MEKTOVI 15 MG

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

BINIMETINIB

متاح من:

MEDISON PHARMA LTD

ATC رمز:

L01XE41

الشكل الصيدلاني:

FILM COATED TABLETS

تركيب:

BINIMETINIB 15 MG

طريقة التعاطي:

PER OS

نوع الوصفة الطبية :

Required

المصنعة من قبل:

ARRAY BIOPHARMA INC, USA

المجال العلاجي:

BINIMETINIB

الخصائص العلاجية:

Binimetinib is a kinase inhibitor indicated, in combination with encorafenib, for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation

تاريخ الترخيص:

2021-06-24

نشرة المعلومات

MEKT-PIL-1221-V1
1
Mektovi-15mg-11_2021-PIL-ENG-D9-F
Patient leaflet in accordance with the Pharmacists' Regulations
(Preparations) -
1986
This medicine is dispensed with a doctor's prescription only
Mektovi 15 mg
Film-coated tablets
Active ingredient: Each film-coated tablet contains 15 mg binimetinib
Inactive ingredients and allergens: see section 2 ‘Important
information about some of this
medicine’s ingredients’, and 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?
Mektovi (binimetinib) is a kinase inhibitor indicated, in combination
with encorafenib, for the treatment
of adult patients with metastatic or unresectable melanoma with a BRAF
V600E or V600K mutation.
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 Mektovi is right
for you. See the ‘Tests and follow-up’ section.
Do not use this medicine if:
You are sensitive (allergic) to binimetinib or to any of the other
ingredients in this
medicine (see section 6).
Special warnings about using this medicine
Before taking Mektovi, tell your doctor about all of your medical
problems, including if:

you have heart problems

you have had blood clots

you have bleeding problems

you have eye problems

you have muscle problems

you have high blood pressure

you have lung or breathing problems

you have liver or kidney problems

you are pregnant or plan to become pregnant. Mektovi can harm your
unborn baby
(see section ‘Pregnancy and breastfeeding’).

you are breastfeeding or plan to breastfeed (see

خصائص المنتج

MEKT-SPC-0521-V1
PHYSICIAN PRESCRIBING INFORMATION
NAME OF THE MEDICINAL PRODUCT
MEKTOVI 15 MG
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 15 mg of binimetinib.
For the full list of excipients,
_see Description (11)_
.
PHARMACEUTICAL FORM
Film-coated tablet
1
THERAPEUTIC INDICATIONS
Binimetinib is a kinase inhibitor indicated, in combination with
encorafenib, for the treatment of adult
patients with unresectable or metastatic melanoma with a BRAF V600E or
V600K mutation
_[see Dosage _
_and Administration (2.1)]_
.
2
DOSAGE AND ADMINISTRATION
2.1
PATIENT SELECTION
Confirm the presence of a BRAF V600E or V600K mutation in tumor
specimens prior to initiating
MEKTOVI
_[Clinical Studies (14)]_
.
2.2
RECOMMENDED DOSAGE
The recommended dosage of MEKTOVI is 45 mg orally taken twice daily,
approximately 12 hours apart, in
combination with encorafenib until disease progression or unacceptable
toxicity. Refer to the encorafenib
prescribing information for recommended encorafenib dosing
information.
MEKTOVI may be taken with or without food
_[see Clinical Pharmacology (12.3)]_
. Do not take a missed
dose of MEKTOVI within 6 hours of the next dose of MEKTOVI.
Do not take an additional dose if vomiting occurs after MEKTOVI
administration but continue with the next
scheduled dose.
2.3
DOSAGE MODIFICATIONS FOR ADVERSE REACTIONS
If encorafenib is permanently discontinued, discontinue MEKTOVI.
Dose reductions for adverse reactions associated with MEKTOVI are
presented in Table 1.
TABLE 1:
RECOMMENDED DOSE REDUCTIONS FOR MEKTOVI FOR ADVERSE REACTIONS
ACTION
RECOMMENDED DOSE
First Dose Reduction
30 mg orally twice daily
Subsequent Modification
Permanently discontinue if unable to tolerate MEKTOVI 30 mg orally
twice daily
Dosage modifications for adverse reactions associated with MEKTOVI are
presented in Table 2.
TABLE 2:
RECOMMENDED DOSAGE MODIFICATIONS FOR MEKTOVI FOR ADVERSE REACTIONS
SEVERITY OF ADVERSE REACTION
A
DOSE MODIFICATION FOR MEKTOVI
_Cardiomyopathy [see Warnings and Precautions (5.1)] _
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