Lonsurf Film-coated Tablet 15 mg6.14 mg (TrifluridineTipiracil)

Country: Malaysia

Language: English

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

Active ingredient:

Trifluridine; Tipiracil Hydrochloride

Available from:

ZUELLIG PHARMA SDN BHD

INN (International Name):

Trifluridine; Tipiracil Hydrochloride

Units in package:

20 Tablets

Manufactured by:

Taiho Pharmaceutical Co., Ltd. Kitajima plant

Patient Information leaflet

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
LONSURF
® FILM-COATED TABLET
Trifluridine/Tipiracil (15 mg/6.14 mg, 20 mg/8.19 mg)
1
WHAT IS IN THIS LEAFLET
1.
What Lonsurf
®
is used for
2.
How Lonsurf
®
works
3.
Before you use Lonsurf
®
4.
How to use Lonsurf
®
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Lonsurf
®
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
11.
Serial number
WHAT LONSURF
® IS USED FOR
Lonsurf
®
is
a
prescription
medicine
used to treat people with:
•
colon or rectal cancer that has
spread
to
other
parts
of
the
body
and
who
have
been
previously
treated
or
cannot
receive
certain
chemotherapy
medicines.
•
a
kind
of
stomach
cancer
called gastric cancer including
adenocarcinoma
of
the
gastroesophageal junction that
has spread to other parts of the
body
and
who
have
been
previously
treated
or
cannot
receive
certain
chemotherapy
medications.
It is not known if Lonsurf
®
is safe and
effective in children.
HOW LONSURF
® WORKS
Lonsurf
®
is
a
type
of
cancer
chemotherapy
which
belongs
to
the
group of medicines called “cytostatic
antimetabolite medicines”.
Lonsurf
®
contains two different active
substances:
trifluridine
and
tipiracil.
Trifluridine stops the growth of cancer
cells.
Tipiracil
stops
the
trifluridine
from being broken down by the body,
helping trifluridine to work longer.
BEFORE YOU USE LONSURF
®
-
_When you must not use it_
_ _
Do not take Lonsurf
®
:
•
if you are allergic to trifluridine or
tipiracil or any of the other ingredients
of this medicine.
-
_Before you start to use it _
Before
you
take
Lonsurf
®
,
tell
your
doctor or pharmacist about all of your
medical conditions, including if you:
•
have kidney or liver problems.
•
are
pregnant
or
plan
to
become
pregnant.
•
are
breastfeeding
or
plan
to
breastfeed.
-
_Taking other medicines _
Tell your doctor or pharmacist about
all the medicines you take, including
prescription
and
over-the-counter
medicines,
vitamins
and
herbal
supplements.
HOW

Summary of Product characteristics

1
HIGHLIGHTS OF PACKAGE INSERT
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO
USE LONSURF
® SAFELY AND EFFECTIVELY. SEE FULL PACKAGE INSERT FOR
LONSURF
®
.
LONSURF
® (TRIFLURIDINE AND TIPIRACIL) FILM-COATED TABLETS, FOR
ORAL USE ____________
INDICATIONS AND USAGE ____________
Lonsurf
®
is a combination of trifluridine, a nucleoside metabolic
inhibitor,
and
tipiracil,
a
thymidine
phosphorylase
inhibitor,
indicated for the treatment of adult patients with:
•
Metastatic
colorectal
cancer
previously
treated
with
fluoropyrimidine-,
oxaliplatin-
and
irinotecan-based
chemotherapy, an anti-VEGF biological therapy, and if RAS
wild-type, an anti-EGFR therapy. (1.1)
•
Metastatic gastric or gastroesophageal junction adenocarcinoma
previously treated with at least two prior lines of chemotherapy
that included a fluoropyrimidine, a platinum, either a taxane or
irinotecan, and if appropriate, HER2/neu-targeted therapy. (1.2) _________
DOSAGE AND ADMINISTRATION _________
•
Recommended dose: 35 mg/m
2
/dose orally twice daily on Days
1 to 5 and Days 8 to 12 of each 28-day cycle. (2.1)
•
Take Lonsurf
®
within 1 hour after completion of morning and
evening meals. (2.4) ________
DOSAGE FORMS AND STRENGTHS _________
Film-coated Tablets:
•
15
mg
trifluridine/6.14
mg
tipiracil
(as
7.065
mg
tipiracil
hydrochloride) (3)
•
20
mg
trifluridine/8.19
mg
tipiracil
(as
9.420
mg
tipiracil
hydrochloride) (3) ______________
CONTRAINDICATIONS ______________
Lonsurf
®
is contraindicated in patients with a history of previous
hypersensitivity to trifluridine, tipiracil or any of the excipient
ingredients. (4) __________
WARNINGS AND PRECAUTIONS __________
•
Severe Myelosuppression: Obtain complete blood counts prior
to and on Day 15 of each cycle. Reduce dose and/or hold
Lonsurf
®
as clinically indicated. (5.1)
•
Embryo-Fetal Toxicity: Can cause fetal harm. Advise females
of reproductive potential of the potential risk to a fetus and to use
effective contraception. (5.2)
•
Gastrointestinal Toxicity: Careful mon