Erelzi

Package leaflet: Information for the user

Erelzi 25 mg solution for injection in pre-filled syringe, 50 mg solution for injection in pre-filled syringe

etanercept (etanerceptum)
Please read all of this 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 provide you with a Patient Medication Guide containing important safety information that you should be aware of 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. Do not give it to other people, even if their symptoms are the same as yours or the child's, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. 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 that causes inflammation in the human body. Erelzi works by reducing the inflammation associated with certain diseases.

In adults (aged 18 years and older), Erelzi can be used for the treatment of moderate to severe rheumatoid arthritis, psoriatic arthritis, severe axial spondyloarthritis, including ankylosing spondylitis, and moderate to severe psoriasis – in each case usually when other widely used treatments have not worked well enough or are not suitable for you.

For rheumatoid arthritis, Erelzi is usually used in combination with methotrexate, although it may also be used alone if treatment with methotrexate is not suitable for you. Whether used alone or in combination with methotrexate, Erelzi can slow down joint damage caused by rheumatoid arthritis and improve your ability to carry out normal daily activities.

For patients with psoriatic arthritis involving multiple joints, Erelzi can improve the ability to perform daily activities.

For patients with painful or swollen symmetric joints (e.g., hands, wrists, and feet), Erelzi can slow down structural damage to these joints caused by the disease.

Erelzi is also prescribed for the treatment of the following conditions in children and adolescents:

• For the following types of juvenile idiopathic arthritis, when treatment with methotrexate has not provided a sufficient response or is not appropriate:
• Polyarthritis (rheumatoid factor positive or negative) and extended oligoarthritis in patients from the age of 2 years with a body weight equal to or greater than 62.5 kg.
• Psoriatic arthritis in patients from the age of 12 years with a body weight equal to or greater than 62.5 kg.
• For enthesitis-related arthritis in patients from the age of 12 years with a body weight equal to or greater than 62.5 kg, when other widely used treatments have not provided a sufficient response or are not appropriate.
• Severe psoriasis in patients from the age of 6 years with a body weight equal to or greater than 62.5 kg who have had an inadequate response to (or cannot take) phototherapy or other systemic therapies.

2. What you should know before using Erelzi

Do not use Erelzi

• if you or the child are allergic to etanercept or to any of the other ingredients of Erelzi (listed in section 6). If allergic reactions such as chest tightness, shortness of breath, dizziness, or rash occur in you or the child, do not inject any further doses of 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 in doubt, contact your doctor.
• if you or the child have any type of infection. If in doubt, consult your doctor.

Warnings and precautions
Talk to your doctor before using Erelzi.

• Allergic reactions: If you or the child experience allergic reactions such as chest tightness, shortness of breath, dizziness, or rash, do not inject any further Erelzi and contact your doctor immediately.
• Infections/surgery: If you or the child develop a new infection or are about to undergo any major surgical procedure, your doctor may want to review your treatment with Erelzi.
• Infections/diabetes: Inform your doctor if you or the child have a history of recurring infections or suffer from diabetes or other conditions that increase the risk of infection.
• Infections/monitoring: Inform your doctor about any recent travel outside Europe. If you or the child develop symptoms of an infection such as fever, chills, or cough, notify your doctor immediately. Your doctor may decide to continue monitoring you or the child for infections even after stopping Erelzi.
• Tuberculosis: Cases of tuberculosis have been reported in patients treated with Erelzi. Your doctor will check for signs and symptoms of tuberculosis before starting Erelzi treatment. This may include a thorough medical history, chest X-rays, and a tuberculin skin test. The results of these tests must be recorded in the Patient Record Card. It is very important that you inform your doctor if you or the child have ever had tuberculosis or have been in close contact with someone who has tuberculosis. If symptoms of tuberculosis (such as persistent cough, weight loss, weakness, 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 had hepatitis B. Your doctor must test for hepatitis B before you or the child start treatment with Erelzi. Treatment with Erelzi may cause reactivation of hepatitis B in patients with prior hepatitis B virus infection. In such cases, you must stop using Erelzi.
• Hepatitis C: Inform your doctor if you or the child have hepatitis C. Your doctor may consider monitoring your treatment with Erelzi if the infection worsens.
• Blood disorders: Seek immediate medical help if you or the child experience any signs or symptoms such as persistent fever, sore throat, bruising, bleeding, or paleness. These symptoms may indicate potentially life-threatening blood disorders that may require discontinuation of Erelzi treatment.
• Nervous system and eye 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 assess 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 should be used with caution in such cases.
• Tumors: Inform your doctor if you have or have ever had lymphoma (a type of blood cancer) or any other tumor before taking Erelzi. Patients with long-standing, severe rheumatoid arthritis 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 tumors. Some children and adolescent patients treated with Erelzi or other medicines similar to Erelzi have developed tumors, including unusual types, sometimes with fatal outcomes. Some patients receiving Erelzi have developed skin tumors. 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 assess whether preventive treatment for chickenpox is appropriate.
• Alcohol abuse: Erelzi must not be used to treat hepatitis related to alcohol abuse. Inform your doctor if you or the child have a history of alcohol abuse.
• Wegener’s granulomatosis: Erelzi is not recommended for the treatment of Wegener’s granulomatosis, a rare inflammatory disease. If you or the child have Wegener’s granulomatosis, consult your doctor.
• Anti-diabetic 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 anti-diabetic 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: Whenever possible, children should be up to date with all vaccinations before starting Erelzi. Some vaccines, such as the oral polio vaccine, must not be taken while receiving Erelzi. Consult your doctor before you or the child receive any vaccine.

