VIMIZIM

Main information

  • Trade name:
  • VIMIZIM elosulfase alfa (rch) 1 mg/mL concentrated solution for injection vial
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • VIMIZIM elosulfase alfa (rch) 1 mg/mL concentrated solution for injection vial
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 215523
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

215523

VIMIZIM elosulfase alfa (rch) 1 mg/mL concentrated solution for injection vial

ARTG entry for

Medicine Registered

Sponsor

BioMarin Pharmaceutical Australia Pty Ltd

Postal Address

119 Willoughby Road,CROWS NEST, NSW, 2065

Australia

ARTG Start Date

9/12/2014

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. VIMIZIM elosulfase alfa (rch) 1 mg/mL concentrated solution for injection vial

Product Type

Single Medicine Product

Effective date

20/06/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Vimizim is indicated for the treatment of mucopolysaccharidosis type IVA (MPS IVA; Morquio A syndrome).

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Vial

Glass Type I Clear

36 Months

Store at 2 to 8

degrees Celsius

Not recorded

Protect from Light

Do not Freeze

Refrigerate

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

Components

1. VIMIZIM elosulfase alfa (rch) 1 mg/mL concentrated solution for injection vial

Dosage Form

Injection, concentrated

Route of Administration

Intravenous Infusion

Visual Identification

Colourless to pale yellow and clear to slightly opalescent solution.

Active Ingredients

elosulfase alfa

1 mg/mL

© 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 08:36:47 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

VIMIZIM

VIMIZIM

®

elosulfase alfa (rch)

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common

questions about Vimizim.

It does not contain all the available

information. It does not take the

place of talking to your doctor or

pharmacist.

All medicines have benefits and

risks. Your doctor has weighed the

risks of treating you with Vimizim

against the benefits expected for you.

If you have any concerns about

receiving this medicine, talk to

your doctor, nurse or the hospital

pharmacist.

Keep this leaflet while you are

being treated with Vimizim.

You may need to read it again.

What Vimizim is used

for

Vimizim is used to treat patients with

MPS IVA (Mucopolysaccharidosis

Type IVA, Morquio A Syndrome).

People with MPS IVA have either a

low level, or reduced activity, of an

enzyme called N-

acetylgalactosamine-6-sulfatase (or

GALNS), which breaks down

specific substances (for example,

keratan sulfate) in the body. As a

result, these specific substances do

not get broken down and processed

by the body as they should. They

accumulate in many tissues in the

body, which causes the symptoms of

MPS IVA.

How Vimizim works

This medicine contains an enzyme

called elosulfase alfa. Elosulfase alfa

is a recombinant version of a human

enzyme produced by genetic

engineering in Chinese Hamster

Ovary (CHO) cells.

It works by replacing the natural

enzyme in MPS IVA patients.

Treatment with VIMIZIM has shown

improvement in walking ability and

reduction of the levels of keratan

sulfate

.

Ask your doctor if you have any

questions about why Vimizim has

been prescribed for you.

Vimizim is available only with a

doctor's prescription.

Use in Children

Vimizim is recommended for use in

children and adults.

Before starting

treatment with

Vimizim

When you must not have it

Do not have Vimizim if you

experience severe or life-

threatening allergic reactions to

elosulfase alfa or any of the other

ingredients of Vimizim and your

doctor is not able to control these

reactions with medicines or other

measures such as slowing the rate

of the infusion or temporarily

stopping the infusion.

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

cough

throat tightness

bluish colour of skin

abnormally low blood pressure

chest discomfort

gastrointestinal symptoms, such

as nausea, stomach ache, dry

heaves, and vomiting.

Your doctor will tell you if you can

have Vimizim or not.

Do not have Vimizim if the expiry

date printed on the carton has

passed.

The nurse or hospital pharmacist will

check the expiry date before giving

Vimizim to you.

Do not have Vimizim if the

packaging is torn or shows signs of

tampering.

The nurse or hospital pharmacist will

check this for you.

Check with your doctor or

pharmacist if you are not sure

about any of the above.

Before you start treatment

with Vimizim

Tell your doctor if you are

pregnant or plan to become

pregnant.

Vimizim has not been studied in

pregnant patients and should not be

VIMIZIM

given during pregnancy unless

clearly necessary.

Tell your doctor if you are

breastfeeding or wish to breastfeed

during this time.

It is not known if Vimizim passes

into breast milk. You and your doctor

should discuss the risks and benefits

of continuing to take Vimizim while

breastfeeding.

Tell your doctor if you have, or

have had, any medical conditions,

especially the following:

A severe allergic reaction to

elosulfase alfa or any of the other

ingredients of Vimizim.

Any severe side effects with

previous Vimizim treatment.

Your doctor may also give you

additional medicines to prevent an

allergic reaction or fever, and may

also monitor you closely during your

next treatment.

Tell your doctor if you are on a

controlled sodium diet.

