Kadcyla

Země: Nový Zéland

Jazyk: angličtina

Zdroj: Medsafe (Medicines Safety Authority)

Aktivní složka:

Trastuzumab emtansine 100mg (plus 6% vial overfill = trastuzumab emtansine 106mg)

Dostupné s:

Roche Products (NZ) Ltd

INN (Mezinárodní Name):

Trastuzumab emtansine 100 mg (plus 6% vial overfill = trastuzumab emtansine 106mg)

Dávkování:

100 mg

Léková forma:

Powder for infusion

Složení:

Active: Trastuzumab emtansine 100mg (plus 6% vial overfill = trastuzumab emtansine 106mg) Excipient: Polysorbate 20 Sodium hydroxide Succinic acid Sucrose

Jednotky v balení:

Vial, glass, single dose, Rubber stopper, 100 mg

Třída:

Prescription

Druh předpisu:

Prescription

Výrobce:

Lonza Ltd

Terapeutické indikace:

Kadcyla as a single agent, is indicated for the treatment of patients with HER2-positive, metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination. Patients should have either: received prior therapy for metastatic disease, or developed disease recurrence during or within six months of completing adjuvant therapy. Kadcyla, as a single agent, is indicated for the adjuvant treatment of patients with HER2-positive early breast cancer who have residual disease after pre-operative systemic treatment that included HER2-targeted therapy.

Přehled produktů:

Package - Contents - Shelf Life: Vial, glass, single dose, Rubber stopper - 100 mg - 48 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 24 hours diluted stored at 2° to 8°C (Refrigerate, do not freeze)

Datum autorizace:

2012-12-12

Informace pro uživatele

Kadcyla20220527
Page 1
NEW ZEALAND CONSUMER MEDICINE INFORMATION
KADCYLA

TRASTUZUMAB EMTANSINE (RCH)
100 MG AND 160 MG POWDER FOR INTRAVENOUS INFUSION
WARNING: DO NOT SUBSTITUTE KADCYLA FOR OR WITH TRASTUZUMAB.
IN ORDER TO PREVENT MEDICATION ERRORS, CHECK THE VIAL LABELS TO ENSURE
THE MEDICINE
BEING PREPARED AND ADMINISTERED IS KADCYLA (TRASTUZUMAB EMTANSINE) AND
NOT
TRASTUZUMAB.
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about Kadcyla.
It does not contain all the available information. It does not take
the place of talking to your
pharmacist or doctor.
All medicines have risks and benefits. Your doctor has weighed the
risks of you taking Kadcyla
against the benefits they expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR
OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT KADCYLA IS USED FOR
Kadcyla contains an active ingredient called trastuzumab emtansine.
Kadcyla belongs to a group of medicines known as anti-neoplastic (or
anti-cancer) agents.
Kadcyla is made up of two substances:
•
trastuzumab - a monoclonal antibody which recognises and attaches to a
protein called human
epidermal growth factor receptor 2 (HER2). HER2 is found in large
amounts on the surface of
some cancer cells. Monoclonal antibodies are proteins made in a
laboratory. These proteins are
designed to recognise and bind to other unique proteins in the body.
•
emtansine - an anti-cancer substance.
Kadcyla is designed to target and deliver the anti-cancer emtansine
directly inside HER2-positive
cancer cells to stop the growth and spread of the cancer cells.
Kadcyla is used to treat the following stages of HER2-positive breast
cancer:
•
early breast cancer following surgery
Kadcyla20220527
Page 2
•
advanced or metastatic breast cancer, i.e. the cancer has spread to
areas near the breast or
to other parts of your body. It is only used in patients whose tumour
has tested positive to
HER2. You may have previously received HER2 targeted therapies.
As

Charakteristika produktu

1
Kadcyla-20230801
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
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
100 mg or 160 mg of Kadcyla powder for concentrate solution, designed
to deliver 5 mL or
8 mL respectively, of 20 mg/mL of trastuzumab emtansine.
Kadcyla (trastuzumab emtansine) is a HER2-targeted antibody-drug
conjugate that contains
the humanised anti-HER2 IgG1, trastuzumab, covalently linked to the
microtubule inhibitory
drug
DM1
(a
maytansine
derivative)
with
the
stable
thioether
linker
MCC
(4-[N-maleimidomethyl] cyclohexane-1-carboxylate). Emtansine refers to
the MCC-DM1
complex. The antibody trastuzumab, is a well characterised recombinant
monoclonal antibody
product produced by mammalian (Chinese hamster ovary) cells, and the
small molecule
components (DM1 and MCC) are produced by chemical synthesis. An
average of 3.5 DM1
molecules are conjugated to each molecule of trastuzumab.
Trastuzumab emtansine has the following chemical structure:
Note: The bracketed structure is DM1 plus MCC which represents the
emtansine component. The n is, on
average, 3.5 DM1 molecules per trastuzumab (Mab) molecule.
For the full list of excipients, see section 6.1.
WARNING: DO NOT SUBSTITUTE KADCYLA FOR OR WITH TRASTUZUMAB
.
In order to prevent medication errors, check the vial labels to ensure
the medicine being
prepared and administered is Kadcyla (trastuzumab emtansine) and not
trastuzumab.
2
Kadcyla-20230801
3.
PHARMACEUTICAL FORM
Powder for concentrate for solution for infusion.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
EARLY BREAST CANCER
Kadcyla, as a single agent, is indicated for the adjuvant treatment of
patients with HER2-
positive early breast cancer who have residual disease after
pre-operative systemic treatment
that included HER2-targeted therapy.
METASTATIC BREAST CANCER
Kadcyla, as a single agent, is indicated for the treatment of patients
with HER2-positive
metastatic brea