Solution for Injection
Fondaparinux sodium
Consumer Medicine Information
Please read this leaflet carefully before you start using Arixtra. You may wish to keep it to read again.
NOTICE: This Consumer Medicine Information (CMI) is intended for persons
living in Australia. This page contains answers to some common
questions about . It does
not contain all the information that is known about
. It does not take the
place of talking to your doctor or pharmacist. All medicines have risks
and benefits. Your doctor has weighed the risk of you using this medicine
against the benefits he/she expects it will have for you. If you have
any concerns about using this medicine, ask your doctor or pharmacist.
Bookmark or print this page, you may need to read it again.
What Arixtra is used for
Arixtra is used to prevent blood clots forming in patients who are recovering from orthopaedic surgery. Arixtra contains the
medication fondaparinux sodium, a synthetic compound which helps prevent blood clots forming in blood vessels. This type of
blood clot, also called deep venous thrombosis, or DVT, can occur in patients who are confined to bed after hip or knee surgery.
Your doctor may have prescribed Arixtra for another reason. Ask your doctor if you have any questions about why Arixtra has
been prescribed for you.
Arixtra is not addictive.
This medicine is available only with a doctor's prescription.
Before you are given Arixtra
When you must not be given it
You should not be given Arixtra if you have any of the following conditions;
You are bleeding excessively
You have severe kidney disease
You have acute bacterial endocarditis (an infection of the heart)
Do not use Arixtra if you have an allergy to it or any of the ingredients listed at the end of this leaflet.
Symptoms of an allergic reaction to Arixtra may include skin rash, itchiness, shortness of breath, or difficulty breathing.
Do not use Arixtra if you are pregnant or intend to become pregnant.
Arixtra is not recommended for use during pregnancy, unless you and your doctor or pharmacist have discussed the risks and
benefits involved.
Do not use Arixtra if you are breast-feeding or plan to breast-feed.
It is not known whether Arixtra passes into human breast milk.
Do not use Arixtra after the expiry date (EXP) printed on the pack.
If you use this medicine after the expiry date has passed, it may not work as well as it should.
Do not use Arixtra if the packaging is torn or shows signs of tampering.
If you are not sure whether you should start using Arixtra, talk to your doctor or pharmacist.
Before you are given it
Tell your doctor or pharmacist if you have allergies to:
any other medicines
any other substances, such as foods, preservatives or dyes
Latex
Tell your doctor or pharmacist if you are pregnant or intend to become pregnant.
Your doctor or pharmacist will discuss the possible risks and benefits of using Arixtra during pregnancy.
Tell your doctor or pharmacist if you are breast-feeding or plan to breast-feed.
Your doctor or pharmacist will discuss the possible risks and benefits of using Arixtra during breast-feeding.
Tell your doctor or pharmacist if you have or have had any medical conditions, especially the following:
a stomach ulcer
bleeding disorders
recent bleeding inside the head
recent surgery on the brain, eye, or spinal column
moderate or severe kidney disease or severe liver disease.
If you have not told your doctor or pharmacist about any of the above, tell them before you start using Arixtra.
Taking other medicines
Tell your doctor or pharmacist if you are taking/using any other medicines, including any that you buy without a prescription
from your pharmacy, supermarket or health food shop.
Some medicines and Arixtra may interfere with each other.
Your doctor or pharmacist may have more information on medicines to be careful with or to avoid while using Arixtra.
How Arixtra is given
How much is given
The usual dose of Arixtra is 2.5 mg given once a day, starting after your operation. Arixtra may be given for up to 31 days.
How it is given
Arixtra is given to you as a subcutaneous injection (an injection just under the skin). The injections can be given by a doctor
or nurse, or you may be taught how to give the injections to yourself.
Instructions on how to use the Arixtra syringe are contained in the package insert in each Arixtra carton.
Overdose
Your doctor or pharmacist has information on how to recognise and treat an overdose. Ask your doctor or pharmacist if you
have any concerns.
While you are using Arixtra
Things you must do
Tell any other doctors, dentists, and pharmacists who are treating you that you are using Arixtra.
If you are about to be started on any new medicine, tell your doctor, dentist or pharmacist that you are using Arixtra.
Immediately tell your doctor if you develop the following:
pain or swelling in the legs
chest pain or difficulty in breathing
These may be signs that a blood clot has formed.
If you have epidural or spinal anaesthesia (a pain killing injection around the spinal cord), tell your doctor or nurse immediately
if you have back pain, numbness or weakness in the legs, or problems with bowel or bladder function.
Things you must not do
Do not give Arixtra to anyone else, even if they have the same condition as you.
Do not use Arixtra to treat any other complaints unless your doctor or pharmacist tells you to.
Side effects
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are using Arixtra.
Arixtra helps most people at risk of blood clots following surgery, but it may have unwanted side effects in some people.
All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment
if you get some of the side effects.
Ask your doctor or pharmacist to answer any questions you may have.
If you get any side effects, do not stop using Arixtra without first talking to your doctor or pharmacist.
Tell your doctor or pharmacist if you notice any of the following:
bleeding
oozing of fluid from the wound
unusual tiredness or weakness
fever
nausea or vomiting
indigestion
low blood pressure
dizziness or confusion
difficulty sleeping
pain at the injection site
urinary tract infection
difficulty or pain when passing urine
diarrhoea or constipation
swelling (oedema)
These are the more common side effects of Arixtra and are usually mild.
Tell your doctor or pharmacist immediately if you notice any of the following:
significant bleeding
These may be signs of serious side effects. You may need urgent medical attention. Serious side effects are rare.
Other side effects not listed above may occur in some patients. Tell your doctor or pharmacist if you notice anything that
is making you feel unwell.
Do not be alarmed by this list of possible side effects.
You may not experience any of them.
After using Arixtra
Storage
Arixtra will normally be stored in the pharmacy or on the hospital ward. The injection should be kept at room temperature
(less than 25°C).
Disposal
If your doctor or pharmacist tells you to stop using Arixtra or the injections have passed their expiry date, ask your pharmacist
what to do with any that are left over.
Product description
What it looks like
Arixtra comes as a pre-filled safety syringe, in pack sizes of 2 pre-filled syringes.
Ingredients
Active ingredients:
fondaparinux sodium
Other ingredients
sodium chloride
water for injections
Manufacturer
Arixtra is supplied in Australia by;
GlaxoSmithKline Australia Pty Ltd
Level 4, 436 Johnston Street
Abbotsford, Victoria, 3067
Arixtra has the following registration No:
2.5 mg - AUST R 80279
This leaflet was prepared on
10 May 2011
Version 3.0