ZYDELIG

Main information

  • Trade name:
  • ZYDELIG idelalisib 100 mg tablet bottle
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ZYDELIG idelalisib 100 mg tablet bottle
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218837
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218837

ZYDELIG idelalisib 100 mg tablet bottle

ARTG entry for

Medicine Registered

Sponsor

Gilead Sciences Pty Ltd

Postal Address

Level 6 / 417 St Kilda Road,MELBOURNE, VIC, 3004

Australia

ARTG Start Date

9/02/2015

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

Conditions

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

1. ZYDELIG idelalisib 100 mg tablet bottle

Product Type

Single Medicine Product

Effective date

3/03/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific 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.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Bottle

HDPE

48 Months

Store below 30

degrees Celsius

Child resistant closure

Store at room

temperature

Pack Size/Poison information

Pack Size

Poison Schedule

60 Tablets, Bottle

(S4) Prescription Only Medicine

Components

1. ZYDELIG idelalisib 100 mg tablet bottle

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

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.

Active Ingredients

idelalisib

100 mg

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 19.10.2017 at 04:54:36 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

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.

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 whose disease no longer

responds to other treatments.

Your doctor may have prescribed

ZYDELIG for another reason.

This medicine is available only with a

doctor's prescription.

Do not give this medicine to a child

under the age of 18 years.

Safety and effectiveness in children

younger than 18 years have not been

established.

Before you take Zydelig

When you must not take it

Together with your doctor, you need to

decide whether ZYDELIG is right for

you.

Do not take ZYDELIG if you have an

allergy to:

any medicine containing idelalisib

any of the ingredients listed at the

end of this leaflet.

Some of the symptoms of an allergic

reaction may include:

shortness of breath

wheezing or difficulty breathing

swelling of the face, lips, tongue or

other parts of the body

rash, itching or hives on the skin.

ZYDELIG

Consumer Medicine Information V3.0 – (1 February 2017) Page 2 of 5

Before you start to take it

Tell your doctor if you have allergies

to any other medicines, foods,

preservatives or dyes.

Tell your doctor if you have or have

had any of the following medical

conditions:

have an active infection

have lung or breathing problems

have liver problems, including

Hepatitis B or Hepatitis C

Your doctor may screen you for

Hepatitis B or Hepatitis C infection

before you start your treatment with

ZYDELIG.

ZYDELIG may increase the risk of

the following symptoms during

treatment:

diarrhoea

fever

Tell your doctor as soon as possible if

you have these symptoms or you

experience any changes in these

symptoms.

Tell your doctor if you are pregnant

or plan to become pregnant or are

breast-feeding.

ZYDELIG is not recommended for use

during pregnancy or breast-feeding.

There is no information about the safety

of ZYDELIG in pregnant women.

Use a reliable method of

contraception to avoid becoming

pregnant while you’re being treated

with ZYDELIG and for 1 month after

your last treatment.

Your doctor will discuss the potential

benefits and risks of taking ZYDELIG

to you and your child.

It is not known whether the ingredients

in ZYDELIG pass into human milk.

If you are breast-feeding, talk to you

doctor to discuss whether you should

continue before starting treatment with

ZYDELIG.

If you have not told your doctor about

any of the above, tell him/her before

you start taking ZYDELIG.

Infection

Tell your doctor right away if you get

any of the following symptoms during

treatment with ZYDELIG:

fever, severe chills, sore throat or

mouth

cough or flu-like symptoms

blood in your phlegm

muscle aches

diarrhoea or stomach pain

burning when you urinate or

urinating more often than normal

tiredness, headaches, being short of

breath when exercising, dizziness

and looking pale.

Severe Skin Reactions

Tell your doctor if you get any of the

following symptoms during treatment

with ZYDELIG:

painful sores or ulcers on your skin,

lips or in your mouth

severe rash with blisters or peeling

skin.

Liver Problems

Tell your doctor right away if you get

any of the following symptoms of liver

problems:

yellowing of your skin or the white

part of your eyes (jaundice)

dark or brown (tea coloured) urine

pain in the upper right side of your

stomach area (abdomen)

bleeding or bruising more easily than

normal.

Blood tests may also show changes in

your liver.

