Enbrel 50 mg solution for injection in pre-filled syringes
Spain
Table of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
Enbrel 25 mg solution for injection in pre-filled syringe
Enbrel 50 mg solution for injection in pre-filled syringe
etanercept
Read the entire leaflet carefully before you start using this medicine, as it contains important information for you.
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Package leaflet
The information in this leaflet is divided into the following 7 sections:
1. What Enbrel is and what it is used for
2. What you need to know before using Enbrel
3. How to use Enbrel
4. Possible side effects
5. Storage of Enbrel
6. Contents of the pack and other information
7. Instructions for use
1. What Enbrel is and what it is used for
Enbrel is a medicine 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.
Enbrel can be used in adults aged 18 years and older for the treatment of moderate to severe rheumatoid arthritis, psoriatic arthritis, severe axial spondyloarthritis, including ankylosing spondylitis, and moderate to severe psoriasis, usually when other treatments have not been sufficiently effective or are not suitable for you.
In the treatment of rheumatoid arthritis, Enbrel is usually used in combination with methotrexate, although it may also be used as a single medicine if treatment with methotrexate is not suitable for you. Enbrel may slow down the joint damage caused by rheumatoid arthritis and improve your ability to perform daily activities, whether used alone or in combination with methotrexate.
In patients with psoriatic arthritis affecting multiple joints, Enbrel may improve your ability to carry out normal daily activities. In patients with multiple swollen or painful joints symmetrically affected (e.g., in hands, wrists, and feet), Enbrel may delay the progression of structural damage to these joints caused by the disease.
Enbrel is also indicated for treatment in children and adolescents with the following conditions:
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For the following types of juvenile idiopathic arthritis when treatment with methotrexate has not worked adequately or is not suitable for them:
- Polyarthritis (with positive or negative rheumatoid factor) and extended oligoarthritis in patients aged 2 years and older.
- Psoriatic arthritis in patients aged 12 years and older.
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For enthesitis-related arthritis in patients aged 12 years and older when other commonly used treatments have not worked adequately or are not suitable for them.
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Severe psoriasis in patients aged 6 years and older who have had an inadequate response to (or are unable to take) phototherapy or other systemic therapies.
2. What you need to know before using Enbrel
Do not use Enbrel
- if you or the child under your care are allergic to etanercept or to any of the other components of Enbrel (listed in section 6). If you or the child experience allergic reactions such as chest tightness, wheezing, dizziness, or rash, do not inject any more Enbrel and contact your doctor immediately.
- if you or the child have or are at risk of developing a serious blood infection called sepsis. If you are unsure, consult your doctor.
- if you or the child have any type of infection. If you are unsure, consult your doctor.
Warnings and precautions
Talk to your doctor before starting to use Enbrel.
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Allergic reactions: If you or the child experience allergic reactions such as chest tightness, wheezing, dizziness, or rash, do not inject any more Enbrel and contact your doctor immediately.
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Infections/surgery: If you or the child develop a new infection or are about to undergo major surgery, your doctor may need to monitor your treatment with Enbrel.
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Infections/diabetes: Inform your doctor if you or the child have a history of recurrent infections or if you have diabetes or other disorders that increase the risk of infection.
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Infections/monitoring: Inform your doctor about any recent travel outside the European region. If you or the child develop symptoms of infection such as fever, chills, or cough, notify your doctor immediately. Your doctor should decide whether continued monitoring for infections is needed after stopping treatment with Enbrel.
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Tuberculosis: Since cases of tuberculosis have been reported in patients treated with Enbrel, your doctor will examine for signs and symptoms of tuberculosis before starting Enbrel. This may include a thorough review of your medical history, chest X-ray, and a tuberculosis test. Completion of these assessments must be recorded on the Patient Information Card. It is very important to tell your doctor if you or the child have had tuberculosis or have been in close contact with someone who had tuberculosis. If symptoms of tuberculosis (such as persistent cough, weight loss, fatigue, low-grade fever) or any other infection appear during or after treatment, inform your doctor immediately.
