ALECENSA HARD CAPSULE 150MG

Страна: Сінгапур

мова: англійська

Джерело: HSA (Health Sciences Authority)

Активний інгредієнт:

Alectinib Hydrochloride 161.33 mg eqv. Alectinib

Доступна з:

ROCHE SINGAPORE PTE. LTD.

Код атс:

L01XE36

Фармацевтична форма:

CAPSULE

Склад:

Alectinib Hydrochloride 161.33 mg eqv. Alectinib 150 mg

Адміністрація маршрут:

ORAL

Тип рецепту:

Prescription Only

Виробник:

Excella GmbH & Co. KG.

Статус Авторизація:

ACTIVE

Дата Авторизація:

2017-04-24

Характеристики продукта

CAP-ALE-2022 01
ALECENSA
®
Alectinib
1. DESCRIPTION
1.1 THERAPEUTIC / PHARMACOLOGIC CLASS OF DRUG
Antineoplastic agent, protein kinase inhibitor
ATC code: L01ED03
1.2 TYPE OF DOSAGE FORM
Alectinib hard capsules, 150 mg are white, Size 1 capsules with
“ALE”
printed in black ink on the cap and “150 mg” printed in black ink
on the
body.
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:
_Capsule content:_
lactose monohydrate, hydroxypropylcellulose, sodium
lauryl sulfate, magnesium stearate, carboxymethylcellulose calcium
_Capsule shell_
: hypromellose, carrageenan, potassium chloride, titanium
dioxide (E171), corn starch, carnauba wax
_Printing ink:_
red iron oxide (E172), yellow iron oxide (E172), FD&C
Blue No. 2, aluminum lake (E132), carnauba wax, white shellac,
glyceryl
monooleate, 1-butanol, dehydrated ethyl alcohol
2. CLINICAL PARTICULARS
2.1 THERAPEUTIC INDICATION
Alecensa
is
indicated
for
the
first-line
treatment
of
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 ALK-positive,
locally advanced or metastatic NSCLC who have progressed on or are
intolerant to crizotinib.
2.2 DOSAGE AND ADMINISTRATION
GENERAL
A validated ALK assay 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. Capsules should be
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