Erelzi 50 mg solution for injection in pre-filled syringe

Package Leaflet: Information for the User

Introduction

Package leaflet: information for the user

Erelzi 25 mg solution for injection in pre-filled syringe

Erelzi 50 mg solution for injection in pre-filled syringe

etanercept

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• Your doctor will also provide you with a Patient Information Card containing important safety information that you need to know before and during treatment with Erelzi.
• If you have any questions, ask your doctor, pharmacist, or nurse.
  • This medicine has been prescribed for you or for the child under your care. Do not give it to others, even if they have the same symptoms as you or the child under your care, as it may harm them.
  • If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of this leaflet:

1. What Erelzi is and what it is used for
2. What you need to know before using Erelzi
3. How to use Erelzi
4. Possible side effects
5. How to store Erelzi
6. Contents of the pack and other information
7. Instructions for using the Erelzi pre-filled syringe

1. What Erelzi is and what it is used for

Erelzi is a medicine made from two human proteins. It blocks the activity of another protein in the body that causes inflammation. Erelzi works by reducing the inflammation associated with certain diseases.

Erelzi 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, Erelzi is normally used in combination with methotrexate, although it may also be used as a single medicine if treatment with methotrexate is not suitable for you. Erelzi may slow down 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, Erelzi may improve your ability to perform normal daily activities.

In patients with multiple swollen or painful joints (for example, in the hands, wrists, and feet), Erelzi may delay the progression of structural damage to these joints caused by the disease.

Erelzi is also 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:
  • Polyarthritis (with positive or negative rheumatoid factor) and extended oligoarthritis in patients aged 2 years and older with a body weight of at least 62.5 kg.
  • Psoriatic arthritis in patients aged 12 years and older with a body weight of at least 62.5 kg.
• For enthesitis-related arthritis in patients aged 12 years and older with a body weight of at least 62.5 kg, when other commonly used treatments have not worked adequately or are not suitable.
• Severe psoriasis in patients aged 6 years and older with a body weight of at least 62.5 kg 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 Erelzi

Do not use Erelzi

• if you or the child in your care are allergic to etanercept or to any of the other components of Erelzi (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 Erelzi 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 Erelzi.

• Allergic reactions: If you or the child experience allergic reactions such as chest tightness, wheezing, dizziness, or rash, do not inject any more Erelzi and contact your doctor immediately.

• Infections/surgery: If you or the child develop a new infection or are about to undergo major surgery, your doctor may need to monitor or adjust treatment with Erelzi.

• Infections/diabetes: Inform your doctor if you or the child have a history of recurrent infections or if you have diabetes or other conditions 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 decide whether continued monitoring for infections is needed after you or the child stop treatment with Erelzi.

• Tuberculosis: Since cases of tuberculosis have been reported in patients treated with Erelzi, your doctor will examine for signs and symptoms of tuberculosis before starting Erelzi. This may include a thorough medical history, chest X-ray, and a tuberculosis test. Completion of these assessments must be recorded in the Patient Information Card. It is very important that you 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 appear 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 Erelzi. Treatment with Erelzi may reactivate hepatitis B in patients who were previously infected with the hepatitis B virus. If this occurs, you must stop using Erelzi.

• Hepatitis C: Inform your doctor if you or the child have hepatitis C. Your doctor may want to monitor treatment with Erelzi 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 disorder that requires discontinuation of Erelzi 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 Erelzi is an appropriate treatment.

• Congestive heart failure: Inform your doctor if you or the child have a history of congestive heart failure, as Erelzi 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 Erelzi.

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 Erelzi may have an increased risk of developing lymphoma or other cancers.

Some adolescents and children who have received Erelzi or other medicines that work similarly to Erelzi have developed cancers, including unusual types, which sometimes resulted in death.

Some patients receiving Erelzi have developed skin cancers. Inform your doctor if you or the child develop any changes in the appearance of the skin or skin growths.

• Chickenpox (varicella): Inform your doctor if you or the child are exposed to chickenpox while using Erelzi. Your doctor will determine whether preventive treatment for chickenpox is appropriate.

• Alcoholism: Erelzi 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.

• Granulomatosis with polyangiitis (Wegener’s granulomatosis): Erelzi is not recommended for the treatment of granulomatosis with polyangiitis, a rare inflammatory disease. If you or the child in your care have granulomatosis with polyangiitis, 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 using Erelzi.