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

Other medicines and Erelzi
Inform your doctor or pharmacist if you or the child are taking, have recently taken, or might take any other medicines (including anakinra, abatacept, or sulfasalazine), even those not prescribed.

You or the child must not use Erelzi together with the active substances anakinra or abatacept.

Pregnancy and breastfeeding
Erelzi should be used during pregnancy only if clearly necessary. If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, consult your doctor.

If you received Erelzi during pregnancy, the newborn may be at increased risk of infection. Furthermore, one study indicated a higher number of birth defects in mothers who received etanercept during pregnancy compared to mothers who did not receive etanercept or other similar medicines (TNF antagonists), although no specific pattern of birth defects was observed. Another study did not show an increased risk of birth defects when mothers received Erelzi during pregnancy. Your doctor will help you decide whether the benefits of treatment outweigh the potential risks to your baby.

Talk to your doctor if you wish to breastfeed while being treated with Erelzi. It is important to inform the child’s pediatrician and other healthcare professionals about the use of Erelzi during pregnancy and breastfeeding before the child 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 (23 mg) of sodium per 25 mg or 50 mg dose, i.e., essentially ‘sodium-free’.

3. How to use Erelzi

Use this medicine exactly as instructed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
If you think the effect of Erelzi is too strong or too weak, contact your doctor or
pharmacist.
Erelzi is available in doses of 25 mg and 50 mg.
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 once weekly by subcutaneous injection.
However, your doctor may prescribe a different dosing schedule for Erelzi.
Plaque psoriasis
The usual dose is 25 mg administered twice weekly or 50 mg administered once weekly.
Alternatively, a dose of 50 mg twice weekly may be given for up to 12 weeks, followed by a dose of 25 mg twice weekly or 50 mg once weekly.
Your doctor will decide how long you should use Erelzi and whether, based on your response, further treatment is needed. If, after 12 weeks, Erelzi has not had any effect on your disease, your doctor may instruct you to stop treatment.
Use in children and adolescents
The appropriate dose and dosing frequency for a child or adolescent will depend on body weight and the condition being treated. Your doctor will determine the correct dose for your child and prescribe an appropriate etanercept dosage. Pediatric patients weighing 62.5 kg or more may receive 25 mg twice weekly or 50 mg once weekly and may use either the pre-filled syringe or the fixed-dose pre-filled pen.
Other etanercept-containing products with dosages suitable for children are available.
For polyarthritis or extended oligoarthritis 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 administered twice weekly or 50 mg administered once weekly.
For psoriasis in patients aged 6 years and older weighing 62.5 kg or more, the usual dose is 50 mg administered once weekly. If Erelzi has not had any effect on the child’s condition after 12 weeks, the doctor may instruct you to discontinue treatment with this medicine.
Your doctor will provide detailed instructions on how to prepare and measure the appropriate dose.
Method and route of administration
Erelzi is administered by injection under the skin (subcutaneous injection).
Detailed instructions on how to inject Erelzi are provided in section 7, “Instructions for using the Erelzi pre-filled syringe”.
Do not mix the Erelzi solution with other medicines.
To help you remember, it may be helpful to write in a diary on which day(s) of the week Erelzi should be used.
If you use more Erelzi than you should
If you have used more Erelzi than you should (either by injecting too much at one time or by using it too frequently), contact a doctor or pharmacist immediately. Always keep the medicine carton with you, even if it is empty.
If you forget to take Erelzi
If you forget a dose, administer 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. Continue taking the medicine on your regularly scheduled day(s). If you have forgotten a dose and the next dose is due the next day, do not take a double dose (two doses on the same day) to make up for the missed dose.
If you stop treatment with Erelzi
After stopping treatment, symptoms of the disease may return.
If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Allergic reactions
If any of the following side effects occur, do not inject Erelzi again. Contact your doctor immediately,
or go to the nearest hospital emergency department.

