Etanercept Powder and Solvent for Solution for Injection; Etanercept Solution for
Injection (pre-filled syringe); Etanercept Solution for Injection (Auto-injector)
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about Enbrel.
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
Enbrel 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 Enbrel is used for
Enbrel is used in the treatment of:
juvenile idiopathic arthritis
non-radiographic axial spondyloarthritis (nr-AxSpA)
Tumour necrosis factor (TNF) is a naturally occurring chemical messenger in your bloodstream.
TNF plays a role in causing pain and swelling in the joints. Enbrel is a biotechnology-derived
protein that works by binding to TNF and preventing it from acting. This reduces the
pain and swelling of rheumatoid arthritis and psoriasis, helps to treat the skin lesions
of psoriasis and psoriatic arthritis, and improves the condition of patients with
ankylosing spondylitis, nr-AxSpA and juvenile idiopathic arthritis.
Your doctor may have prescribed Enbrel for another reason. Ask your doctor if you
have any questions about why Enbrel has been prescribed for you.
Enbrel is not currently recommended for use in children under 2 years of age as it
has not been tested in children under 2 years.
This medicine is available only with a doctor's prescription.
Enbrel is not addictive.
Before you use Enbrel
When you must not use it
Do not use Enbrel if:
1. You have an allergy to Enbrel or any of the ingredients listed at the end of this
Symptoms of an allergic reaction may include wheezing, shortness of breath, difficulty
breathing, or a tight feeling in your chest, swelling of the face, lips, tongue or
other parts of the body, rash, itching, hives or flushed red skin, dizziness or light-headedness.
2. You have, or are at risk of developing, sepsis (blood poisoning), or long-term or
localised infection (for example, leg ulcer).
Sepsis is a serious infection causing fever, headache, joint aches and pains, sore
or weak muscles, and increased heart rate. Enbrel can affect your body's ability to
fight a serious infection.
If you are not sure whether you have a serious infection, check with your doctor.
3. You are currently taking anakinra or other similar medicines known as Interleukin-1
4. The packaging is torn or shows signs of tampering.
5. The expiry date (EXP) printed on the pack has passed.
If you use Enbrel after the expiry date has passed, it may have no effect at all,
or worse, have an entirely unexpected effect.
If you are not sure whether you should start taking this medicine, talk to your doctor.
Before you use it
Tell your doctor if:
1. You have any allergies to:
Latex, as the needle cover of the pre-filled syringe and auto-injector and the rubber
closure of the diluent syringe (vial presentation) contain dry natural rubber
Any other medicines
Any other substances, such as foods, preservatives or dyes.
2. You are pregnant or intend to become pregnant.
The effects of Enbrel in pregnant women are not well understood, therefore the use
of Enbrel is not recommended during pregnancy. Women of childbearing age are advised
to use contraception to avoid falling pregnant. If you become pregnant while using
Enbrel, contact your doctor.
3. You are breast-feeding or plan to breast-feed.
Enbrel passes through breast milk. Therefore, if you are breast-feeding, you should
discuss with your doctor whether to stop breast-feeding or stop using Enbrel.
4. You have or have had any other medical conditions, especially the following:
Serious infection including sepsis, tuberculosis or a history of recurring infections
Low resistance to disease
Liver problems or hepatitis B or hepatitis C, viruses that affect the liver
Are about to have major surgery
Nerve disorders including multiple sclerosis or optic neuritis (inflammation of the
nerves of the eyes)
Chicken pox or have been recently exposed to chickenpox.
Make sure that children are up to date with all vaccinations (including chicken pox)
before they start treatment with Enbrel.
Live vaccines, such as oral polio vaccine, should not be given while receiving Enbrel.