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Hepatitis B: Inform your doctor if you or the child have or have previously had hepatitis B. Your doctor should test for hepatitis B before you or the child start treatment with Enbrel. Treatment with Enbrel may reactivate hepatitis B in patients previously infected with the hepatitis B virus. If this occurs, you must stop using Enbrel.
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Hepatitis C: Inform your doctor if you or the child have hepatitis C. Your doctor may want to monitor treatment with Enbrel in case the infection worsens.
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Blood disorders: Inform your doctor immediately if you or the child have signs or symptoms such as persistent fever, sore throat, bruising, bleeding, or paleness. These symptoms may indicate a serious blood disorder requiring discontinuation of Enbrel treatment.
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Nervous system and vision disorders: Inform your doctor if you or the child have multiple sclerosis, optic neuritis (inflammation of the optic nerves), or transverse myelitis (inflammation of the spinal cord). Your doctor will decide whether Enbrel is an appropriate treatment.
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Congestive heart failure: Inform your doctor if you or the child have a history of congestive heart failure, as Enbrel must be used with caution in such cases.
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Cancer: Inform your doctor if you have or have previously had lymphoma (a type of blood cancer) or any other cancer before receiving Enbrel.
Patients with severe rheumatoid arthritis who have had the disease for a long time may have a higher than average risk of developing lymphoma.
Children and adults taking Enbrel may have an increased risk of developing lymphoma or other cancers.
Some adolescents and children who have received Enbrel or other medicines that work similarly to Enbrel have developed cancers, including unusual types, which sometimes resulted in death.
Some patients receiving Enbrel have developed skin cancers. Inform your doctor if you or the child develop any changes in skin appearance or skin growths.
- Chickenpox: Inform your doctor if you or the child are exposed to chickenpox while using Enbrel. Your doctor will determine whether preventive treatment for chickenpox is appropriate.
- Latex: The needle cap is made of latex (dry natural rubber). Contact your doctor before using Enbrel if the needle cap will be handled by, or if Enbrel will be administered to, someone with known or possible hypersensitivity (allergy) to latex.
- Alcoholism: Enbrel should not be used to treat hepatitis related to alcoholism. Please inform your doctor if you or the child under your care have a history of alcoholism.
- Wegener's granulomatosis: Enbrel is not recommended for the treatment of Wegener's granulomatosis, a rare inflammatory disease. If you or the child under your care have Wegener's granulomatosis, discuss this with your doctor.
- Antidiabetic medicines: Inform your doctor if you or the child have diabetes or are taking medicines to treat diabetes. Your doctor may decide whether you or the child need a lower dose of antidiabetic medicine while taking Enbrel.
Children and adolescents
Vaccinations: If possible, children should be up to date with all vaccinations before using Enbrel. Some vaccines, such as the oral polio vaccine, should not be given while using Enbrel. Consult your doctor before you or the child receive any vaccine.
Enbrel should normally not be used in children under 2 years of age with polyarticular juvenile idiopathic arthritis or extended oligoarticular juvenile idiopathic arthritis, in children under 12 years of age with enthesitis-related arthritis or psoriatic arthritis, or in children under 6 years of age with psoriasis.
Other medicines and Enbrel
Inform your doctor or pharmacist if you or the child are using, have recently used, or might need to use any other medicines (including anakinra, abatacept, or sulfasalazine), even those not prescribed by your doctor. You or the child should not use Enbrel together with medicines containing the active substances anakinra or abatacept.
Pregnancy and breastfeeding
Enbrel should only be used during pregnancy if clearly necessary. Consult your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant.
If you have received Enbrel during pregnancy, your baby may have an increased risk of infection. In addition, one study reported more birth defects when mothers had received Enbrel during pregnancy compared to mothers who had not received Enbrel or similar medicines (TNF antagonists), but there was no pattern in the types of birth defects reported. Another study found no increased risk of congenital malformations when mothers received Enbrel during pregnancy. Your doctor will help you decide whether the benefits of treatment outweigh the potential risks to your baby.
