Enbrel 10 mg powder and solvent for solution for injection for pediatric use

Spain
Brand name Enbrel 10 mg powder and solvent for solution for injection for pediatric use
Form powder and solvent for solution for injection
Active substance / Dosage
ETANERCEPT · 10 mg
Prescription type Hospital Diagnosis
Registration number 99126022
Enbrel 10 mg powder and solvent for solution for injection for pediatric use powder and solvent for solution for injection

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Enbrel 10 mg powder and solvent for injectable solution for paediatric use

etanercept

Read the entire patient information leaflet carefully before you start using 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 the child under your care and must not be given to other people, even if they have the same symptoms as the child under your care, as it may harm them.
  • If you experience any adverse effects, talk to your doctor or pharmacist, even if the effects are not listed in this leaflet. See section 4.

Package leaflet contents

The information contained 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

  1. Possible side effects

  2. Storage of Enbrel

  3. Contents of the pack and other information

  4. 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 is indicated for the treatment of 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 the child:

  • Polyarthritis (rheumatoid factor positive or negative) and extended oligoarthritis in patients aged 2 years and older.

  • Psoriatic arthritis in patients aged 12 years and older.

  • For enthesitis-related arthritis in patients aged 12 years and older who have not responded adequately to, or for whom other commonly used treatments are not suitable.

  • 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 the child in your care is allergic to etanercept or to any of the other components of Enbrel (listed in section 6). If the child experiences allergic reactions such as chest tightness, wheezing, dizziness, or rash, do not inject any more Enbrel and contact your doctor immediately.

  • if the child has or is at risk of developing a serious blood infection called sepsis. If you are unsure, consult your doctor.

  • if the child has any type of infection. If you are unsure, consult your doctor.

Warnings and precautions

Talk to your doctor before starting to use Enbrel.

  • Allergic reactions: If the child experiences 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 (dry natural rubber). 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 the child develops a new infection or is about to undergo major surgery, your doctor may need to review the child's treatment with Enbrel.

  • Infections/diabetes: Inform your doctor if the child has a history of recurrent infections or if the child has diabetes or other disorders that increase the risk of infection.

  • Infections/monitoring: Inform your doctor about any recent travel outside the European region. If the child develops symptoms of an infection such as fever, chills, or cough, notify your doctor immediately. Your doctor should decide whether continued monitoring for infections is needed after the child stops treatment with Enbrel.

  • 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. These evaluations must be recorded on the Patient Information Card. It is very important that you tell your doctor if the child has had tuberculosis or has 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.

  • Hepatitis B: Inform your doctor if the child has or has ever had hepatitis B. Your doctor should test for hepatitis B before the child starts treatment with Enbrel. Treatment with Enbrel may reactivate hepatitis B in patients previously infected with the hepatitis B virus. If this occurs, Enbrel must be discontinued.

  • Hepatitis C: Inform your doctor if the child has hepatitis C. Your doctor may wish to monitor treatment with Enbrel in case the infection worsens.

  • Blood disorders: Inform your doctor immediately if the child has symptoms such as persistent fever, sore throat, bruising, bleeding, or paleness. These symptoms may indicate a serious blood disorder that requires discontinuation of Enbrel treatment.

  • Nervous system and vision disorders: Inform your doctor if the child develops 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 the child has a history of congestive heart failure, as Enbrel must be used with caution in such cases.

  • Cancer: Inform your doctor if the child has or has had lymphoma (a type of blood cancer) or any other cancer before Enbrel is administered.

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 sometimes resulted in death.

Some patients receiving Enbrel have developed skin cancers. Inform your doctor if the child develops any changes in skin appearance or skin growths.

  • Chickenpox: Inform your doctor if the child is 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 the child in your care has a history of alcoholism.
  • Wegener's granulomatosis: Enbrel is not recommended for the treatment of Wegener's granulomatosis, a rare inflammatory disease. If the child in your care has Wegener's granulomatosis, discuss this with your doctor.
  • Antidiabetic medicines: Inform your doctor if the child has diabetes or is taking medicines to treat diabetes. Your doctor may decide that the child needs a lower dose of antidiabetic medicine while taking Enbrel.

Children and adolescents

Vaccinations: If possible, children should have all vaccinations up to date before starting Enbrel. Some vaccines, such as the oral polio vaccine, should not be given while using Enbrel. Consult the child's doctor before administering any vaccine.

Enbrel is generally not recommended for children under 2 years of age with polyarticular or extended oligoarticular juvenile idiopathic arthritis, for children under 12 years of age with enthesitis-related arthritis or psoriatic arthritis, or for children under 6 years of age with psoriasis.