If you have not told your doctor about any of the above, tell them before you start
Taking other medicines
Tell your doctor or pharmacist if you are taking any other medicines, including any
that you get without a prescription from your pharmacy, supermarket or health food
Some medicines may affect the way others work. Your doctor or pharmacist will be able
to tell you what to do when using Enbrel with other medicines. Enbrel may interact
with other medicines such as:
Abatacept, sulfasalazine or Interleukin-1 antagonists such as anakinra. These medicines
are used to treat rheumatoid arthritis and other inflammatory diseases
Cyclophosphamide, a medicine used to treat cancer or prevent transplant rejection
Digoxin, a medicine used to improve the strength and efficiency of the heart, or to
control the rate and rhythm of the heartbeat
Warfarin, a medicine used to thin the blood and prevent blood clots
Medicines used to treat diabetes.
How to use Enbrel
Powder for injection only:
Enbrel powder for injection contains no additives that would prevent the growth of
bacteria once the powder is dissolved. For this reason, the vial should not be stored
for more than 6 hours after dissolving the powder with the diluent provided.
Solution for injection only:
After allowing the Enbrel solution to reach room temperature (approximately 15 to
30 minutes), immediate use is recommended.
Each vial or syringe of Enbrel is for single use only, in one patient only. Discard
Follow all directions given to you by your doctor or pharmacist carefully.
They may differ from the information contained in this leaflet.
If you are injecting Enbrel yourself, you must follow the detailed instructions provided
in the leaflet inside the pack.
Enbrel is injected under the skin. When using the syringes provided with the Enbrel
vial or pre-filled syringe presentations, it is important that you do not pull back
on the plunger. Enbrel can be injected by your doctor, nurse, carer or by yourself.
When you have finished injecting Enbrel, discard the needle and syringe into a sharps
If you do not understand the instructions for injecting Enbrel found in the carton,
ask your doctor or pharmacist for help.
To help you remember, use a diary to write in the days of the week you or your child
should have an Enbrel injection.
How much to use
Your doctor will tell you how to inject Enbrel. A different site should be used for
each new injection. Each new injection should be given at least 3 cm from an old site.
The recommended dose for adults is 50 mg per week, injected under the skin. This can
be given as either a single 50 mg injection once weekly, or two separate 25 mg injections,
3-4 days apart. Your doctor may determine a different frequency at which to inject
Enbrel. If you are being treated for psoriasis, your doctor may prescribe a higher
dose of Enbrel when you first begin your treatment. If you are being treated for nr-AxSpA
and Enbrel has no effect on your condition within 12 weeks, your doctor may tell you
to stop using this medicine.
The appropriate dose and frequency of dosing for children and teenagers will depend
on body weight and the disease. Your child's doctor will provide detailed directions
for preparing and measuring the appropriate dose for your child.
For juvenile idiopathic arthritis the recommended dose is 0.8 mg of Enbrel per kg
bodyweight (up to a maximum of 50 mg) given once weekly. Enbrel may also be given
twice weekly at a dose of 0.4 mg of Enbrel per kg bodyweight (up to a maximum of 25
For psoriasis patients the recommended dose is 0.8 mg of Enbrel per kg bodyweight
(up to a maximum of 50 mg) given once weekly. If Enbrel has no effect on the child's
condition after 12 weeks, your doctor may tell you to stop using this medicine.
How long to take it
You should continue to inject Enbrel for as long as your doctor recommends.
Never inject more than the dose recommended by your doctor.
If you feel that the effect of Enbrel is too strong or too weak, talk to your doctor
If you forget to take it
If you forget to give yourself or your child an injection, you should inject the next
dose as soon as you remember if it is within 48 hours since the scheduled dose time.
If it is more than 48 hours since the last dose was due, wait for the next scheduled
Do not use a double dose to make up for the dose that you missed.
If you are not sure what to do, ask your doctor or pharmacist.
If you have trouble remembering to use your medicine, ask your pharmacist for some
If you take too much (overdose)
Immediately telephone your doctor or the Poisons Information Centre (tel 13 11 26)
for advice or go to Accident and Emergency at your nearest hospital, if you think
that you or anyone else may have used too much Enbrel. Do this even if there are no
signs of discomfort or poisoning. Always take the labelled medicine carton with you,
even if it is empty.
