BRAFTOVI 75 MG

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

ENCORAFENIB

متاح من:

MEDISON PHARMA LTD

ATC رمز:

L01XE46

الشكل الصيدلاني:

HARD GELATIN CAPSULES

تركيب:

ENCORAFENIB 75 MG

طريقة التعاطي:

PER OS

نوع الوصفة الطبية :

Required

المصنعة من قبل:

ARRAY BIOPHARMA INC, USA

المجال العلاجي:

ENCORAFENIB

الخصائص العلاجية:

BRAF V600E or V600K Mutation-Positive Unresectable or Metastatic MelanomaEncorafenib is a kinase inhibitor indicated, in combination with binimetinib, for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation .BRAF V600E Mutation-Positive Metastatic Colorectal Cancer (CRC)Encorafenib is indicated in combination with cetuximab, for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, as detected by an approved test after prior therapy.

تاريخ الترخيص:

2021-07-01

نشرة المعلومات

1
BRAF-PIL-0522-V1
Braftovi-75mg_11-2021-ENG-D10-F
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) -
1986
THIS MEDICINE IS DISPENSED WITH A DOCTOR'S PRESCRIPTION ONLY
BRAFTOVI 75 MG
CAPSULES
ACTIVE INGREDIENT: encorafenib 75 mg
INACTIVE INGREDIENTS AND ALLERGENS: 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 THIS MEDICINE INTENDED FOR?
Braftovi (encorafenib) is a kinase inhibitor indicated for use:
•
in combination with binimetinib, for the treatment of adult patients
with unresectable or
metastatic melanoma with a BRAF V600E or V600K mutation.
•
In combination with cetuximab, for the treatment of adult patients
with metastatic
colorectal cancer with a BRAF V600E mutation, as detected by an
approved test
after prior therapy.
THERAPEUTIC GROUP: antineoplastic agents, protein kinase inhibitors.
2.
BEFORE USING THIS MEDICINE
Before beginning the treatment, your doctor will perform a test to
make sure that Braftovi
is right for you.
For women who are of childbearing age - your doctor will do a
pregnancy test before you
start treatment.
DO NOT USE THIS MEDICINE IF:
You are sensitive (allergic) to encorafenib or to any of the other
ingredients in this
medicine (see section 6).
SPECIAL WARNINGS ABOUT USING THIS MEDICINE
•
Braftovi is not intended for treatment of wild-type BRAF melanoma or
wild-type BRAF
colorectal cancer.
•
New primary malignancies
•
Tumor promotion in BRAF wild-type tumors
•
Increased risk of appearance of skin side effects, when Braftovi is
administered
as monotherapy
BEFORE TAKING BRAFTOVI, TELL YOUR DOCTOR ABOUT ALL OF YOUR MEDICAL
PROBLEMS,
INCLUDING IF:
-
you have had bleeding pr

خصائص المنتج

BRAF-SPC-1123-V1
PHYSICIAN PRESCRIBING INFORMATION
NAME OF THE MEDICINAL PRODUCT
BRAFTOVI 75 MG
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 75 mg of encorafenib
For the full list of excipients,
_see Description (10)_
.
PHARMACEUTICAL
FORM
Hard capsule
1
THERAPEUTIC INDICATIONS
1.1
BRAF V600E or V600K Mutation-Positive Unresectable or Metastatic
Melanoma
BRAFTOVI
®
- encorafenib is a kinase inhibitor indicated, in combination with
binimetinib, for the
treatment of adult patients with unresectable or metastatic melanoma
with a BRAF V600E or V600K
mutation _[see Dosage and Administration (2.1)]_.
1.2
BRAF V600E Mutation-Positive Metastatic Colorectal Cancer (CRC)
BRAFTOVI
®
- encorafenib is indicated, in combination with cetuximab, for the
treatment of adult patients
with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, as
detected by an -approved test,
after prior therapy _[see Dosage and Administration (2.1)]_.
1.3
Limitations of Use
BRAFTOVI is not indicated for treatment of patients with wild-type
BRAF melanoma or wild-type BRAF
CRC _[see Warnings and Precautions (5.2)]_.
2
DOSAGE AND ADMINISTRATION
2.1
Patient Selection
BRAF V600E or V600K Mutation-Positive Unresectable or Metastatic
Melanoma
Confirm the presence of a BRAF V600E or V600K mutation in tumor
specimens prior to initiating
BRAFTOVI _[see Warnings and Precautions (5.2), Clinical Studies
(13.1)]_.
BRAF V600E Mutation-Positive Metastatic Colorectal Cancer (CRC)
Confirm the presence of a BRAF V600E mutation in tumor specimens prior
to initiating BRAFTOVI _[see _
_Warnings and Precautions (5.2), Clinical Studies (13.2))]_
2.2
Recommended Dosage for BRAF V600E or V600K Mutation-Positive
Unresectable or Metastatic
Melanoma
The recommended dosage of BRAFTOVI is 450 mg (six 75 mg capsules)
orally once daily in combination
with binimetinib until disease progression or unacceptable toxicity.
Refer to the binimetinib prescribing
information for recommended binimetinib dosing information.
2.3
Recommended Dosage for BRAF V6