INGEFITINIB FILM COATED TABLET 250MG

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Gefitinib

Available from:

INTEGA PTE LTD

ATC code:

L01XE02

Pharmaceutical form:

TABLET, FILM COATED

Composition:

Gefitinib 250.00 mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

REMEDICA LTD

Authorization status:

ACTIVE

Authorization date:

2020-12-04

Summary of Product characteristics

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INGEFITINIB FILM COATED TABLET 250 MG
PRESENTATION
Brown, round, biconvex, film-coated tablet impressed with “250” on
one side and plain
on the other. Each tablet contains 250 mg gefitinib.
INDICATIONS
INGEFITINIB is indicated for the treatment of patients with locally
advanced or
metastatic Non Small Cell Lung Cancer (NSCLC) who have activating
mutations of the
EGFR TK.
DOSAGE AND ADMINISTRATION
INGEFITINIB treatment should only be initiated by a medical specialist
experienced in
the treatment of patients with advanced NSCLC.
The recommended dose of INGEFITINIB is one 250 mg tablet once a day,
taken with or
without food. If a dose of INGEFITINIB is missed, it should be taken
as soon as the
patient remembers. If it is less than 12 hours to the next dose, the
patient should not take
the missed dose. Patients should not take a double dose (two doses at
the same time) to
make up for a forgotten dose.
Where dosing of whole tablets is not possible, such as patients who
are only able to
swallow liquids, tablets may be administered as a dispersion in water.
The tablet should
be dropped into half a glass of drinking water (non-carbonated),
without crushing, and
the glass stirred until the tablet has dispersed (approximately 15
minutes) and the contents
subsequently drunk immediately. The glass should be rinsed with a
further half glass of
water and the contents drunk. The liquid can also be administered via
a nasogastric tube.
INGEFITINIB is not recommended for use in children or adolescents as
safety and
effectiveness in these patient populations has not been studied.
No dosage adjustment is required on the basis of patient age, body
weight, gender,
ethnicity, mild to moderate renal impairment or in patients with
moderate to severe
hepatic impairment due to liver metastases (see 'PHARMACOKINETIC
PROPERTIES'
section).
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DOSAGE ADJUSTMENT:
Patients with poorly tolerated diarrhoea or skin adverse drug
reactions may be successfully managed by providing a brief (up to 14
days) therapy
interruption followed by r