BRAFTOVI HARD CAPSULE 50MG

국가: 싱가포르

언어: 영어

출처: HSA (Health Sciences Authority)

유효 성분:

Encorafenib

제공처:

PIERRE FABRE SINGAPORE PTE. LTD.

ATC 코드:

L01EC03

약제 형태:

CAPSULE

구성:

Encorafenib 50mg

관리 경로:

ORAL

처방전 유형:

Prescription Only

Manufactured by:

Catalent Pharma Solutions LLC

승인 상태:

ACTIVE

승인 날짜:

2023-07-19

제품 특성 요약

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
Encorafenib
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each BRAFTOVI 50 mg hard capsule contains encorafenib 50 mg.
Each BRAFTOVI 75 mg hard capsule contains encorafenib 75 mg.
For the list of excipients, see section 6.1 _List of excipients_.
3. PHARMACEUTICAL FORM
BRAFTOVI 50 mg hard capsules
Swedish orange opaque cap and flesh-coloured opaque body, printed with
a stylised “A” on the cap and “LGX 50 mg” on the body. The
length of the capsule
is approximately 22 mm.
BRAFTOVI 75 mg hard capsules
Flesh-coloured opaque cap and white opaque body, printed with a
stylised
“A” on the cap and “LGX 75 mg” on the body. The length of the
capsule is
approximately 23 mm.
4. CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
MELANOMA
Encorafenib, in combination with binimetinib, is indicated for the
treatment
of adult patients who have unresectable or metastatic melanoma with
a _BRAF_ V600E or V600K mutation, as detected by a validated test.
COLORECTAL CANCER
Encorafenib, in combination with cetuximab, is indicated for the
treatment
of adult patients who have metastatic colorectal cancer (mCRC) with
a _BRAF_ V600E mutation as detected by a validated test, and who have
received
prior systemic therapy.
4.2. DOSE AND METHOD OF ADMINISTRATION
Treatment with encorafenib should only be initiated and supervised by
a physician experienced in the use of anti-cancer medicines.
PATIENT SELECTION
Prior to treatment with encorafenib, the _BRAF_ V600 mutation status
of a
patient’s melanoma or colorectal cancer must be confirmed by a
validated test,
conducted by an experienced laboratory (see section 5.1
_Pharmacodynamic _
_properties, Clinical trials_).
The efficacy and safety of encorafenib have only