PEMAZYRE 9 MG

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

PEMIGATINIB

متاح من:

MEDISON PHARMA LTD

ATC رمز:

L01EX20

الشكل الصيدلاني:

TABLETS

تركيب:

PEMIGATINIB 9 MG

طريقة التعاطي:

PER OS

نوع الوصفة الطبية :

Required

المصنعة من قبل:

INCYTE BIOSCIENCES INTERNATIONAL SÀRL, SWITZERLAND

المجال العلاجي:

PEMIGATINIB

الخصائص العلاجية:

PEMAZYRE is a kinase inhibitor indicated for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as determined by a validated test.

تاريخ الترخيص:

2022-05-31

نشرة المعلومات

Page 1 of 6
PEMAZYRE-PIL-0923-V1
Patient leaflet in accordance with the Pharmacists' Regulations
(Preparations) - 1986
This medicine is dispensed with a doctor’s prescription only
Pemazyre 4.5 mg tablets
Pemazyre 9 mg tablets
Pemazyre 13.5 mg tablets
Active ingredient and its quantity:
Each tablet of Pemazyre 4.5 mg contains 4.5 mg of pemigatinib.
Each tablet of Pemazyre 9 mg contains 9 mg of pemigatinib.
Each tablet of Pemazyre 13.5 mg contains 13.5 mg of pemigatinib.
For inactive and allergenic ingredients in the preparation – see
section 6 “Additional
Information”.
Read the entire leaflet carefully before you start using this
medicine. This leaflet contains
concise information about this medicine.
If you have any further questions, consult your doctor or pharmacist.
This medicine has been prescribed to treat your illness. Do not pass
it on to others. It may harm
them, even if it seems to you that their illness is similar to yours.
1.
What is the medicine intended for?
Pemazyre is indicated to treat adults with bile duct cancer that has
spread
to other parts of the
body or cannot be removed by surgery and after treatment with other
medicine
Pemazyre can only be used if a test has shown that cancer cells have
an abnormal form of the
FGFR2 protein.
Therapeutic group: Antineoplastic agents, tyrosine kinase inhibitors
Pemazyre contains the active substance pemigatinib, which belongs to a
group of cancer drugs
called tyrosine kinase inhibitors. It blocks the action of proteins in
the cell called fibroblast
growth factor receptor types 1,2 and 3 (FGFR1, FGFR2, and FGFR3) which
help regulate cell
growth. Cancer cells may have an abnormal form of this protein. By
blocking FGFR, pemigatinib
can prevent the growth of such cancer cells.
2.
Before using the medicine
Do not use this medicine if:
•
You are sensitive (allergic) to the active substance (pemigatinib) or
to any of the other
ingredients in this medicine (see section 6 "Additional information").
•
You are using St John’s wort (Hypericum), a medicine

خصائص المنتج

1
Physician Prescribing Information
1.
NAME OF THE MEDICINAL PRODUCT
Pemazyre 4.5 mg
Pemazyre 9 mg
Pemazyre 13.5 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Pemazyre 4.5 mg
Each tablet contains 4.5 mg of pemigatinib.
Pemazyre 9 mg
Each tablet contains 9 mg of pemigatinib.
Pemazyre 13.5 mg
Each tablet contains 13.5 mg of pemigatinib.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
Pemazyre 4.5 mg tablets
Round (5.8 mm), white to off-white tablet debossed on one side with
"I" and "4.5" on the reverse.
Pemazyre 9 mg tablets
Oval (10 × 5 mm), white to off-white tablet debossed on one side with
"I" and "9" on the reverse.
Pemazyre 13.5 mg tablets
Round (8.5 mm), white to off-white tablet debossed on one side with
"I" and "13.5" on the reverse.
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
Pemazyre is a kinase inhibitor indicated for the treatment of adults
with previously treated,
unresectable locally advanced or metastatic cholangiocarcinoma with a
fibroblast growth factor
receptor 2 (FGFR2) fusion or other rearrangement as determined by a
validated test.
4.2
Posology and method of administration
Therapy should be initiated by a physician experienced in the
diagnosis and treatment of patients with
biliary tract cancer.
FGFR 2 fusion positivity status must be known prior to initiation of
Pemazyre therapy. Assessment for
FGFR 2 fusion positivity in tumor specimen should be performed with an
appropriate diagnostic test.
2
Posology
The recommended dose is 13.5 mg pemigatinib taken once daily for 14
days followed by 7 days off
therapy.
If a dose of pemigatinib is missed by 4 or more hours or vomiting
occurs after taking a dose, an
additional dose should not be administered and dosing should be
resumed with the next scheduled
dose.
Treatment should be continued as long as the patient does not show
evidence of disease progression or
unacceptable toxicity.
During the use of this medicine phosphate levels should be monitored
in accordance with physician’s
clinical consideration.
In