LORVIQUA FILM-COATED TABLET 25MG

国家: 新加坡

语言: 英文

来源: HSA (Health Sciences Authority)

有效成分:

Lorlatinib

可用日期:

PFIZER PRIVATE LIMITED

ATC代码:

L01XE44

药物剂型:

TABLET, FILM COATED

组成:

Lorlatinib 25mg

给药途径:

ORAL

处方类型:

Prescription Only

厂商:

Pfizer Manufacturing Deutschland GmbH

授权状态:

ACTIVE

授权日期:

2019-10-16

资料单张

LORVIQUA
TABLE OF CONTENT
_Please click on either of the following links to access the required
information: _
PRESCRIBING INFORMATION
PATIENT INFORMATION LEAFLET
Page 1 of 24
LORVIQUA FILM-COATED TABLET
Lorlatinib
1.
NAME OF THE MEDICINAL PRODUCT
LORVIQUA
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 is indicated for the first line treatment of adult patients
with anaplastic
lymphoma kinase (ALK)-positive advanced non-small cell lung cancer
(NSCLC).
LORVIQUA is indicated for the treatment of patients with anaplastic
lymphoma kinase
(ALK)-positive metastatic non-small cell lung cancer (NSCLC) whose
disease has progressed
on
•
crizotinib and at least one other ALK inhibitor for metastatic
disease; or
•
alectinib as the first ALK inhibitor therapy for metastatic disease;
or
•
ceritinib as the first ALK inhibitor therapy for metastatic disease.
Page 2 of 24
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
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
demonstrated
proficiency in the specific technology being utilised. 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 until disease progression or
unacceptable t

产品特点

LORVIQUA
Table of Content
Please click on either of the following links to access the required
information:
Prescribing information
Patient information leaflet
Page 1 of 24
LORVIQUA FILM-COATED TABLET
Lorlatinib
1.
NAME OF THE MEDICINAL PRODUCT
LORVIQUA
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 is indicated for the first line treatment of adult patients
with anaplastic
lymphoma kinase (ALK)-positive advanced non-small cell lung cancer
(NSCLC).
LORVIQUA is indicated for the treatment of patients with anaplastic
lymphoma kinase
(ALK)-positive metastatic non-small cell lung cancer (NSCLC) whose
disease has progressed
on

crizotinib and at least one other ALK inhibitor for metastatic
disease; or

alectinib as the first ALK inhibitor therapy for metastatic disease;
or

ceritinib as the first ALK inhibitor therapy for metastatic disease.
Page 2 of 24
4.2
Posology and method of administration
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
demonstrated
proficiency in the specific technology being utilised. 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 until disease progression or
unacceptable toxicity