You may need urgent medical attention. There is very limited data on overdose with
Enbrel. Ask your doctor if you have any concerns.
While you are using Enbrel
Things you must do
Tell any other doctors, dentists and pharmacists who are treating you that you are
Tell your doctor if Enbrel is not making your condition better.
If you have or develop any serious infection while using Enbrel, do not inject any
more Enbrel and contact your doctor immediately.
Seek medical advice immediately if you have any symptoms such as persistent fever,
sore throat, bruising, bleeding or paleness.
These symptoms may point to the existence of a potentially life-threatening blood
disorder, which may require you to stop taking Enbrel.
Be careful driving or operating dangerous machinery until you know how it affects
It is not known whether Enbrel causes dizziness or drowsiness.
Things you must not do
Do not shake the solution of Enbrel after you have added the sterile water for injection.
Shaking the solution will cause it to froth (create lots of bubbles). This may affect
the medicine so that it may not work.
Do not give Enbrel to anyone else even if they have the same condition as you.
Do not use Enbrel to treat any other complaints unless your doctor tells you to.
Do not stop using Enbrel, or lower the dosage, without checking with your doctor.
Do not stop using Enbrel because you are feeling better, unless your doctor advises
Your condition may flare up if you reduce the dose or stop using Enbrel.
Check with your doctor as soon as possible if you have any problems while taking Enbrel,
even if you do not think the problems are connected with the medicine or are not listed
in this leaflet.
Like other medicines, Enbrel can cause some side effects. If they occur, most are
likely to be minor and temporary. However, some may be serious and need medical attention.
The most common side effects with Enbrel are injection site reactions, infections,
allergic reactions, itching, rash and fever. Please see below for more detail.
Ask your doctor or pharmacist to answer any questions you may have.
Injection site reactions
The most common side effect is a mild reaction in the area where Enbrel was injected,
Bleeding, swelling, pain or hardness around the injection site.
These reactions generally do not occur as often after the first month of treatment.
If you are concerned about injection site reactions, contact your doctor or pharmacist.
When injecting Enbrel, some people have developed a reaction to an injection site
Infections, including colds and sinus infections, are very common.
Serious infections may occur including tuberculosis and blood poisoning.
Tell your doctor immediately if you notice any of the following:
Signs of an infection such as fever, chills, mouth ulcers or sore throat
Signs of lung disease such as breathlessness during exercise or a dry cough
Signs of soft tissue infections such as bumps or sores that do not heal, are swollen,
red or have pus
Signs of nervous system disorders such as seizures, numbness or tingling throughout
your body, weakness in your arms and/or legs and dizziness, or problems with your
Inflammation of the spinal cord
Inflammation of the inner eye
Inflammation of blood vessels in the skin or lymph glands
Diarrhoea or mucus or blood in your stools
Signs of an allergic reaction such as swelling of the face, lips or tongue which may
cause difficulty in swallowing or breathing, or hives
Signs of lupus or lupus-like syndrome, such as weight changes, persistent rash, fever,
joint or muscle pain, or fatigue
Other signs of immune system disorders such as skin rash, blisters and ulcers on the
skin, in the mouth or airways
Signs of a blood disorder such as tiredness, headaches, shortness of breath when exercising,
dizziness, paleness, nose bleeds, unusual bleeding or bruising or more frequent infections
Signs of heart failure such as shortness of breath, persistent cough, difficulty exercising,
fast or irregular heartbeat, swelling in the legs or feet, tiredness and weakness.
These may be very serious side effects. You may need urgent medical attention or hospitalisation.
These side effects are rare.
Other side effects not listed above may also occur in some patients. Tell your doctor
if you notice anything else that is making you unwell.
There have been reports of some types of cancer developing in patients using Enbrel
and other TNF blocking medicines. These include skin cancers, cancers that affect
the lymph system called lymphoma, or affect the blood system called leukaemia. The
role of Enbrel in the development of cancer is not known.