• Difficulty swallowing or breathing
• Swelling of the face, throat, hands or feet
• Feeling nervous or anxious, palpitations, sudden flushing of the skin and/or feeling of warmth
• Severe rash, itching, hives (raised red or pale patches on the skin which often itch)

Severe allergic reactions are rare. However, any of the symptoms listed above may indicate an allergic reaction to Erelzi; therefore, you must seek immediate medical attention.
Serious side effects
If you notice any of the following effects, you or the child may need urgent medical care.

• Symptoms of serious infections such as high fever which may be accompanied by cough, shortness of breath, chills, weakness, or a warm, red, tender, painful area on the skin or joints.
• Symptoms of blood disorders, such as bleeding, bruising or paleness.
• Symptoms of nerve problems, such as numbness or tingling, changes in vision, eye pain, or sudden weakness in an arm or leg.
• Symptoms 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 colouring of the fingernails or lips.
• Symptoms of tumours: tumours can affect any part of the body, including the skin and blood, and possible symptoms depend on the type and location of the tumour. These symptoms may include weight loss, fever, swelling (with or without pain), persistent cough, or presence of cysts or growths on the skin.
• Symptoms of autoimmune reactions (where antibodies are produced that may damage normal body tissues), such as pain, itching, weakness, breathing problems, or changes in thinking, sensation or vision.
• Symptoms of lupus or lupus-like syndrome, such as changes in body weight, persistent rash, fever, joint or muscle pain, or fatigue.
• Symptoms of inflammation of blood vessels, such as pain, fever, redness or warmth of the skin, or itching.

These side effects are rare or uncommon, but they are serious conditions (some of which may rarely lead to death). If these symptoms occur, contact your doctor immediately or go to the nearest hospital emergency department.
The known side effects of Erelzi include those listed below, grouped by decreasing 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 a reaction at a recently used injection site);
  headache.

• Common (may affect up to 1 in 10 people): Allergic reactions; fever; rash; itching; antibodies directed against normal tissue (formation of autoantibodies).

• Uncommon (may affect up to 1 in 100 people): Serious infections (including pneumonia, deep skin infections, joint infections, blood infections and infections at various sites); worsening of congestive heart failure; low red blood cell count, low white blood cell count, low neutrophil count (a type of white blood cell); reduced platelet count in the blood; skin tumour (excluding melanoma); localized swelling of the skin (angioedema); hives (raised red or pale patches on the skin which often itch); eye inflammation; psoriasis (new onset or worsening); inflammation of blood vessels affecting more than one organ; elevated liver enzymes in the blood (in patients also being treated with methotrexate, the frequency of elevated liver enzymes in the blood is common); abdominal pain and cramps, diarrhoea, weight loss or blood in the stools (symptoms of intestinal problems).

• Rare (may affect up to 1 in 1,000 people): Severe allergic reactions (including severe localized swelling of the skin and breathing difficulties); lymphoma (a type of blood cancer); leukaemia (a cancer affecting the blood and bone marrow); melanoma (a type of skin cancer); decreased numbers of platelets, red blood cells and white blood cells together; nervous system disorders (with severe muscle weakness and signs and symptoms similar to multiple sclerosis or inflammation of the nerves in the eye or spinal cord); tuberculosis; new onset of congestive heart failure; seizures; lupus or lupus-like syndrome (symptoms may include persistent rash, fever, joint pain and fatigue); rash which may lead to severe blistering and peeling of the skin; lichenoid reactions (itchy reddish/purplish rash and/or white-grey thread-like lines on mucous membranes); liver inflammation caused by your immune system (autoimmune hepatitis; in patients also being treated with methotrexate, the frequency is uncommon); an immune disorder which may affect the lungs, skin and lymph nodes (sarcoidosis); lung inflammation or scarring (in patients also being treated with methotrexate, the frequency of lung inflammation or scarring is uncommon); damage to the tiny filters in the kidneys leading to reduced kidney function (glomerulonephritis).

• Very rare (may affect up to 1 in 10,000 people): Failure of the bone marrow to produce essential blood cells.

• Not known (frequency cannot be estimated from the available data): Merkel cell carcinoma (a type of skin cancer); Kaposi's sarcoma, a rare form of cancer associated with human herpesvirus 8 infection. Kaposi's sarcoma most commonly appears as purple skin lesions; excessive activation of white blood cells involved in inflammation (macrophage activation syndrome); reactivation of hepatitis B (a liver infection); worsening of a condition called dermatomyositis (muscle inflammation and weakness accompanied by a skin rash).