Consult your doctor if you wish to breastfeed while on Enbrel treatment. It is important to inform the pediatrician and other healthcare professionals about the use of Enbrel during pregnancy and breastfeeding before your baby receives any vaccine.
Driving and using machines
Enbrel is not expected to affect the ability to drive or use machines.
Enbrel contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose unit; essentially “sodium-free”.
3. How to use Enbrel
Follow exactly the administration instructions for this medicine given by your doctor. If in doubt, consult your doctor or pharmacist again.
If you think that the effect of Enbrel is too strong or too weak, inform your doctor or pharmacist.
The pre-filled syringe is available in 25 mg and 50 mg doses.
Dosage for adult patients (aged 18 years and older)
Rheumatoid arthritis, psoriatic arthritis, and axial spondyloarthritis, including ankylosing spondylitis
The usual dose is 25 mg administered twice weekly or 50 mg administered once weekly, as a subcutaneous injection. However, your doctor may determine an alternative dosing frequency for Enbrel.
Plaque psoriasis
The usual dose is 25 mg twice weekly or 50 mg once weekly.
Alternatively, 50 mg may be administered twice weekly for up to 12 weeks, followed by 25 mg twice weekly or 50 mg once weekly.
Your doctor will decide how long you should take Enbrel and whether treatment should be repeated based on your response. If Enbrel has no effect on your disease after 12 weeks, your doctor may instruct you to stop using this medicine.
Use in children and adolescents
The appropriate dose and dosing frequency will depend on the child's or adolescent's body weight and condition. Your doctor will determine the appropriate dose for the child and will prescribe the most suitable presentation of Enbrel (10 mg, 25 mg, or 50 mg).
For polyarticular or extended oligoarticular juvenile idiopathic arthritis in patients aged 2 years and older, or enthesitis-related arthritis or psoriatic arthritis in patients aged 12 years and older, the usual dose is 0.4 mg of Enbrel per kg of body weight (up to a maximum of 25 mg) twice weekly, or 0.8 mg of Enbrel per kg of body weight (up to a maximum of 50 mg) once weekly.
For psoriasis in patients aged 6 years and older, the usual dose is 0.8 mg of Enbrel per kg of body weight (up to a maximum of 50 mg) once weekly. If Enbrel has no effect on the child's disease after 12 weeks, your doctor may instruct you to stop using this medicine.
Your doctor will provide precise instructions for preparing and calculating the correct dose.
Method and route of administration
Enbrel is administered by subcutaneous injection.
Enbrel may be administered with or without food or drink.
Detailed instructions for injecting Enbrel are included in section 7, “Instructions for use”. The Enbrel solution must not be mixed with any other medicine.
To help you remember, it may be helpful to record in a diary which day(s) of the week you should use Enbrel.
If you use more Enbrel than you should
If you use more Enbrel than you should (either by injecting a higher amount at one time or by using it too frequently), you should speak to a doctor or pharmacist immediately. Always carry the medicine carton with you, even if it is empty.
If you forget to inject Enbrel
If you miss a dose, you should inject it as soon as you remember, unless the next dose is scheduled for the following day, in which case you should skip the missed dose. Then continue injecting the medicine on your usual day(s). If you do not remember until the day you are due to administer the next dose, do not inject a double dose (two doses on the same day) to make up for the missed dose.
If you stop using Enbrel
Your symptoms may return after stopping treatment.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Allergic reactions
If you notice any of the following reactions, do not inject any more Enbrel. Contact your doctor immediately or go to the nearest hospital Emergency Department.
- Difficulty swallowing or breathing.
- Swelling of the face, throat, hands, and feet.
- Feeling nervous or anxious, palpitations, sudden redness of the skin and/or sensation of warmth.
- Severe rash, itching, or hives (prominent, red or pale welts on the skin, often accompanied by itching).
Severe allergic reactions are rare. However, any of the above symptoms may indicate an allergic reaction to Enbrel, so you must seek immediate medical attention.
Serious adverse effects
If you notice any of the following effects, you or the child may require urgent medical attention.
