Enbrel 25 mg powder and solvent for solution for injection

Package Leaflet: Information for the user

Introduction

Package Leaflet: Information for the user

Enbrel 25 mg powder and solvent for solution for injection

etanercept

Read the entire leaflet carefully before starting to use this medicine, as it contains important information for you. Keep this leaflet, as you may need to read it again. Your doctor will also provide you with a Patient Information Card, which contains important safety information you need to know before and during treatment with Enbrel. If you have any questions, consult your doctor, pharmacist, or nurse. This medicine has been prescribed for you or for the child in your care; do not give it to other people, even if they have the same symptoms as you or the child in your care, as it may harm them. If you experience any adverse effects, consult your doctor or pharmacist, even if these adverse effects are not listed in this leaflet. See section 4.

Package leaflet contents

The information in this leaflet is organized 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 additional 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 found 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 depending on the individual case, 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 when treatment with methotrexate is not suitable for you. Enbrel can slow down the joint damage caused by rheumatoid arthritis and improve your ability to carry out daily activities, whether used alone or in combination with methotrexate.

In patients with psoriatic arthritis affecting multiple joints, Enbrel can improve their ability to perform normal daily activities. In patients with multiple symmetric swollen or painful joints (for example, in the hands, wrists, and feet), Enbrel can 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:

• 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 from 2 years of age.
  • Psoriatic arthritis in patients from 12 years of age.

• For enthesitis-related arthritis in patients from 12 years of age for whom other commonly used treatments have not worked adequately or are not suitable.

• Severe psoriasis in patients from 6 years of age who have had an inadequate response to (or are unable to take) phototherapies or other systemic therapies.

2. What you need to know before using Enbrel

Do not use Enbrel

• if you or the child in 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 an infection of any kind. If you are unsure, consult your doctor.

Warnings and precautions

Talk to your doctor before starting to use Enbrel.

• 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.

• Latex: The cap of the syringe is made of latex (natural rubber latex). Contact your doctor before using Enbrel if the syringe will be handled by, or if Enbrel will be administered to, someone with known or possible hypersensitivity (allergy) to latex.

• 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 Enbrel treatment.

• 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.

• Infections/monitoring: Inform your doctor about 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 should continue monitoring you or the child for signs of infection after stopping Enbrel treatment.

• Tuberculosis: Since 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, 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 has had tuberculosis. If symptoms of tuberculosis (such as persistent cough, weight loss, lack of energy, low-grade fever), or any other infection occur during or after treatment, inform your doctor immediately.

• 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.

• Hepatitis C: Inform your doctor if you or the child have hepatitis C. Your doctor may want to monitor Enbrel treatment in case the infection worsens.

• 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 problem that requires discontinuation of Enbrel treatment.

• 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.

• 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.

• Cancer: Inform your doctor if you have or have previously had lymphoma (a type of blood cancer) or any other cancer before being given 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 adolescent and pediatric patients who have received Enbrel or other medicines that work similarly to Enbrel have developed cancers, including unusual types, which in some cases have 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.
• Alcoholism: Enbrel should not be used to treat hepatitis related to alcoholism. Please inform your doctor if you or the child in 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 in 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 that 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 starting 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 developing an infection. In addition, one study reported more birth defects when the mother had received Enbrel during pregnancy compared to mothers who had not received Enbrel or other similar medicines (TNF antagonists), but there was no consistent pattern in the types of birth defects reported. Another study found no increased risk of congenital malformations when the mother had received Enbrel during pregnancy. Your doctor will help you decide whether the benefits of treatment outweigh the potential risk 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.

3. How to use Enbrel

Follow exactly the instructions for administration of this medicine as 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.

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 injection 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 you need a repeat course of treatment, depending 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 advise you on how to prepare and measure the correct dose.

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.

Method and route of administration

Enbrel is administered by subcutaneous injection (injection under the skin).

Enbrel may be taken with or without food or drink.

The powder must be dissolved before use. Detailed instructions for the preparation and injection of 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 larger amount at one time or by using it too frequently), you should contact 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 gets them.

Allergic reactions

If you notice any of the following reactions, do not inject any more Enbrel. Inform 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 (raised, red or pale areas of 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 emergency medical attention.

