ELOCTATE

Main information

  • Trade name:
  • ELOCTATE efmoroctocog alfa (rhu) 250 IU powder for injection vial and diluent pre-filled syringe
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ELOCTATE efmoroctocog alfa (rhu) 250 IU powder for injection vial and diluent pre-filled syringe
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 210521
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

210521

ELOCTATE efmoroctocog alfa (rhu) 250 IU powder for injection vial and diluent pre-filled syringe

ARTG entry for

Medicine Registered

Sponsor

Bioverativ Australia Pty Ltd

Postal Address

Level 27 AMP Centre 50 Bridge Street,Sydney, NSW, 2000

Australia

ARTG Start Date

27/06/2014

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. ELOCTATE efmoroctocog alfa (rhu) 250 IU powder for injection vial and diluent pre-filled syringe

Product Type

Composite Pack

Effective date

12/04/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

ELOCTATE is a long-acting antihaemophilic factor (recombinant) indicated in adults and children with haemophilia A (congenital factor VIII deficiency)

for:

- control and prevention of bleeding episodes

- routine prophylaxis to prevent or reduce the frequency of bleeding episodes

- perioperative management (surgical prophylaxis).

ELOCTATE does not contain von Willebrand factor, and therefore is not indicated in patients with von Willebrand's disease.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Multiple containers

Not recorded

48 Months

Store at 2 to 8

degrees Celsius

Not recorded

Protect from Light

Refrigerate

Do not Freeze

Pack Size/Poison information

Pack Size

Poison Schedule

1s (vial + diluent)

exempt from scheduling - Appendix A; prescription medicine

Components

1. vial adaptor reconstitution device

Dosage Form

Drug delivery system

Route of Administration

Intravenous

Visual Identification

2. syringe

Dosage Form

Injection, solvent for

Route of Administration

Intravenous Infusion

Visual Identification

Clear, colorless, odorless liquid, essentially free from visible particulates

3. vial

Dosage Form

Injection, powder for

Route of Administration

Intravenous Infusion

Visual Identification

white to off-white powder to cake

Active Ingredients

efmoroctocog alfa

250 IU

Public Summary

Page 1 of

Produced at 20.10.2017 at 08:10:55 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

© 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 2 of

Produced at 20.10.2017 at 08:10:55 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

ELOCTATE

ELOCTATE

®

Efmoroctocog alfa (recombinant coagulation factor VIII Fc fusion protein) 250, 500, 750, 1000, 1500,

2000, 3000 IU/vial

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common

questions about ELOCTATE.

It does not contain all of the available

information. It does not take the

place of talking to your doctor or

pharmacist.

This leaflet was last updated on the

date at the end of this leaflet.

Speak to your doctor or your

Haemophilia Treatment Centre to

obtain the most up to date

information on this medicine.

You can also download the most

up to date leaflet from

www.medicines.org.au.

All medicines have risks and

benefits. Your doctor has weighed

the risks of you using ELOCTATE

against the benefits they expect it

will have for you.

If you have any concerns about using

this medicine, ask your doctor.

Keep this leaflet with the medicine.

You may need to read it again.

What ELOCTATE is

used for

ELOCTATE is used for the

management of haemophilia A

(congenital factor VIII deficiency).

ELOCTATE is used to:

control and prevent bleeding

episodes

routinely prevent and reduce the

frequency of bleeding episodes

reduce bleeding before, during,

and after surgery.

Eloctate does not contain von

Willebrand factor and therefore is not

suitable for use in Von Willebrand’s

disease.

People with haemophilia A lack

sufficient factor VIII to control

bleeding. ELOCTATE works by

replacing factor VIII to enable blood

to clot.

Ask your doctor if you have any

questions about why this medicine

has been prescribed for you.

Your doctor may have prescribed it

for another reason.

This medicine is not addictive.

It is available only with a doctor's

prescription.

Do not give this medicine to anyone

else.

It may harm them, even if their

symptoms are the same as yours.

Before you use

ELOCTATE

When you must not use it

Do not use ELOCTATE if you

have an allergy to:

ELOCTATE or other factor VIII

replacement factors

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.

If any of these signs occur, stop

using ELOCTATE and see your

doctor immediately.

Do not use this medicine after the

expiry date printed on the pack or

if the packaging is torn or shows

signs of tampering.

If it has expired or is damaged,

return it to your Haemophilia

Treatment Centre or Australian Red

Cross Blood Service for disposal.

Do not use ELOCTATE if the

medicine is cloudy, contains

particles or is discoloured.

It should be clear to slightly

opalescent and colourless.

If you are not sure whether you

should start using this medicine,

talk to your doctor.

Before you start to use it

Tell your doctor if you have

allergies to any other medicines,

foods, preservatives or dyes.

Tell your doctor if you are

pregnant or intend to become

pregnant.

