MEKTOVI FILM-COATED TABLET 15MG

Ország: Szingapúr

Nyelv: angol

Forrás: HSA (Health Sciences Authority)

Aktív összetevők:

Binimetinib

Beszerezhető a:

PIERRE FABRE SINGAPORE PTE. LTD.

ATC-kód:

L01EE03

Gyógyszerészeti forma:

TABLET, FILM COATED

Összetétel:

Binimetinib 15mg

Az alkalmazás módja:

ORAL

Recept típusa:

Prescription Only

Gyártó:

ALMAC Pharma Services Limited

Engedélyezési státusz:

ACTIVE

Engedély dátuma:

2023-07-19

Termékjellemzők

XXXXX
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This therapeutic product is subject to additional monitoring
in Singapore. This will allow quick identification of new safety
information. Healthcare professionals are asked to report any
suspected adverse events at HSA: Healthcare professionals’ guide
to adverse events reporting.
PRODUCT INFORMATION
1. NAME OF THE MEDICINE
Binimetinib
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each MEKTOVI film-coated tablet contains binimetinib 15mg.
Contains lactose. Contains sugars. For a full list of excipients,
see section 6.1 _List of excipients_.
3. PHARMACEUTICAL FORM
MEKTOVI 15 mg film-coated tablets are yellow/dark yellow,
unscored biconvex, ovaloid film-coated tablets, approximately
12 mm in length and 5 mm in width, with the “A” logo debossed
on one face of the tablet and “15” on the opposing face.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Binimetinib in combination with encorafenib is indicated for
the treatment of adult patients with unresectable or metastatic
melanoma with a BRAF V600E or V600K mutation, as detected
by a validated test.
4.2. DOSE AND METHOD OF ADMINISTRATION
Treatment with binimetinib in combination with encorafenib
should only be initiated and supervised by a physician
experienced in the use of anti-cancer medicines.
DOSAGE
Patients treated with binimetinib in combination with encorafenib
must have their BRAF V600 mutant melanoma status confirmed
by a validated test conducted by an experienced laboratory
(see 5.1 Clinical Trials).
The recommended dose of binimetinib is 45 mg (three 15 mg
tablets) twice daily (corresponding to a total dose of 90 mg),
approximately 12 hours apart, when used in combination with
encorafenib.
ADMINISTRATION
Binimetinib tablets should be swallowed whole with water,
with or without food.
DURATION OF TREATMENT
Treatment should continue until the patient no longer derives
benefit or unacceptable toxicity develops.
MISSED DOSE
If a dose of binimetinib is missed, it should not be taken if it is
less
than 6 hours until the next dose is due.
V