Serious adverse effects

If you notice any of the following effects, you or the child may require emergency 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, changes in vision, 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, feeling of fullness in the neck or abdomen, shortness of breath at night or cough, bluish color 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 presence of lumps or thickening in the skin.
• Signs of autoimmune reactions (in which 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 may, in rare cases, 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 cold, 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 injection site reactions at sites 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 infection 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 (raised, red or pale areas of 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 skin swelling and wheezing); 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; new-onset congestive heart failure; seizures; lupus or lupus-like syndrome (symptoms may include persistent rash, fever, joint pain and fatigue); skin rash, which 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, 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, 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):

Failure of the bone marrow 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 infection by human herpesvirus 8. 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 (inflammation and weakness of muscles accompanied by skin rash).

Other adverse effects in children and adolescents

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 adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can 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 carton and label 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.

Before preparing the Enbrel solution, 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 on which Enbrel was removed from the refrigerator and the date by which Enbrel must be discarded (no later than 4 weeks after removal from the refrigerator).

After reconstituting the Enbrel solution, immediate use is recommended. However, the solution may be used within 6 hours after reconstitution when stored at temperatures not exceeding 25 °C.

Do not use this medicine if you notice that the solution is not clear or contains particles. The solution should be clear, colourless to pale yellow or pale brown, and free from lumps, flakes, or particles.

Properly discard any unused Enbrel solution that has not been injected within 6 hours.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Enbrel

The active substance in Enbrel is etanercept. Each Enbrel 25 mg vial contains 25 mg of etanercept.

The other components are:

Powder: Mannitol (E421), sucrose and tromethamine

Solvent: Water for injections

Appearance of the medicinal product and contents of the pack

Enbrel 25 mg is presented as a white powder and solvent for solution for injection (powder for injectable solution). Each pack contains 4, 8 or 24 single-dose vials, 4, 8 or 24 pre-filled syringes with water for injections, 4, 8 or 24 needles, 4, 8 or 24 vial adapters, and 8, 16 or 48 alcohol-impregnated cotton pads. 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 revision 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:

1. Introduction
2. Preparing for an injection
3. Preparing the Enbrel dose for injection
4. Adding the solvent
5. Drawing the Enbrel solution from the vial
6. Attaching the needle to the syringe
7. Choosing an injection site
8. Preparing the injection site and injecting the Enbrel solution
9. Disposal of materials

a. Introduction

The following instructions explain how to prepare and inject Enbrel. Read the instructions carefully and follow them step by step. Your doctor or nurse will teach 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.

This injection must not be mixed with any other medicine.

b. Preparing for an injection

• Wash your hands thoroughly.
• Choose a well-lit area and a flat working surface.
• The tray should contain the items listed below. (If not, do not use it 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 adapter
2 Alcohol-impregnated cotton pads

• Check the expiry date on the labels of the vial and syringe. Do not use after the month and year indicated.

c. Preparing the Enbrel dose for injection

• Remove the contents from the tray.
• Remove the plastic cap from the Enbrel vial (see Figure 1). DO NOT remove the grey stopper or the aluminium cap surrounding the top of the vial.

Figure 1

• Use a new alcohol pad to clean the vial stopper. After cleaning, do not touch the stopper with your hands or allow it to come into contact with any surface.
• Place the vial upright on a clean, flat surface.
• Remove the paper covering the vial adapter packaging.
• While still in its plastic packaging, place the vial adapter onto the top of the Enbrel vial, ensuring that the adapter's spike is centred within the circle on the top of the vial stopper (Figure 2).
• Hold the vial firmly in place on the flat surface with one hand. With the other hand, firmly press the adapter housing STRAIGHT DOWN until you feel and hear the adapter's rim SNAP INTO PLACE (see Figure 3). DO NOT press the adapter at an angle (see Figure 4). It is important that the vial adapter's spike fully penetrates the vial stopper.

Figure 2	Figure 3	Figure 4
	CORRECT	INCORRECT

• While holding the vial in one hand, remove the plastic packaging from the vial adapter (see Figure 5).

Figure 5

• Remove the protective cap from the end of the syringe by breaking the white cap along the perforation. This is done by holding the ring of the white cap while grasping the end of the white cap with the other hand and bending it up and down until it breaks (see Figure 6). DO NOT remove the white ring that remains attached to the syringe.

Figure 6

• Do not use the syringe if this perforation is already broken. Start again with a new dose tray.
• Holding the glass body of the syringe (not the white ring) in one hand and the vial adapter (not the vial) in the other hand, connect the syringe to the vial adapter by inserting the end into the opening and turning clockwise until fully secured (see Figure 7).

