Zydelig

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Idelalisib 100mg;  

Available from:

Gilead Sciences (NZ)

INN (International Name):

Idelalisib 100 mg

Dosage:

100 mg

Pharmaceutical form:

Film coated tablet

Composition:

Active: Idelalisib 100mg   Excipient: Croscarmellose sodium Hyprolose Opadry orange 85F130017; formulation provided Magnesium stearate Microcrystalline cellulose Sodium starch glycolate

Prescription type:

Prescription

Manufactured by:

Cambrex Karlskoga AB

Therapeutic indications:

ZYDELIG is indicated in combination with rituximab for the treatment of patients with chronic lymphocytic leukaemia (CLL)/small lymphocytic leukaemia (SLL), including patients with 17p deletion or TP53 mutation, upon relapse after at least one prior therapy in patients for whom chemo-immunotherapy is not considered suitable. ZYDELIG is not recommended for first-line treatment of CLL/SLL.

Product summary:

Package - Contents - Shelf Life: Bottle, plastic, White, HDPE 60 ml with child-resistant PP screw cap and al foil liner - 60 tablets - 60 months from date of manufacture stored at or below 30°C

Authorization date:

2015-02-19

Patient Information leaflet

ZYDELIG
®
Consumer Medicine Information V2.0– (23 June 2016) Page 1 of 4
ZYDELIG
®
TABLETS
_(ZI-DEL-IG) _
100 MG AND 150 MG TABLETS
_Idelalisib _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
READ ALL OF THIS LEAFLET CAREFULLY BEFORE
YOU START TAKING THIS MEDICINE.
This leaflet answers some of the
common questions about ZYDELIG
tablets. It does not contain all of the
available information. It does not take
the place of talking to your doctor or
pharmacist about your medical
condition or treatment.
If you have further questions, please ask
your doctor or your pharmacist.
KEEP THIS LEAFLET WITH YOUR MEDICINE.
You may need to read it again.
WHAT IS ZYDELIG USED FOR
ZYDELIG contains the active substance
idelalisib, which belongs to a group of
medicines called antineoplastic agents.
This medicine blocks the effects of an
enzyme called PI3K-delta. It affects the
growth of malignant (cancerous)
lymphocytes (a type of white blood
cell), causing them to die.
Your doctor may prescribe ZYDELIG
for the treatment of:
_CHRONIC LYMPHOCYTIC _
_LEUKAEMIA/SMALL LYMPHOCYTIC _
_LYMPHOMA _
Chronic lymphocytic leukaemia
(CLL)/small lymphocytic lymphoma
(SLL) are cancers of the blood which
affect a type of white blood cell called
lymphocytes. The lymphocytes become
abnormal causing them to multiply too
quickly and live for too long. Patients
with CLL/SLL have too many abnormal
lymphocytes circulating in the blood,
causing the symptoms you may have.
The disease can also affect other organs
in your body.
ZYDELIG is used in combination with
other medicines, for the treatment of
CLL/SLL in patients whose disease has
returned following a period of
improvement.
_FOLLICULAR LYMPHOMA _
Follicular lymphoma (FL) is a cancer of
the lymphatic system affecting a type of
white blood cell called lymphocytes.
The lymphocytes become abnormal
causing them to multiply too quickly
and live for too long and are involved in
the cause of some of the symptoms you
may have. ZYDELIG is a medicine that
can be used for the treatment of FL in
patients

Summary of Product characteristics

ZYDELIG Data Sheet v2.0– ( 23 June 2016) Page 1 of 16
DATA SHEET
ZYDELIG
® (100 MG AND 150 MG IDELALISIB) TABLETS
NAME OF THE MEDICINE
ZYDELIG (100 mg and 150 mg idelalisib) tablets.
The active substance in ZYDELIG tablets is idelalisib.
ZYDELIG is the brand name for idelalisib, an isoform-selective,
small-molecule
inhibitor of phosphatidylinositol 3-kinase p110δ (PI3Kδ).
DESCRIPTION
_IDELALISIB: _The chemical name for idelalisib is
5-fluoro-3-phenyl-2-[(1_S_)-1-(9_H_-purin-6-
ylamino)propyl]quinazolin-4(3_H_)-one. It has a molecular formula of C
22
H
18
FN
7
O and a
molecular weight of 415.42. It has the following structural formula:
CAS registry number: 870281-82-6
Idelalisib is a white to off-white solid with a pH-dependent aqueous
solubility ranging
from <0.1 mg/mL at pH 5-7 to over 1 mg/mL at pH 2 under ambient
conditions. The partition coefficient
(_log p_) for idelalisib is 2.0 and the pKa is 1.6, 3.4 and 9.8.
ZYDELIG 100 mg tablets are for oral administration. Each tablet
contains 100 mg
of idelalisib and the following ingredients as excipients:
_Tablet core_; microcrystalline cellulose, hydroxypropylcellulose,
croscarmellose sodium, sodium starch
glycolate, and magnesium stearate.
_Film-coating_: sunset yellow FCF aluminium lake (E110), macrogol 3350
(E1521), talc (E553B), polyvinyl
alcohol (E1203), and titanium dioxide (E171).
ZYDELIG 150 mg tablets are for oral administration. Each tablet
contains 150 mg
of idelalisib and the following ingredients as excipients:
_Tablet core:_cellulose-microcrystalline, hydroxypropylcellulose,
croscarmellose sodium, sodium starch
glycolate, and magnesium stearate.
ZYDELIG Data Sheet v2.0– ( 23 June 2016) Page 2 of 16
_Film-coating_: iron oxide red (E172), macrogol 3350 (E1521), talc
(E553B), polyvinyl alcohol (E1203),
and titanium dioxide (E171).
The tablets are supplied in bottles with child resistant closures.
PHARMACOLOGY
_Pharmacotherapeutic group:_ antineoplastic agents, ATC code: L01XX47.
_ _
MECHANISM OF ACTION
Idelalisib inhibits PI3Kδ kinase, which is