Other medicines and Enbrel

Inform your doctor or pharmacist if the child is taking, has recently taken, or might need to take any other medicines (including anakinra, abatacept, or sulfasalazine), even those not prescribed by the child's doctor. 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 a higher number of birth defects when mothers received Enbrel during pregnancy compared to mothers who did not receive 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 abnormalities 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 your ability to drive or use machines.

3. How to use Enbrel

Use in children and adolescents

Follow exactly the instructions given by your doctor for administering this medicine. 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 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.

The 10 mg vial is intended for children who have been prescribed a dose equal to or less than 10 mg. Each vial is for single use and for a single patient only; any remaining solution in the vial must be discarded.

For polyarthritis or extended oligoarthritis in patients aged 2 years and older, or for 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 not shown 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 injection under the skin (subcutaneous injection).

Enbrel may be administered with or without food or drink.

The powder must be dissolved before use. Detailed instructions for the preparation and injection of Enbrel are provided 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 on which days of the week Enbrel should be used.

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 administering the medicine on your usual day(s). If you do not remember until the day the next dose is due, do not give the child a double dose (2 doses on the same day) to make up for the missed dose.

If you stop treatment with Enbrel

Your symptoms may return after stopping treatment.

If you have any further questions about using 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 in the child, do not give the child any more Enbrel. Contact your doctor immediately or take the child 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 welts on the skin, often accompanied by itching).

Severe allergic reactions are rare. If the child experiences any of the above symptoms, this may be due to an allergic reaction to Enbrel, and you should seek immediate medical attention.

Serious adverse effects

If you notice any of the following effects, 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 child's 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, cough, or bluish coloration of the child's 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 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 recently used sites); 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 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 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; 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 (pruritic reddish-purple skin rash and/or thick whitish-grey 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):

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 purple-colored 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 type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect 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 container 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, the medicine 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 after removal from the refrigerator. It is advisable to record the date when Enbrel was removed from the refrigerator and the date after which Enbrel must be discarded (no later than 4 weeks after removal from the refrigerator). This new date must not exceed the expiry date stated on the container.

After preparing the Enbrel solution, immediate use is recommended. However, the solution may be used within 6 hours if stored at a maximum temperature of 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.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and containers that you no longer need. This 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 10 mg powder and solvent for injectable solution for paediatric use vial contains 10 mg of etanercept. Once reconstituted, the solution contains 10 mg/mL of etanercept.

The other components are:

Powder: Mannitol (E421), sucrose and tromethamine.

Solvent: Water for injections.

Appearance of the product and contents of the pack

Enbrel 10 mg powder and solvent for injectable solution for paediatric use is presented as a white powder with solvent for injectable solution (powder for injectable use). Each pack contains 4 vials, 4 pre-filled syringes of water for injections, 4 needles, 4 vial adapters and 8 alcohol wipes.

Marketing Authorization Holder:

Pfizer Europe MA EEIG

Boulevard de la Plaine 17

1050 Brussels

Belgium

Manufacturer responsible:

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 latest 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:

a. Introduction

b. Preparing for the injection

c. Preparing the Enbrel dose for injection

d. Adding the solvent

e. Withdrawing the Enbrel solution from the vial

f. Attaching the needle to the syringe

g. Choosing an injection site

h. Preparing the injection site and injecting the Enbrel solution

i. Disposal of materials

a. Introduction

The following instructions explain how to prepare and inject Enbrel. Please read the instructions carefully and follow them step by step. The child's doctor or nurse will show you the correct technique for giving an injection and the amount to be administered to the child. Do not attempt to give the child an injection until you are certain that you understand how to prepare and administer it correctly.

This injection must not be mixed in the same syringe or vial with any other medicine. See section 5 for instructions on how to store Enbrel.

b. Preparing for the injection

  • Wash your hands thoroughly.
  • Select a flat, clean, and well-lit working surface.
  • The tray should contain all the items listed below. (If any of the listed items are missing from the tray, do not use the tray and consult your pharmacist.) Use only the items listed. DO NOT use any other syringe.

1 Enbrel vial

1 Pre-filled syringe containing a clear, colourless solvent (water for injections)

1 Needle

1 Vial adapter

2 Alcohol wipes

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

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 ring surrounding the top of the vial.

Figure 1

A hand holding a cylindrical vial pointing upwards
  • Use a new alcohol wipe to clean the grey stopper of the Enbrel vial. After cleaning, do not touch the stopper with your hands and avoid letting it touch 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 the adapter's spike is centred within the circle on the top of the vial stopper (see Figure 2).

