Lorviqua

Country: Европска Унија

Језик: Енглески

Извор: EMA (European Medicines Agency)

Активни састојак:

Lorlatinib

Доступно од:

Pfizer Europe MA EEIG

АТЦ код:

L01ED05

INN (Међународно име):

lorlatinib

Терапеутска група:

Antineoplastic agents, Protein kinase inhibitors

Терапеутска област:

Carcinoma, Non-Small-Cell Lung

Терапеутске индикације:

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; orcrizotinib and at least one other ALK TKI.

Резиме производа:

Revision: 11

Статус ауторизације:

Authorised

Датум одобрења:

2019-05-06

Информативни летак

34
B. PACKAGE LEAFLET
35
PACKAGE LEAFLET: INFORMATION FOR THE USER
LORVIQUA 25 MG FILM-COATED TABLETS
LORVIQUA 100 MG FILM-COATED TABLETS
lorlatinib
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
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 Lorviqua is and what it is used for
2.
What you need to know before you take Lorviqua
3.
How to take Lorviqua
4.
Possible side effects
5.
How to store Lorviqua
6.
Contents of the pack and other information
1.
WHAT LORVIQUA IS AND WHAT IT IS USED FOR
WHAT LORVIQUA IS
Lorviqua contains the active substance lorlatinib, a medicine that is
used for treatment of adults with
advanced stages of a form of lung cancer called non-small cell lung
cancer (NSCLC). Lorviqua
belongs to the group of medicines that inhibit an enzyme called
anaplastic lymphoma kinase (ALK).
Lorviqua is only given to patients who have an alteration in the ALK
gene, see HOW LORVIQUA WORKS
below.
WHAT LORVIQUA IS USED FOR
Lorviqua is used to treat adults with a type of lung cancer called
non-small cell lung cancer (NSCLC).
It is used if your lung cancer:
-
is ALK-positive
–
this means your cancer cells have a fault in a gene that makes an
enzyme
called ALK (anaplastic lymphoma kinase), see HOW LORVIQUA WORKS,
below; and
-
is advanced.
Lorviqua can be prescribed to you if:
-
you have not been previousl

Карактеристике производа

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions.
See section 4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
Lorviqua 25 mg film-coated tablets
Lorviqua 100 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Lorviqua 25 mg film-coated tablets
Each film-coated tablet contains 25 mg of lorlatinib.
_Excipient with known effect_
Each film-coated tablet contains 1.58 mg of lactose monohydrate.
Lorviqua 100 mg film-coated tablets
Each film-coated tablet contains 100 mg of lorlatinib.
_Excipient with known effect_
Each film-coated tablet contains 4.20 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Lorviqua 25 mg film-coated tablets
Round (8 mm) light pink immediate release film-coated tablet, debossed
with “Pfizer” on one side and
“25” and “LLN” on the other side.
Lorviqua 100 mg film-coated tablets
Oval (8.5 × 17 mm) dark pink 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.
3
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.
Detection of ALK-positive NSCLC is necessary for