ZYDELIG idelalisib 150 mg tablet bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

idelalisib, Quantity: 150 mg

Available from:

Gilead Sciences Pty Ltd

INN (International Name):

idelalisib

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: hyprolose; sodium starch glycollate; croscarmellose sodium; magnesium stearate; titanium dioxide; purified talc; iron oxide red; polyvinyl alcohol; macrogol 3350

Administration route:

Oral

Units in package:

60 Tablets, Bottle

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

ZYDELIG in combination with rituximab is indicated for the treatment of adult patients with chronic lymphocytic leukaemia (CLL)/small lymphocytic lymphoma (SLL) upon relapse in patients for whom chemo-immunotherapy is not considered suitable. ? ZYDELIG in combination with ofatumumab is indicated for the treatment of adult patients with CLL/SLL upon relapse in patients for whom chemo-immunotherapy is not considered suitable. ? ZYDELIG is indicated as monotherapy for the treatment of patients with follicular lymphoma which is refractory to at least two prior systemic therapies. The disease must be refractory to both rituximab and an alkylating agent.

Product summary:

Visual Identification: Each 150 mg ZYDELIG tablet is oval-shaped, film-coated and pink in colour. Each tablet is debossed with GSI on one side and 150 on the other.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 60 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Licence status A

Authorization date:

2015-02-09

Patient Information leaflet

ZYDELIG
®
Consumer Medicine Information V3.0 – (1 February 2017) Page 1 of 5
ZYDELIG
®
TABLETS
_(ZI-DEL-IG) _
100 MG AND 150 MG TABLETS
_Idelalisib _
CONSUMER MEDICINE INFORMATION
WARNING: ZYDELIG CAN CAUSE SERIOUS INFECTIONS THAT MAY LEAD TO DEATH.
TELL YOUR DOCTOR RIGHT AWAY IF
YOU HAVE A FEVER OR ANY SIGNS OF AN INFECTION WHILE TAKING ZYDELIG.
IF YOU HAVE THE ABOVE SERIOUS SIDE EFFECT DURING TREATMENT WITH
ZYDELIG, YOUR DOCTOR MAY COMPLETELY
STOP YOUR TREATMENT, STOP YOUR TREATMENT FOR A PERIOD OF TIME, OR
CHANGE YOUR DOSE OF ZYDELIG.
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.
_FOLLIC

Summary of Product characteristics

ZYDELIG Product Information v7.0 – (11 December 2020) Page 1
PRODUCT INFORMATION
AUSTRALIAN PRODUCT INFORMATION
ZYDELIG
® (100 MG AND 150 MG IDELALISIB) TABLETS
1
NAME OF THE MEDICINE
ZYDELIG (idelalisib)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
ZYDELIG (100 mg and 150 mg idelalisib) tablets. The active substance
in ZYDELIG tablets is idelalisib.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
ZYDELIG is available as tablets. ZYDELIG tablets are for oral
administration. Each tablet contains 100
mg or 150 mg idelalisib. Each 100 mg ZYDELIG tablet is oval-shaped,
film-coated and orange in colour.
Each tablet is debossed with ‘GSI’ on one side and ‘100’ on
the other side. Each 150 mg ZYDELIG tablet
is oval-shaped, film-coated and pink in colour. Each tablet is
debossed with ‘GSI’ on one side and ‘150’
on the other side.
ZYDELIG
is
the
brand
name
for
idelalisib,
an
isoform-selective,
small-molecule
inhibitor
of
phosphatidylinositol 3-kinase p110δ (PI3Kδ).
IDELALISIB CAN CAUSE SERIOUS INFECTIONS.
The increased risk of infection may be due to
immunomodulatory effects of the drug.
In three large randomised studies in relapsed early-line iNHL and
first-line CLL patients, more
patients died in idelalisib-containing arms than in placebo-containing
arms (7.4% vs 3.5%). Death
often occurred within 180 days of treatment starting (4.4% vs 1.0%
respectively) and was often due
to infection (e.g. sepsis and pneumonia). These studies were stopped
early.
In approved uses of idelalisib, the risk of serious infection is also
considered present, therefore:
−
Do not start idelalisib treatment in patients with active infection.
−
Use antibiotic prophylaxis against
_Pneumocystis jirovecii _
throughout idelalisib treatment and for
a period of time after treatment is stopped.
−
Monitor closely for laboratory and clinical evidence of CMV infection.
Use of idelalisib may
need to be interrupted or stopped.
See section 4.4 Special warnings and precautions for use– Seriou