Children and adolescents

The use of Erelzi is not indicated in children and adolescents weighing less than 62.5 kg.

• Vaccinations: If possible, children should have all vaccinations up to date before starting Erelzi. Some vaccines, such as the oral polio vaccine, should not be given while using Erelzi. Consult your doctor before you or the child receive any vaccine.

Normally, Erelzi should not be used in children under 2 years of age or weighing less than 62.5 kg with polyarticular or extended oligoarticular juvenile idiopathic arthritis, in children under 12 years of age or weighing less than 62.5 kg with enthesitis-related arthritis or psoriatic arthritis, or in children under 6 years of age or weighing less than 62.5 kg with psoriasis.

Other medicines and Erelzi

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 must not use Erelzi together with medicines containing the active substances anakinra or abatacept.

Pregnancy and breastfeeding

Erelzi 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 Erelzi 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 the mother had received etanercept during pregnancy compared to mothers who had not received etanercept 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 Erelzi 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 being treated with Erelzi. It is important to inform the pediatrician and other healthcare professionals about the use of Erelzi during pregnancy and breastfeeding before your baby receives any vaccine.

Driving and using machines

Erelzi is not expected to affect the ability to drive or use machines.

Erelzi contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per 25 mg or 50 mg dose; essentially, it is “sodium-free”.

3. How to use Erelzi

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 Erelzi is too strong or too weak, tell your doctor or pharmacist.

Erelzi is available in 25 mg and 50 mg presentations.

Use in 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 Erelzi.

Plaque psoriasis

The usual dose is 25 mg twice weekly or 50 mg once weekly.

Alternatively, 50 mg twice weekly may be administered for up to 12 weeks, followed by 25 mg twice weekly or 50 mg once weekly.

Your doctor will decide how long you should use Erelzi and whether treatment needs to be repeated, depending on your response. If Erelzi 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 etanercept formulation. Pediatric patients weighing 62.5 kg or more may be prescribed a dose of 25 mg twice weekly or 50 mg once weekly using a single-dose prefilled syringe or prefilled pen.

Other etanercept medicines with doses appropriate for children are available.

For polyarticular or extended oligoarticular juvenile idiopathic arthritis in patients aged 2 years and older weighing 62.5 kg or more, or for enthesitis-related arthritis or psoriatic arthritis in patients aged 12 years and older weighing 62.5 kg or more, the usual dose is 25 mg twice weekly or 50 mg once weekly.

For psoriasis in patients aged 6 years and older weighing 62.5 kg or more, the usual dose is 50 mg once weekly. If Erelzi 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

Erelzi is administered by subcutaneous injection.

Detailed instructions for injecting Erelzi are provided in section 7, “Instructions for use of the Erelzi prefilled syringe.”

The Erelzi solution must not be mixed with any other medicine.

To help you remember, it may be useful to record in a diary the day(s) of the week on which you should use Erelzi.

If you use more Erelzi than you should

If you use more Erelzi than you should (either by injecting a larger amount at one time or by using it too frequently), you should speak to a doctor or pharmacist immediately.

Always keep the medicine carton with you, even if it is empty.

If you forget to inject Erelzi

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 Erelzi

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 Erelzi. 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 (raised, 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 Erelzi, so you should 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, 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, 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 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 Erelzi, 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 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 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 onset 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; new-onset 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).

• 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); excessive activation of white blood cells associated with inflammation (macrophage activation syndrome); reactivation of hepatitis B (a liver infection); damage to the small filters in the kidneys leading to impaired kidney function (glomerulonephritis); worsening of a condition called dermatomyositis (inflammation and weakness of muscles 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 adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system listed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Erelzi

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 on the label of the prefilled syringe after "CAD"/"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 prefilled syringes in their outer packaging to protect them from light.

After removing the syringe from the refrigerator, wait approximately 15–30 minutes for the Erelzi solution to reach room temperature. Do not heat it by any other method. Immediate use is recommended thereafter.

Erelzi may be stored outside the refrigerator at a maximum temperature of 25 °C for a single period of up to 4 weeks; after this time, the medicine must not be refrigerated again. Erelzi must be discarded if not used within 4 weeks of removal from the refrigerator. It is advisable to record the date when Erelzi was removed from the refrigerator and the date by which Erelzi must be discarded (no later than 4 weeks after removal from the refrigerator).

