Vizimpro 15 mg Film-Coated Tablets

Country: Малезија

Језик: Енглески

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

Активни састојак:

Dacomitinib Monohydrate

Доступно од:

PFIZER (MALAYSIA) SDN. BHD.

INN (Међународно име):

Dacomitinib Monohydrate

Јединице у пакету:

30 Tablets

Произведен од:

Pfizer Manufacturing Deutschland GmbH.

Информативни летак

Pfizer Confidential
_Consumer Medication Information Leaflet (RiMUP)_
VIZIMPRO
®
FILM COATED TABLET
Dacomitinib (15mg, 30mg, 45mg)
PLD Title
: Dacomitinib (VIZIMPRO)
PLD Date
: 18 February 2020
Country
: Malaysia
Reference Document
: VIZIMPRO Malaysia LPD, Dated 07 February 2020
: EU/UK PIL, Dated April 2019
: US PIL, Dated September 2018
Reason for Change
: PfLEET 2019-0052133 (D), New PIL creation
: PfLEET 2020-0058603 (D), To update as per BOH recommendation and to
align as per new template
Pfizer Confidential
_Consumer Medication Information Leaflet (RiMUP)_
VIZIMPRO
®
FILM COATED TABLET
Dacomitinib (15mg, 30mg, 45mg)
1
WHAT IS IN THIS LEAFLET
1.
What VIZIMPRO is used for
2.
How VIZIMPRO works
3.
Before you use VIZIMPRO
4.
How to use VIZIMPRO
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of VIZIMPRO
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial Number
WHAT VIZIMPRO IS USED FOR
VIZIMPRO contains the active substance
dacomitinib, which is an oral kinase
inhibitor. VIZIMPRO is a prescription
medicine used to treat non-small cell lung
cancer (NSCLC) that has spread to other
parts of the body (metastatic).
VIZIMPRO can be used as your first
treatment if your tumour has certain types
of abnormal epidermal growth factor
receptor (EGFR) gene(s).
Your doctor will perform a test to make
sure that VIZIMPRO is right for you.
It is not known if VIZIMPRO is safe and
effective in children.
HOW VIZIMPRO WORKS
VIZIMPRO inhibits the activity of
epidermal growth factor receptor (EGFR)
which is involved in development of
cancer.
BEFORE YOU USE VIZIMPRO
-
_When you must not use it_
If you are allergic to any of the
ingredients present in VIZIMPRO.
_Pregnancy and lactation_
Do not take VIZIMPRO if you are
pregnant, trying to get pregnant or think
you may be pregnant. Your doctor may
do a pregnancy test before you start
treatment with VIZIMPRO and may also
suggest you to use effective birth control
(contraception) during treatment and for
at least 17 day

Карактеристике производа

Pfizer Confidential
1
PFIZER
VIZIMPRO
® 15 MG FILM-COATED TABLETS
VIZIMPRO
® 30 MG FILM-COATED TABLETS
VIZIMPRO
® 45 MG FILM-COATED TABLETS
FULL PRESCRIBING INFORMATION
1
INDICATIONS AND USAGE
VIZIMPRO is indicated for the first-line treatment of patients with
metastatic non-small cell
lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon
19 deletion or
exon 21 L858R substitution mutations
_[see Dosage and Administration (2.1)]_
.
2
DOSAGE AND ADMINISTRATION
2.1
PATIENT SELECTION
Select patients for the first-line treatment of metastatic NSCLC with
VIZIMPRO based on
the presence of an EGFR exon 19 deletion or exon 21 L858R substitution
mutation in tumor
specimens.
2.2
RECOMMENDED DOSAGE
The recommended dosage of VIZIMPRO is 45 mg taken orally once daily,
until disease
progression or unacceptable toxicity occurs. VIZIMPRO can be taken
with or without food
_[see Dosage and Administration (2.4) and Clinical Pharmacology (10)]_
.
Take VIZIMPRO the same time each day. If the patient vomits or misses
a dose, do not take
an additional dose or make up a missed dose but continue with the next
scheduled dose.
2.3
DOSAGE MODIFICATIONS FOR ADVERSE REACTIONS
Reduce the dose of VIZIMPRO for adverse reactions as described in
Table 1. Dosage
modifications for specific adverse reactions are provided in Table 2.
TABLE 1. VIZIMPRO RECOMMENDED DOSE REDUCTIONS FOR ADVERSE REACTIONS
DOSE LEVEL
DOSE (ONCE DAILY)
First dose reduction
30 mg
Second dose reduction
15 mg
Pfizer Confidential
2
TABLE 2. VIZIMPRO DOSAGE MODIFICATIONS FOR ADVERSE REACTIONS
ADVERSE
REACTION
SEVERITY
A
DOSAGE MODIFICATION
Interstitial lung
disease (ILD)
_[see Warnings _
_and Precautions _
_(5.1)] _
Any Grade
•
Permanently discontinue VIZIMPRO.
Diarrhea
_[see _
_Warnings and _
_Precautions _
_(5.2)] _
Grade 2
•
Withhold VIZIMPRO until recovery to less than or equal to
Grade 1; then resume VIZIMPRO at the same dose level.
•
For recurrent Grade 2 diarrhea, withhold until recovery to less
than or equal to Grade 1; then resume VIZIMPRO at a
re