ELELYSO

Main information

  • Trade name:
  • ELELYSO taliglucerase alfa rpc 200 units powder for injection
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ELELYSO taliglucerase alfa rpc 200 units powder for injection
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 207695
  • Last update:
  • 10-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

207695

ELELYSO taliglucerase alfa rpc 200 units powder for injection

ARTG entry for

Medicine Registered

Sponsor

Pfizer Australia Pty Ltd

Postal Address

38-42 Wharf Road,WEST RYDE, NSW, 2114

Australia

ARTG Start Date

21/05/2014

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. ELELYSO taliglucerase alfa rpc 200 units powder for injection

Product Type

Single Medicine Product

Effective date

14/09/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

ELELYSO is indicated for long-term enzyme replacement therapy for adult and paediatric patients with a confirmed diagnosis of Type 1 Gaucher disease

associated with at least one of the following: splenomegaly, hepatomegaly, anaemia, thrombocytopenia.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Vial

Glass Type I Clear

2 Years

Store at 2 to 8

degrees Celsius

Not recorded

Do not Freeze

Refrigerate

Protect from Light

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

Components

1. ELELYSO taliglucerase alfa rpc 200 units powder for injection

Dosage Form

Injection, powder for

Route of Administration

Intravenous

Visual Identification

white to off-white powder, may form cake.

Active Ingredients

Taliglucerase alfa

212 U

© 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 28.11.2017 at 12:09:52 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

Elelyso

®

taliglucerase alfa rpc

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common

questions about Elelyso.

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 using Elelyso against

the benefits it is expected to have for

you.

Ask your doctor or pharmacist if

you have any concerns about using

this medicine.

Keep this leaflet as you may need

to read it again.

What Elelyso is used

for

Elelyso is an Enzyme Replacement

Therapy which is used to treat Type

1 Gaucher disease in adults and

children (2 to 17 years of age) with at

least one of the following signs of the

condition:

Spleen or liver enlargement

A low number of red blood cells

(anaemia)

A tendency to bleed easily caused

by a low blood platelet count.

(platelets stop blood loss by

forming a plug inside a blood

vessel).

Elelyso has not been studied in Type

2 Gaucher disease.

How Elelyso works

Gaucher disease is a genetic disorder

caused by a missing or defective

enzyme named glucocerebrosidase.

When this enzyme is missing or does

not work properly, a substance called

glucocerebroside builds up inside

cells in the body. The build-up of this

material causes the signs and

symptoms found in Gaucher disease.

Elelyso is designed to replace the

missing or defective enzyme,

glucocerebrosidase, in patients with

Type 1 Gaucher disease.

Ask your doctor if you have any

questions about why this medicine

has been prescribed for you.

Before you are given

Elelyso

When you must not use it

Do not use Elelyso if you have an

allergy to:

Any medicine containing

taliglucerase alfa rpc

Any of the ingredients listed at

the end of this leaflet

Other Enzyme Replacement

Therapies such as Cerezyme

Vpriv

Talk to your doctor if you are not

sure whether you should start

using this medicine.

Before you start to use it

Tell your doctor if you have

previously experienced an

infusion-related reaction or

allergic reaction to other Enzyme

Replacement Therapy for Gaucher

disease.

If you have an infusion-related

reaction you may be given additional

medicines to treat or help prevent

future reactions. These medicines

may include antihistamines,

antipyretics (medicine used to lower

high temperature/fever), and

corticosteroids.

Tell your doctor if you have an

allergy to carrots.

Taliglucerase alfa rpc is

manufactured using carrot cells.

Tell your doctor if you are on a low

salt diet.

Patients on a controlled salt (sodium)

diet should consider that Elelyso is

given in a solution containing sodium

chloride.

Tell your doctor if you are

pregnant or plan to become

pregnant or are breast-feeding.

Your doctor can discuss with you the

risks and benefits involved.

Tell your doctor if you have

experienced difficulty breathing.

Tell your doctor if you have

allergies to any other medicines,

foods, preservatives or dyes.

If you have not told your doctor

about any of the above, tell him/

her before you start taking Elelyso.

Taking other medicines

Tell your doctor or pharmacist if

you are taking any other

medicines, including:

All prescription medicines

All medicines, vitamins, herbal

supplements or natural therapies

you buy without a prescription

ELELYSO

from a pharmacy, supermarket,

naturopath or health food shop.

Some medicines may be affected by

Elelyso 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 will advise you.

Your doctor and pharmacist have

more information on medicines to be

careful with or avoid while using this

medicine.

How Elelyso is given

Elelyso is given through a drip into a

vein (by intravenous infusion). The

drip should be given over at least 60

minutes. It may be given to you at a

hospital, a clinic or, at your home, if

your doctor considers this

appropriate.

Elelyso should only be administered

under the supervision of a doctor (or

healthcare professional) who is

knowledgeable in the treatment of

Gaucher disease.

Home administration may be

considered for patients who tolerate

their infusion well. For home

administration, Elelyso should be

administered by a healthcare

professional trained in managing

infusion-related reactions, under the

direction of a doctor.

How much to use

Your doctor will decide the dosage

and the frequency of the dose

suitable for you.

If you forget to use it

If you miss a dose of Elelyso, tell

your doctor.