- Signs of serious infections, such as high fever which may be accompanied by cough, shortness of breath, chills, weakness, or a painful, tender, red, and warm area on the skin or joints.
- Signs of blood disorders, such as bleeding, bruising, or paleness.
- Signs of nervous system disorders, such as numbness or tingling, vision disturbances, eye pain, or sudden weakness in an arm or leg.
- Signs of heart failure or worsening heart failure, such as fatigue or shortness of breath during activity, swelling of the ankles, a feeling of fullness in the neck or abdomen, shortness of breath at night, or cough, bluish discoloration of the nails or around the lips.
- Signs of cancer: cancer can affect any part of the body including the skin and blood, and possible signs depend on the type and location of the cancer. These signs may include weight loss, fever, swelling (with or without pain), persistent cough, or lumps or thickening in the skin.
- Signs of autoimmune reactions (where antibodies develop that may damage normal body tissues), such as pain, itching, weakness, and abnormal breathing, thinking, sensation, or vision.
- Signs of lupus or lupus-like syndrome, such as weight changes, persistent rash, fever, muscle or joint pain, or fatigue.
- Signs of inflammation of blood vessels, such as pain, fever, redness or warmth of the skin, or itching.
These adverse effects are rare or uncommon, but they are serious conditions (some of which, rarely, may be fatal). If any of these signs occur, inform your doctor immediately or go to the nearest hospital Emergency Department.
The following is a list of known adverse effects of Enbrel, grouped in decreasing order of frequency:
- Very common (may affect more than 1 in 10 people):
Infections (including colds, sinusitis, bronchitis, urinary tract infections, and skin infections); injection site reactions (including bleeding, bruising, redness, itching, pain, and swelling) (these occur less frequently after the first month of treatment; some patients have developed reactions at injection sites they had recently used); and headache.
- Common (may affect up to 1 in 10 people):
Allergic reactions; fever; rash; itching; antibodies directed against normal tissues (formation of autoantibodies).
- Uncommon (may affect up to 1 in 100 people):
Serious infections (including pneumonia, non-superficial skin infections, joint infections, blood infections, and generalized infections); worsening of congestive heart failure; low red blood cell count, low white blood cell count, low neutrophil count (a type of white blood cell); low platelet count; skin cancer (excluding melanoma); localized swelling of the skin (angioedema); hives (prominent, red or pale welts on the skin, often accompanied by itching); eye inflammation, psoriasis (new or worsening); inflammation of blood vessels affecting multiple organs; increased liver enzymes in blood tests (in patients also receiving methotrexate, increased liver enzymes are common); abdominal cramps and pain, diarrhea, weight loss, or blood in the stool (signs of intestinal problems).
- Rare (may affect up to 1 in 1,000 people):
Severe allergic reactions (including severe localized swelling of the skin and labored breathing); lymphoma (a type of blood cancer); leukemia (cancer affecting blood and bone marrow); melanoma (a type of skin cancer); combined low counts of red blood cells, white blood cells, and platelets; nervous system disorders (with severe muscle weakness and signs and symptoms similar to multiple sclerosis or inflammation of the optic nerves or spinal cord); tuberculosis; newly developed congestive heart failure; seizures; lupus or lupus-like syndrome (symptoms may include persistent rash, fever, joint pain, and fatigue); skin rash that may lead to severe blistering and peeling of the skin; lichenoid reactions (itchy, reddish-purple skin rash and/or thick whitish-gray lines on mucous membranes); liver inflammation caused by the immune system (autoimmune hepatitis; in patients also receiving methotrexate, the frequency is uncommon); an immune disorder that may affect the lungs, skin, and lymph nodes (sarcoidosis); lung inflammation or scarring (in patients also receiving methotrexate, the frequency of lung inflammation or scarring is uncommon); damage to the small filters within the kidneys, leading to impaired kidney function (glomerulonephritis).
- Very rare (may affect up to 1 in 10,000 people):
Bone marrow failure to produce essential blood cells.