Before and during treatment with

ZYDELIG, you will have regular blood

tests to check for the proper functioning

of your liver. Your doctor may decide to

temporarily interrupt treatment to allow

your liver to recover, before resuming

treatment at the same or a lower dose.

Immunisation and ZYDELIG

There is not enough information

available about the use of immunisation

with ZYDELIG.

Your doctor will determine if you are at

substantial risk of an infection (eg,

influenza or pneumoccal sepsis) that

may be prevented by immunisation.

Your doctor may consider giving you

the vaccine prior to treatment.

Progressive multifocal

leukoencephalopathy (PML)

PML is a serious and life threatening

brain condition. PML has been reported

in some patients who have received

immunotherapy.

Taking other medicines

Tell your doctor or pharmacist if you

are taking any other medications,

herbal supplements, or vitamins

including any that you get without a

prescription from your pharmacy,

supermarket or health food shop.

Some medicines and ZYDELIG may

interfere with each other. These include:

carbamazepine, phenytoin (used to

prevent seizures)

rifampicin (used to prevent and treat

tuberculosis and other infections)

St. John’s Wort (Hypericum

perforatum, a herbal remedy used for

depression and anxiety)

alfentanil, fentanyl (used for pain

relief)

ciclosporin, sirolimus, tacrolimus

(used to control your body’s immune

response after a transplant)

dihydroergotamine, ergotamine

(used to treat migraine headache)

ZYDELIG

Consumer Medicine Information V3.0 – (1 February 2017) Page 3 of 5

pimozide (used to treat illnesses

affecting the way you think, feel or

behave)

quinidine (used to correct irregular

heartbeats).

These medicines may be affected by

ZYDELIG or may affect how well it

works. You may need different amounts

of your medicines, or you may need to

take different medicines.

Your doctor and pharmacist have more

information on medicines to be careful

with or avoid while taking this

medicine.

Know the medicines you take. Keep a

list of medicines and show it to your

doctor and pharmacist when you get a

new medicine.

Do not start any new medicines while

you are taking ZYDELIG without

first talking with your doctor or

pharmacist.

How to take Zydelig

Follow all directions given to you by

your doctor or pharmacist carefully.

They may differ from the information

contained in this leaflet.

If you do not understand the

instructions on the bottle, ask your

doctor or pharmacist for help.

How much to take

The recommended dose for adults is

150 mg administered orally twice daily.

Take the exact amount of ZYDELIG

your doctor has prescribed for you.

Never change the dose on your own.

Your dose may be reduced by your

doctor to 100 mg (taken orally twice

daily) if you experience particular side

effects.

How to take it

Swallow the tablet whole.

Do not chew, crush or split the tablet.

Tell your doctor if you have problems

swallowing tablets.

When to take it

Take your medicine at about the same

times each day.

Taking it at the same times each day

will help you remember when to take it.

ZYDELIG can be taken with or without

food.

How long to take it

Continue taking your medicine for as

long as your doctor tells you.

It is important to keep taking your

medicine even if you feel well.

Do not stop this medicine unless your

healthcare provider tells you to stop.

If you forget to take it

If you miss a dose of ZYDELIG by

less than 6 hours, take the missed dose

right away.

Then take your next dose as you would

normally.

If you miss a dose of ZYDELIG by

more than 6 hours, skip the dose you

missed and take your next dose when

you would normally.

Do not change your dose or stop

taking ZYDELIG without first

talking to your doctor.

If you take too much

(overdose)

Immediately telephone your doctor or

Poisons Information Centre: 131126

(Australia) and 0800 764 766 (New

Zealand) or go to the accident and

emergency department at your

nearest hospital, if you think you or

anyone else may have taken too many

ZYDELIG tablets. Do this even if

there are no signs of discomfort or

poisoning. This may need urgent

medical attention.

If you accidentally take more than the

recommended dose of ZYDELIG you

may be at increased risk of experiencing

possible side effects with this medicine.

While you are taking

Zydelig

Things you must not do

Do not breast-feed. See “Before you

start to take it”

Do not take ZYDELIG after the

expiry or “use by” date (EXP) printed

on the bottle. If you take it after the

expiry date has passed, it may not

work as well.

Do not take ZYDELIG if the

packaging is torn or shows signs of

tampering.

