Information specific to: Enbrel 25mg powder and solvent for solution for injection vials when used in Ankylosing spondylitis
Enbrel (En-brell) is a medicine which is used in ankylosing spondylitis, cervical spondylitis and ankylosing spondylitis when prevention of NSAID-induced gastric and duodenal ulceration is needed. Enbrel contains etanercept. It is supplied by Wyeth Pharmaceuticals.
The information in this Medicine Guide for Enbrel varies according to the condition being treated and the particular preparation used.
Enbrel is an immunosuppressive medicine. It helps to suppress overactivity of the immune system in arthritic conditions and in plaque psoriasis. It can help to reduce pain and swelling by limiting inflammation. Enbrel is usually used with the medicinemethotrexate when treating rheumatoid arthritis.
Due to its effects on the immune system, people who have Enbrel are prone to getting infections. This includes serious infections such as sepsis. It is for this reason that people who have Enbrel are monitored for infections. People who have Enbrel must be careful to avoid exposure to chicken poxinfections whenever possible. If you have been exposed to chickenpox during treatment with Enbrel you must get immediate medical advice.
Other information about Enbrel:
- in certain circumstances, such as when you are going to have your medicine regularly over a long period of time, you may be shown how to inject the medicine yourself
- people taking this medicine should be given an alert card. You should keep it with you at all times as it can alert anyone involved in your medical care that you are having Enbrel. If you have any concerns or questions about having Enbrel you should discuss them with your prescriber
- if possible, children should be brought up to date with all immunisation before initiating Enbrel therapy
Enbrel needs to be injected. Your prescriber will show you how to inject this medicine yourself.
There should also be instructions on how to inject this medicine in the Patient Information Leaflet that comes with this medicine or on the pharmacy label.
The pharmacy label on your medicine tells you how much medicine you should have. It also tells you how often you should have your medicine. This is the dose that you and your prescriber have agreed you should have. You should not change the dose of your medicine unless you are told to do so by your prescriber.
Do not share your medicine with other people. It may not be suitable for them and may harm them.
If you feel that the medicine is making you unwell or you do not think it is working, then talk to your prescriber.
Whether this medicine is suitable for you
Enbrel is not suitable for everyone and some people should never use it. Other people should only use it with special care. It is important that the person prescribing this medicine knows your full medical history.
Your prescriber may only prescribe this medicine with special care or may not prescribe it at all if you:
- are allergic or sensitive to or have had a reaction to any of the ingredients in the medicine
- are taking or have recently taken immunosuppressants
- have a weakened immune system or are prone to infections
- have alcoholicliver disease
- have been in close contact with somebody with tuberculosis
- have certain types of vasculitis
- have come into contact with someone who has an infection
- have diabetes
- have had blood problems
- have had PUVA treatment for a long time
- have heart problems
- have hepatitis Binfection or are at risk of having hepatitis Binfection
- have kidney problems
- have liver problems
- have or have had cancer
- have or have had demyelinating disorders
- have or have had hepatitis Cinfection
- have or have had infections
- have or have had tuberculosis
- have psoriasis
- have recently been, or are going to be, vaccinated with live vaccines. For more information about vaccines, ask your prescriber, nurse or pharmacist
- have risk factors for skin cancer
Furthermore the prescriber may only prescribe this medicine with special care or may not prescribe it at all for a child under eight years of age.
As part of the process of assessing suitability to take this medicine a prescriber may also arrange tests:
- to check that this medicine is not having any undesired effects
Over time it is possible that Enbrel can become unsuitable for some people, or they may become unsuitable for it. If at any time it appears that Enbrel has become unsuitable, it is important that the prescriber is contacted immediately.
Alcohol can interact with certain medicines.
In the case of Enbrel:
- there are no known interactions between alcohol and Enbrel
Medicines can interact with certain foods. In some cases, this may be harmful and your prescriber may advise you to avoid certain foods.
In the case of Enbrel:
- there are no specific foods that you must exclude from your diet when having Enbrel
Driving and operating machinery
When taking any medicine you should be aware that it might interfere with your ability to drive or operate machinery safely.
Like all medicinesEnbrel can cause side effects. You should see how this medicine affects you and then judge if you are safe to drive or operate machinery. If you are in any doubt, talk to your prescriber.
Family planning and pregnancy
Most medicines, in some way, can affect the development of a baby in the womb. The effect on the baby differs between medicines and also depends on the stage of pregnancy that you have reached when you take the medicine.
