Enbrel 25 mg powder and solvent for solution for injection
Etanercept
Read all (both sides) of this leaflet carefully before you start using this medicine.
- Keep this leaflet. You may need to read it again.
- Your doctor will also give you a Patient Alert Card, which contains important safety information that you need to be aware of before and during treatment with Enbrel.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you or a child in your care. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours or those of the child you are caring for.
- If you are concerned about any side effect, or if you notice any side effects that are not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
Information in this leaflet is organised under the following 7 sections:
1. What Enbrel is and what it is used for
2. Before you use Enbrel
3. How to use Enbrel
4. Possible side effects
5. How to store Enbrel
6. Further information
7. Instructions for preparing and giving an injection of Enbrel (See overleaf)
What Enbrel Is And What It Is Used For
Enbrel is a medicine that is made from two human proteins. It blocks the activity of another protein in the body that causes inflammation. Enbrel works by reducing the inflammation associated with certain diseases.
In adults (aged 18 and over), Enbrel can be used for moderate or severe rheumatoid arthritis, psoriatic arthritis, severe ankylosing spondylitis and moderate or severe psoriasis – in each case usually when other widely used treatments have not worked well enough or are not suitable for you.
For rheumatoid arthritis, Enbrel is usually used in combination with methotrexate, although it may also be used alone if treatment with methotrexate is unsuitable for you. Whether used alone or in combination with methotrexate, Enbrel can slow down the damage to your joints caused by the rheumatoid arthritis and improve your ability to do normal daily activities.
For psoriatic arthritis patients with multiple joint involvement, Enbrel can improve your ability to do normal daily activities. For patients with multiple symmetrical painful or swollen joints (e.g., hands, wrists and feet), Enbrel can slow down the structural damage to those joints caused by the disease.
Enbrel is also prescribed for the treatment of the following diseases in children and adolescents:
- Polyarticular juvenile idiopathic arthritis (a type of juvenile arthritis that affects many joints) in patients from the age of 4 years who have had an inadequate response to (or are unable to take) methotrexate.
- Severe psoriasis in patients from the age of 8 years who have had an inadequate response to (or are unable to take) phototherapies or other systemic therapies.
Before You Use Enbrel
Do not use Enbrel
- Allergy: Do not use Enbrel if you, or the child you are caring for, are allergic to etanercept or any of the other ingredients of Enbrel. If you or the child experience allergic reactions such as chest tightness, wheezing, dizziness or rash, do not inject more Enbrel, and contact your doctor immediately.
- Serious blood infection: Do not use Enbrel if you or the child have, or are at risk of developing a serious blood infection called sepsis. If you are not sure, please contact your doctor.
- Infections: Do not use Enbrel if you or the child have an infection of any kind. If you are not sure, please talk to your doctor.
Take special care with Enbrel
- Allergic reactions: If you or the child experience allergic reactions such as chest tightness, wheezing, dizziness or rash, do not inject more Enbrel, and contact your doctor immediately.
- Infections/surgery: If you or the child develop a new infection, or are about to have any major surgery, your doctor may wish to monitor the treatment with Enbrel.
- Infections/diabetes: Tell your doctor if you or the child have a history of recurrent infections or suffer from diabetes or other conditions that increase the risk of infection.
- Infections/monitoring: Tell your doctor of any recent travel outside the European region. If you or the child develop symptoms of an infection such as fever, chills or cough, notify your doctor immediately. Your doctor may decide to continue to monitor you or the child for the presence of infections after you or the child stop using Enbrel.
- Tuberculosis: As cases of tuberculosis have been reported in patients treated with Enbrel, your doctor will check for signs and symptoms of tuberculosis before starting Enbrel. This may include a thorough medical history, a chest X-ray and a tuberculin test. The conduct of these tests should be recorded on the Patient Alert Card. It is very important that you tell your doctor if you or the child have ever had tuberculosis, or have been in close contact with someone who has had tuberculosis. If symptoms of tuberculosis (such as persistent cough, weight loss, listlessness, mild fever), or any other infection appear during or after therapy, tell your doctor immediately.
- Hepatitis B: Your doctor may decide to test for the presence of hepatitis B infection before you or the child begin treatment with Enbrel.
- Hepatitis C: Tell your doctor if you or the child have hepatitis C. Your doctor may wish to monitor the treatment with Enbrel in case the infection worsens.
- Blood disorders: Seek medical advice immediately if you or the child have any signs or symptoms such as persistent fever, sore throat, bruising, bleeding or paleness. Such symptoms may point to the existence of potentially life-threatening blood disorders, which may require discontinuation of Enbrel.
