Alecensa

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

alectinib hydrochloride

Saatavilla:

Roche Registration GmbH

ATC-koodi:

L01ED03

INN (Kansainvälinen yleisnimi):

alectinib

Terapeuttinen ryhmä:

Antineoplastic agents

Terapeuttinen alue:

Carcinoma, Non-Small-Cell Lung

Käyttöaiheet:

Alecensa as monotherapy is indicated for the first-line treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC).Alecensa as monotherapy is indicated for the treatment of adult patients with ALK‑positive advanced NSCLC previously treated with crizotinib.

Tuoteyhteenveto:

Revision: 14

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2017-02-16

Pakkausseloste

36
B. PACKAGE LEAFLET
37
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ALECENSA 150 MG HARD CAPSULES
alectinib
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 Alecensa
is and what it is used for
2.
What you need to know before you take Alecensa
3.
How to take Alecensa
4.
Possible side effects
5.
How to store Alecensa
6.
Contents of the pack and other information
1.
WHAT ALECENSA IS AND WHAT IT IS USED FOR
WHAT ALECENSA IS
Alecensa is a cancer medicine that contains the active substance
alectinib.
WHAT ALECENSA IS USED FOR
Alecensa 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 Alecensa works’,
below
●
and is advanced.
Alecensa can be prescribed to you as first treatment of your lung
cancer, or if you have been
previously treated with a medicine containing ‘crizotinib’.
HOW ALECENSA WORKS
Alecensa blocks the action of an enzyme called ‘ALK tyrosine
kinase’. Abnormal forms of this
enzyme (due to fault in the gene that makes it) help encourage cancer
cell growth. Alecensa may slow
down or stop the growth of your cancer. It may also help to shrink
your cancer.
If you have any questions about how Alecensa works or why this
medicine has been prescribed for
you, ask your doctor, pharmacist or nurse.
38
2.
WHAT YOU NEED TO

Valmisteyhteenveto

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Alecensa 150 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains alectinib hydrochloride equivalent to 150
mg alectinib.
Excipients with known effect
Each hard capsule contains 33.7 mg lactose (as monohydrate) and 6 mg
sodium (as sodium
laurilsulfate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule.
White hard capsule of 19.2 mm length, with “ALE” printed in black
ink on the cap and “150 mg”
printed in black ink on the body.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Alecensa as monotherapy is indicated for the first-line treatment of
adult patients with anaplastic
lymphoma kinase (ALK)-positive advanced non-small cell lung cancer
(NSCLC).
Alecensa as monotherapy is indicated for the treatment of adult
patients with ALK-positive advanced
NSCLC previously treated with crizotinib.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with Alecensa should be initiated and supervised by a
physician experienced in the use of
anticancer medicinal products.
A validated ALK assay is necessary for the selection of ALK-positive
NSCLC patients. ALK-positive
NSCLC status should be established prior to initiation of Alecensa
therapy.
Posology
The recommended dose of Alecensa is 600 mg (four 150 mg capsules)
taken twice daily with food
(total daily dose of 1200 mg).
Patients with underlying severe hepatic impairment (Child-Pugh C)
should receive a starting dose of
450 mg taken twice daily with food (total daily dose of 900 mg).
_Duration of treatment _
Treatment with Alecensa should be continued until disease progression
or unacceptable toxicity.
_Delayed or missed doses _
If a planned dose of Alecensa is missed, patients can make up that
dose unless the next dose is due
within 6 hours. Patients should not take two doses at the same time to
make up for a missed dose. If
vomiting occurs after taking a dose of Alecensa, patients should take
the next dose at the