MARGENZA

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

MARGETUXIMAB

Available from:

NEOPHARM LTD, ISRAEL

ATC code:

L01FD06

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

MARGETUXIMAB 25 MG / 1 ML

Administration route:

I.V

Prescription type:

Required

Manufactured by:

MACROGENICS INC., USA

Therapeutic area:

MARGETUXIMAB

Therapeutic indications:

MARGENZA is indicated, in combination with chemotherapy, for the treatment of adult patients with metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease.

Authorization date:

2023-02-23

Patient Information leaflet

PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
1986
-
(MEDICINAL PRODUCTS)
This medicine is dispensed with a doctor's prescription only
MARGENZA 25mg/ml
INTRAVENOUS INJECTION
ACTIVE INGREDIENT: Each 10ml vial contains 250mg margetuximab.
For the list of excipients in the medicinal product, please see
section 6: “Additional information”.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THE MEDICINE.
This leaflet contains
concise information about the medicine. If you have any further
questions, contact the physician or
the pharmacist.
1. WHAT IS THE MEDICINE INTENDED FOR?
MARGENZA is intended, in combination with chemotherapy, for the
treatment of adult
patients with metastatic HER2-positive breast cancer who have received
two or more prior
anti-HER2 regimens, at least one of which was for metastatic disease.
THERAPEUTIC GROUP: antineoplastic agents, monoclonal antibodies
(mAbs).
2. BEFORE USING THIS MEDICINE:
DO NOT USE THE MEDICINE IF:
-
You are hypersensitive (allergic) to the active ingredient or any of
the other ingredients
that this medicine contains (see section 6: “Additional
information”).
SPECIAL WARNINGS REGARDING THE USE OF THIS MEDICINE:
Infusion-Related Reactions (IRRs)
MARGENZA can cause infusion-related reactions (IRRs) (see section 4:
"side effects").
These effects will be monitored during MARGENZA administration and as
clinically indicated after
completion of infusion. Medications and emergency equipment will be
available for immediate use to
treat IRRs. If you experience dyspnea or clinically significant
hypotension, MARGENZA infusion will
be interrupt and medical therapy will be given. Monitoring will occur
until resolution of signs and
symptoms.
If you experience mild or moderate IRRs, premedications will be
considered, including
antihistamines, corticosteroids, and antipyretics, and infusion rate
will be decreased.
Left Ventricular Cardiac Dysfunction
Left ventricular cardiac dysfunction can occur with MARGENZA.
Withholding of treatment with
MARGENZA may be re