurate and validated assay.Metastatic gastric cancerOgivri in combination with capecitabine or 5-fluorouracil and cisplatin is indicated for the treatment of adult patients with HER2 positive metastatic adenocarcinoma of the stomach or gastroesophageal junction who have not received prior anti-cancer treatment for their metastatic disease.Ogivri should only be used in patients with metastatic gastric cancer (MGC) whose tumours have HER2 overexpression as defined by IHC2+ and a confirmatory SISH or FISH result, or by an IHC 3+ result. Accurate and validated assay methods should be used.

Rezumat produs:

Revision: 11

Statutul autorizaţiei:

Authorised

Data de autorizare:

2018-12-12

Prospect

48
B. PACKAGE LEAFLET
49
PACKAGE LEAFLET: INFORMATION FOR THE USER
OGIVRI 150 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
OGIVRI 420 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
trastuzumab
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 Ogivri is and what it is used for
2.
What you need to know before you are given Ogivri
3.
How Ogivri is given
4.
Possible side effects
5.
How to store Ogivri
6.
Contents of the pack and other information
1.
WHAT OGIVRI IS AND WHAT IT IS USED FOR
Ogivri contains the active substance trastuzumab, which is a
monoclonal antibody. Monoclonal
antibodies attach to specific proteins or antigens. Trastuzumab is
designed to bind selectively to an
antigen called human epidermal growth factor receptor 2 (HER2). HER2
is found in large amounts on
the surface of some cancer cells where it stimulates their growth.
When Ogivri binds to HER2 it stops
the growth of such cells and causes them to die.
Your doctor may prescribe Ogivri for the treatment of breast and
gastric cancer when:
•
You have early breast cancer, with high levels of a protein called
HER2.
•
You have metastatic breast cancer (breast cancer that has spread
beyond the original
tumour)
with
high levels of HER2. Ogivri may be prescribed in combination with the
chemotherapy
medicine paclitaxel or docetaxel as first treatment for metastatic
breast cancer or it may be
prescribed alone if other treatments have proved unsuccessful. It is
also used in combination
with medicines called aromatase inhibitors with patients with high
levels of HER2 and hormone
receptor-positive metastatic breast cancer (cancer that is sensitive
to the presence

Caracteristicilor produsului

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Ogivri 150 mg powder for concentrate for solution for infusion
Ogivri 420 mg powder for concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ogivri 150 mg powder for concentrate for solution for infusion
One vial contains 150 mg of trastuzumab, a humanised IgG1 monoclonal
antibody produced by
mammalian (Chinese hamster ovary) cell suspension culture and purified
by affinity and ion exchange
chromatography including specific viral inactivation and removal
procedures.
Ogivri 420 mg powder for concentrate for solution for infusion
One vial contains 420 mg of trastuzumab, a humanised IgG1 monoclonal
antibody produced by
mammalian (Chinese hamster ovary) cell suspension culture and purified
by affinity and ion exchange
chromatography including specific viral inactivation and removal
procedures.
The reconstituted Ogivri solution contains 21 mg/mL of trastuzumab.
Excipient with known effect
Each 150 mg vial contains 115.2 mg sorbitol (E420).
Each 420 mg vial contains 322.6 mg sorbitol (E420).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for concentrate for solution for infusion (powder for
concentrate).
White to pale yellow lyophilised powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Breast cancer
_Metastatic breast cancer _
Ogivri is indicated for the treatment of adult patients with HER2
positive metastatic breast cancer
(MBC):
-
as monotherapy for the treatment of those patients who have received
at least two chemotherapy
regimens for their metastatic disease. Prior chemotherapy must have
included at least an
anthracycline and a taxane unless patients are unsuitable for these
treatments. Hormone receptor
positive patients must also have failed hormonal therapy, unless
patients are unsuitable for these
treatments
3
-
in combination with paclitaxel for the treatment of those patients who
have not received
chemotherapy for their metastatic disease and for whom an
anth