Additional side effects in children and adolescents
The side effects and their frequency observed in children and adolescents are similar to those described above.
Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system referred to in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store 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
pre-filled syringe after "Exp./EXP". The expiry date refers to the last day of that month.
Store in a refrigerator (2 °C - 8 °C). Do not freeze.
Keep the pre-filled syringes in their outer packaging to protect the medicine from light.
After removing a syringe from the refrigerator, wait approximately 15-30 minutes to allow the
Erelzi solution in the syringe to reach room temperature. Do not heat it in any other way. Immediate use is therefore recommended.
Erelzi may be stored at a maximum temperature of 25 °C for up to 4 weeks, for one single time only; after this period it must not be returned to the refrigerator. If not used within 4 weeks outside the refrigerator, Erelzi must be discarded. It is recommended to record the date when Erelzi was removed from the refrigerator and the date by which Erelzi must be discarded (no more than 4 weeks outside the refrigerator).
Inspect the solution inside the syringe. The solution should be from clear to slightly opalescent, from colourless to slightly yellowish, and may contain small white or almost translucent protein particles. This is the normal appearance of Erelzi. Do not use this solution if there are changes in colour, if it appears cloudy, or if particles different from those described are visible. If you have any doubts about the appearance of the solution, contact your pharmacist for advice.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Erelzi contains
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 citrate dihydrate, sodium chloride, sucrose, L-lysine hydrochloride, sodium hydroxide, hydrochloric acid and water for injections.

Description of the appearance of Erelzi and contents of the pack
Erelzi is supplied as a pre-filled syringe containing a solution for injection (injectable preparation), from clear to slightly opalescent, colourless to slightly yellowish.
The pre-filled syringes are made of Type I glass, with a rubber plunger stopper (bromobutyl rubber), plunger, attached 29 G stainless steel needle, and needle cap (thermoplastic elastomer). The syringes are supplied with an automatic needle protection device. Each carton contains 1, 2 or 4 pre-filled syringes with needle protection device. Multiple packs contain 12 (3 packs of 4) pre-filled syringes of 25 mg or 50 mg with needle protection device, or 8 (2 packs of 4) or 24 (6 packs of 4) pre-filled syringes of 25 mg with needle protection device. Not all pack sizes may be marketed.

Marketing Authorisation 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 further information about this medicine, please contact the local representative of the Marketing Authorisation Holder.

België/Belgique/Belgien Lietuva
Sandoz nv/sa Sandoz Pharmaceuticals d.d filialas
Tél/Tel: +32 2 722 97 97 Tel: +370 5 2636 037
България Luxembourg/Luxemburg
Сандоз България КЧТ Sandoz nv/sa
Тел.: +359 2 970 47 47 Tél/Tel.: +32 2 722 97 97
Česká republika Magyarország
Sandoz s.r.o. Sandoz Hungária Kft.
Tel: +420 225 775 111 Tel.: +36 1 430 2890
Danmark/Norge/Ísland/Sverige Malta
Sandoz A/S Sandoz Pharmaceuticals d.d.
Tlf/Sími/Tel: +45 63 95 10 00 Tel: +35699644126
Deutschland Nederland
Hexal AG Sandoz B.V.
Tel: +49 8024 908 0 Tel: +31 36 52 41 600
Eesti Österreich
Sandoz d.d. Eesti filiaal Sandoz GmbH
Tel: +372 665 2400 Tel: +43 5338 2000
Ελλάδα Polska
SANDOZ HELLAS ΜΟΝΟΠΡΟΣΩΠΗ Α.Ε. Sandoz Polska Sp. z o.o.
Τηλ: +30 216 600 5000 Tel.: +48 22 209 70 00
España Portugal
Sandoz Farmacéutica, S.A. Sandoz Farmacêutica Lda.
Tel: +34 900 456 856 Tel: +351 21 000 86 00
France România
Sandoz SAS Sandoz Pharmaceuticals SRL
Tél: +33 1 49 64 48 00 Tel: +40 21 407 51 60
Hrvatska Slovenija
Sandoz d.o.o. Sandoz farmacevtska družba d.d.
Tel: +385 1 23 53 111 Tel: +386 1 580 29 02
Ireland Slovenská republika
Rowex Ltd. Sandoz d.d. - organizačná zložka
Tel: +353 27 50077 Tel: +421 2 48 20 0600
Italia Suomi/Finland
Sandoz S.p.A. Sandoz A/S
Tel: +39 02 96541 Puh/Tel: +358 10 6133 400
Κύπρος United Kingdom (Northern Ireland)
SANDOZ HELLAS ΜΟΝΟΠΡΟΣΩΠΗ Α.Ε. Sandoz GmbH
Τηλ: +30 216 600 5000 Tel: +43 5338 2000
Latvija
Sandoz d.d. Latvia filiāle
Tel: +371 67 892 006

More detailed information on this medicine is available on the website of the European Medicines Agency: https://www.ema.europa.eu

7. Instructions for Use of Erelzi Prefilled Syringe

READ THESE INSTRUCTIONS IN FULL BEFORE ADMINISTERING THE INJECTION.
It is important not to attempt self-injection until you have been properly trained by your
doctor, nurse, or pharmacist. The package contains one or more prefilled syringes of
Erelzi, each individually sealed in a plastic blister.
DO NOT USE In this configuration, the needle safety device is ACTIVE – DO NOT USE the prefilled syringe
READY FOR USE In this configuration, the needle safety device is NOT ACTIVE and the prefilled syringe is ready for use

Appearance of Erelzi prefilled syringe with needle safety device and add-on grip

After injection of the medicine, the needle safety device is activated. This is designed to help protect healthcare professionals, patients who self-inject, physicians and other prescribers, and caregivers from accidental needle-stick injuries.