- Nervous system and eye disorders: Tell your doctor if you or the child have multiple sclerosis, optic neuritis (inflammation of the nerves of the eyes) or transverse myelitis (inflammation of the spinal cord). Your doctor will determine if Enbrel is an appropriate treatment.
- Congestive heart failure: Tell your doctor if you or the child have a history of congestive heart failure, because Enbrel needs to be used with caution under these circumstances.
- Cancer: Tell your doctor if you have or have ever had lymphoma (a type of blood cancer) or any other cancer before you are given Enbrel.
Patients with severe rheumatoid arthritis, who have had the disease for a long time, may be at higher than average risk of developing lymphoma.
Children and adults taking Enbrel may have an increased risk of developing lymphoma or another cancer.
Some children and teenage patients who have received Enbrel or other medicines that work the same way as Enbrel have developed cancers, including unusual types, which sometimes resulted in death.
Some patients receiving Enbrel have developed skin cancers called non-melanoma skin cancer. Tell your doctor if you or the child develop any change in the appearance of the skin or growths on the skin. - Vaccinations: If possible, children should be up to date with all vaccinations before using Enbrel. Some vaccines, such as oral polio vaccine, should not be given while using Enbrel. Please consult your doctor before you or the child receive any vaccines.
- Chickenpox: Tell your doctor if you or the child are exposed to chickenpox when using Enbrel. Your doctor will determine if preventive treatment for chickenpox is appropriate.
- Alcohol abuse: Enbrel should not be used for the treatment of hepatitis related to alcohol abuse. Please tell your doctor if you or the child in your care have a history of alcohol abuse.
- Wegener’s granulomatosis: Enbrel is not recommended for the treatment of Wegener’s granulomatosis, a rare inflammatory disease. If you or the child in your care have Wegener’s granulomatosis, talk to your doctor.
- Anti-diabetic medicines: Tell your doctor if you or the child have diabetes or are taking medicines to treat diabetes. Your doctor may decide if you or the child need less anti-diabetic medicine while taking Enbrel.
Using other medicines
Tell the doctor or pharmacist if you or the child are taking or have recently taken any other medicines (including anakinra, abatacept or sulfasalazine), even those not prescribed by the doctor. You or the child should not use Enbrel with medicines that contain the active substance anakinra or abatacept.
Taking Enbrel with food and drink
Enbrel can be taken with or without food or drink.
Pregnancy and breast-feeding
The effects of Enbrel in pregnant women are not known, and so the use of Enbrel during pregnancy is not recommended. Women using Enbrel should not become pregnant. If the patient becomes pregnant, you should consult the patient's doctor.
Women using Enbrel should not breast-feed, since it is not known if Enbrel passes into human breast milk.
Driving and using machines
The use of Enbrel is not expected to affect the ability to drive or use machines.
How To Use Enbrel
Always use Enbrel exactly as the doctor has told you. You should check with the doctor or pharmacist if you are not sure.
If you feel that the effect of Enbrel is too strong or too weak, talk to your doctor or pharmacist.
Dosing for adult patients (aged 18 years or over)
Rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis
The usual dose is 25 mg given twice a week or 50 mg once a week as an injection under the skin. However, your doctor may determine an alternative frequency at which to inject Enbrel.
Plaque psoriasis
The usual dose is 25 mg twice a week or 50 mg once a week.
Alternatively, 50 mg may be given twice a week for up to 12 weeks, followed by 25 mg twice a week or 50 mg once a week.
Your doctor will decide how long you should take Enbrel and whether retreatment is needed based on your response. If Enbrel has no effect on your condition after 12 weeks, your doctor may tell you to stop taking this medicine.
Dosing for children and adolescents
The appropriate dose and frequency of dosing for the child or adolescent will depend on body weight and disease. The doctor will provide you with detailed directions for preparing and measuring the appropriate dose.
For polyarticular juvenile idiopathic arthritis in patients from the age of 4 years, the usual dose is 0.4 mg of Enbrel per kg bodyweight (up to a maximum of 25 mg), and should be given twice weekly.
For psoriasis in patients from the age of 8 years, the usual dose is 0.8 mg of Enbrel per kg bodyweight (up to a maximum of 50 mg), and should be 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.
Method and route of administration
Enbrel is administered by an injection under the skin (by subcutaneous injection).
Enbrel can be taken with or without food or drink.