- Frequency not known (cannot be estimated from available data):
Merkel cell carcinoma (a type of skin cancer); Kaposi's sarcoma, an uncommon cancer associated with human herpesvirus 8 infection. Kaposi's sarcoma usually presents more frequently as purplish skin lesions; excessive activation of white blood cells associated with inflammation (macrophage activation syndrome); reactivation of hepatitis B (a liver infection); worsening of a condition called dermatomyositis (muscle inflammation and weakness accompanied by skin rash).
Other adverse effects in children and adolescents
The adverse effects observed in children and adolescents, as well as their frequencies, are similar to those described above.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Enbrel
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging and on the pre-filled syringe after "EXP". The expiry date refers to the last day of the month indicated.
Store in a refrigerator (2 °C - 8 °C). Do not freeze.
Keep the pre-filled syringes in their outer packaging to protect them from light.
After removing the syringe from the refrigerator, wait approximately 15 to 30 minutes to allow the Enbrel solution to reach room temperature. Do not heat it in any other way. Immediate use is then recommended.
Enbrel may be stored outside the refrigerator at a maximum temperature of 25 °C for a single period of up to 4 weeks; after this period, the medicine must not be refrigerated again. Enbrel must be discarded if not used within 4 weeks of removal from the refrigerator. It is advisable to record the date when Enbrel was removed from the refrigerator and the date from which Enbrel must be discarded (no more than 4 weeks after removal from the refrigerator).
Inspect the solution in the syringe. It should be clear or slightly opalescent, colourless to pale yellow or pale brown, and may contain small white or almost transparent protein particles. This is the normal appearance of Enbrel. Do not use the solution if it is discoloured or cloudy, or if it contains particles different from those described above. If you are concerned about the appearance of the solution, contact your pharmacist for any assistance you may need.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Enbrel
Enbrel 25 mg solution for injection in pre-filled syringe
The active substance in Enbrel is etanercept. Each pre-filled syringe of Enbrel 25 mg contains 0.5 ml of solution with 25 mg of etanercept.
Enbrel 50 mg solution for injection in pre-filled syringe
The active substance in Enbrel is etanercept. Each pre-filled syringe of Enbrel 50 mg contains 1.0 ml of solution with 50 mg of etanercept.
The other components are sucrose, sodium chloride, L-arginine hydrochloride, monosodium phosphate dihydrate, disodium phosphate dihydrate, and water for injections.
Appearance of the product and contents of the pack
Enbrel 25 mg solution for injection in pre-filled syringe
Enbrel is supplied as a pre-filled syringe containing a clear, colourless to pale yellow or pale brown solution for injection (injectable solution). Each pack contains 4, 8, 12 or 24 pre-filled syringes and 4, 8, 12 or 24 alcohol-impregnated cotton swabs. Only certain pack sizes may be marketed.
Enbrel 50 mg solution for injection in pre-filled syringe
Enbrel is supplied as a pre-filled syringe containing a clear, colourless to pale yellow or pale brown solution for injection (injectable solution). Each pack contains 2, 4 or 12 pre-filled syringes and 2, 4 or 12 alcohol-impregnated cotton swabs. Only certain pack sizes may be marketed.
Marketing Authorization Holder: Pfizer Europe MA EEIG Boulevard de la Plaine 17 1050 Brussels Belgium | |
Manufacturer: Pfizer Manufacturing Belgium NV Rijksweg 12, 2870 Puurs-Sint-Amands Belgium | |
You can request further information about this medicine by contacting the local representative of the marketing authorisation holder:
Spain
Pfizer, S.L.
Tel: +34 91 490 99 00
Date of the most recent review of this leaflet:
Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.
7. Instructions for use
This section is divided into the following parts:
Introduction
Step 1: Preparing for an injection
Step 2: Choosing an injection site
Step 3: Injecting the Enbrel solution
Step 4: Disposal of materials
Introduction
The following instructions explain how to prepare and inject Enbrel. Please read the instructions carefully and follow them step by step. Your doctor or nurse will show you the techniques for self-injection or for administering an injection to a child. Do not attempt to give an injection until you are certain that you understand how to prepare and administer the injection correctly.