Do not be alarmed by this list of possible side effects. You may not experience any
After using Enbrel
Keep Enbrel where children cannot reach it.
Keep Enbrel in a refrigerator where the temperature stays between 2°C and 8°C. Do
not freeze. Do not store Enbrel or any other medicine in the bathroom or near a sink.
Do not leave it in the car or on window sills. Enbrel pre-filled syringes and Auto-injectors
should be stored in their cartons to protect them from light.
Heat and dampness can destroy some medicines.
If it is not possible to store Enbrel in the refrigerator, it may be stored out of
the refrigerator (below 25°C) for up to 4 weeks (e.g. when travelling). Do not use
Enbrel if it has been exposed to high temperatures, or has been out of the refrigerator
for more than 4 weeks.
Powder for injection only:
Dispose of any Enbrel solution that has been prepared more than 6 hours ago, but not
Enbrel powder in vials does not contain a preservative, therefore, once the powder
is mixed, the solution may spoil after 6 hours.
For additional advice on storing Enbrel, contact Pfizer Medical Information on 1800
Ask your pharmacist how to dispose of medicines no longer required.
What it looks like
Powder for injection:
Enbrel powder for injection is supplied as a pack containing four single dose glass
vials of Enbrel powder. Each vial of Enbrel contains 25 mg of the active ingredient,
etanercept. The pack also includes four pre-filled glass syringes of sterile water
for injections. The rubber closure of the diluent syringe contains dry natural rubber
(a derivative of latex). The powder must be dissolved in 1 mL of the sterile water
for injections before use. Four sterile vial adaptors and four sterile needles are
also supplied. The vial adaptor is for delivering the water into the Enbrel vial.
It should be replaced with a needle for injection after the Enbrel solution has been
drawn up into the syringe.
Pre-filled Syringe (Solution for injection):
Enbrel Pre-filled Syringe is supplied in a kit containing four single-dose pre-filled
glass syringes containing Enbrel solution. Each syringe contains 50 mg of etanercept
in 1 mL of Enbrel solution. The needle cover of the pre-filled syringe presentation
contains dry natural rubber (a derivative of latex). Four alcohol swabs are also provided
in the kit.
Auto-injector (Solution for injection)
The Enbrel Auto-injector is supplied in a kit containing either one or four single-dose
pre-filled glass syringes, each housed in a plastic Auto-injector. The needle cap
of the Auto-injector contains dry natural rubber (a derivative of latex). Each syringe
contains 50 mg of etanercept in 1 mL of Enbrel solution. Alcohol swabs are also provided
in the kit.
Powder for injection:
Enbrel powder for injection contains 25 mg of the active ingredient etanercept. Enbrel
also contains mannitol, trometamol and sucrose.
Solution for injection:
Enbrel solution for injection contains 50 mg of the active ingredient etanercept.
The Enbrel solution also contains sucrose, sodium chloride, arginine hydrochloride,
monobasic sodium phosphate dihydrate, dibasic sodium phosphate dihydrate and water.
Enbrel powder for injection and solution for injection do not contain lactose, gluten,
tartrazine or any other azo dyes.
Australian Patient Support Program details
Your ENBREL Experience is a complimentary support program offered for people taking
ENBREL. The program is designed based on feedback from many people already taking
ENBREL, and nurses who work with them. Call 1800 ENBREL (1800 362 735) or visit www.1800ENBREL.com.au
Enbrel is supplied in Australia by:
Pfizer Australia Pty Ltd
Toll Free Number: 1800 675 229
Administration kit was prepared by:
Pfizer Manufacturing Belgium
Australian Registration Number
25 mg powder with diluent kit: AUST R 90456
50 mg solution for injection kit: AUST R 124422
50 mg Auto-injector solution for injection: AUST R 157622
Date of preparation
This leaflet was prepared in June 2019.
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