ENHERTU

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

TRASTUZUMAB DERUXTECAN

متاح من:

ASTRAZENECA (ISRAEL) LTD

ATC رمز:

L01XC03

الشكل الصيدلاني:

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

تركيب:

TRASTUZUMAB DERUXTECAN 100 MG

طريقة التعاطي:

I.V

نوع الوصفة الطبية :

Required

المصنعة من قبل:

DAIICHI SANKYO EUROPE GMBH, GERMANY

المجال العلاجي:

TRASTUZUMAB

الخصائص العلاجية:

HER2-Positive Metastatic Breast CancerENHERTU is indicated for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received a prior anti-HER2-based regimen either:• in the metastatic setting, or• in the neoadjuvant or adjuvant setting and have developed disease recurrence during or within six months of completing therapy.HER2-Low Metastatic Breast CancerENHERTU is indicated for the treatment of adult patients with unresectable or metastatic HER2-low (IHC 1+ orIHC 2+/ISH-) breast cancer who have received a prior chemotherapy in the metastatic setting or developed diseaserecurrence during or within 6 months of completing adjuvant chemotherapyUnresectable or Metastatic HER2-Mutant Non-Small Cell Lung CancerENHERTU is indicated for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, as detected by an approved test, and who have received a prior systemic therapy. Locally Advanced or Metastatic Gastric CancerENHERTU is indicated for the treatment of adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen.

تاريخ الترخيص:

2021-06-30

نشرة المعلومات

PATIENT PACKAGE INSERT IN ACCORDANCE WITH
THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986
This medicine is dispensed with a doctor’s prescription only
Enhertu
®
Powder for concentrate for solution for infusion
Each vial contains:
Trastuzumab Deruxtecan 100 mg
For inactive ingredients in the medicine - please see section 6
“Further Information”.
Read this leaflet carefully in its entirety before using the medicine.
This leaflet contains
concise information about the medicine. If you have any further
questions, ask the doctor
or pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may harm
them, even if it seems to you that their ailment is similar.
In addition to the leaflet, a Patient Safety Information Card is
available for Enhertu. This
card contains important safety information which you must know prior
to starting
treatment and during the treatment with Enhertu and follow it. Read
the Patient Safety
Information Card and the Patient Leaflet prior to starting treatment
with the medicinal
product. Keep the card for further reading if required.
1.
WHAT THE MEDICINE INTENDED FOR?
•
HER2-Positive Metastatic Breast Cancer
Enhertu is indicated for the treatment of adult patients with
unresectable or metastatic HER2-
positive breast cancer who have received a prior anti-HER2-based
regimen either:
•
in the metastatic setting,
or
•
in the neoadjuvant or adjuvant setting and have developed disease
recurrence during or within
six months of completing therapy.
•
HER2-Low Metastatic Breast Cancer
ENHERTU is indicated for the treatment of adult patients with
unresectable or metastatic HER2-
low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received a prior
chemotherapy in the
metastatic setting or developed disease recurrence during or within 6
months of completing
adjuvant chemotherapy
•
Unresectable or Metastatic HER2-Mutant Non-Small Cell Lung Cancer
ENHERTU is indicated for the treatment of adult patients with
unresectable or metastatic non-
small cell lung cancer

خصائص المنتج

1
FULL PRESCRIBING INFORMATION
1. NAME OF THE MEDICINAL PRODUCT
Enhertu
®
QUALITATIVE AND QUANTITATIVE COMPOSITION
One vial of powder for concentrate for solution for infusion contains
100 mg of trastuzumab deruxtecan. After
reconstitution, one vial of 5 mL solution contains 20 mg/mL of
trastuzumab deruxtecan (see section 11).
Trastuzumab deruxtecan is an antibody-drug conjugate (ADC) that
contains a humanised anti-HER2 IgG1 monoclonal
antibody (mAb) with the same amino acid sequence as trastuzumab,
produced by mammalian (Chinese Hamster
Ovary) cells, covalently linked to DXd, an exatecan derivative and a
topoisomerase I inhibitor, via a tetrapeptide-
based cleavable linker. Approximately 8 molecules of deruxtecan are
attached to each antibody molecule. For the
full list of excipients, see section 11.
PHARMACEUTICAL FORM
Powder for concentrate for solution for infusion
For the full list of excipients, see section 11.
Patient safety information Card
The marketing of Enhertu is subject to a risk management plan (RMP)
including a "patient safety information
card". The patient safety information card, emphasizes important
safety information that the patient should
be aware of before and during treatment. Please explain to the patient
the need to review the card before
starting treatment
WARNING: INTERSTITIAL LUNG DISEASE and EMBRYO-FETAL TOXICITY
•
Interstitial Lung Disease (ILD) and pneumonitis, including fatal
cases, have been reported with ENHERTU.
Monitor for and promptly investigate signs and symptoms including
cough, dyspnea, fever, and other new
or worsening respiratory symptoms. Permanently discontinue ENHERTU in
all patients with Grade 2 or
higher ILD/pneumonitis. Advise patients of the risk and the need to
immediately report symptoms _[see _
_Dosage and Administration (_
3
_), Warnings and Precautions (6.1)]_.
•
Embryo-Fetal Toxicity: Exposure to ENHERTU during pregnancy can cause
embryo-fetal harm. Advise
patients of these risks and the need for effective contraception _[see
Warnings and Precautions (