There is no information on the use

of ELOCTATE during pregnancy.

Your doctor will discuss the risks

and benefits of using it if you are

pregnant.

Tell your doctor if you are breast-

feeding or planning to breastfeed.

It is not known whether ELOCTATE

passes into breast milk. Your doctor

will discuss the risks and benefits of

using it if you are breast-feeding.

ELOCTATE

If you have not told your doctor

about any of the above, tell them

before you start using

ELOCTATE.

Taking other medicines

Tell your doctor or Haemophilia

Treatment Centre if you are taking

any other medicines, including any

that you get without a prescription

from your pharmacy, supermarket

or health food shop.

Your doctor or Haemophilia

Treatment Centre have more

information on medicines to be

careful with or avoid while using this

medicine.

How to use

ELOCTATE

Follow all directions given to you

by your doctor carefully.

They may differ from the

information contained in this leaflet.

If you do not understand the

instructions on the box, ask your

doctor or Haemophilia Treatment

Centre for help.

How much to use

Your doctor will decide how much

ELOCTATE you use. This will

depend on your individual need for

replacement factor VIII therapy.

Your doctor may change the dose

you use during your treatment.

Do not stop using ELOCTATE or

change the dosage, without

checking with your doctor unless

you have an allergic reaction.

How to use it

ELOCTATE is given by slow

injection directly into your veins.

ELOCTATE is provided as a powder

and sterile water for injections

(diluent) which need to be mixed

together before use.

It is important to not shake

ELOCTATE when mixing it.

Shaking can damage this medicine.

Mix the ELOCTATE powder with

the diluent provided only when you

are ready to use it.

If you mix the powder and diluent

and are interrupted, you can keep

the mixed product for a maximum

of 6 hours when stored at room

temperature (below 30°C). Protect

the product from direct sunlight.

Do not put it in the freezer.

Always inspect ELOCTATE after

it has been mixed and before use.

The medicine should be clear to

slightly opalescent and colourless.

Do not inject if the solution is

discoloured or cloudy or contains

particles.

Refer to the leaflet in the pack for

step-by-step instructions about

how to prepare and inject

ELOCTATE.

Use in one patient on one occasion

only. Dispose of all unused

solution, empty vials, and used

needles and syringes into a sharps

bin.

Talk to your doctor or Haemophilia

Treatment Centre, or telephone 1800

852 289 in Australia or 0800 852 289

in NZ, if you have any questions

about how to use ELOCTATE.

How long to use it

Continue using your medicine for

as long as your doctor tells you.

This medicine helps to control your

condition, but does not cure it.

If you forget to use it

Use your dose of ELOCTATE as

soon as you remember, and resume

your normal dosing schedule.

Do not use a double dose to make

up for the dose that you missed.

This may increase the chance of you

getting an unwanted side effect.

If you are not sure what to do, ask

your doctor or Haemophilia

Treatment Centre.

If you use too much

(overdose)

Immediately telephone your doctor

or the Poisons Information Centre

(in Australia telephone 13 11 26, in

New Zealand telephone 0800 764

766) for advice, or go to

Emergency at the nearest hospital,

if you think that you or anyone else

may have used too much

ELOCTATE. Do this even if there

are no signs of discomfort or

poisoning.

You may need urgent medical

attention.

While you are using

ELOCTATE

Things you must do

Tell your doctor immediately if

bleeding is not controlled after

using ELOCTATE.

If you become pregnant while on

treatment with ELOCTATE,

immediately tell your doctor.

Always talk to your doctor or

Haemophilia Treatment Centre

before using any other medicine

while you are using ELOCTATE.

Do not use more than the

recommended dose.

Tell any other doctors, dentists and

pharmacists who treat you that

you are using this medicine.

If you are about to have any blood

tests, tell your doctor that you are

using ELOCTATE.

Keep all of your doctor's

appointments so that your progress

can be checked.

Your doctor may do some blood tests

before you start your treatment and

from time to time during your

treatment to monitor your progress.

Things you must not do

Do not use ELOCTATE to treat

any other complaints unless your

doctor tells you to.

ELOCTATE

Do not give your medicine to

anyone else, even if they appear to

have the same condition as you.

Do not stop using your medicine or

change the dosage without

checking with your doctor.

Side effects

Tell your doctor or Haemophilia

Treatment Centre as soon as possible

if you do not feel well while you are

using ELOCTATE.

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.

Do not be alarmed by the following

lists of side effects. You may not

experience any of them.

Ask your doctor or Haemophilia

Treatment Centre to answer any

questions you may have.

Tell your doctor or Haemophilia

Treatment Centre if you notice any

of the following and they worry you:

joint pain or joint swelling

general discomfort (malaise)

feeling cold

feeling hot

headache

stomach pain

dizziness

cough

rash

aching muscles, muscle

tenderness or weakness, not

caused by exercise

taste disturbance or loss of taste

(dysgeusia)

high blood pressure

back pain

low blood pressure (symptoms

include dizziness or feeling

lightheaded)

slow heart beat (bradycardia)

chest pain.

