LONSURF 15/6.14 trifluridine 15 mg/ tipiracil hydrochloride 7.065 mg (equivalent to tipiracil 6.14 mg) film-coated tablet blister pack

Pays: Australie

Langue: anglais

Source: Department of Health (Therapeutic Goods Administration)

Ingrédients actifs:

tipiracil hydrochloride, Quantity: 7.065 mg; trifluridine, Quantity: 15 mg

Disponible depuis:

Servier Laboratories (Aust) Pty Ltd

DCI (Dénomination commune internationale):

tipiracil hydrochloride,trifluridine

forme pharmaceutique:

Tablet, film coated

Composition:

Excipient Ingredients: Carnauba Wax; pregelatinised maize starch; lactose monohydrate; iron oxide yellow; titanium dioxide; macrogol 8000; indigo carmine aluminium lake; hypromellose; stearic acid; iron oxide red; Shellac; purified talc; magnesium stearate

Mode d'administration:

Oral

Unités en paquet:

60 film-coated tablets, 20 film-coated tablets

Type d'ordonnance:

(S4) Prescription Only Medicine

indications thérapeutiques:

Colorectal cancer LONSURF is indicated for the treatment of adult patients with metastatic colorectal cancer (mCRC) who have been previously treated with, or are not considered candidates for fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-VEGF agents, and anti-EGFR agents.,Gastric cancer LONSURF is indicated for the treatment of adult patients with 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.

Descriptif du produit:

Visual Identification: White, round, biconvex, immediate-release film-coated tablet imprinted with "15" on one side, and "102" and "15 mg" on the other side in grey ink.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

Statut de autorisation:

Licence status A

Date de l'autorisation:

2017-05-23

Notice patient

LONSURF
®
_Trifluridine/Tipiracil Hydrochloride_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about LONSURF. It does
not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking LONSURF
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST FOR MORE
ADVICE.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT LONSURF IS
USED FOR
LONSURF is a medicine used to
treat cancer by slowing down the
growth and spread of cancer cells.
LONSURF is used to treat adults
with colon or rectal cancer -
sometimes called 'colorectal' cancer.
It is also used to treat gastric cancer-
sometimes called 'stomach' cancer.
•
It is used when the cancer has
spread to other parts of the body.
•
It is used when other treatments
have not worked - or when other
treatments are not suitable for
you.
LONSURF is a type of cancer
chemotherapy which belongs to a
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.
This medicine is available only with
a doctor's prescription.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
There is no evidence that LONSURF
is addictive.
BEFORE YOU TAKE
LONSURF
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE LONSURF IF YOU HAVE
AN ALLERGY TO:
•
TIPIRACIL AND/OR TRIFLURIDINE (THE
ACTIVE INGREDIENTS IN
LONSURF)
•
ANY OF THE INGREDIENTS LISTED AT
THE END OF THIS LEAFLET.
Symptoms of an allergic reaction to
LONSURF may include:
•
shortness of breath, wheezing or
difficulty breathing
•
sw

Résumé des caractéristiques du produit

AUSTRALIAN PRODUCT INFORMATION –
LONSURF (TRIFLURIDINE/TIPIRACIL)
Version: 10
1/28
AUSTRALIAN PI – LONSURF (TRIFLURIDINE/TIPIRACIL)
1
NAME OF THE MEDICINE
Trifluridine / tipiracil hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each LONSURF 15/6.14 film-coated tablet contains 15 mg of trifluridine
and tipiracil hydrochloride
7.065 mg (equivalent to tipiracil 6.14 mg). Each LONSURF 20/8.19
film-coated tablet contains 20 mg
of trifluridine and tipiracil hydrochloride 9.420 mg (equivalent to
tipiracil 8.19 mg).
The active components of LONSURF are trifluridine and tipiracil
hydrochloride.
Excipients with known effect:
Each LONSURF 15/6.14 tablet contains 90.735 mg of lactose.
Each LONSURF 20/8.19 tablet contains 120.980 mg of lactose.
For the full list of excipients, see _section 6.1 - List of
excipients_.
3
PHARMACEUTICAL FORM
LONSURF 15/6.14: white, biconvex, round, film-coated tablet, imprinted
with ‘15’ on one side, and
‘102’ and ’15 mg’ on the other side, in grey ink.
LONSURF 20/8.19: pale red, biconvex, round, film-coated tablet,
imprinted with ‘20’ on one side, and
‘102’ and ‘20 mg’ on the other side, in grey ink.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
COLORECTAL CANCER
LONSURF is indicated for the treatment of adult patients with
metastatic colorectal cancer (mCRC)
who have been previously treated with, or are not considered
candidates for fluoropyrimidine-,
oxaliplatin- and irinotecan-based chemotherapies, anti-VEGF agents,
and anti-EGFR agents.
GASTRIC CANCER
LONSURF is indicated for the treatment of adult patients with
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.
4.2
D
OSE AND METHOD OF ADMINISTRATION
AUSTRALIAN PRODUCT INFORMATION –
LONSURF (TRIFLURIDINE/TIPIRACIL)
Version: 10
2/28
DOSAGE (DOSE AND INTERVAL)
LONSURF must be administered by doctors w