The powder must be dissolved before use. Detailed instructions on how to prepare and inject Enbrel are provided in section 7, “INSTRUCTIONS FOR PREPARING AND GIVING AN INJECTION OF ENBREL”. Do not mix the Enbrel solution with any other medicine.
To help you remember, it may be helpful to write in a diary which day(s) of the week Enbrel should be used.
If you use more Enbrel than you should
If you have used more Enbrel than you should (either by injecting too much on a single occasion or by using it too frequently), talk to a doctor or pharmacist immediately. Always have the outer carton of the medicine with you, even if it is empty.
If you forget to inject Enbrel
If you forget a dose, you should inject it as soon as you remember, unless the next scheduled dose is the next day; in which case you should skip the missed dose. Then continue to inject the medicine on the usual day(s). If you do not remember until the day that the next injection is due, do not take a double dose (two doses on the same day) to make up for a forgotten dose.
If you stop using Enbrel
Your symptoms may return upon discontinuation.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible Side Effects
Like all medicines, Enbrel can cause side effects, although not everybody gets them.
Other side effects that are not listed in this leaflet may occur. If you are concerned about any side effect, or if you notice any side effects that are not listed in this leaflet, please tell your doctor or pharmacist.
Allergic reactions
If any of the following happen, do not inject more Enbrel. Tell your doctor immediately, or go to the casualty department at your nearest hospital.
- Trouble swallowing or breathing
- Swelling of the face, throat, hands, or feet
- Feeling nervous or anxious, throbbing sensations, sudden reddening of the skin and/or a warm feeling
- Severe rash, itching, or hives (elevated patches of red or pale skin that often itch)
Serious allergic reactions are rare. However, any of the above symptoms may indicate an allergic reaction to Enbrel, so you should seek immediate medical attention.
Serious side effects
If you notice any of the following, you or the child may need urgent medical attention.
- Signs of serious infections, such as high fever that may be accompanied by cough, shortness of breath, chills, weakness, or a hot, red, tender, sore area on the skin or joints
- Signs of blood disorders, such as bleeding, bruising, or paleness
- Signs of nerve disorders, such as numbness or tingling, changes in vision, eye pain, or onset of weakness in an arm or leg
- Signs of worsening heart failure, such as fatigue or shortness of breath with activity, swelling in the ankles, a feeling of fullness in the neck or abdomen, night-time shortness of breath or coughing, bluish colour of the nails or the lips
These are rare or uncommon side effects, but are serious conditions (some of which may rarely be fatal). If these signs occur, tell your doctor immediately, or visit the casualty department at your nearest hospital.
The frequency of possible side effects listed below is defined using the following convention:
- Very common (affects more than 1 user in 10)
- Common (affects 1 to 10 users in 100)
- Uncommon (affects 1 to 10 users in 1,000)
- Rare (affects 1 to 10 users in 10,000)
- Very rare (affects less than 1 user in 10,000)
- Not known (frequency cannot be estimated from the available data)
The side effects listed below are those that have been seen in adult patients. The side effects seen in children and adolescents are similar to those seen in adults.
- Very common: Infections (including colds, sinusitis, bronchitis, urinary tract infections and skin infections); injection site reactions (including bleeding, bruising, redness, itching, pain, and swelling). Reactions at the injection site are very common, but do not occur as often after the first month of treatment. Some patients have developed a reaction at an injection site that was used before.
- Common: allergic reactions; fever; itching; antibodies directed against normal tissue (autoantibody formation).
- Uncommon: serious infections (including pneumonia, deep skin infections, joint infections, blood infection, and infections at various sites); low blood platelet count; skin cancer (excluding melanoma); localised swelling of the skin (angioedema); hives (elevated patches of red or pale skin that often itch); eye inflammation; psoriasis (new or worsening); rash; inflammation or scarring of the lungs.
- Rare: serious allergic reactions (including severe localised swelling of the skin and wheezing); lymphoma (a type of blood cancer); combined low platelet, red, and white blood cell count; nervous system disorders (with signs and symptoms similar to those of multiple sclerosis or inflammation of the nerves of the eyes or spinal cord); tuberculosis; worsening congestive heart failure; seizures; lupus or lupus-like syndrome (symptoms may include persistent rash, fever, joint pain, and tiredness); inflammation of the blood vessels; low red blood cell count, low white blood cell count, low neutrophil (a type of white blood cell) count; elevated liver blood tests; skin rash, which may lead to severe blistering and peeling of the skin.