Inspect the solution in the syringe. It should be clear or slightly opalescent, colourless to slightly yellowish, and may contain small particles of white or almost translucent protein. This is the normal appearance of Erelzi. Do not use the solution if it is discoloured or cloudy, or if it contains particles different from those described above. If you have concerns about the appearance of the solution, contact your pharmacist for assistance.

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 Erelzi

The active substance is etanercept.

Each pre-filled syringe contains 25 mg of etanercept or 50 mg of etanercept.

The other components are anhydrous citric acid, sodium dihydrogen citrate dihydrate, sodium chloride, sucrose, L-lysine hydrochloride, sodium hydroxide, hydrochloric acid, and water for injections.

Appearance of the product and contents of the pack

Erelzi is presented as a pre-filled syringe containing a clear or slightly opalescent, colourless to slightly yellowish injectable solution (injection). The pre-filled syringes are made of Type I glass, a plunger rubber stopper (bromobutyl rubber), a plunger rod, a 29-gauge stainless steel needle, and a needle cap (thermoplastic elastomer). The syringes are equipped with a needle safety guard. Each pack contains 1, 2 or 4 pre-filled syringes with a needle safety guard; multipacks contain 12 (3 packs of 4) pre-filled syringes of 25 mg or 50 mg with a needle safety guard, or 8 (2 packs of 4) or 24 (6 packs of 4) pre-filled syringes of 25 mg with a needle safety guard. Not all pack sizes may be marketed.

Marketing Authorization Holder

Sandoz GmbH

Biochemiestrasse 10

6250 Kundl

Austria

Manufacturer

Sandoz GmbH Schaftenau

Biochemiestrasse 10

6336 Langkampfen

Austria

Novartis Pharmaceutical Manufacturing GmbH

Biochemiestrasse 10

6336 Langkampfen

Austria

For more information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Belgium/Belgium/Belgium Sandoz nv/sa Tel/Tel: +32 2 722 97 97	Latvia Sandoz d.d. Latvia branch Tel: +371 67 892 006 Lithuania Sandoz Pharmaceuticals d.d. branch Tel: +370 5 2636 037
Czech Republic Sandoz s.r.o. Tel: +420 234 142 222	Luxembourg/Luxembourg Sandoz nv/sa (Belgium/Belgium) Tél/Tel: +32 2 722 97 97
Denmark/Norway/Iceland/Sweden Sandoz A/S Tlf./Tlf/Sími/Tel: +45 63 95 10 00	Hungary Sandoz Hungária Kft. Tel.: +36 1 430 2890
Germany Hexal AG Tel: +49 8024 908 0	Malta Sandoz Pharmaceuticals d.d. Tel: +356 9964 4126
Estonia Sandoz d.d. Estonian branch Tel: +372 665 2400	Netherlands Sandoz B.V. Tel: +31 36 52 41 600
Greece SANDOZ HELLAS MONOPROSOPIKI EPE Tel: +30 216 600 5000	Austria Sandoz GmbH Tel: +43 5338 2000
Spain Sandoz Farmacéutica, S.A. Tel: +34 900 456 856	Poland Sandoz Polska Sp. z o.o. Tel.: +48 22 209 70 00
France Sandoz SAS Tél: +33 1 49 64 48 00	Portugal Sandoz Farmacêutica Lda. Tel: +351 21000 86 00
Croatia Sandoz d.o.o. Tel: +385 1 23 53 111	Romania Sandoz Pharmaceuticals SRL Tel: +40 21 407 51 60
Ireland Rowex Ltd. Tel: +353 27 50077	Slovenia Sandoz farmacevtska družba d.d. Tel: +386 1 580 21 11
Italy Sandoz S.p.A. Tel: +39 02 81280696	Slovak Republic Sandoz d.d. - organizational unit Tel: +421 2 48 20 0600
Cyprus SANDOZ HELLAS MONOPROSOPIKI EPE (Greece) Tel: +30 216 600 5000	Finland/Finland Sandoz A/S Puh/Tel: +358 10 6133 400

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 of the Erelzi pre-filled syringe

Read ALL instructions before injecting the medicine.

It is important that you do not attempt to inject the medicine yourself until your doctor, nurse, or pharmacist has shown you how to do it. The pack contains the Erelzi pre-filled syringe(s) in individual plastic blisters.