The above list includes the more

common side effects of your

medicine. If any of these persist or

worsen, talk to your doctor.

If any of the following happen, tell

your doctor immediately or go to

Emergency at your nearest

hospital:

swelling of your face, lips, tongue

or other parts of the body, rash or

hives

shortness of breath, wheezing,

difficulty breathing, chest pain or

discomfort.

The above list includes very serious

side effects. You may need urgent

medical attention or hospitalisation.

These side effects are very rare.

ELOCTATE may increase the risk of

formation of abnormal blood clots in

your body if you have risk factors for

developing blood clots.

Your body can make antibodies

called “inhibitors” against

ELOCTATE, which may stop

ELOCTATE from working properly.

Tell your doctor or Haemophilia

Treatment Centre if you notice

anything that is making you feel

unwell.

After using

ELOCTATE

Storage

Keep your ELOCTATE in the

pack until it is time to use it.

This medicine should be protected

from light.

Keep ELOCTATE in the

refrigerator at 2°C to 8°C.

If necessary, you can keep

ELOCTATE out of the refrigerator

for a single 6 month period.

If out of the refrigerator, store the

sealed carton in a cool dry place

where the temperature stays below

30°C. The date that the product is

removed from the refrigerator should

be recorded on the carton.

Do not use any ELOCTATE that

has been out of the refrigerator for

more than 6 months (refer to

Disposal below).

Once reconstituted, you can keep

ELOCTATE at room temperature

(below 30°C) for up to 6 hours.

Protect the product from direct

sunlight.

Do not store ELOCTATE or any

other medicine in the bathroom or

near a sink. Do not leave it on a

window sill or in the car.

Heat and dampness can destroy some

medicines.

Do not freeze ELOCTATE.

Do not place in the freezer or

freezing compartment of a

refrigerator.

Keep it where children cannot

reach it.

A locked cupboard at least one-and-

a-half metres above the ground is a

good place to store medicines.

Disposal

If your doctor tells you to stop using

this medicine or the expiry date has

passed, ask your Haemophilia

Treatment Centre what to do with

any medicine that is left over.

Product description

What it looks like

ELOCTATE comes as a white to off-

white powder to cake in a glass vial.

Each pack contains:

1 vial of sterile ELOCTATE

powder

1 pre-filled syringe of diluent

1 sterile vial adapter

reconstitution device.

ELOCTATE is available in 7

strengths: 250 IU, 500 IU, 750IU,

1000 IU, 1500IU, 2000 IU and

3000IU.

ELOCTATE

Ingredients

ELOCTATE contains efmoroctocog

alfa as the active ingredient.

Other ingredients:

sucrose

sodium chloride

histidine

calcium chloride

polysorbate 20.

Further information

You can obtain more information

from your doctor or your

Haemophilia Treatment Centre,

or by telephoning 1800 852 289 in

Australia or 0800 852 289 in New

Zealand.

Sponsor

ELOCTATE is supplied in Australia

Biogen Australia Pty Ltd

Level 3, 123 Epping Road

North Ryde NSW 2113

ELOCTATE is supplied in New

Zealand by:

Biogen NZ Biopharma Limited

54 Carbine Road

Mt Wellington, Auckland

= Registered Trademark or

© Copyright

This leaflet was prepared in

June 2017.

ELOCTATE 250 IU - AUST R

210521

ELOCTATE 500 IU - AUST R

210519

ELOCTATE 750 IU - AUST R

210523

ELOCTATE 1000 IU - AUST R

210525

ELOCTATE 1500 IU - AUST R

210522

ELOCTATE 2000 IU - AUST R

210524

ELOCTATE 3000 IU - AUST R

210520

ELOCTATE® is a registered

trademark of Biogen.

BIOGEN® is a registered trademark

of Biogen MA Inc.

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ALPROLIX (Swedish Orphan Biovitrum AB (publ))

ALPROLIX (Swedish Orphan Biovitrum AB (publ))

ALPROLIX (Active substance: eftrenonacog alfa) - Centralised - Yearly update - Commission Decision (2018)3776 of Mon, 11 Jun 2018

Europe -DG Health and Food Safety

18-5-2018

Ovaleap (Teva B.V.)

Ovaleap (Teva B.V.)

Ovaleap (Active substance: Follitropin alfa) - Centralised - Renewal - Commission Decision (2018)3154 of Fri, 18 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2608/R/23

Europe -DG Health and Food Safety

16-5-2018

Elonva (Merck Sharp and Dohme B.V.)

Elonva (Merck Sharp and Dohme B.V.)

Elonva (Active substance: corifollitropin alfa) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3049 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1106/T/40

Europe -DG Health and Food Safety