- Very rare: failure of the bone marrow to produce crucial blood cells.
- Not known: leukaemia (cancer affecting the blood and bone marrow); excessive activation of white blood cells associated with inflammation (macrophage activation syndrome).
How To Store Enbrel
Keep out of the reach and sight of children.
Do not use Enbrel after the expiry date which is stated on the carton and the label after “EXP”. The expiry date refers to the last day of that month.
Store in a refrigerator (2°C – 8°C). Do not freeze.
After preparing the Enbrel solution, immediate use is recommended. However, the solution may be used for up to 6 hours if stored in the refrigerator (2°C – 8°C).
Do not use Enbrel if you notice the solution is not clear or contains particles. The solution should be clear, colourless or pale yellow, with no lumps or flakes or particles.
Carefully dispose of any Enbrel solution that has not been injected within 6 hours.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Further Information
What Enbrel contains
The active substance in Enbrel is etanercept. Each vial of Enbrel 25 mg contains 25 mg of etanercept.
The other ingredients are:
Powder: Mannitol (E421), sucrose and trometamol
Solvent: Water for injections
What Enbrel looks like and contents of the pack
Enbrel 25 mg is supplied as a white powder and solvent for solution for injection (powder for injection). Each pack contains 4, 8 or 24 single dose vials, 4, 8 or 24 pre-filled syringes of water for injections, 4, 8 or 24 needles, 4, 8 or 24 vial adaptors and 8, 16 or 48 alcohol swabs. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Manufacturer:
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
This leaflet was last approved in 07/2010
Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Instructions For Preparing And Giving An Injection Of Enbrel
This section is divided into the following sub-sections:
a. Introduction
b. Setting up for an injection
c. Preparing the Enbrel dose for injection
d. Adding solvent
e. Withdrawing the Enbrel solution from the vial
f. Placing the needle on the syringe
g. Choosing an injection site
h. Preparing the injection site and injecting the Enbrel solution
i. Disposing of supplies
a. Introduction
The following instructions explain how to prepare and inject Enbrel. Please read the instructions carefully and follow them step by step. You will be instructed by your doctor or his/her assistant on the techniques of self-injection or on giving an injection to a child. Do not attempt to administer an injection until you are sure that you understand how to prepare and give the injection.
This injection should not be mixed with any other medicine.
b. Setting up for an injection
- Wash your hands thoroughly.
- Select a clean well-lit, flat working surface.
- The dose tray should contain the items listed below. (If not, don’t use the dose tray and consult your pharmacist). Use only the items listed. Do NOT use any other syringe.
1 Enbrel vial
1 Pre-filled syringe containing clear, colourless solvent (water for injections)
1 Needle
1 Vial adaptor
2 Alcohol swabs - Inspect the expiry dates on both the vial label and the syringe label. They should not be used after the month and year shown.
c. Preparing the Enbrel dose for injection
- Remove the contents of the tray
- Remove the plastic cap from the Enbrel vial (see Diagram 1). Do NOT remove the grey stopper or aluminium ring around the top of the vial.
- Use a new alcohol swab to clean the grey stopper on the Enbrel vial. After cleaning, do not touch the stopper with your hands or allow it to touch any surface.
- Place the vial upright on a clean, flat surface.
- Remove the paper backing from the vial adaptor package.
- While still in the plastic package, place the vial adaptor on top of the Enbrel vial so that the vial adaptor spike is centered within the raised circle on top of the vial stopper (see Diagram 2).
- Hold the vial firmly on the flat surface with one hand. With the other hand, push STRAIGHT DOWN FIRMLY on the adaptor package until you feel the adaptor spike penetrate the vial stopper and FEEL AND HEAR THE ADAPTOR RIM LOCK INTO PLACE (see Diagram 3). Do NOT push down the adaptor at an angle (see Diagram 4). It is important that the vial adaptor spike completely penetrates the vial stopper.
- While holding the vial in one hand, remove the plastic packaging from the vial adaptor (see Diagram 5).
- Remove the protective cover from the syringe tip by breaking the white cap along the perforation. This is done by holding the collar of the white cap while grasping the end of the white cap with the other hand and bending it down and then up until it is broken (see Diagram 6). Do NOT remove the white collar that remains on the syringe.
- Do not use the syringe if this perforation is already broken. Start again with another dose tray.