The Enbrel solution must not be mixed with any other medicine before use.
Step 1: Preparing for an injection
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Select a clean, flat, and well-lit work surface.
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Remove the Enbrel package, containing the prefilled syringes, from the refrigerator and place it on a flat surface. Starting from one of the upper corners, peel off the paper cover from the top and sides of the tray. Remove one prefilled syringe and one alcohol wipe and place them on the work surface. Do not shake the Enbrel prefilled syringe. Fold the paper cover back over the tray and return the tray containing the remaining prefilled syringes to the refrigerator. Please read section 5, which includes instructions for the storage of Enbrel. If you have any doubts about storage, contact your doctor, nurse, or pharmacist for further information.
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You must wait between 15 and 30 minutes for the Enbrel solution in the syringe to reach room temperature. DO NOT remove the needle cap until the syringe has reached room temperature. Waiting for the solution to reach room temperature may make the injection more comfortable for you. Do not heat Enbrel in any other way (for example, do not heat it in a microwave or in hot water).
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Gather the additional supplies you will need to administer the injection. This includes the alcohol wipe from the pack and a cotton ball or gauze pad.
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Wash your hands thoroughly with soap and warm water.
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Examine the solution in the syringe. It should be clear or slightly opalescent, colourless to pale yellow or pale brown, and may contain small white or almost transparent protein particles. This is the normal appearance of Enbrel. Do not use the solution if it is discoloured or cloudy, or if it contains particles different from those described above. If you are concerned about the appearance of the solution, contact your pharmacist for assistance.
Step 2: Choosing an injection site
- The three recommended sites for Enbrel injection using a prefilled syringe are: (1) the front of the thighs, (2) the abdomen, except for an area of 5 cm around the navel, and (3) the outer upper arm (see Figure 1). If you are self-injecting, you should not inject into the outer upper arms.
Figure 1
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A different site should be used for each new injection. Each new injection should be given at least 3 cm away from the previous injection site. Do not administer the injection into areas of skin that are tender, bruised, red, or hardened. Avoid areas with scars or stretch marks. (It may be helpful to record the sites of previous injections.)
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If you or the child has psoriasis, try not to inject directly into any raised, thickened, red, or scaly skin patches (psoriatic skin lesions).
Step 3: Injecting the Enbrel solution
- Clean the injection site with the alcohol wipe using a circular motion. DO NOT touch this area again until the injection has been administered.
- Pick up the prefilled syringe from the flat work surface. Remove the needle cap by pulling firmly in a straight line (see Figure 2). Be careful not to bend or twist the cap when removing it, to avoid damaging the needle.
When removing the needle cap, there may be a drop of liquid at the tip of the needle; this is normal. Do not touch the needle and avoid letting it touch any surface. Do not touch or shake the plunger. Doing so may cause the liquid to spill.
Figure 2
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Once the cleaned skin area has dried, pinch and firmly hold the skin with one hand. With the other hand, hold the syringe like a pencil.
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With a quick, short motion, push the needle fully into the skin at an angle between 45º and 90º (see Figure 3). With practice, you will find the angle that is most comfortable for you or the child. Be careful not to insert the needle too slowly or with excessive force.
Figure 3
- When the needle is fully inserted into the skin, release the skin you were holding. With your free hand, hold the needle near its base to stabilise it. Then, push the plunger to inject all the solution at a slow, steady rate (see Figure 4).
Figure 4
- When the syringe is empty, remove the needle from the skin, taking care to keep the syringe at the same angle as when it was inserted. There may be slight bleeding at the injection site. You may press a cotton ball or gauze pad over the injection site for 10 seconds. Do not rub the injection site. If necessary, you may cover the injection site with a bandage.
Step 4: Disposal of materials
- The prefilled syringe is intended for single use only. The syringe and needle MUST NEVER be reused. NEVER recap a needle. Dispose of the needle and syringe according to the instructions provided by your doctor, nurse, or pharmacist.
If you have any questions, consult a doctor, nurse, or pharmacist familiar with the use of Enbrel.