HERCEPTIN SC 600 mg INFUSION (PARENTERAL)

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

Roche Products (Pty) Ltd

Dosage:

See ingredients

Pharmaceutical form:

INFUSION (PARENTERAL)

Composition:

EACH 5,0 ml SOLUTION CONTAINS TRASTUZUMAB 600,0 mg

Authorization status:

Registered

Authorization date:

2018-08-04

Patient Information leaflet

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_Page 1 of 7 _ PATIENT INFORMATION LEAFLET
SCHEDULING STATUS
S4
PROPRIETARY NAME, STRENGTH AND PHARMACEUTICAL FORM
HERCEPTIN
® 21 MG/ML IV Infusion
BACTERIOSTATIC WATER FOR INJECTION FOR HERCEPTIN
® Diluent for injection
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START RECEIVING
HERCEPTIN 21 MG/ML IV
-
Keep this leaflet. You may need to read it again.
-
If you have further questions, please ask your doctor or your
pharmacist.
-
Herceptin 21 mg/ml IV has been prescribed for you personally and you
should not share
your medicine with other people. It may harm them, even if their
symptoms are the same
as yours.
WHAT HERCEPTIN 21 MG/ML IV CONTAINS
Herceptin 21 mg/ml IV contains 21 mg trastuzumab per ml.
Herceptin 21 mg/ml IV contains the excipients αα-trehalose,
l-histadine, polysorbate 20 and
water for injection.
Bacteriostatic Water for Injection for Herceptin: The solvent for
reconstitution of Herceptin 21
mg/ml IV, contains bacteriostatic water with 1,1 % m/v benzyl alcohol,
as preservative.
WHAT HERCEPTIN 21 MG/ML IV IS USED FOR
Herceptin 21 mg/ml IV contains the active substance trastuzumab, which
is a humanised
monoclonal antibody.
Herceptin 21 mg/ml IV is used for the treatment of breast and gastric
cancer if you have high
levels of a protein called HER2 and your chemotherapy is finished.
IF YOU HAVE METASTATIC BREAST CANCER (MBC), HERCEPTIN 21 MG/ML IV IS
INDICATED:

As monotherapy if you have received at least two chemotherapy regimens
for your
metastatic disease.

In combination with paclitaxel or docetaxel if you have not received
chemotherapy for your
metastatic disease.

in
combination
with
an
aromatase
inhibitor
if
you
have
hormone-receptor
positive
metastatic breast cancer.
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_Page 2 of 7 _
IF YOU HAVE EARLY BREAST CANCER (EBC), HERCEPTIN 21 MG/ML IV IS
INDICATED:

following
surgery,
chemotherapy
(neoadjuvant
or
adjuvant)
and
radiotherapy
(if
applicable); and

in combination with adjuvant chemotherapy consisting of docetaxel and
carboplatin.

In combinatio

Summary of Product characteristics

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_Page 1 of 23 _
WARNINGS
CARDIOMYOPATHY: Herceptin 21 mg/ml IV administration can result in the
development
of ventricular dysfunction and congestive heart failure. Left
ventricular function should be
evaluated in all patients prior to and during treatment with Herceptin
21 mg/ml IV.
Discontinuation of Herceptin 21 mg/ml IV treatment should be strongly
considered in
patients who develop a clinically significant decrease in left
ventricular function. The
incidence and severity of cardiac dysfunction was particularly high in
patients who
received
Herceptin
21
mg/ml
IV
in
combination
with
anthracyclines
and
cyclophosphamide (see WARNINGS AND SPECIAL PRECAUTIONS).
HYPERSENSITIVITY REACTIONS INCLUDING ANAPHYLAXIS, INFUSION REACTIONS,
PULMONARY
EVENTS.
Herceptin 21 mg/ml IV administration can result in severe
hypersensitivity reactions
(including anaphylaxis), infusion reactions and pulmonary events.
These may be fatal. In
most cases, symptoms occurred during or within 24 hours of
administration of Herceptin
21
mg/ml
IV.
Herceptin
21
mg/ml
IV
infusion
should
be
interrupted
for
patients
experiencing dyspnoea or clinically significant hypotension. Patients
should be monitored
until signs and symptoms completely resolve. Discontinuation of
Herceptin 21 mg/ml IV
should be strongly considered for patients who develop anaphylaxis,
angioedema, or acute
respiratory distress syndrome (see WARNINGS AND SPECIAL PRECAUTIONS).
SCHEDULING STATUS
S4
PROPRIETARY NAME AND DOSAGE FORM
HERCEPTIN
® 21 MG/ML IV Infusion
BACTERIOSTATIC WATER FOR INJECTION FOR HERCEPTIN
® Diluent for injection
COMPOSITION
Herceptin 21 mg/ml IV: Each multidose vial contains 440 mg of
trastuzumab. Reconstituted
Herceptin 21 mg/ml IV concentrate contains 21 mg/mℓ trastuzumab.
Excipients: α,α-trehalose, l-histidine, polysorbate 20, water for
injection.
Bacteriostatic Water for Injection for Herceptin: Each vial contains
20 mℓ sterile bacteriostatic
water for injection with 1,1 % m/v benzyl alcohol as preservative.
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_Page 2 of 23 _