Inlyta Film-coated Tablets 1mg

Country: Մալայզիա

language: անգլերեն

source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

active_ingredient:

Axitinib

MAH:

PFIZER (MALAYSIA) SDN. BHD.

INN:

Axitinib

units_in_package:

28tablet Tablets; 56tablet Tablets; 180tablet Tablets

manufactured_by:

Pfizer Manufacturing Deutschland GmbH.

PIL

PFIZER CONFIDENTIAL
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
INLYTA
® FILM-COATED TABLETS
Axitinib (1 mg, 5 mg)
_ _
1
WHAT IS IN THIS LEAFLET:
1.
What Inlyta is used for
2.
How Inlyta works
3.
Before you use Inlyta
4.
How to use Inlyta
5.
While you are using it
6.
Side Effects
7.
Storage and Disposal of Inlyta
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
11.
Serial Number
WHAT INLYTA IS USED FOR
Inlyta is used to treat a certain type of
kidney cancer called advanced renal
cell carcinoma (RCC) when another
medicine (called sunitinib or a
cytokine) is no longer effective.
HOW INLYTA WORKS
Inlyta belongs to a group of medicines
called tyrosine kinase inhibitors. It
contains the active substance axitinib. It
works by reducing the blood supply,
slowing down tumour growth and
preventing spread of the cancer.
BEFORE YOU USE INLYTA
-
_When you must not use it_
_ _
Do not take Inlyta:
•
If you have any allergy to any
medicine containing axitinib or any
of the inactive ingredients listed at
the end of this leaflet
•
If you have severe hypertension.
Your hypertension must be
managed first before starting
treatment
•
If you have had a recent active
gastrointestinal bleed or cancer
which have spread to the brain
•
If you have nephrotic syndrome,
which is a collection of symptoms
due to kidney damage, one of
which is proteinuria (presence of
excess protein in urine)
•
If you have severe liver impairment
(classified as Child-Pugh class C)
•
If you have lactose intolerance, as
this product contains lactose
If you think you may be allergic ask
your doctor for advice.
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue or
other parts of the body
•
rash, itching or hives on the skin.
If you are not sure whether you should
start taking this medicine, talk to your
doctor.
_Pregnancy and lactation _
_ _
Tell your doctor if you are pregnant or
think you may be

SPC

1
1.
NAME(S) OF THE MEDICINAL PRODUCT
INLYTA
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Inlyta 1 mg film-coated tablets
Each film-coated tablet contains 1 mg of axitinib.
Inlyta 5 mg film-coated tablets
Each film-coated tablet contains 5 mg of axitinib.
_Excipients with known effect:_
Inlyta 1 mg film-coated tablets
Each film-coated tablet contains 33.6 mg of lactose monohydrate.
Inlyta 5 mg film-coated tablets
Each film-coated tablet contains 58.8 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Inlyta 1 mg film-coated tablets
Red, oval, film-coated tablets debossed with "Pfizer" on one side and
"1 XNB" on
the other.
Inlyta 5 mg film-coated tablets
Red, triangular, film-coated tablets debossed with "Pfizer" on one
side and "5
XNB" on the other.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Axitinib is indicated for the treatment of adult patients with
advanced renal cell
carcinoma (RCC) after failure of prior treatment with sunitinib or a
cytokine.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with Axitinib should be conducted by a physician experienced
in the use
of anticancer therapies.
2
_Posology_
The recommended starting dose of axitinib is 5 mg twice daily.
Treatment should continue as long as clinical benefit is observed or
until
unacceptable toxicity occurs that cannot be managed by concomitant
medicinal
products or dose adjustments.
If the patient vomits or misses a dose, an additional dose should not
be taken. The
next prescribed dose should be taken at the usual time.
_Dose adjustments_
Dose increase or reduction is recommended based on individual safety
and
tolerability.
Patients who tolerate the axitinib starting dose of 5 mg twice daily
with no adverse
reactions >Grade 2 (i.e. without severe adverse reactions according to
the Common
Terminology Criteria for Adverse Events [CTCAE] version 3.0) for two
consecutive weeks may have their dose increased to 7 mg twice daily
unless the
patient’s blood pressure is >150/90 m