What you need for the injection:

• Alcohol swab
• Cotton ball or gauze pad
• Sharps disposal container

Important safety information
Caution: Keep the syringe out of the sight and reach of children.

1. Do not open the outer packaging until it is time to use the medicine.
2. Do not use this medicine if the blister seal is damaged, as use may not be safe.
3. Do not shake the syringe.
4. Never leave the syringe unattended where others could damage it.
5. The prefilled syringe is equipped with a needle safety device that activates at the end of the injection, covering the needle. The needle safety device helps prevent needle-stick injuries in anyone handling the prefilled syringe. Be careful not to touch the wings of the needle safety device before use, as this may cause premature activation.
6. Do not remove the needle cap until you are ready to inject.
7. The syringe cannot be reused. Dispose of the syringe immediately after use in a sharps disposal container.
8. Do not use the syringe if it has been dropped on a hard surface or if it was 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 the refrigerator at 2°C – 8°C. DO NOT FREEZE.
2. Before preparing the syringe for injection, remove the blister from the refrigerator and allow it to reach room temperature (15–30 minutes).
3. Do not use the syringe after the expiry date stated on the carton after “Exp.” or on the syringe label after “EXP.” If expired, return the entire package to the pharmacy.

Injection site

The injection site refers to the area of the body where the prefilled syringe will be used.

• The recommended sites are the front of the thighs. You may also use the lower abdomen, but not the area within 5 centimeters of the navel.
• Choose a different site each time you give an injection.
• Do not inject into areas where the skin is tender, bruised, red, scaly, or hard. Avoid areas with scars or stretch marks. If you have psoriasis, do not inject directly into raised, thickened, red, or scaly areas of skin (“psoriatic skin lesions”).

If the injection is administered by someone assisting you, the outer upper arms may also be used.

Preparing the Erelzi prefilled syringe

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

How to use the Erelzi prefilled syringe

Carefully remove the needle cap from the syringe and discard it. A small drop of liquid may appear at the tip of the needle. This is normal.

Gently pinch the skin at the injection site and insert the needle as shown. Push the needle fully in to ensure complete delivery of the medicine. Hold the syringe grip as illustrated. Press the plunger slowly and all the way down until the plunger head is between the wings of the needle safety device. Continue holding the plunger down while keeping the syringe in place for 5 seconds.

Keep the plunger continuously depressed while carefully withdrawing the needle from the injection site. Slowly release the plunger to allow the needle safety device to automatically cover the exposed needle.

Mild bleeding at the injection site may occur. If so, apply a cotton ball or gauze pad to the site and hold for 10 seconds. Do not rub the injection site. If needed, a small adhesive bandage may be applied.

Disposal instructions

Dispose of the used syringe by placing it in a dedicated sharps disposal container (a puncture-resistant, closable container). For your safety and the safety of others, used needles and syringes must never be reused.

If you have any questions, consult your doctor, nurse, or pharmacist familiar with Erelzi.

Package leaflet: information for the user

Erelzi 50 mg solution for injection in pre-filled pen

etanercept (etanerceptum)
Please read this leaflet carefully before using this medicine because it contains important information for you

• Keep this leaflet. You may need to read it again.
• Your doctor will provide you with a Patient Information Card containing important safety information you should be aware of before and during treatment with Erelzi.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you or for the child. Do not give it to others, even if their symptoms are the same as yours or the child's, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. 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 pen

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 that causes inflammation in the human body. Erelzi works by reducing the inflammation associated with certain diseases.

In adults (aged 18 years and older), Erelzi can be used for the treatment of moderate to severe rheumatoid arthritis, psoriatic arthritis, severe axial spondyloarthritis, including ankylosing spondylitis, and moderate to severe psoriasis – in each case, it is usually used when other widely used treatments have not worked well enough or are not suitable for you.

For rheumatoid arthritis, Erelzi is usually used in combination with methotrexate, although it may also be used alone if treatment with methotrexate is not suitable for you. Whether used alone or in combination with methotrexate, Erelzi may slow down joint damage caused by rheumatoid arthritis and improve your ability to perform normal daily activities.

For patients with psoriatic arthritis involving multiple joints, Erelzi may improve the ability to carry out daily activities.

