BRAFTOVI encorafenib 75 mg capsule blister pack

Country: Ástralía

Tungumál: enska

Heimild: Department of Health (Therapeutic Goods Administration)

Virkt innihaldsefni:

encorafenib, Quantity: 75 mg

Fáanlegur frá:

Pierre Fabre Australia Pty Ltd

Lyfjaform:

Capsule, hard

Samsetning:

Excipient Ingredients: magnesium stearate; copovidone; iron oxide black; Gelatin; iron oxide red; iron oxide yellow; poloxamer; titanium dioxide; crospovidone; colloidal anhydrous silica; microcrystalline cellulose; succinic acid

Stjórnsýsluleið:

Oral

Einingar í pakka:

42

Gerð lyfseðils:

(S4) Prescription Only Medicine

Ábendingar:

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.

Vörulýsing:

Visual Identification: 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.; Container Type: Blister Pack; Container Material: Other composite material; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Leyfisstaða:

Registered

Leyfisdagur:

2019-01-03

Upplýsingar fylgiseðill

BRAFTOVI
®
B
R
A
F
T
O
V
I
®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
▼
This medicine is new or being used differently. Please report side
effects. See the full CMI for further details.
1.
WHY AM I TAKING BRAFTOVI?
BRAFTOVI contains the active ingredient encorafenib. BRAFTOVI can be
used:
•
in combination with a medicine called binimetinib (MEKTOVI
®
) to treat adult patients with a type of skin cancer called melanoma,
which has spread to other parts of the body, or cannot be removed by
surgery; or
•
in combination with a medicine called cetuximab to treat adults with
cancer of the large intestine (colorectal cancer) that has
been previously treated with other anticancer medicines.
For more information, see Section 1. Why am I using BRAFTOVI? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE BRAFTOVI?
Do not use if you have ever had an allergic reaction to Braftovi or
any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2.
What should I know before I use BRAFTOVI? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with BRAFTOVI and affect how it works. A
list of these medicines is in Section 3. What if I am taking
other medicines? in the full CMI.
4.
HOW DO I USE BRAFTOVI?
•
Melanoma - The recommended dose of BRAFTOVI, when taken in combination
with MEKTOVI, is six 75 mg capsules once
daily (corresponding to a daily dose of 450 mg).
•
Colorectal cancer - The recommended dose of BRAFTOVI, when taken in
combination with cetuximab is four 75 mg capsules
once daily (corresponding to a daily dose of 300 mg).
•
Swallow the capsules whole with a full glass of water. BRAFTOVI can be
taken with or without food. Avoid grapefruit juice.
More instructions can

Vara einkenni

BRAFTOVI – PI 22 November 2021
Page 1 of 44
▼ This medicinal product is subject to additional monitoring in
Australia. This will allow
quick identification of new safety information. Healthcare
professionals are asked to report
any suspected adverse events at www.tga.gov.au/reporting-problems.
AUSTRALIAN 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
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 22 November 2021
Page 2 of 44
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 sect