Figure 7

d. Adding the solvent

• While keeping the vial in an upright position on a flat surface, push the plunger VERY SLOWLY until all the solvent has entered the vial. This will help reduce foam formation (many bubbles) (see Figure 8).
• Once the solvent has been added to Enbrel, the plunger may move on its own. This is due to air pressure and is not a cause for concern.

Figure 8

• With the syringe still inserted, gently swirl the vial in circles for a few minutes to dissolve the powder (see Figure 9). DO NOT shake the vial. Wait until all the powder has dissolved (usually less than 10 minutes). The solution should be clear and colorless to pale yellow or pale brown, without clumps, flakes, or particles. It is normal for some white foam residue to remain in the vial. DO NOT use Enbrel if not all the powder has dissolved within 10 minutes. Start again with a new dose tray.

Figure 9

e. Withdrawing the Enbrel solution from the vial

• With the syringe still inserted into the vial and its adapter, hold the inverted vial at eye level. Push the plunger completely into the syringe (see Figure 10).

Figure 10

• Then, slowly pull back the plunger to withdraw the liquid into the syringe (see Figure 11). For adult patients, withdraw the full volume. For children, withdraw only the portion of liquid specified by the child's doctor. After withdrawing Enbrel from the vial, you may notice some air in the syringe. Do not worry, as the air will be removed in a final step.

Figure 11

• Hold the vial in an inverted position and disconnect the syringe from the vial adapter by turning it counterclockwise (see Figure 12).

Figure 12

• Place the filled syringe on a clean, flat surface. Ensure the tip does not touch anything. Be careful not to press the plunger down.

(Note: After completing these steps, a small amount of liquid may remain in the vial. This is normal.)

f. Attaching the needle to the syringe

• The needle is enclosed in a plastic package to maintain sterility.
• To open the plastic package, hold the shorter, wider end in one hand. Place the other hand over the longer end of the package.
• To break the seal, bend the longer end up and down until it breaks (see Figure 13).

Figure 13

• Once the seal is broken, remove the shorter, wider part of the plastic package.
• The needle will remain in the longer part of the package.
• While holding the needle and package in one hand, take the syringe and insert its tip into the needle opening.
• Insert the syringe into the needle by turning it clockwise until fully secured (see Figure 14).

Figure 14

• Remove the needle cap from the syringe by pulling firmly, taking care not to touch the needle and ensuring the needle does not contact any surface (see Figure 15). Be careful not to bend or twist the cap while removing it to avoid damaging the needle.

Figure 15

• While holding the syringe upright, remove air bubbles by slowly pushing the plunger until air is expelled (see Figure 16).

Figure 16

g. Choosing the injection site

• The three recommended injection sites for Enbrel include: (1) the central front area of the thighs; (2) the abdomen, except for the 5 cm area surrounding the navel; and (3) the outer upper part of the arms (see Figure 17). If you are self-injecting, you should not inject into the outer upper part of the arms.

Figure 17

• 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 inject into areas of skin that are tender, bruised, red, or hardened. Avoid areas with scars or stretch marks. (It may be helpful to record previous injection sites.)
• If you or the child has psoriasis, try not to inject directly into any thickened, raised, red, or scaly areas of skin ("psoriatic skin lesions").

h. Preparing the injection site and injecting the Enbrel solution

• Clean the injection site where Enbrel will be administered using an alcohol-impregnated cotton wipe, using a circular motion. DO NOT touch this area again until the injection has been administered.

• Once the cleaned skin area has dried, pinch and firmly hold it with one hand. With the other hand, hold the syringe like a pencil.

• With a quick, short motion, insert the needle fully, penetrating the skin at an angle between 45º and 90º (see Figure 18). With practice, you will find the angle most comfortable for you or the child. Be careful not to insert the needle too slowly or with excessive force.

Figure 18

• When the needle is fully inserted into the skin, release the skin you are holding. With your free hand, hold the needle near its base to stabilize it. Then, push the plunger to inject the entire solution at a slow and steady rate (see Figure 19).

Figure 19

• When the syringe is empty, withdraw the needle from the skin, taking care to keep the syringe at the same angle as when it was inserted.
• Apply gentle pressure with a cotton ball over the injection site for 10 seconds. Mild bleeding may occur. DO NOT rub the injection site. You may apply a bandage or adhesive dressing if desired.

1. Disposal of materials

• The syringe and needles MUST NEVER be reused. Dispose of them according to the instructions provided by your doctor, nurse, or pharmacist.

If you have any questions, consult a doctor, nurse, or pharmacist who is familiar with the use of Enbrel.