HERZUMA

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Trastuzumab 440mg

Available from:

Celltrion Healthcare New Zealand Limited

Dosage:

440 mg

Pharmaceutical form:

Powder for infusion concentrate

Composition:

Active: Trastuzumab 440mg Excipient: Histidine Histidine hydrochloride Polysorbate 20 Trehalose dihydrate Benzyl alcohol Water for injection

Prescription type:

Prescription

Therapeutic indications:

Herzuma is indicated for patients with metastatic breast cancer who have tumours that overexpress HER2: - as monotherapy for the treatment of those patients who have received one or more chemotherapy regimens for their metastatic disease; or - in combination with taxanes for the treatment of those patients who have not received chemotherapyfor their metastatic disease; or - in combination with a aromatase inhibitor for the treatment of post-menopausal patients with hormone-receptor positive metastatic breast cancer.

Product summary:

Package - Contents - Shelf Life: Combination pack, 1 vial product, 1 vial diluent - 0.44 g - 72 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 28 days reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) 24 hours diluted stored at 2° to 8°C (Refrigerate, do not freeze) - Vial, glass, Diluent, Type 1, 20mL, with chlorobutyl rubber stopper - 20 mL - 72 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) - Vial, glass, multi-dose, Type 1, 50mL, with chlorobutyl rubber stopper - 0.44 g - 72 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 28 days reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) 24 hours diluted stored at 2° to 8°C (Refrigerate, do not freeze)

Authorization date:

2017-07-12

Patient Information leaflet

Celltrion Healthcare New Zealand Limited
CMI
Trastuzumab 150 mg, 440mg Powder for Injection for IV Infusion
1
CONSUMER MEDICINE INFORMATION
HERZUMA
®
TRASTUZUMAB
150 MG AND 440 MG POWDER FOR INJECTION FOR INTRAVENOUS INFUSION
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about HERZUMA infusion.
It does not contain all the available information.
It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the
risks of you being given
HERZUMA against the
benefits expected for you.
IF YOU HAVE ANY CONCERNS ABOUT BEING GIVEN THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT HERZUMA IS USED FOR
HERZUMA contains the active ingredient trastuzumab.
HERZUMA belongs to a group of medicines known as antineoplastic (or
anti-cancer) agents. There
are many
different classes of antineoplastic agents. HERZUMA belongs to a class
called
monoclonal antibodies.
Monoclonal antibodies are proteins made in a laboratory. These
proteins are designed to recognise
and bind to other
unique proteins in the body.
HERZUMA binds selectively to a protein called human epidermal growth
factor receptor 2 (HER2).
HER2 is found
in large amounts on the surface of some cancer cells. When HERZUMA
binds to
HER2 it stops the growth and
spread of the cancer cells.
HERZUMA is used to treat breast and gastric cancer. It is only used in
patients whose tumours has
tested positive to
HER2.
HERZUMA may be used alone or with other medicines that treat breast
cancer, such as an
aromatase inhibitor
(hormone receptor positive breast cancer) or a taxane (e.g. paclitaxel
or
docetaxel).
For the treatment of gastric cancer, HERZUMA is used with the
chemotherapy medicines cisplatin
and capecitabine
(or 5FU).
For further information about other medicines you are receiving with
HERZUMA, please ask your
doctor, nurse or
pharmacist for the Consumer medicine Information (CMI) leaflet.
ASK YOUR DOCTOR IF YOU HAVE ANY Q

Summary of Product characteristics

1
NEW ZEALAND DATA SHEET
1.
NAME OF MEDICINE
HERZUMA
®
150 mg POWDER FOR INJECTION FOR INTRAVENOUS INFUSION
HERZUMA
®
440 mg POWDER FOR INJECTION FOR INTRAVENOUS INFUSION
Herzuma is a biosimilar medicine.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE INGREDIENT
Trastuzumab.
Dosage Preparations: Herzuma 150 mg single-dose vial contains 150 mg
trastuzumab and Herzuma
440 mg multi-dose vial contains 440 mg trastuzumab as a powder for
injection for intravenous infusion.
Reconstituted Herzuma concentrate contains 21
mg/mL of trastuzumab.
For the full list of excipients, see section 6.1.
The prescribing physician should be involved in any decision regarding
interchangeability (unless the
product is known to be non-interchangeable). Additional information is
available on the following website
(
www.medsafe.govt.nz/profs/RIss/Biosimilars.asp
).
Data
comparing
Herzuma
to
reference
product
(Herceptin
®
) can be found under “5. Pharmacological properties” section of
this datasheet.
Trastuzumab is a recombinant DNA derived humanized monoclonal antibody
that selectively targets the
extracellular domain of the human epidermal growth factor receptor 2
protein (HER2). The antibody is
an IgG1 kappa that contains human framework regions with the
complementarity determining regions of
a murine anti-p185 HER2 antibody that binds to HER2. Trastuzumab is
composed of 1,328 amino acids
and has a molecular weight of ~148 kDa. The humanized antibody against
HER2 is produced by
recombinant mammalian cells (Chinese hamster ovary (rch)) in
suspension culture in a nutrient medium
and purified by affinity chromatography and ion exchange, including
specific viral inactivation and
removal procedures.
3.
PHARMACEUTICAL FORM
Powder for injection for intravenous infusion.
Herzuma is a white to pale yellow lyophilized powder. The Herzuma 440
mg solvent is a clear to slightly
opalescent liquid.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
2
METASTATIC BREAST CANCER
Herzuma is indicated for the treatment of patients with metastatic