Zydelig 150mg tablets

देश: यूनाइटेड किंगडम

भाषा: अंग्रेज़ी

स्रोत: MHRA (Medicines & Healthcare Products Regulatory Agency)

सक्रिय संघटक:

Idelalisib

थमां उपलब्ध:

Gilead Sciences International Ltd

INN (इंटरनेशनल नाम):

Idelalisib

डोज़:

150mg

फार्मास्यूटिकल फॉर्म:

Tablet

प्रशासन का मार्ग:

Oral

वर्ग:

No Controlled Drug Status

प्रिस्क्रिप्शन प्रकार:

Valid as a prescribable product

उत्पाद समीक्षा:

BNF: 08010500; GTIN: 5391507141125

सूचना पत्रक

1
B. PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ZYDELIG 150 MG FILM-COATED TABLETS
Idelalisib
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.
-
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:
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 or ofatumumab) in
patients who have certain high-risk factors or in patients whose
cancer has come back after at least one
previous treat

उत्पाद विशेषताएं

OBJECT 1
ZYDELIG (IDELALISIB) 150MG
Summary of Product Characteristics Updated 26-Jun-2018 | Gilead
Sciences Ltd
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
Zydelig 150 mg film-coated tablets
2. Qualitative and quantitative composition
Each film-coated tablet contains 150 mg of idelalisib.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet.
Pink, oval-shaped, film-coated tablet of dimensions 10.0 mm by 6.8 mm,
debossed on one side with
“GSI” and “150” on the other side.
4. Clinical particulars
4.1 Therapeutic indications
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 (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 anticancer
therapies.
Posology
The recommended dose of Zydelig is 150 mg, taken orally, 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