If you receive too much

(overdose)

Your doctor will supervise how

much Elelyso you are given. If you

think that you have been given too

much Elelyso tell your doctor or

nurse immediately.

If you need further advice, contact

the Poisons Information Centre

(telephone 13 11 26).

If you stop using Elelyso

Tell your doctor if you intend to

stop the treatment.

Patients should be aware that there

are potential serious consequences in

stopping the treatment and you are

advised to discuss this with your

doctor before doing so.

If you have any further questions

on the use of this medicine, ask

your doctor.

While you are using

Elelyso

Things you must do

If you are about to be started on

any new medicine, remind your

doctor and pharmacist that you

are being given Elelyso.

Tell any other doctors, dentists,

and pharmacists who treat you

that you are using this medicine.

If you are going to have surgery,

tell the surgeon or anaesthetist that

you are using this medicine.

It may affect other medicines used

during, or after surgery.

If you become pregnant while

being given this medicine, tell your

doctor immediately.

If you are about to have any blood

tests, tell your doctor that you are

using this medicine.

It may interfere with the results of

certain tests.

Keep all of your doctor or clinic

appointments so that your progress

can be checked.

Your doctor may do certain tests,

including blood tests, from time to

time to make sure the medicine is

working and to prevent unwanted

side effects.

Things you must not do

Do not stop using your medicine or

lower the dosage without checking

with your doctor.

If you stop using it suddenly, your

condition may worsen or you may

have unwanted side effects.

It is important to have your infusion

at the appropriate time to make sure

the medicine is effective in treating

your condition.

Things to be careful of

Be careful driving or operating

machinery until you know how

Elelyso may affect you.

Be careful when drinking alcohol

while you are using this medicine.

Side effects

Tell your doctor or pharmacist as

soon as possible if you do not feel

well while you are being given

Elelyso.

All medicines can have side effects.

Sometimes they are serious, most of

the time they are not. You may need

medical attention if you get some of

the side effects.

It can be difficult to tell whether side

effects are the result of using Elelyso,

effects of your condition or side

effects of other medicines you may

be taking. For this reason it is

important to tell your doctor of any

change in your condition.

Do not be alarmed by the list of

side effects.

You may not experience any of them.

Ask your doctor or pharmacist to

answer any questions you may

have.

Infusion-related reactions

Common side effects occurring

during infusion or within 24 hours of

receiving Elelyso include:

Muscle pain, joint pain or spasm

Headache

ELELYSO

Vomiting

Stomach pains

Pain in hands or feet

Itching

Allergic reaction

Nausea

Limb swelling

Throat irritation

Redness of skin

Urticaria (slightly elevated

patches on the skin) or hives

Swelling of the eyes

Feeling hot (flushing)

Feeling uncomfortable in your

chest

Diarrhoea

Shaking

Rash.

Other common side effects

Dizziness

Bone pain

Back pain

Infusion site pain

Tiredness

Weight increase.

Tell your doctor if...

Severe allergic reactions are less

common side effects of Elelyso but

may be serious.

Tell your doctor immediately if

you experience any of the allergic

reactions listed below:

Difficulty breathing or shortness

of breath

Swelling of the face, lips, tongue

or throat.

If you experience any of the

allergic reactions listed above go to

hospital immediately as you may

require urgent medical attention.

Tell your doctor or pharmacist if

you notice anything else that is

making you feel unwell.

Other side effects not listed above

may also occur in some people.

Some of these side effects can only

be found when your doctor does tests

from time to time to check your

progress.

After using Elelyso

Storage

Keep out of the reach and sight of

children.

Unopened vials

Store in a refrigerator (2°C to 8°C).

Do not freeze. Protect from light.

Keep the vial in the outer carton until

use.

Do not use Elelyso after the expiry

date printed on the label. The expiry

date refers to the last date of that

month.

Reconstituted and diluted solutions

Elelyso should be mixed

(reconstituted) and diluted just before

use and used immediately. If not

used immediately, in-use storage

times and conditions of the

reconstituted solution and the diluted

solution prior to use are the

responsibility of the user.

The reconstituted vial and the diluted

solution that is made from the

reconstituted vial can be stored for a

combined time of not more than 24

hours at 2°C to 8°C under protection

from light after the initial

reconstitution step.

Disposal

If your doctor tells you to stop

using this medicine or the expiry

date has passed, ask your

pharmacist what to do with any

medicine that is left over.

Product description

What it looks like

Elelyso 200 units is presented as a

powder for injection (a single vial in

a carton).

Elelyso is supplied as a white to off-

white powder that may form a cake.

After reconstitution the solution is a

clear, colourless liquid. The

reconstituted solution must be further

diluted for infusion.

Ingredients

The active ingredient in Elelyso is

taliglucerase alfa rpc.

The other ingredients are:

Mannitol

Sodium citrate dihydrate

Polysorbate 80.

This medicine does not contain

lactose, sucrose, gluten, tartrazine or

any other azo dyes.

Supplier

Pfizer Australia Pty Ltd

ABN 50 008 422 348

38-42 Wharf Road

West Ryde NSW 2114

Australia

Toll Free number: 1800 675 229

Australian registration

numbers

AUST R 207695.

Date of preparation

This leaflet was prepared in October

2017.

= Registered Trademark

© Pfizer Australia Pty Ltd 2017.

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