In the case of Enbrel:
- the use of this medicine during pregnancy is not recommended. If you could become pregnant, you must use effective contraception or abstain from penetrative sex. You must contact your prescriber if you become pregnant, or think you have become pregnant, while having Enbrel
You should discuss your personal circumstances with your doctor if you are pregnant or want to become pregnant. This is so that together you can make a decision about what treatment you may need during your pregnancy.
You should discuss whether there are any other medicines which you could take during pregnancy which would treat your condition.
Certain medicines can pass into breast milk and may reach your baby through breast-feeding.
In the case of Enbrel:
- you should only have this medicine while breast-feeding if your doctor thinks you need it
Before you have your baby you should discuss breast-feeding with your doctor or midwife. They will help you decide what is best for you and your baby based on the benefits and risks associated with this medicine. You should only breast-feed your baby while taking this medicine on the advice of your doctor or midwife.
Taking other medicines
If you are taking more than one medicine they may interact with each other. At times your prescriber may decide to use medicines that interact, in other cases this may not be appropriate.
The decision to use medicines that interact depends on your specific circumstances. Your prescriber may decide to use medicines that interact, if it is believed that the benefits of taking the medicines together outweigh the risks. In such cases, it may be necessary to alter your dose or monitor you more closely.
Tell your prescriber the names of all the medicines that you are taking so that they can consider all possible interactions. This includes all the medicines which have been prescribed by your GP, hospital doctor, dentist, nurse, health visitor, midwife or pharmacist. You must also tell your prescriber about medicines which you have bought over the counter without prescriptions.
The following medicines may interact with Enbrel:
The following types of medicine may interact with Enbrel:
- live vaccines
If you are taking Enbrel and one of the above medicines or types of medicines, make sure your prescriber knows about it.
Complementary preparations and vitamins
Medicines can interact with complementary preparations and vitamins. In general, there is not much information available about interactions between medicines and complementary preparations or vitamins.
If you are planning to take or are already taking any complementary preparations and vitamins you should ask your prescriber whether there are any known interactions with Enbrel.
Your prescriber can advise whether it is appropriate for you to take combinations that are known to interact. They can also discuss with you the possible effect that the complementary preparations and vitamins may have on your condition.
If you experience any unusual effects while taking this medicine in combination with complementary preparations and vitamins, you should tell your prescriber.
Ingredients of your medicine
Medicines contain active ingredients. They may also contain other, additional ingredients that help ensure the stability, safety and effectiveness of the medicine. Some may be used to prolong the life of the medicine.
- mannitol (E421)
- water for injections
If you are not able to take any of the ingredients in your medicine, talk to your prescriber or pharmacist to see if they can suggest an alternative medicine. If you have reacted badly to Enbrel before, do not have Enbrel. Talk to your prescriber, pharmacist or nurse as soon as possible.
How to take your medicine
This medicine needs to be injected. Your medical team will train you how to inject the medicine yourself. For more information see the Patient Information Leaflet or contact one of your medical team.
In the case of Enbrel:
- detailed advice on how to have Enbrel can be found in the Patient Information Leaflet that comes with this medicine
If you have any concerns about this medicine or about the process of having it you should talk to someone who is involved in your medical care.
When to take your medicine
Some medicines work best if they are taken at a specific time of day. If someone is giving you this injection, the person with responsibility for giving you your medicine will make sure that you have your medicine at the prescribed times.
If you are injecting this medicine yourself, make sure that you find out from your prescriber the best time to have Enbrel.
Taking too much of your medicine
Taking extra doses of some medicines can be harmful. In some cases even one extra dose can cause you problems.
The person who is responsible for giving you your medicine will make sure that you are given the correct dose of your medicine. If you inject the medicine yourself, make sure that you do not take any extra doses as this could cause you problems. If you take extra doses of your medicine, you must get medical advice immediately. You may need a test to assess the effect of taking extra doses. This is because the effects of taking too much medicine are very complex so it is very important that you seek medical advice.
Contact your prescriber, pharmacist, specialist clinic or NHS Direct on 0845 46 47 for advice.
Make sure you take all of your medicinecontainers with you if you are advised to go to hospital.
Stopping your medicine
Suddenly stopping your medicine may cause your original condition to return. The person in charge of your care will make the decision about whether you should stop this medicine. If you experience any problems while having this medicine talk to someone who is involved in your care. If you are injecting this medicine yourself, and are not having any problems with the medicine, do not stop having it, even if you feel better, unless advised to do so by your prescriber.
If you are in any doubt, contact your prescriber, pharmacist, specialist clinic or NHS Direct on 0845 46 47.
Looking after your medicine
If you are injecting this medicine yourself, read the pharmacy label to find out how you should look after your medicine. It is a good idea to keep your medicine in the original container. This will help to keep your medicine in the best condition and also allow you to check the instructions.
