Lorviqua 100 mg Film-Coated Tablets

Χώρα: Μαλαισία

Γλώσσα: Αγγλικά

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

Δραστική ουσία:

Lorlatinib

Διαθέσιμο από:

PFIZER (MALAYSIA) SDN. BHD.

INN (Διεθνής Όνομα):

Lorlatinib

Μονάδες σε πακέτο:

30 Tablets; 10 Tablets

Κατασκευάζεται από:

Pfizer Manufacturing Deutschland GmbH.

Φύλλο οδηγιών χρήσης

Pfizer Confidential
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
LORVIQUA
®
FILM COATED TABLET
Lorlatinib (25 mg and 100 mg)
WHAT IS IN THIS LEAFLET
1.
What LORVIQUA is used for
2.
How LORVIQUA works
3.
Before you use LORVIQUA
4.
How to use LORVIQUA
5.
While you are using it
6.
Side Effects
7.
Storage and Disposal of
LORVIQUA
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
11.
Serial Number
WHAT LORVIQUA IS USED FOR
LORVIQUA is used to treat adults with
lung cancer called advanced non-small
cell lung cancer (NSCLC) whose
tumors are caused by a gene defect
called anaplastic lymphoma kinase
(ALK).
Lorviqua can be prescribed to you if:
-
you have not been previously
treated with an ALK inhibitor; or
-
you have been previously treated
with a medicine called alectinib
or ceritinib, which are ALK
inhibitors; or
-
you have been previously treated
with crizotinib followed by
another ALK inhibitor.
HOW LORVIQUA WORKS
LORVIQUA blocks the action of an
enzyme called ALK tyrosine kinase and
therefore inhibits tumour growth. In
addition to that, LORVIQUA helps to
address issues of resistance after
previous treatment with other ALK
inhibitors. LORVIQUA is also able to
penetrate the brain to cause tumour
shrinkage hence prolonging survival.
BEFORE YOU USE LORVIQUA
_- When you must not use it _
Do not take LORVIQUA
-
if you are allergic to LORVIQUA
or any of its ingredients
-
if you are currently taking certain
other medicines called strong
CYP3A inducers. It may damage
your liver
-
if you have moderate to severe liver
problems
-
if you are pregnant
-
while you are breastfeeding
Ask your doctor or pharmacist for
advice before taking any medicine.
_- Before you start to use it _
As male fertility may be reduced
during treatment with LORVIQUA,
men should seek advice on fertility
preservation before treatment
Ensure that you have discontinued
usage of any CYP3A inducers (for
e.g., rifampin) for a sufficient amount
of time advised by your doctor before
starting LORVIQUA
Before taking

Αρχείο Π.Χ.Π.

PFIZER
LORVIQUA
®
1.
NAME OF THE MEDICINAL PRODUCT
LORVIQUA 25 MG FILM COATED TABLETS
LORVIQUA 100 MG FILM COATED TABLETS
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 25 mg film-coated tablet contains 25 mg of lorlatinib.
Each 100 mg film-coated tablet contains 100 mg of lorlatinib.
For the full list of excipients, see Section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
25 mg: 8 mm round tan immediate release film-coated tablet, debossed
with “Pfizer”
on one side and “25” and “LLN” on the other side.
100 mg: oval (8.5 × 17 mm) lavender immediate release film-coated
tablet, debossed
with “Pfizer” on one side and “LLN 100” on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
LORVIQUA as monotherapy is indicated for the treatment of adult
patients with
anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung
cancer
(NSCLC) previously not treated with an ALK inhibitor.
LORVIQUA as monotherapy is indicated for the treatment of adult
patients with ALK
positive advanced NSCLC whose disease has progressed after:
•
alectinib or ceritinib as the first ALK tyrosine kinase inhibitor
(TKI) therapy; or
•
crizotinib and at least one other ALK TKI
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with lorlatinib should be initiated and supervised by a
physician experienced
in the use of anticancer medicinal products.
ALK testing
Detection of ALK positive NSCLC is necessary for selection of patients
for treatment
with lorlatinib because these are the only patients for whom benefit
has been shown.
Assessment for ALK positive NSCLC should be performed by laboratories
with
1
demonstrated proficiency in the specific technology being utilized.
Improper assay
performance can lead to unreliable test results.
Recommended dosing
The recommended dose schedule of LORVIQUA is 100 mg taken orally once
daily
continuously. Continue treatment as long as the patient is deriving
clinical benefit from
therapy.
LORVIQUA may be taken with or without food (see Section 5.2).
Patients sh