BRAFTOVI HARD CAPSULE 75MG

Land: Singapore

Sprog: engelsk

Kilde: HSA (Health Sciences Authority)

Aktiv bestanddel:

Encorafenib

Tilgængelig fra:

PIERRE FABRE SINGAPORE PTE. LTD.

ATC-kode:

L01EC03

Lægemiddelform:

CAPSULE

Sammensætning:

Encorafenib 75mg

Indgivelsesvej:

ORAL

Recept type:

Prescription Only

Fremstillet af:

Catalent Pharma Solutions LLC

Autorisation status:

ACTIVE

Autorisation dato:

2023-07-19

Produktets egenskaber

BRAFTOVI – PI January 2024
Page 1 sur 46
▼ 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
BRAFTOVI
®
(encorafenib) capsules
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
BRAFTOVI – PI January 2024
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who have metastatic colorectal cancer (mCRC) with a BRAF V600E
mutation as detected by
a validated test, and who have received prior systemic therapy.
BRAFTOVI – PI January 2024
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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 te