Zydelig
Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
Indlægsseddel
(PIL)
23-06-2023
Produktets egenskaber
(SPC)
23-06-2023
Offentlige vurderingsrapport
(PAR)
10-01-2020
Aktiv bestanddel:
Idelalisib
Tilgængelig fra:
Gilead Sciences Ireland UC
ATC-kode:
L01XX47
INN (International Name):
idelalisib
Terapeutisk gruppe:
Antineoplastic agents, Other antineoplastic agents
Terapeutisk område:
Lymphoma, Non-Hodgkin; Leukemia, Lymphocytic, Chronic, B-Cell
Terapeutiske indikationer:
Zydelig is indicated in combination with an anti‑CD20 monoclonal antibody (rituximab or ofatumumab) for the treatment of adult patients with chronic lymphocytic leukaemia (CLL):who have received at least one prior therapy, oras first line treatment in the presence of 17p deletion or TP53 mutation in patients who are not eligible for any other therapies.Zydelig is indicated as monotherapy for the treatment of adult patients with follicular lymphoma (FL) that is refractory to two prior lines of treatment.
Produkt oversigt:
Revision: 20
Autorisation status:
Authorised
Autorisation dato:
2014-09-18
Indlægsseddel
54
B. PACKAGE LEAFLET
55
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ZYDELIG 100 MG FILM-COATED TABLETS
idelalisib
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.
-
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. This includes any
possible side effects not listed
in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Zydelig is and what it is used for
2.
What you need to know before you take Zydelig
3.
How to take Zydelig
4.
Possible side effects
5.
How to store Zydelig
6.
Contents of the pack and other information
1.
WHAT ZYDELIG IS AND WHAT IT IS USED FOR
Zydelig is a cancer medicine that contains the active substance
idelalisib. It works by blocking the
effects of an enzyme involved in multiplication and survival of
certain white blood cells called
lymphocytes. Because this enzyme is overactivated in certain cancerous
white blood cells, by blocking
it, Zydelig will kill and reduce the number of cancer cells.
Zydelig may be used for the treatment of two different cancers in
adults:
CHRONIC LYMPHOCYTIC LEUKAEMIA
_Chronic lymphocytic leukaemia_
(CLL) is a cancer of a type of white blood cell called B-lymphocytes.
In this disease, the lymphocytes multiply too quickly and live for too
long, so that there are too many
of them circulating in the blood.
In CLL Zydelig treatment is used in combination with another medicine
(rituximab) in patients who
have certain high-risk factors or in patients whose cancer has come
back after at least one previous
treatment.
FOLLICULAR LYMPHOMA
_Follicular lymphoma_
(FL) is a cancer of a type of white blood cell called B-lymphocytes.
In follicular
lymphoma, the B-lymphocytes multiply too quickly and live for too
long, so there are too many of
th
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Produktets egenskaber
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Zydelig 100 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 100 mg of idelalisib.
Excipient with known effect
Each tablet contains 0.1 mg sunset yellow FCF (E110) (see section
4.4).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Orange, oval-shaped, film-coated tablet of dimensions 9.7 mm by 6.0
mm, debossed on one side with
“GSI” and “100” on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Zydelig is indicated in combination with rituximab for the treatment
of adult patients with chronic
lymphocytic leukaemia (CLL):
•
who have received at least one prior therapy (see section 4.4), or
•
as first line treatment in the presence of 17p deletion or
_TP53 _
mutation in patients who are not
eligible for any other therapies (see section 4.4).
Zydelig is indicated as monotherapy for the treatment of adult
patients with follicular lymphoma (FL)
that is refractory to two prior lines of treatment (see section 4.4).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with Zydelig should be conducted by a physician experienced
in the use of anti-cancer
therapies.
Posology
The recommended dose is 150 mg idelalisib twice daily. Treatment
should be continued until disease
progression or unacceptable toxicity.
If the patient misses a dose of Zydelig within 6 hours of the time it
is usually taken, the patient should
take the missed dose as soon as possible and resume the normal dosing
schedule. If a patient misses a
dose by more than 6 hours, the patient should not take the missed dose
and simply resume the usual
dosing schedule.
_Dose modification _
_ _
_Elevated liver transaminases_
Treatment with Zydelig must be withheld in the event of a Grade 3 or 4
aminotransferase elevation
(alanine aminotransferase [ALT]/aspartate aminotransferase [AST] > 5 x
upper limit of normal
[ULN]). Once values have returned to Grade 1 or below
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