Vizimpro

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

dacomitinib monohydrate

Available from:

Pfizer Europe MA EEIG

ATC code:

L01EB07

INN (International Name):

dacomitinib

Therapeutic group:

Antineoplastic agents

Therapeutic area:

Carcinoma, Non-Small-Cell Lung

Therapeutic indications:

Vizimpro, as monotherapy, is indicated for the first-line treatment of adult patients with locally advanced or metastatic non small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) activating mutations.

Product summary:

Revision: 2

Authorization status:

Authorised

Authorization date:

2019-04-02

Patient Information leaflet

31
B. PACKAGE LEAFLET
32
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
VIZIMPRO 15 MG FILM-COATED TABLETS
VIZIMPRO 30 MG FILM-COATED TABLETS
VIZIMPRO 45 MG FILM-COATED TABLETS
dacomitinib
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, pharmacist or
nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Vizimpro is and what it is used for
2.
What you need to know before you take Vizimpro
3.
How to take Vizimpro
4.
Possible side effects
5.
How to store Vizimpro
6.
Contents of the pack and other information
1.
WHAT VIZIMPRO IS AND WHAT IT IS USED FOR
Vizimpro contains the active substance dacomitinib, which belongs to a
group of medicines called
protein tyrosine kinase inhibitors which are used to treat cancer.
Vizimpro is used to treat adults with a type of lung cancer called
‘non-small cell lung cancer’. If a test
has shown that your cancer has certain changes (mutations) in a gene
called ‘EGFR’ (epidermal
growth factor receptor) and has spread to your other lung or other
organs, your cancer is likely to
respond to treatment with Vizimpro.
Vizimpro can be used as your first treatment once your lung cancer has
spread to your other lung or
other organs.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE VIZIMPRO
DO NOT TAKE VIZIMPRO
•
if you are allergic to dacomitinib or any of the other ingredients of
this medicine (listed in
section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before taking Vizimpro:
•
if you ever had any other lung problems. Some lung problems may get
worse during treatment
with Vizimpro, as Vizimpro may

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Vizimpro 15 mg film-coated tablets
Vizimpro 30 mg film-coated tablets
Vizimpro 45 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Vizimpro 15 mg film-coated tablets
Each film-coated tablet contains dacomitinib monohydrate equivalent to
15 mg dacomitinib.
_Excipients with known effect _
Each film-coated tablet contains 40 mg of lactose monohydrate.
Vizimpro 30 mg film-coated tablets
Each film-coated tablet contains dacomitinib monohydrate equivalent to
30 mg dacomitinib.
_Excipients with known effect _
Each film-coated tablet contains 81 mg of lactose monohydrate.
Vizimpro 45 mg film-coated tablets
Each film-coated tablet contains dacomitinib monohydrate equivalent to
45 mg dacomitinib.
_Excipients with known effect _
Each film-coated tablet contains 121 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Vizimpro 15 mg film-coated tablets
Blue film-coated, 6.35 mm, round biconvex tablet, debossed with
“Pfizer” on one side and “DCB15”
on the other.
Vizimpro 30 mg film-coated tablets
Blue film-coated, 7.5 mm, round biconvex tablet, debossed with
“Pfizer” on one side and “DCB30” on
the other.
Vizimpro 45 mg film-coated tablets
Blue film-coated, 9.0 mm, round biconvex tablet, debossed with
“Pfizer” on one side and “DCB45” on
the other.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Vizimpro, as monotherapy, is indicated for the first-line treatment of
adult patients with locally
advanced or metastatic non-small cell lung cancer (NSCLC) with
epidermal growth factor receptor
(EGFR)-activating mutations.
3
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with Vizimpro should be initiated and supervised by a
physician experienced in the use of
anticancer medicinal products.
EGFR mutation status should be established prior to initiation of
dacomitinib therapy (see section 4.4).
Posology
The recommended dose of Vizimpr