ALECENSA

País: Indonésia

Língua: indonésio

Origem: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Ingredientes ativos:

ALECTINIB HYDROCHLORIDE

Disponível em:

MENARINI INDRIA LABORATORIES - Indonesia

DCI (Denominação Comum Internacional):

ALECTINIB HYDROCHLORIDE

Dosagem:

161,33 MG

Forma farmacêutica:

KAPSUL

Unidades em pacote:

DUS, 4 DUS @ 7 BLISTER @ 8 KAPSUL

Fabricado por:

EXCELLA GMBH & CO. KG - Federal Republic of Germany

Data de autorização:

2021-12-23

Características técnicas

_ _
________________________________________________________________
ALECENSA
Alectinib
______________________________________________ ______
1.
DESCRIPTION
1.1
THERAPEUTIC/PHARMACOLOGIC CLASS OF DRUG
Antineoplastic agent, protein kinase inhibitor
ATC Code: L01XE36
1.2
TYPE OF DOSAGE FORM
Hard capsule
1.3
ROUTE OF ADMINISTRATION
Oral
1.4
STERILE/RADIOACTIVE STATEMENT
Not applicable
1.5
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient: Alectinib
Each
hard
capsule
contains:
Alectinib
150
mg
(equivalent
to
161.3
mg
alectinib
hydrochloride).
Excipients:_ _
Lactose
monohydrate,
hydroxypropylcellulose,
sodium
lauryl
sulphate,
carboxymethylcellulose calcium, magnesium stearate.
2.
CLINICAL PARTICULARS
2.1
THERAPEUTIC INDICATION(S)
Alecensa is indicated for treatment naive patients with anaplastic
lymphoma kinase (ALK)-
positive locally advanced or metastatic non-small cell lung cancer
(NSCLC).
Alecensa is indicated for the treatment of patients with anaplastic
lymphoma kinase
(ALK)-positive, locally advanced (not amenable to curative therapy) or
metastatic non-
small cell lung cancer (NSCLC) who have progressed on or are
intolerant to crizotinib.
2.2
DOSAGE AND ADMINISTRATION
GENERAL
DISETUJUI OLEH BPOM : 28/11/2021
EREG100364VR12000375 - EREG100364VR12000376
_ _
A validated ALK assay such as immunohistochemistry or FISH test is
required for the
selection of ALK-positive NSCLC patients. ALK-positive NSCLC status
should be
established prior to initiation of Alecensa therapy.
Alecensa hard capsules should be taken with food, swallowed whole and
must not be
opened or dissolved.
The recommended dose of Alecensa is 600 mg (four 150 mg capsules)
given orally, twice
daily (total daily dose of 1200 mg) (see section_ 3.2 Pharmacokinetic
Properties_).
Patients with underlying severe hepatic impairment should receive a
dose of 450 mg given
orally twice daily (total daily dose of 900 mg) (see sections
_2.2.1 Special Dosage _
_Instructions_ and _3.2.5 Pharmacokinetics in Special Populations_).
DURATION OF TREATMENT
It is r