For patients with symmetrical painful or swollen joints (e.g., hands, wrists, and feet), Erelzi may slow down structural damage to these joints caused by the disease.

Erelzi is also prescribed for the treatment of the following conditions in children and adolescents:

• For the following types of juvenile idiopathic arthritis when treatment with methotrexate has not provided a sufficiently good response or is not appropriate:
• Polyarthritis (rheumatoid factor positive or negative) and extended oligoarthritis in patients from the age of 2 years with body weight equal to or greater than 62.5 kg.
• Psoriatic arthritis in patients from the age of 12 years with body weight equal to or greater than 62.5 kg.
• For enthesitis-related arthritis in patients from the age of 12 years with body weight equal to or greater than 62.5 kg, when other widely used treatments have not provided a sufficiently good response or are not appropriate.
• Severe psoriasis in patients from the age of 6 years with body weight equal to or greater than 62.5 kg who have had an inadequate response to (or cannot take) phototherapy or other systemic therapies.

2. What you should know before using Erelzi

Do not use Erelzi

• if you or the child 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, shortness of breath, dizziness, or skin 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 in doubt, contact your doctor.
• if you or the child have any type of infection. If in doubt, consult your doctor.

Warnings and precautions
Talk to your doctor before using Erelzi.

• Allergic reactions: If you or the child experience allergic reactions such as chest tightness, shortness of breath, dizziness, or skin 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 any major surgical procedure. Your doctor may need to review your treatment with Erelzi.
• Infections/diabetes: Inform your doctor if you or the child have a history of recurrent infections or suffer from diabetes or other conditions that increase the risk of infection.
• Infections/monitoring: Inform your doctor about any recent travel outside Europe. If you or the child develop symptoms of an infection such as fever, chills, or cough, inform your doctor immediately. Your doctor may decide to continue monitoring you or the child for infections even after stopping Erelzi.
• Tuberculosis: Cases of tuberculosis have been reported in patients treated with Erelzi. Your doctor will check for signs and symptoms of tuberculosis before starting treatment with Erelzi. This may include a thorough medical history, chest X-ray, and tuberculin skin test. The results of these tests must be recorded in the Patient Record Card. It is very important that you inform your doctor if you or the child have ever had tuberculosis or have been in close contact with someone who has tuberculosis. If symptoms of tuberculosis (such as persistent cough, weight loss, weakness, 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 had hepatitis B. Your doctor must perform a hepatitis B test before starting treatment with Erelzi. Treatment with Erelzi may reactivate hepatitis B in patients with previous hepatitis B virus infection. In such cases, you must stop using Erelzi.
• Hepatitis C: Inform your doctor if you or the child have hepatitis C. Your doctor may consider monitoring treatment with Erelzi if the infection worsens.
• Blood disorders: Seek immediate medical attention if you or the child experience any signs or symptoms such as persistent fever, sore throat, bruising, bleeding, or paleness. These symptoms may indicate potentially life-threatening blood disorders that may require discontinuation of Erelzi treatment.
• Nervous system and eye 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 assess 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 should be used with caution in such cases.
• Tumours: Inform your doctor if you have or have ever had lymphoma (a type of blood cancer) or any other tumour before taking Erelzi. Patients with long-standing, severe rheumatoid arthritis may have an increased risk of developing lymphoma. Children and adults taking Erelzi may have a higher risk of developing lymphoma or other tumours. Some children and adolescent patients treated with Erelzi or other medicines acting similarly to Erelzi have developed tumours, including unusual types, sometimes with fatal outcomes. Some patients receiving Erelzi have developed skin tumours. 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 assess whether preventive treatment for chickenpox is appropriate.
• Alcohol abuse: Erelzi must not be used to treat hepatitis related to alcohol abuse. Inform your doctor if you or the child have a history of alcohol abuse.
• Wegener’s granulomatosis: Erelzi is not recommended for the treatment of Wegener’s granulomatosis, a rare inflammatory disease. If you or the child have Wegener’s granulomatosis, consult 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 to reduce the dose of anti-diabetic 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: Whenever possible, children should be up to date with all vaccinations before starting Erelzi. Some vaccines, such as oral polio vaccine, must not be taken while receiving Erelzi. Consult your doctor before you or the child receive any vaccine.

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

Other medicines and Erelzi
Inform your doctor or pharmacist if you or the child are taking, have recently taken, or might take any other medicines (including anakinra, abatacept, or sulfasalazine), even those not prescribed.
You or the child must not use Erelzi together with the active substance anakinra or abatacept.