Do not use the medicine if the packaging appears to have been tampered with or if the medicine shows any signs of damage. Specific information about how to look after Enbrel can be found in the Patient Information Leaflet that comes with this medicine. Make sure that the medicine is out of the sight and reach of children.
In the case of Enbrel:
- store in a fridge at temperatures between 2-8°C
- you must not freeze this medicine
- use this medicine immediately after you have made it up. If you need to store it after it has been made up, keep it in the fridge between 2-8°C and use it within 6 hours. Discard the medicine if you have not used it within 6 hours
Do not use the medicine after the expiry date shown on the packaging. If you have any unused medicine, return it to your pharmacist who will dispose of it safely.
A medicine is only made available to the public if the clinical trials have shown that the benefits of taking the medicine outweigh the risks.
Once a medicine has been licensed, information on the medicine’s effects, both intended and unintended, is continuously recorded and updated.
Some side-effects may be serious while others may only be a mild inconvenience.
Everyone’s reaction to a medicine is different. It is difficult to predict which side-effects you will have from taking a particular medicine, or whether you will have any side-effects at all. The important thing is to tell your prescriber or pharmacist if you are having problems with your medicine.
Very common: More than 1 in 10 people who have Enbrel
- infections – some of the infections caused by Enbrel may be fatal. You must immediately seek medical advice if you get any symptoms of an infection such as a persistent fever while having Enbrel
- injection site problems such as bleeding, bruising, redness, itching, pain or swelling
Common: More than 1 in 100 people who have Enbrel
- fever – you must immediately seek medical advice if you develop a fever because this could be a sign of infection
- hypersensitivity reactions or allergic reactions including anaphylactic type reactions – if you develop symptoms such angioedema or bronchospasm, stop having Enbrel and seek medical advice immediately
- production of antibodies to Enbrel
Uncommon: More than 1 in 1000 people who have Enbrel
- blood or bone marrow problems – some of the blood problems caused by Enbrel may be fatal. You or your carer should seek medical advice if any of these occur: fever, sore throat, bruising, bleeding or paleness
- eye or eyesight problems including irritation or inflammation of the eye
- lung problems such as pneumonitis and pulmonary fibrosis which may be fatal
- psoriasis or psoriasis-like rash; worsening of psoriasis
- skin cancers
- skin rash or rashes
Rare: More than 1 in 10,000 people who have Enbrel
- abnormal laboratory test results
- brain or central nervous system problems
- erythema multiforme
- lupus or lupus-like problem
- Stevens-Johnson syndrome
- tuberculosis – some of the tuberculosisinfections caused by Enbrel may be fatal. You must seek medical advice if you get a persistent cough, fever or weight loss
- worsening of heart problems
Very rare: Fewer than 1 in 10,000 people who have Enbrel
- demyelinating polyneuropathies including Guillain-Barré syndrome, chronic inflammatory polyneuropathy and multifocal motor neuropathy or worsening of existing demyelinating problems
- toxic epidermal necrolysis
The frequency of these side-effects is unknown
- autoimmune problems
- bowel problems
- ear or hearing problems
- gallbladder problems
- gastrointestinal problems
- joint problems
- leg ulcers
- muscle problems
- reactivation of hepatitis B
- recall injection site reactions
- skin ulcers
- tumours including breast or lung malignancies
- worsening of hepatitis C
If you feel unwell or if you have concerns about a side-effect, you will need to seek advice. If you feel very ill, get medical help straight away. Contact your prescriber, pharmacist, nurse or call NHS Direct on 0845 46 47.
The Yellow card Scheme is vital in helping the MHRA monitor the safety of the medicines and vaccines that are on the market.
Before a medicine is granted a licence so that it can be made available in the United Kingdom, it must pass strict tests and checks to ensure that it is acceptably safe and effective. All effective medicines however, can cause side effects.
This medicine is also available as:
- Enbrel 50mg/1ml solution for injection pre-filled syringes
- Enbrel 25mg/0.5ml solution for injection pre-filled syringes
- Enbrel 50mg/1ml solution for injection 1ml pre-filled MyClic pen
Printable guides available for this medicine:
- Rheumatoid Arthritis (112.46 KB)
- Ankylosing Spondylitis (112.45 KB)
- Psoriatic Arthritis (112.44 KB)
- Plaque Psoriasis (112.72 KB)
- Juvenile Chronic Arthritis (112.53 KB)
Data from: http://www.nhs.uk/Conditions/Ankylosing-spondylitis/Pages/MedicineOverview.aspx?condition=Ankylosing spondylitis&medicine=Enbrel&preparation=Enbrel 25mg powder and solvent for solution for injection vials