Lorviqua 25 mg Film-Coated Tablets

국가: 말레이시아

언어: 영어

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

유효 성분:

Lorlatinib

제공처:

PFIZER (MALAYSIA) SDN. BHD.

INN (International Name):

Lorlatinib

패키지 단위:

30 Tablets; 90 Tablets; 120 Tablets; 60 Tablets

Manufactured by:

Pfizer Manufacturing Deutschland GmbH.

환자 정보 전단

Pfizer Confidential
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
LORVIQUA
® FILM COATED TABLET
Lorla tinib
(25 mg and 100 mg)
PLD Title
: Lorlatinib (LORVIQUA
®
)
PLD Date
: 122060 MayJanuaryAugustAugust 202210
Country
: Malaysia
Reference Document
: 25 mg and 100 mg LORVIQUA Film-coated tablet Malaysia CLD dated
1010243
MayJanuaryuneJuly 202210
Reason for change
: New PLD creation
: PfLEET Number 2021-0068787 (S1): - To update PLD as per effective
Malaysia CLD dated 23 June 20212020-0058803 (D) -
To update as per BOH recommendation and update according to new
template
: PfLEET Number 2019-0057286 (D): line extension for 1
st
line indicationTo amend serial number
: PfLEET 2022-00783312022-0075271 (M) : To align indication as per
CDSEU SPC.
: To add serial number
: PfLEET 2020-0060746 (D)- To incorporate BOH suggestion
: PfLEET 2020-0062523 (S1)- To update PLD as per BOH request
: PfLEET 2020-0063658 (S2)- To update PLD as per BOH request dated 18
August 2020
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Pfizer Confidential
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
LORVIQUA
®
FILM COATED TABLET
Lorlatinib (25 mg and 100 mg)
1
FORMATTED: Font: Not Bold
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 Eeffects
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
metastatic 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 if you have not be

제품 특성 요약

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