MEKINIST FILM-COATED TABLETS 0.5MG

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Trametinib Dimethyl Sulfoxide 0.5635mg eqv trametinib

Available from:

NOVARTIS (SINGAPORE) PTE LTD

ATC code:

L01EE01

Pharmaceutical form:

TABLET, FILM COATED

Composition:

Trametinib Dimethyl Sulfoxide 0.5635mg eqv trametinib 0.5mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

GlaxoSmithKline Manufacturing SpA

Authorization status:

ACTIVE

Authorization date:

2017-02-27

Summary of Product characteristics

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Page 1 of 46
1
TRADENAME
MEKINIST
®
0.5 mg and 2 mg film-coated tablets.
2
DESCRIPTION AND COMPOSITION
PHARMACEUTICAL FORM
0.5 MG FILM-COATED TABLETS
Yellow, modified oval, biconvex, film-coated tablets with ‘GS’
debossed on one face and ‘TFC’
on the opposing face.
Yellow, ovaloid, biconvex, unscored film-coated tablets with beveled
edges and with the
Novartis logo debossed on one side and ‘TT’ on the other side.
2 MG FILM-COATED TABLETS
Pink, round, biconvex, film-coated tablets with ‘GS’ debossed on
one face and ‘HMJ’ on the
opposing face.
Pink, round, biconvex, unscored film-coated tablets with beveled edges
and with the Novartis
logo debossed on one side and ‘LL’ on the other side.
Certain dosage strengths and dosage forms may not be available in all
countries.
ACTIVE SUBSTANCE
0.5 MG FILM-COATED TABLETS
Each film-coated tablet contains trametinib-dimethylsulfoxide (1:1)
equivalent to 0.5 mg
trametinib.
2 MG FILM-COATED TABLETS
Each
film-coated
tablet
contains
trametinib-dimethylsulfoxide
(1:1)
equivalent
to
2
mg
trametinib.
EXCIPIENTS
TABLET CORE:
mannitol, microcrystalline cellulose, hypromellose, croscarmellose
sodium,
magnesium stearate (vegetable source), sodium laurylsulfate, colloidal
silicon dioxide.
TABLET FILM COATING:
hypromellose, titanium dioxide, polyethylene glycol, iron oxide yellow
(for 0.5 mg tablets), polysorbate 80 and iron oxide red (for 2 mg
tablets).
Pharmaceutical formulations may vary between countries.
3
INDICATIONS
UNRESECTABLE OR METASTATIC MELANOMA
Trametinib as monotherapy or in combination with dabrafenib is
indicated for the treatment of
adult patients with unresectable or metastatic melanoma with a BRAF
V600 mutation (
_see _
_section 6 Warnings and Precautions and section 12 Clinical studies_
).
Trametinib monotherapy has not demonstrated clinical activity in
patients who have progressed
on a prior BRAF inhibitor therapy
_(see section 12 Clinical studies)_
.
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ADJUVANT TREATMENT OF MELANOMA
Tramet