Kadcyla

מדינה: האיחוד האירופי

שפה: אנגלית

מקור: EMA (European Medicines Agency)

מרכיב פעיל:

trastuzumab emtansine

זמין מ:

Roche Registration GmbH

קוד ATC:

L01XC14

INN (שם בינלאומי):

trastuzumab emtansine

קבוצה תרפויטית:

Antineoplastic agents

איזור תרפויטי:

Breast Neoplasms

סממני תרפויטית:

Early Breast Cancer (EBC)Kadcyla, as a single agent, is indicated for the adjuvant treatment of adult patients with HER2-positive early breast cancer who have residual invasive disease, in the breast and/or lymph nodes, after neoadjuvant taxane-based and HER2-targeted therapy.Metastatic Breast Cancer (MBC)Kadcyla, as a single agent, is indicated for the treatment of adult patients with HER2-positive, unresectable locally advanced or metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination. Patients should have either:Received prior therapy for locally advanced or metastatic disease, orDeveloped disease recurrence during or within six months of completing adjuvant therapy.

leaflet_short:

Revision: 15

מצב אישור:

Authorised

תאריך אישור:

2013-11-15

עלון מידע

41
B. PACKAGE LEAFLET
42
PACKAGE LEAFLET: INFORMATION FOR THE USER
KADCYLA 100 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
KADCYLA 160 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
trastuzumab emtansine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START BEING GIVEN 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 Kadcyla is and what it is used for
2.
What you need to know before you are given Kadcyla
3.
How you are given Kadcyla
4.
Possible side effects
5.
How to store Kadcyla
6.
Contents of the pack and other information
1.
WHAT KADCYLA IS AND WHAT IT IS USED FOR
WHAT KADCYLA IS
Kadcyla contains the active substance trastuzumab emtansine, which is
made up of two parts that are
linked together:
•
trastuzumab - a monoclonal antibody that binds selectively to an
antigen (a target protein) 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
trastuzumab binds to HER2 it can
stop the cancer cells growth and cause them to die.
•
DM1 – an anti-cancer substance that becomes active once Kadcyla
enters the cancer cell.
WHAT KADCYLA IS USED FOR
Kadcyla is used to treat breast cancer in adults when:
•
the cancer cells have many HER2 proteins on them - your doctor will
test your cancer cells for
this.
•
you have already received the medicine trastuzumab and a medicine
known as a taxane.
•
the cancer has spread to areas near the breast or to other parts of
your body (metastasized)
•
the cancer has not spread to other parts of the body and treatment is
going to be given after surgery
(treatment after surgery is called adjuvant therapy).
2.
WHAT YOU NEED TO KNOW

מאפייני מוצר

1
_ _
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Kadcyla 100 mg powder for concentrate for solution for infusion.
Kadcyla 160 mg powder for concentrate for solution for infusion.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Kadcyla 100 mg powder for concentrate for solution for infusion
One vial of powder for concentrate for solution for infusion contains
100 mg of trastuzumab
emtansine. After reconstitution one vial of 5 mL solution contains 20
mg/mL of trastuzumab
emtansine (see section 6.6).
Kadcyla 160 mg powder for concentrate for solution for infusion
One vial of powder for concentrate for solution for infusion contains
160 mg of trastuzumab
emtansine. After reconstitution one vial of 8 mL solution contains 20
mg/mL of trastuzumab
emtansine (see section 6.6).
Trastuzumab emtansine is an antibody-drug conjugate that contains
trastuzumab, a humanised IgG1
monoclonal antibody produced by mammalian (Chinese hamster ovary) cell
suspension culture,
covalently linked to DM1, a microtubule inhibitor, via the stable
thioether linker MCC
(4-[N-maleimidomethyl] cyclohexane-1-carboxylate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for concentrate for solution for infusion.
White to off-white lyophilised powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Early Breast Cancer (EBC)
Kadcyla, as a single agent, is indicated for the adjuvant treatment of
adult patients with HER2-positive
early breast cancer who have residual invasive disease, in the breast
and/or lymph nodes, after
neoadjuvant taxane-based and HER2-targeted therapy.
_ _
Metastatic Breast Cancer (MBC)
Kadcyla, as a single agent, is indicated for the treatment of adult
patients with HER2-positive,
unresectable locally advanced or metastatic breast cancer who
previously received trastuzumab and a
taxane, separately or in combination. Patients should have either:
•
Received prior therapy for locally advanced or metastatic disease, or
•
Developed disease recurrence during or with