Ontruzant

Country: Evrópusambandið

Tungumál: enska

Heimild: EMA (European Medicines Agency)

Virkt innihaldsefni:

trastuzumab

Fáanlegur frá:

Samsung Bioepis NL B.V.

ATC númer:

L01FD01

INN (Alþjóðlegt nafn):

trastuzumab

Meðferðarhópur:

Antineoplastic agents

Lækningarsvæði:

Stomach Neoplasms; Breast Neoplasms

Ábendingar:

Breast cancerMetastatic breast cancerOntruzant 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.in 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 suitable.in combination with docetaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease.in combination with an aromatase inhibitor for the treatment of postmenopausal patients with hormone-receptor positive MBC, not previously treated with trastuzumab.Early breast cancerOntruzant 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 docetaxel.in combination with adjuvant chemotherapy consisting of docetaxel and carboplatin.in combination with neoadjuvant chemotherapy followed by adjuvant Ontruzant therapy, for locally advanced (including inflammatory) disease or tumours >2 cm in diameter.Ontruzant should only be used in patients with metastatic or early breast cancer whose tumours have either HER2 overexpression or HER2 gene amplification as determined by an accurate and validated assay.Metastatic gastric cancerOntruzant 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 gastro-oesophageal junction who have not received prior anti-cancer treatment for their metastatic disease.Ontruzant 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.

Vörulýsing:

Revision: 14

Leyfisstaða:

Authorised

Leyfisdagur:

2017-11-15

Upplýsingar fylgiseðill

43
B. PACKAGE LEAFLET
44
PACKAGE LEAFLET: INFORMATION FOR THE USER
ONTRUZANT 150 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
ONTRUZANT 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 or pharmacist.
-
If you get any side effects, talk to your doctor, or pharmacist or
nurse. This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Ontruzant is and what it is used for
2.
What you need to know before you are given Ontruzant
3.
How Ontruzant is given
4.
Possible side effects
5.
How to store Ontruzant
6.
Contents of the pack and other information
1.
WHAT ONTRUZANT IS AND WHAT IT IS USED FOR
Ontruzant 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 Ontruzant binds to HER2 it
stops the growth of such cells and causes them to die.
Your doctor may prescribe Ontruzant 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. Ontruzant 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

Vara einkenni

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Ontruzant 150 mg powder for concentrate for solution for infusion
Ontruzant 420 mg powder for concentrate for solution
for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ontruzant 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
several chromatography
steps including
specific viral inactivation
and removal procedures.
Ontruzant 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
several chromatography
steps including
specific viral inactivation
and removal procedures.
The reconstituted Ontruzant solution
contains 21 mg/mL of trastuzumab.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for concentrate for solution
for infusion.
White to pale yellow lyophilised powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Breast cancer
_Metastatic breast cancer_
Ontruzant 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.
-
in 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
suitable.
-
in combination
with docetaxel for the treatment of those patients who have not
received chemotherapy for their metastatic disease.
3
-
i