CELAZADINE

Main information

  • Trade name:
  • CELAZADINE azacitidine 100mg powder for injection vial
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CELAZADINE azacitidine 100mg powder for injection vial
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 216327
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

216327

CELAZADINE azacitidine 100mg powder for injection vial

ARTG entry for

Medicine Registered

Sponsor

Celgene Pty Ltd

Postal Address

Level 15 / 60 City Road,Southbank, VIC, 3006

Australia

ARTG Start Date

20/10/2014

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. CELAZADINE azacitidine 100mg powder for injection vial

Product Type

Single Medicine Product

Effective date

5/09/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

a)Intermediate-2 and High-risk Myelodysplastic Syndromes (MDS) according to the International Prognostic Scoring System (IPSS), b)Chronic

Myelomonocytic Leukemia (CMMoL 10%-29% marrow blasts without Myeloproliferative Disorder)), c) Acute Myeloid Leukemia (AML) with 20-30% blasts

and multi-lineage dysplasia, according to World Health Organisation Classification (WHO), in whom allogenic stem cell transplantation is not indicated.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Vial

Glass Type I Clear

4 Years

Store below 25

degrees Celsius

Not recorded

See Product

information for shelf

life

Pack Size/Poison information

Pack Size

Poison Schedule

1 vial

(S4) Prescription Only Medicine

Components

1. CELAZADINE azacitidine 100 mg powder for injection vial

Dosage Form

Injection, powder for

Route of Administration

Subcutaneous

Intravenous Infusion

Visual Identification

White to off-white, sterile lyophilised powder

Active Ingredients

Azacitidine

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 26.11.2017 at 07:28:20 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

CELAZADINE

powder for injection

azacitidine 100 mg

Consumer Medicine Information

WHAT IS IN THIS

LEAFLET

This leaflet answers some common

questions about Celazadine.

It does not contain all the available

information.

It does not take the place of talking to

your doctor or pharmacist.

All medicines have risks and

benefits. Your doctor has weighed

the risks of you taking Celazadine

against the benefits this medicine is

expected to have for you.

If you have any concerns about

taking this medicine, ask your

doctor or pharmacist.

Keep this leaflet with the medicine.

You may need to read it again.

WHAT IS

CELAZADINE USED

FOR

Celazadine is an anti-cancer agent.

This product contains a medicine

called azacitidine which prevents the

growth of cancer cells. Celazadine

has been prescribed by your doctor

for the treatment of myelodysplastic

syndrome (MDS). Myelodysplastic

syndrome is a blood disorder in

which the bone marrow is not

working normally and does not

produce enough mature blood cells.

This causes a lack of healthy blood

cells that can function properly in the

body.

Ask your doctor if you have any

questions about how this medicine

works, or why this medicine has

been prescribed for you.

Your doctor may have prescribed it

for another reason.

Celazadine will only be prescribed to

you by a doctor who has experience

in medicines to treat cancers of the

blood.

BEFORE YOU ARE

GIVEN CELAZADINE

When you must not be given

Celazadine

Tell your doctor:

If you are allergic to azacitidine

or any of the other ingredients

of the product 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.

If you have advanced liver

cancer.

If you are pregnant.

If you have severe problems

with your kidney function.

Before you are given

Celazadine

1.

Use by women

Avoid becoming pregnant while

receiving this medicine but, if you

do, tell your doctor immediately.

Use an effective method of

contraception during treatment

with this medicine and for up to

three (3) months after

discontinuation of the medicine.

Do not breast-feed while you are

receiving Celazadine but, if you do,

tell your doctor immediately.

It is not known if azacitidine is

excreted in human milk.

2.

Use by men

Do not father a child while

receiving treatment with

Celazadine.

Use barrier methods of

contraception (e.g. condoms)

during treatment and for up to

three (3) months after

discontinuation of this medicine, if

your partner is of childbearing

potential.

Talk to your doctor if you wish to

conserve your sperm before having

this treatment.

3.

Use by all patients

Tell your doctor if you have

allergies to any other medicines,

foods, preservatives or dyes.

Do not give Celazadine to children

(under 18 years).

Before receiving this medicine, tell

your doctor if you have had any

heart problems or lung disease.

You will have blood tests before you

begin treatment with Celazadine and

at the start of each period of

treatment (called a 'cycle'). This is to

check that you have enough blood

CELAZADINE - AU CMI CELGENE V2.4.1 - MAY 2017

cells and that your liver and kidneys

are working properly.

If you are older than 65 years, your

doctor will give you the regular

blood tests described above but may

also check your kidney function

during your treatment with other

tests.

Taking other medicines

Tell your doctor if you are taking

any other medicines or have

recently taken any other

medicines, including any medicines

that you buy without a

prescription from a pharmacy,

supermarket or health food shop.

HOW YOU WILL BE

GIVEN CELAZADINE

Celazadine will be given to you as an

injection under the skin

(subcutaneously i.e. under the skin

on your thigh, abdomen or upper

arm) or as an intravenous infusion by

a doctor or nurse.

Your doctor will choose the correct

dose of this medicine for you.

Your dose will depend on your

general condition and your height

and weight.

Your dose will be calculated

based on your body surface area,

with the usual dose of 75 mg

Celazadine per m

of body

surface.

Initially, this medicine will be

given daily for 7 days. 21 days

later, you will have Celazadine

for another 7 days. This is called

a cycle. The cycle is repeated

every 28 days for a minimum of 6

cycles.

Your doctor will check your

progress and may change your

dose if necessary.

Celazadine can cause nausea and

vomiting. To stop you from getting

sick (nausea and vomiting), your

doctor may give you another

medicine at the start of each

treatment cycle with Celazadine.

If you have any further questions on

the use of this medicine, ask your

doctor or pharmacist.