DO NOT USE	In this configuration, the needle shield IS ACTIVATED. DO NOT USE the pre-filled syringe.
READY FOR USE	In this configuration, the needle shield is NOT ACTIVATED. The pre-filled syringe is ready for use.

Your pre-filled Erelzi syringe with needle shield and additional finger grip

Once the medication has been injected, the needle shield will activate to cover the needle. This is designed to protect against accidental needle-stick injuries for healthcare professionals, patients who self-inject the prescribed medication, and individuals assisting patients with self-injection.

What else you need for the injection:

Alcohol wipe. Cotton or gauze. Sharps container for disposal of sharp objects.

Important safety information

Warning: Keep the syringe out of sight and reach of children.

1. Do not open the carton until you are ready to use this medicine.
2. Do not use this medicine if the blister seal is broken, as it may not be safe to use.
3. Do not shake the syringe.
4. Never leave the syringe where others might touch it.
5. The prefilled syringe has a needle shield that will automatically activate to cover the needle after the injection is administered. The needle shield will help prevent needlestick injuries in anyone using the prefilled syringe.

Take great care not to touch the activation clips of the needle shield before use. Doing so may cause the needle shield to activate prematurely.

1. Do not remove the needle cap until immediately before injecting.
2. The syringe cannot be reused. After use, immediately dispose of the syringe in a sharps container.
3. Do not use if the syringe has been dropped on a hard surface or dropped after removing the needle cap.

Storage of the Erelzi prefilled syringe

1. Store this medicine in its original carton to protect it from light. Store in a refrigerator at 2°C to 8°C. DO NOT FREEZE.
2. Remember to remove the blister from the refrigerator to allow it to reach room temperature before preparing the injection (15–30 minutes).
3. Do not use the syringe after the expiry date stated on the carton or syringe label after “CAD”/”EXP”. If expired, return the entire package to the pharmacy.

Injection sites

The injection site is the location where you will administer the pre-filled syringe. The upper thighs are recommended. You may also use the lower abdomen, but not within a 5 cm area around the navel. Choose a different site each time you give the injection. Do not inject into areas where the skin is tender, damaged, red, scaly, or hard. Avoid areas with scars or stretch marks. If you have psoriasis, DO NOT administer the injection directly into any raised, thick, red, or scaly skin areas or lesions (“psoriatic skin lesions”).

If the injection is being administered by the patient's caregiver, the upper arms may also be used.

Preparing the Erelzi pre-filled syringe

1. Remove the blister pack containing the syringe from the refrigerator and leave it unopened for 15–30 minutes to allow it to reach room temperature.
2. When ready to use the syringe, open the blister pack and wash your hands thoroughly with soap and water.
3. Clean the injection site thoroughly with an alcohol wipe.
4. Remove the syringe from the blister pack.
5. Inspect the syringe. The liquid should be clear or slightly opalescent, colorless to slightly yellowish, and may contain small, almost translucent or white protein particles. This is the normal appearance of Erelzi. Do not use if the liquid is cloudy, discolored, or contains large clumps, flakes, or colored particles. Do not use if the syringe is damaged or if the needle safety guard has been activated. In all these cases, return the complete package to the pharmacy.

How to use the Erelzi pre-filled syringe

	Carefully remove the needle cap from the syringe. Discard it. You may see a drop at the tip of the needle. This is normal.
	Gently pinch the skin at the injection site and insert the needle as shown in the figure. Insert the needle completely to ensure that the full dose of medication is delivered.
	Hold the grip to position your fingers on the syringe as shown. Press the plunger slowly and fully until the plunger head engages the activation clips of the needle shield. Keep holding the plunger while keeping the syringe in place for 5 seconds.
	Without releasing the plunger, carefully withdraw the needle from the injection site.
	Slowly release the plunger and allow the needle shield to automatically cover the needle. There may be a small amount of blood at the injection site. You may press a cotton ball or gauze pad against the injection site for 10 seconds. Do not rub the injection site. You may apply a bandage if needed.

Disposal instructions

Dispose of the used syringe in a sharps container (a closed, puncture-resistant container). For safety and health reasons (for you and others), used needles and syringes must never be reused.

If you have any questions, consult a doctor, nurse, or pharmacist who is familiar with Erelzi.