KADCYLA trastuzumab emtansine (rch) 100 mg powder for injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Trastuzumab emtansine, Quantity: 106 mg

Available from:

Roche Products Pty Ltd

INN (International Name):

Trastuzumab emtansine

Pharmaceutical form:

Injection, powder for

Composition:

Excipient Ingredients: sucrose; polysorbate 20; succinic acid; sodium hydroxide

Administration route:

Intravenous Infusion

Units in package:

1 vial

Prescription type:

(S4) Prescription Only Medicine

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 invasive disease after neoadjuvant taxane and trastuzumab-based treatment.,Metastatic Breast Cancer,Kadcyla, as a single agent, is indicated for the treatment of patients with HER2-positive metastatic (Stage IV) 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.

Product summary:

Visual Identification: white to off-white, lyophilized cake; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 48 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2013-09-03

Patient Information leaflet

KADCYLA
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CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
WARNING: Important safety information is provided in a boxed warning
in the full CMI. Read before using this medicine.
1.
WHY AM I USING KADCYLA?
Kadcyla contains the active ingredient trastuzumab emtansine (rch).
Kadcyla is used to treat early HER2-positive breast cancer
following surgery and advanced or metastatic HER2-positive breast
cancer, i.e. the cancer has spread to areas near the breast or to
other parts of your body. For more information, see Section 1. Why am
I using Kadcyla? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE KADCYLA?
Do not use if you have ever had an allergic reaction to trastuzumab
emtansine or any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2.
What should I know before I use Kadcyla? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Kadcyla and affect how it works. A
list of these medicines is in Section 3. What if I am taking
other medicines? in the full CMI.
4.
HOW IS KADCYLA GIVEN?
Kadcyla is given by a slow drip into a vein (intravenous (IV)
infusion) by a doctor or nurse once every three weeks. The first
infusion
will be over 90 minutes. If the first infusion is well tolerated, your
drip time may be shortened to 30 minutes. More instructions can be
found in Section 4. How is Kadcyla given? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING KADCYLA?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are
receiving Kadcyla. Be sure to keep all of
your appointments with your doctor so that your progress can be
checked.
THINGS YOU
SHOULD NOT DO
•
Do not stop using this medicine without speaking to your

Summary of Product characteristics

Kadcyla20220718
1
AUSTRALIAN PRODUCT INFORMATION
KADCYLA
® (TRASTUZUMAB EMTANSINE)
1.
NAME OF THE MEDICINE
trastuzumab emtansine
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Kadcyla is available as a single-use vial containing 100 mg or 160 mg
of trastuzumab
emtansine.
For the full list of excipients,
_see section 6.1 List of excipients_
.
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
Kadcyla, as a single agent, is indicated for the adjuvant treatment of
patients with HER2-
positive early breast cancer who have residual invasive disease after
neoadjuvant taxane and
trastuzumab-based treatment.
METASTATIC BREAST CANCER
Kadcyla, as a single agent, is indicated for the treatment of patients
with HER2-positive
metastatic (Stage IV) 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.
4.2
DOSE AND METHOD OF ADMINISTRATION
Patients treated with Kadcyla should have HER2 positive tumour status,
defined as a score of
3+ by immunohistochemistry (IHC) or a ratio of ≥ 2.0 by in situ
hybridization (ISH) assessed
by a validated test.
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.
Kadcyla20220718
2
Kadcyla therapy should only be administered under the supervision of a
healthcare professional
experienced in the treatment of cancer patients.
IN ORDER TO PREVENT MEDICATION ERRORS, IT IS IMPORTANT TO CHECK THE
VIAL LABELS TO ENSURE
THE MEDICINE BEING PREPARED AND ADMINISTERED IS KADCYLA (TRASTUZUMAB
EMTANSINE) AND
NOT TRASTUZUMAB.
In order to improve traceability of biological medicinal products, the