Zykadia

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

ceritinib

Available from:

Novartis Europharm Limited

ATC code:

L01XE

INN (International Name):

ceritinib

Therapeutic group:

Antineoplastic agents

Therapeutic area:

Carcinoma, Non-Small-Cell Lung

Therapeutic indications:

Zykadia is indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK) positive advanced non small cell lung cancer (NSCLC) previously treated with crizotinib.

Product summary:

Revision: 18

Authorization status:

Authorised

Authorization date:

2015-05-06

Patient Information leaflet

71
B. PACKAGE LEAFLET
72
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ZYKADIA 150 MG HARD CAPSULES
ceritinib
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 or pharmacist.
-
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 or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Zykadia is and what it is used for
2.
What you need to know before you take Zykadia
3.
How to take Zykadia
4.
Possible side effects
5.
How to store Zykadia
6.
Contents of the pack and other information
1.
WHAT ZYKADIA IS AND WHAT IT IS USED FOR
WHAT ZYKADIA IS
Zykadia is a cancer medicine that contains the active substance
ceritinib. It is used to treat adults with
advanced stages of a form of lung cancer called non-small cell lung
cancer (NSCLC). Zykadia is only
given to patients whose disease is due to a defect in a gene called
ALK (anaplastic lymphoma kinase).
HOW ZYKADIA WORKS
In patients with ALK defects, an abnormal protein is produced that
stimulates the growth of the cancer
cells. Zykadia blocks the action of this abnormal protein and thus
slows down the growth and spread
of NSCLC.
If you have any questions about how Zykadia works or why this medicine
has been prescribed for you,
ask your doctor or pharmacist.
73
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ZYKADIA
DO NOT TAKE ZYKADIA
−
if you are allergic to ceritinib or any of the other ingredients of
this medicine (listed in
section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Zykadia:
−
if you have problems with your liver.
−
if you have problems with your lungs or problems breathing.
−
if you have problems with your heart, including reduced he

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Zykadia 150 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 150 mg ceritinib.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule.
Capsule with white opaque body and blue opaque cap, size 00
(approximate length: 23.3 mm), with
“LDK 150MG” imprinted on the cap and “NVR” on the body,
containing white to almost white
powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Zykadia 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).
Zykadia as monotherapy is indicated for the treatment of adult
patients with anaplastic lymphoma
kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC)
previously treated with
crizotinib.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with ceritinib should be initiated and supervised by a
physician experienced in the use of
anti-cancer medicinal products.
ALK testing
An accurate and validated ALK assay is necessary for the selection of
ALK-positive NSCLC patients
(see section 5.1).
ALK-positive NSCLC status should be established prior to initiation of
ceritinib therapy. Assessment
for ALK-positive NSCLC should be performed by laboratories with
demonstrated proficiency in the
specific technology being utilised.
3
Posology
The recommended dose of ceritinib is 450 mg taken orally once daily
with food at the same time each
day.
The maximum recommended dose with food is 450 mg taken orally once
daily. Treatment should
continue as long as clinical benefit is observed.
If a dose is missed, the patient should make up that dose, unless the
next dose is due within 12 hours.
If vomiting occurs during the course of treatment, the patient should
not take an additional dose, but
should continue with the next scheduled dose.
Ceritinib should be discontinued in patients unable to tolerate 150 mg
daily taken with f