Pregnancy and breastfeeding
Erelzi should be used during pregnancy only if clearly necessary. If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, consult your doctor.
If you received Erelzi during pregnancy, the newborn may be at increased risk of infection. In addition, one study indicated a higher number of birth defects in mothers who received etanercept during pregnancy compared to mothers who did not receive etanercept or other similar medicines (TNF antagonists), but no specific pattern of birth defects was identified. Another study did not show an increased risk of birth defects when mothers received Erelzi during pregnancy. Your doctor will help you decide whether the benefits of treatment outweigh the potential risks to your baby.
Talk to your doctor if you wish to breastfeed while being treated with Erelzi. It is important to inform the child’s paediatrician and other healthcare professionals about the use of Erelzi during pregnancy and breastfeeding before the child receives any vaccine.

Driving and using machines
Erelzi is not expected to affect the ability to drive vehicles or use machinery.

Erelzi contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per 50 mg, i.e. essentially ‘sodium-free’.

3. How to use Erelzi

Use this medicine exactly as your doctor has told you. If you have any doubts, consult your doctor or pharmacist.
If you think that the effect of Erelzi is too strong or too weak, talk to your doctor or pharmacist.
You have been prescribed a 50 mg dose of Erelzi. A 25 mg dose of Erelzi is available for 25 mg doses.

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 once weekly by subcutaneous injection. However, your doctor may decide on a different frequency for administering Erelzi.

Plaque psoriasis
The usual dose is 25 mg administered twice weekly or 50 mg administered once weekly.
Alternatively, a dose of 50 mg may be given twice weekly for up to 12 weeks, followed by a dose of 25 mg twice weekly or 50 mg once weekly.
Your doctor will decide how long you should use Erelzi and whether, based on your response, further treatment is needed. If, after 12 weeks, Erelzi has not had any effect on your disease, your doctor may tell you to stop treatment.

Use in children and adolescents
The appropriate dose and dosing frequency for a child or adolescent will depend on body weight and condition. Your doctor will determine the correct dose for your child and will prescribe an appropriate etanercept dosage. Pediatric patients weighing 62.5 kg or more may receive 25 mg twice weekly or 50 mg once weekly and may use either the pre-filled syringe or the fixed-dose pre-filled pen.
Other etanercept-containing products with dosages suitable for children are available.

For polyarthritis or extended oligoarthritis 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 administered twice weekly or 50 mg administered once weekly.

For psoriasis in patients aged 6 years and older weighing 62.5 kg or more, the usual dose is 50 mg administered once weekly. If Erelzi has not had any effect on the child's condition after 12 weeks, the doctor may instruct you to discontinue treatment with this medicine.
Your doctor will provide detailed instructions on how to prepare and measure the appropriate dose.

Method and route of administration
Erelzi is administered by injection under the skin (subcutaneous injection).
Detailed instructions on how to inject Erelzi are provided in section 7, “Instructions for using the Erelzi pre-filled pen”.
Do not mix the Erelzi solution with other medicines.
To help you remember, it may be useful to write down in a diary on which day(s) of the week Erelzi should be used.

If you use more Erelzi than you should
If you have used more Erelzi than you should (either by injecting too much at one time or by using it too frequently), contact a doctor or pharmacist immediately. Always keep the medicine pack with you, even if it is empty.

If you forget to use Erelzi
If you forget a dose, administer 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 regularly scheduled day(s). If you have forgotten a dose and the next dose is due the next day, do not take a double dose (two doses on the same day) to make up for the missed dose.

If you stop treatment with Erelzi
After stopping treatment, symptoms of the disease may return.
If you have any questions about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Allergic reactions
If any of the following side effects occur, do not inject Erelzi again. Contact your doctor immediately,
or go to the nearest hospital emergency department.

• Difficulty swallowing or breathing
• Swelling of the face, throat, hands or feet
• Feeling restless or anxious, palpitations, sudden redness of the skin and/or sensation of warmth
• Severe rash, itching, hives (raised red or pale patches of itchy skin)

Severe allergic reactions are rare. However, any of the symptoms listed above may indicate an
allergic reaction to Erelzi; therefore, you must seek immediate medical attention.
Serious side effects
If you notice any of the following side effects, you or the child may need urgent medical care.

• Symptoms of serious infections , such as high fever which may be accompanied by cough, shortness of breath, chills, weakness, or a warm, red, tender, painful area on the skin or joints.
• Symptoms of blood disorders , such as bleeding, bruising or paleness.
• Symptoms of nerve disorders , such as numbness or tingling, changes in vision, eye pain, or sudden weakness in one arm or leg.
• Symptoms 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 colour of the fingernails or lips.
• Symptoms of tumours : tumours may affect any part of the body, including the skin and blood, and possible symptoms depend on the type and location of the tumour. These symptoms may include weight loss, fever, swelling (with or without pain), persistent cough, or presence of cysts or skin growths.
• Symptoms of autoimmune reactions (where antibodies are produced that may damage normal body tissues), such as pain, itching, weakness, breathing problems, changes in thinking, sensation or vision.
• Symptoms of lupus or lupus-like syndrome, such as changes in body weight, persistent rash, fever, joint or muscle pain, or fatigue.
• Symptoms of inflammation of blood vessels , such as pain, fever, redness or warmth of the skin, or itching.