WHILE YOU ARE

BEING TREATED

WITH CELAZADINE

Things you must do

Tell any other doctors, dentists,

and pharmacists who are treating

you that you are being treated with

Celazadine.

Tell your doctor immediately if

you stop passing urine or if you are

passing less urine than normal.

If you are about to be started on

any new medicine, tell your doctor,

dentist or pharmacist that you are

being treated with this medicine.

If you become pregnant while

taking this medicine, tell your

doctor immediately.

Keep all your doctor's

appointments so that your progress

can be checked.

Your doctor will do some tests e.g.

blood tests, at regular intervals to

make sure the medicine is working

and to prevent any unwanted side

effects.

Things to be careful of

Be careful driving or operating

machinery until you know how

Celazadine affects you.

SIDE EFFECTS

Tell your doctor or pharmacist as

soon as possible if you do not feel

well while you are receiving

Celazadine.

Like all medicines, this medicine can

have side effects, although not

everybody gets them. Sometimes

they are serious, most of the time

they are not. You may need medical

attention if you get some of the side

effects.

Do not be alarmed by the following

list of side effects. You may not

experience any of them.

Tell your doctor or pharmacist if

you notice any of the following and

they worry you:

Sore throat or trouble

swallowing; feeling of tension in

the nose, cheeks or behind your

eyes; runny or blocked nose.

Trouble sleeping; feeling tired or

lacking energy; dizziness;

headache; anxiety; or feeling

confused.

Loss of appetite, decreased

weight, constipation, stomach

pain, indigestion.

Cold sores or bleeding from the

gums.

Red or purple, flat, pinhead spots

under the skin; itching; rash;

bruising, redness of the skin;

soreness and swelling at the

injection site; unusual hair loss or

thinning.

Muscle or joint pain.

Chest pain.

The above list includes the more

common side effects of your

medicine.

Tell your doctor as soon as possible

if you notice any of the following:

Bleeding (including nose-

bleeds) or bruising in the

absence of injury, or you are

more tired than usual.

Celazadine can reduce the

number of red blood cells that

carry oxygen around the body and

can also reduce the number of

platelets, which are responsible

for making the blood clot

appropriately.

Pain in one or both eyes,

changes in vision.

This could be due bleeding in

your eyes.

Blood in the urine.

CELAZADINE - AU CMI CELGENE V2.4.1 - MAY 2017

The above list includes serious side

effects that may require medical

attention.

If any of the following happen, tell

your doctor immediately or go to

Accident and Emergency at your

nearest hospital:

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.

These could be symptoms of an

allergic reaction.

A sudden severe headache;

weakness or numbness in the

face, arm or leg; changes in

vision; trouble speaking or

understanding speech; or loss

of coordination.

These could be signs of bleeding

in the brain (a type of stroke).

Fever; chills; shortness of

breath; cough; phlegm; or

occasionally coughing up blood.

These could be the symptoms of

pneumonia (a serious lung

infection).

Fever; severe chills; hot, tender

and red skin; rapid breathing;

rapid pulse; confusion; nausea;

vomiting; diarrhoea; pain or

burning when you urinate; sore

mouth or throat; or mouth

ulcers.

These could be symptoms of

sepsis (blood infection) or other

frequent infections.

Vomiting blood or material that

looks like coffee grounds;

bleeding from the back

passage; black sticky bowel

motions (stools); or bloody

diarrhoea.

These could be signs of bleeding

in your gut.

The above list includes very serious

side effects. You may need urgent

medical attention or hospitalisation.

Tell your doctor or pharmacist if

you notice anything that is making

you unwell.

Other side effects not listed above

may also occur in some people.

Some of these side effects (for

example, high blood pressure) can

only be found when your doctor does

tests from time to time to check your

progress.

AFTER BEEN GIVEN

CELAZADINE

Storage

Your doctor or pharmacist is

responsible for storing Celazadine.

They are also responsible for

disposing of any unused product

correctly.

PRODUCT

DESCRIPTION

What this medicine looks

like

Celazadine is a white powder for

suspension for injection and is

supplied in a glass vial containing

100 mg of azacitidine.

Ingredients

The active substance is

azacitidine.

The other ingredient is mannitol.

This medicine does not contain

lactose.

Supplier

Celazadine is supplied in Australia

Celgene Pty Limited

Level 15, 60 City Road

Southbank VIC 3006.

Telephone: 1800 CELGENE (1800

235 4363)

® = Registered Trademark

This leaflet was updated in May

2017.

Australian Registration Number:

216327

CELAZADINE - AU CMI CELGENE V2.4.1 - MAY 2017

18-7-2018

Orphan designation:  Azacitidine,  for the: Treatment of acute myeloid leukaemia

Orphan designation: Azacitidine, for the: Treatment of acute myeloid leukaemia

Europe - EMA - European Medicines Agency

1-8-2018

Vidaza (Celgene Europe B.V.)

Vidaza (Celgene Europe B.V.)

Vidaza (Active substance: Azacitidine) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5208 of Wed, 01 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/978/T/42

Europe -DG Health and Food Safety

27-6-2018

EU/3/07/509 (Celgene Europe B.V.)

EU/3/07/509 (Celgene Europe B.V.)

EU/3/07/509 (Active substance: Azacitidine) - Transfer of orphan designation - Commission Decision (2018)4086 of Wed, 27 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/OD/085/07/T/02

Europe -DG Health and Food Safety

27-6-2018

EU/3/01/084 (Celgene Europe B.V.)

EU/3/01/084 (Celgene Europe B.V.)

EU/3/01/084 (Active substance: Azacitidine) - Transfer of orphan designation - Commission Decision (2018)4083 of Wed, 27 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/OD/059/01/T/02

Europe -DG Health and Food Safety