Things to be careful of

Driving and using machines

You may feel tired after taking

ZYDELIG, which may affect your

ability to drive or use any tools or

machinery.

Side effects

Tell your doctor or pharmacist as

soon as possible if you do not feel well

while you are taking ZYDELIG, even

if you do not think the problems are

connected with the medicine or are

not listed in this leaflet.

All medicines can have side effects.

Sometimes they are serious, most of the

time they are not. You may need

ZYDELIG

Consumer Medicine Information V3.0 – (1 February 2017) Page 4 of 5

medical attention if you get some of the

side effects.

Do not be alarmed by the following

lists of side effects. You may not

experience any of them.

Ask your doctor or pharmacist to

answer any questions you may have.

Tell your doctor or pharmacist if you

notice any of the following:

diarrhoea/inflammation of the large

intestine

decreased number of white blood

cells

infections

rash

fever

The above list includes the more

common side effects of your medicine

(may affect at least 1 in every 10

patients treated).

Other side effects include:

lung inflammation

increased blood levels of liver

enzymes or fats

Tell your doctor right away if you get

new or worsening cough, shortening

of breath, difficulty breathing, or

wheezing.

Ask your doctor or pharmacist if you

don’t understand anything in this list.

This is not a complete list of side effects

possible with ZYDELIG. Ask your

doctor or pharmacist for a more

complete list of side effects of

ZYDELIG and all the medicines you

will take.

After taking ZYDELIG

Storage

Keep ZYDELIG tablets where

children cannot reach them.

A locked cupboard at least one-and-a

half metres above the ground is a good

place to store them.

Keep ZYDELIG tablets in a cool, dry

place where it stays below 30°C.

Do not store ZYDELIG or any other

medicine in a bathroom or near a

sink.

Do not leave ZYDELIG in the car or

on a window sill.

Heat and dampness can destroy some

medicines.

Keep your ZYDELIG tablets in the

bottle with the cap tightly closed until

you take them.

If you take ZYDELIG tablets out of

their pack they may not keep well.

Do not use this medicine after the

expiry date which is stated on the

bottle and carton after EXP.

The expiry date refers to the last day of

that month.

Product description

What it looks like

ZYDELIG 150 mg film-coated tablets

are pink, oval-shaped film-coated

tablets, debossed on one side with “GSI”

and “150” on the other side.

ZYDELIG 100 mg film-coated tablets

are orange, oval-shaped film-coated

tablets, debossed on one side with “GSI”

and “100” on the other side.

ZYDELIG tablets are supplied in bottles

containing 60 tablets.

Ingredients

ZYDELIG 150 mg film-coated tablets

contain 150 mg of idelalisib as the

active ingredient.

It also contains:

microcrystalline cellulose

hyprolose

croscarmellose sodium

sodium starch glycolate

magnesium stearate

Film-coating:

polyvinyl alcohol (E1203)

macrogol 3350 (E1521)

titanium dioxide (E171)

talc (E553B)

iron oxide red (E172)

ZYDELIG 100 mg film-coated tablets

contain 100 mg of idelalisib as the

active ingredient.

It also contains:

microcrystalline cellulose

hyprolose

croscarmellose sodium

sodium starch glycolate

magnesium stearate

Film-coating:

Polyvinyl alcohol (E1203)

macrogol 3350 (E1521)

titanium dioxide (E171)

talc (E553B)

sunset yellow FCF aluminium lake

(E110).

Sponsor

ZYDELIG is supplied in Australia by:

Gilead Sciences Pty Ltd

Level 6, 417 St Kilda Road

Melbourne, Victoria 3004

Date of Preparation: 1 February 2017

AUST R 218837 - 100 mg

AUST R 218839 - 150 mg

ZYDELIG

Consumer Medicine Information V3.0 – (1 February 2017) Page 5 of 5

ZYDELIG is a trademark or registered

trademark of Gilead Sciences, Inc., or its

related companies. All other trademarks

referenced herein are the property of

their respective owners.

11-6-2018

Zydelig (Gilead Sciences Ireland UC)

Zydelig (Gilead Sciences Ireland UC)

Zydelig (Active substance: idelalisib) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3765 of Mon, 11 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3843/T/40

Europe -DG Health and Food Safety