- Holding the glass barrel of the syringe (not the white collar) in one hand, and the vial adaptor (not the vial) in the other, connect the syringe to the vial adaptor by inserting the tip into the opening and turn clockwise until completely secured (see Diagram 7).
d. Adding solvent
- While holding the vial upright on the flat surface, push the plunger VERY SLOWLY until all the solvent is in the vial. This will help to reduce foaming (lots of bubbles) (see Diagram 8).
- Once the solvent is added to the Enbrel, the plunger may move up by itself. This is due to air pressure and should not be of concern.
- With the syringe still attached, gently move the vial in circles a few times, to dissolve the powder (see Diagram 9). Do NOT shake the vial. Wait until all the powder dissolves (usually less than 10 minutes). The solution should be clear and colourless, with no lumps, flakes, or particles. Some white foam may remain in the vial - this is normal. Do NOT use Enbrel if all the powder in the vial is not dissolved within 10 minutes. Start again with another dose tray.
e. Withdrawing the Enbrel solution from the vial
- With the syringe still attached to the vial and vial adaptor, hold the vial upside down at eye level. Push the plunger all the way into the syringe (see Diagram 10).
- Then, slowly pull the plunger back to draw the liquid into the syringe (see Diagram 11). For adult patients, withdraw the entire volume. For children, remove only the portion of liquid as directed by your child’s doctor. After you have withdrawn the Enbrel from the vial, you may have some air in the syringe. Do not be concerned, as you will remove the air in a later step.
- With the vial held upside down, unscrew the syringe from the vial adaptor by turning it anti-clockwise (see Diagram 12).
- Place the filled syringe on the clean, flat surface. Make sure that the tip does not touch anything. Be careful not to push down on the plunger.
(Note: After you have completed these steps, a small amount of liquid may remain in the vial. This is normal.)
f. Placing the needle on the syringe
- The needle has been placed in a plastic container to keep it sterile.
- To open the plastic container, hold the short, wide end in one hand. Place your other hand on the longer portion of the container.
- To break the seal, bend the larger end down and then up until broken (see Diagram 13).
- Once the seal has been broken, remove the short, wide end of the plastic container.
- The needle will remain in the long part of the package.
- While holding the needle and container in one hand, pick up the syringe and insert the syringe tip into the needle opening.
- Attach the syringe to the needle by turning it clockwise until completely secured (see Diagram 14).
- Remove the needle cover by firmly pulling it straight off the syringe taking care not to touch the needle or allow the needle to touch any surfaces (see Diagram 15). Be careful not to bend or twist the cover during removal to avoid damage to the needle.
- While holding the syringe upright, remove any air bubbles by slowly pushing on the plunger until the air is removed (see Diagram 16).
g. Choosing an injection site
- The three recommended injection sites for Enbrel include: (1) the front of the middle thighs; (2) the abdomen, except for the 5 cm area right around the navel; and (3) the outer area of the upper arms (see Diagram 17). If you are self injecting, you should not use the outer area of the upper arms.
- A different site should be used for each new injection. Each new injection should be given at least 3 cm from an old site. Do NOT inject into areas where the skin is tender, bruised, red, or hard. Avoid areas with scars or stretch marks. (It may be helpful to keep notes on the location of the previous injections.)
- If you or the child have psoriasis, you should try not to inject directly into any raised, thick, red, or scaly skin patches (“psoriasis skin lesions”).
h. Preparing the injection site and injecting the Enbrel solution
- Wipe the site where Enbrel is to be injected with an alcohol swab, using a circular motion. Do NOT touch this area again before giving the injection.
- When the cleaned area of skin has dried, pinch and hold it firmly with one hand. With the other hand, hold the syringe like a pencil.
- With a quick, short motion, push the needle all the way into the skin at an angle between 45° and 90° (see Diagram 18). With experience, you will find the angle that is most comfortable for you or the child. Be careful not to push the needle into the skin too slowly, or with great force.
- When the needle is completely inserted into the skin, release the skin that you are holding. With your free hand, hold the syringe near its base to stabilise it. Then push the plunger to inject all of the solution at a slow, steady rate (see Diagram 19).
- When the syringe is empty, remove the needle from the skin; being careful to keep it at the same angle it was when it was inserted.
- Press a cotton ball over the injection site for 10 seconds. Slight bleeding may occur. Do NOT rub the injection site. A bandage is optional.
i. Disposing of supplies
- The syringe and needles should NEVER be re-used. Dispose of the needles and syringe as instructed by your doctor, nurse or pharmacist.
If you have any questions, please talk to a doctor, nurse or pharmacist who is familiar with Enbrel.
Doc ID: 61170 (Taken from Doc ID: 61169 and annex)
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