ZYKADIA CAPSULE 150mg

国: シンガポール

言語: 英語

ソース: HSA (Health Sciences Authority)

有効成分:

Ceritinib

から入手可能:

NOVARTIS (SINGAPORE) PTE LTD

ATCコード:

Pending

医薬品形態:

CAPSULE

構図:

Ceritinib 150.00mg

投与経路:

ORAL

処方タイプ:

Prescription Only

製:

Novartis Pharma Stein AG

認証ステータス:

ACTIVE

承認日:

2015-04-24

製品の特徴

ZYKADIA
®
Protein kinase inhibitors
DESCRIPTION AND COMPOSITION
PHARMACEUTICAL FORM
Hard gelatin capsules
150 mg: Size #00 hard gelatin capsule with blue opaque cap with black
imprint “LDK 150MG”
and white opaque body with black imprint “NVR”, containing white
to almost white powder.
ACTIVE SUBSTANCE
Ceritinib
Each capsule contains 150 mg ceritinib free base.
EXCIPIENTS
CAPSULE
CONTENT:
silica,
colloidal
anhydrous;
hydroxypropylcellulose,
low-substituted;
magnesium stearate; cellulose, microcrystalline; sodium starch
glycolate
CAPSULE SHELL:
gelatin; indigotine (E132); titanium dioxide (E171)
PRINTING INK:
ammonium hydroxide; iron oxide black (E172); propylene glycol; shellac
glaze
Pharmaceutical formulations may vary between countries.
INDICATIONS
Zykadia is indicated for the treatment of patients with anaplastic
lymphoma kinase (ALK)-
positive, locally advanced or metastatic non-small cell lung cancer
(NSCLC), with or without
metastases to the brain.
DOSAGE REGIMEN AND ADMINISTRATION
DOSAGE REGIMEN
GENERAL TARGET POPULATION
The recommended dose of Zykadia is 450 mg taken orally once daily with
food at the same
time each day.
The maximum recommended dose is 450 mg taken orally once daily with
food.
Continue treatment as long as the patient is deriving clinical benefit
from therapy.
DOSE ADJUSTMENTS
Temporary dose interruption and/or dose reduction of Zykadia therapy
may be required based
on individual safety and tolerability. If dose reduction is required
due to an adverse drug
reaction not listed in Table 1, then the daily dose of Zykadia should
be reduced by decrements
of 150 mg. Early identification and management of adverse drug
reactions with standard
supportive care measures should be considered.
Zykadia Jan 2021.SIN
Page 2 of 37
Zykadia should be discontinued in patients unable to tolerate 150 mg
taken once daily with
food.
Table 1 summarizes recommendations for dose interruption, reduction,
or discontinuation of
Zykadia in the management of selected adverse drug reactions (ADRs).
TABLE 1
ZYKADIA