Figure 2

Figure 3

Figure 4

Schematic diagram showing a transparent protective cap over a medical vial with screw cap and central white label

Schematic diagram showing a protective cap being removed from a medication vial with two arrows pointing downward

Black and white schematic drawing of a medication vial with a large cross over it indicating prohibition of use or error

CORRECT

INCORRECT

  • Hold the vial firmly with one hand on a flat surface. With the other hand, push the adapter package STRAIGHT DOWN firmly until you feel and hear the adapter's spike pierce the vial stopper and UNTIL YOU FEEL AND HEAR THE ADAPTER'S LATCH SNAP INTO PLACE (see Figure 3). DO NOT push the adapter at an angle (see Figure 4). It is important that the vial adapter's spike fully penetrates the vial stopper.

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

Figure 5

Diagram showing the lifting of a cap with two arrows pointing upward
  • 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 with one hand and grasping the end of the white cap with the other hand, then 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

Two hands holding and separating the two components of a medical device with an arrow pointing upward
  • Do not use the syringe if the perforation between the end and the ring of the cap is already broken. Start again with a new dose tray.
  • Holding the glass barrel 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 tip into the opening and turning clockwise until securely fastened (see Figure 7).

Figure 7

Technical drawing showing the

d. Adding the solvent

  • While keeping the vial upright 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

A hand holding the base of a syringe while the
  • With the syringe still inserted, gently swirl the vial in a circular motion several times to dissolve the powder (see Figure 9). DO NOT shake the vial. Wait until all the powder is dissolved (usually less than 10 minutes). The solution should be clear, colorless to pale yellow or pale brown, and free of clumps, flakes, or particles. It is normal for some white foam residue to remain in the vial. DO NOT use Enbrel if the powder has not completely dissolved within 10 minutes. Start again with a new dose tray.

Figure 9

Two hands holding a syringe vertically and rotating a vial at its base following the direction of black curved arrows

e. Withdrawing the Enbrel solution from the vial

  • Your doctor or nurse will have instructed you on the correct amount of solution to withdraw from the vial. If your doctor has not provided these instructions, please contact them.
  • With the syringe still inserted into the vial and its adapter, hold the vial inverted at eye level. Push the plunger fully inward (see Figure 10).

Figure 10

Technical drawing showing a hand holding a syringe and pushing the plunger downward
  • Then, slowly pull the plunger back to draw the liquid into the syringe (see Figure 11). Withdraw only the portion of liquid your child's doctor has instructed. After withdrawing Enbrel from the vial, you may find some air in the syringe. Do not worry, as this air will be removed in a final step.

Figure 11

A hand holding the upper part of a syringe while the
  • Hold the vial in an inverted position and disconnect the syringe from the vial adapter by turning it counterclockwise (see Figure 12).

Figure 12

Black and white diagram showing rotational movement of a vial and a syringe with curved arrows indicating direction
  • Place the filled syringe on a clean, flat surface. Ensure the tip does not touch anything. Be careful not to press the plunger down.

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 on 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

Two hands holding a syringe with black curved arrows indicating a rotational movement to prepare the medical device
  • Once the seal is broken, remove the shorter, wider end of the plastic package.
  • The needle will remain in the longer part of the package.
  • While holding the needle and its package in one hand, take the syringe and insert its tip into the needle's opening.
  • Insert the syringe into the needle by turning clockwise until fully secured (see Figure 14).

Figure 14

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

Figure 15

Technical drawing of a syringe with needle pointing downward
  • While holding the syringe upright, remove air bubbles by slowly pushing the plunger until air is expelled (see Figure 16).

Figure 16

A hand holding a syringe vertically with needle pointing downward

g. Choosing an injection site

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

Figure 17

Front and back human body diagram with gray areas indicating injection sites on the
  • 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 the child has psoriasis, try not to inject directly into any raised, thick, red, or scaly skin areas ("psoriatic skin lesions").

  • Preparing the injection site and injecting the Enbrel solution

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

  • Once the cleaned skin area has dried, use one hand to pinch and firmly hold the skin. 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 45° and 90° (see Figure 18). With practice, you will find the angle most comfortable for the child. Be careful not to insert the needle too slowly or with excessive force.

Figure 18Technical drawing showing a hand holding a syringe for a

  • Once 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 stabilize it. Then push the plunger to inject all the solution at a SLOW and steady rate (see Figure 19).

Figure 19

Two hands holding a syringe with needle pointing downward on a flat surface to prepare the
  • When the syringe is empty, withdraw the needle from the skin, taking care to keep the syringe at the same angle as during insertion.

  • Press 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 strip if desired.

i. Disposal of materials

  • The syringe and needle MUST NEVER be reused. 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.