Each 5 mL

vial of Vimizim contains 8 mg

sodium.

Tell your doctor if you have a fever

or any respiratory conditions

including sleep apnoea. Sleep

apnoea is a condition where you

temporarily stop breathing during

your sleep

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 receiving Vimizim.

Taking other medicines

Tell your doctor if you are taking

any other medicines, including any

that you buy without a

prescription from a pharmacy,

supermarket, naturopath or health

food shop.

How to use Vimizim

How much to use

The dose you receive is based on

your body weight. The recommended

dose regimen is 2 mg/kg body weight

administered once every week

through a drip into a vein (by

intravenous infusion).

Each infusion will take

approximately 4 hours.

How to use Vimizim

Your doctor or nurse will administer

Vimizim to you.

The medicine has to be diluted before

being given and should not be mixed

with other products.

How long to use Vimizim for

Your doctor will decide how long

you will receive Vimizim for.

If you miss a dose

If you miss a dose, talk to your

doctor or nurse and arrange another

visit as soon as possible.

While you are being

treated with Vimizim

MPS IVA can cause pressure on the

spinal cord.

Tell your doctor if you notice any

of the following:

back pain

numbness or loss of feeling in

parts of your body

any bowel or bladder problems

Things you must do

Keep all appointments with your

doctor and always discuss anything

that worries you during or after

treatment with Vimizim.

Before starting any new medicine,

remind your doctor or pharmacist

that you are receiving Vimizim.

Tell all the doctors, dentists and

pharmacists who are treating you

that you are receiving Vimizim.

If you become pregnant while you

are treated with Vimizim, tell your

doctor immediately.

Things you must not do

Do not stop going to your visits for

treatment with Vimizim without

checking with your doctor.

Your condition may worsen if you

stop receiving Vimizim.

Things to be careful of

Be careful driving or operating

machinery until you know how

Vimizim affects you.

This medicine may cause dizziness in

some people. If you feel dizzy, do

not drive or operate machinery.

Side effects

Tell your doctor or nurse as soon

as possible if you do not feel well

while you are receiving Vimizim.

All medicines, including Vimizim,

can have unwanted side effects.

Sometimes they are serious, most of

the time they are not.

Do not be alarmed by this list of

possible side effects.

You may not experience any of them.

Tell your doctor or nurse if you

experience any of the following:

Headache

Nausea

Vomiting

Fever

Chills

Abdominal pain

Diarrhoea

Mouth and throat pain

Stomach ache

Dizziness

Shortness of breath

VIMIZIM

Muscle pain

These are the most common side

effects of your medicine. Most side

effects have occurred either during

the infusion or within one day after

the infusion.

Allergic reactions

Tell your doctor or nurse

immediately if you experience any

of the following side effects:

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 can be symptoms of an allergic

reaction, which can be serious. If you

have an allergic reaction, your doctor

may slow down, or stop your

infusion. Your doctor may also give

you additional medicines to manage

any allergic reaction. Your doctor

will decide when you can restart

Vimizim treatment.

Ask your doctor to answer any

questions you may have.

Tell your doctor if you notice

anything else that is making you

feel unwell.

Other side effects not listed above

may also occur in some patients.

After being treated

with Vimizim

Storage

Vimizim must be kept in a

refrigerator at 2°C to 8°C, but it must

not be frozen. The vial should be

kept in the carton to protect it from

light.

Each vial is intended for single use

only.

Product description

What it looks like

Vimizim is a clear, colourless to pale

yellow solution. It is supplied in a

5 mL clear glass vial with a rubber

stopper and aluminium seal. Each

pack contains 1 vial.

Ingredients

The active ingredient in Vimizim is

elosulfase alfa. Each 5 mL vial

contains 5 mg elosulfase alfa.

The solution also contains the

following inactive ingredients:

sodium acetate trihydrate

monobasic sodium phosphate

monohydrate

arginine hydrochloride

sorbitol

polysorbate 20

water for injections

Vimizim solution does not contain

any preservative.

Supplier

Vimizim is supplied in Australia by:

BioMarin Pharmaceutical Australia

Pty Ltd

119 Willoughby Road

Crows Nest, NSW 2065

Telephone (02) 8520 3255

Vimizim is supplied in New Zealand

Pharmacy Retailing (NZ) Limited t/a

Healthcare Logistics

58 Richard Pearse Drive

Airport Oaks 2022

Auckland

Telephone (09) 918 5100

For enquiries about Vimizim, contact

medinfoasia@bmrn.com or call

BioMarin:

Australia: 1800 387 876

New Zealand: 0800 882 012

To report adverse events, contact

drugsafety@bmrn.com or call

BioMarin:

Australia: 1800 387 876

New Zealand: 0800 882 012

Australian registration

number:

AUST R 215523

Date of preparation

This leaflet was prepared in

December 2016

® Registered trademark

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