Herceptin

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Trastuzumab 150mg (excludes 4% overage);  ;  ;  

Available from:

Roche Products (NZ) Ltd

INN (International Name):

Trastuzumab 150 mg (excludes 4% overage)

Dosage:

150 mg

Pharmaceutical form:

Powder for infusion concentrate

Composition:

Active: Trastuzumab 150mg (excludes 4% overage)       Excipient: Histidine Histidine hydrochloride monohydrate Polysorbate 20 Trehalose

Units in package:

Vial, glass, single dose, Type I Single use vial, 150 mg

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Roche Singapore Technical Operations

Therapeutic indications:

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

Product summary:

Package - Contents - Shelf Life: Vial, glass, single dose, Type I Single use vial - 150 mg - 48 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze). 48 hours if reconstituted in controlled and validated aseptic conditions

Authorization date:

2001-08-16

Patient Information leaflet

Herceptin IV 200131
1
CONSUMER MEDICINE INFORMATION
HERCEPTIN
®
TRASTUZUMAB
150 MG AND 440 MG POWDER FOR CONCENTRATE, SOLUTION FOR INTRAVENOUS
INFUSION
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about HERCEPTIN 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
HERCEPTIN against the benefits expected for you.
IF YOU HAVE ANY CONCERNS ABOUT BEING GIVEN THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
HERCEPTIN IS ALSO AVAILABLE AS A SUBCUTANEOUS (SC) INJECTION. FOR MORE
INFORMATION ON
HERCEPTIN SC PRODUCT PLEASE REFER TO THE SEPARATE CMI FOR HERCEPTIN SC
OR SPEAK WITH YOUR
DOCTOR OR PHARMACIST
.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT HERCEPTIN IS USED FOR
HERCEPTIN contains the active ingredient trastuzumab.
HERCEPTIN belongs to a group of medicines known as antineoplastic (or
anti-cancer) agents. There
are many different classes of antineoplastic agents. HERCEPTIN 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.
HERCEPTIN 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 HERCEPTIN binds to
HER2 it stops the growth and spread of the cancer cells.
HERCEPTIN is used to treat breast and gastric cancer. It is only used
in patients whose tumours has
tested positive to HER2.
HERCEPTIN 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, HERCEPTIN is used with the
chemotherapy medicines cisplatin
and capecitabine (or 5FU).
Herceptin IV 200131
2
For further information about other med

Summary of Product characteristics

herceptin20210319
1
NEW ZEALAND DATA SHEET
HERCEPTIN (TRASTUZUMAB)
1.
PRODUCT NAME
Herceptin 150 mg powder for concentrate for solution for infusion
Herceptin 440 mg powder for concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Herceptin 150mg vial contains 150mg trastuzumab
Herceptin 440mg vial contains 440mg trastuzumab
For the full list of excipients, see section 6.1.
_Also available in solution for subcutaneous (SC) injection (Herceptin
SC) containing 600 mg/5mL of _
_trastuzumab (see separate Herceptin SC Data Sheet). _
3.
PHARMACEUTICAL FORM
Powder for concentrate for solution for infusion.
White to pale yellow lyophilised powder.
Herceptin 440mg solvent is a clear to slightly opalescent liquid.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
METASTATIC BREAST CANCER
Herceptin is indicated for the treatment of 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 chemotherapy
for their metastatic disease; or
•
in combination with an aromatase inhibitor for the treatment of
post-menopausal patients with
hormone-receptor positive metastatic breast cancer.
EARLY BREAST CANCER
Herceptin is indicated for the treatment of patients with:
•
HER2-positive locally advanced breast cancer in combination with
neoadjuvant chemotherapy,
followed by adjuvant Herceptin; or
•
HER2-positive early breast cancer following surgery, sequentially or
concurrently with chemotherapy
and, if applicable, radiotherapy.
Herceptin should only be used in early breast cancer patients with a
normal left ventricular ejection fraction.
ADVANCED GASTRIC CANCER
Herceptin is indicated in combination with cisplatin and either
capecitabine or 5-FU for the treatment of
patients with HER2 positive advanced adenocarcinoma of the stomach or
gastro-oesophageal ju