These side effects are rare or uncommon, but are serious conditions (some of which may rarely lead to death). If these symptoms occur, contact your doctor immediately or go to the nearest hospital emergency department.
Known side effects of Erelzi include those listed below, grouped by decreasing 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 a reaction at a recently used injection site); headache.

• Common (may affect up to 1 in 10 people): Allergic reactions; fever; rash; itching; antibodies directed against normal tissue (formation of autoantibodies).

• Uncommon (may affect up to 1 in 100 people): Serious infections (including pneumonia, deep skin infections, joint infections, blood infections and infections at various sites); worsening of congestive heart failure; low red blood cell count, low white blood cell count, low neutrophil count (a type of white blood cell); reduced number of platelets in the blood; skin tumour (excluding melanoma); localized swelling of the skin (angioedema); urticaria (raised red or pale patches of itchy skin); eye inflammation; psoriasis (new onset or worsening); inflammation of blood vessels affecting more than one organ; elevated liver enzymes in the blood (in patients also being treated with methotrexate, the frequency of increased liver enzymes in the blood is common); abdominal pain and cramps, diarrhoea, weight loss or blood in the stool (symptoms of intestinal problems).

• Rare (may affect up to 1 in 1,000 people): Severe allergic reactions (including severe localized swelling of the skin and breathing difficulties); lymphoma (a type of blood cancer); leukaemia (a cancer affecting blood and bone marrow); melanoma (a type of skin cancer); combined reduction in platelets, red blood cells and white blood cells; nervous system disorders (with severe muscle weakness and signs and symptoms similar to multiple sclerosis or inflammation of the nerves of the eye or spinal cord); tuberculosis; new onset of congestive heart failure; seizures; lupus or lupus-like syndrome (symptoms may include persistent rash, fever, joint pain and fatigue); rash that may lead to severe blistering and peeling of the skin; lichenoid reactions (itchy reddish-purple rash and/or whitish-grey thread-like lines on mucous membranes); liver inflammation caused by your immune system (autoimmune hepatitis; in patients also being treated with 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 being treated with methotrexate, the frequency of lung inflammation or scarring is uncommon); damage to the tiny filters within the kidneys leading to reduced kidney function (glomerulonephritis).

• Very rare (may affect up to 1 in 10,000 people): Failure of the bone marrow to produce essential blood cells.

• Not known (frequency cannot be estimated from the available data): Merkel cell carcinoma (a type of skin cancer); Kaposi's sarcoma, a rare form of cancer associated with human herpesvirus 8 infection. Kaposi's sarcoma most commonly presents with purple skin lesions; excessive activation of white blood cells involved in inflammation (macrophage activation syndrome); reactivation of hepatitis B (a liver infection); worsening of a condition called dermatomyositis (muscle inflammation and weakness, accompanied by a skin rash).

Additional side effects in children and adolescents
The side effects and their frequency observed in children and adolescents are similar to those described above.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store 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 pre-filled pen after "Exp./EXP". The expiry date refers to the last day of that month.
Store in a refrigerator (2 °C - 8 °C). Do not freeze.
Keep the pre-filled pens in their outer packaging to protect the medicine from light.
After removing a pre-filled pen from the refrigerator, wait approximately 15–30 minutes to allow
the Erelzi solution in the pen to reach room temperature. Do not heat it in any other way. Immediate use is therefore recommended.
Erelzi may be stored at a maximum temperature of 25 °C for up to 4 weeks, for one single period only; after this time it must not be returned to the refrigerator. If not used within 4 weeks outside the refrigerator, Erelzi must be discarded. It is recommended to record the date when Erelzi was removed from the refrigerator and the date by which Erelzi must be discarded (no more than 4 weeks outside the refrigerator).
Inspect the solution inside the pen by looking through the transparent inspection window. The solution should be from clear to slightly opalescent, from colourless to slightly yellowish, and may contain small white or almost translucent protein particles. This is the normal appearance of Erelzi. Do not use this solution if it shows changes in colour, appears cloudy, or if particles different from those described are visible. If you have any doubts about the appearance of the solution, contact your pharmacist for assistance.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Erelzi contains
The active substance is etanercept.
Each pre-filled pen contains 50 mg of etanercept.
The other components are anhydrous citric acid, sodium citrate dihydrate, sodium chloride, sucrose, L-lysine hydrochloride, sodium hydroxide, hydrochloric acid and water for injections.

Description of the appearance of Erelzi and contents of the pack
Erelzi is supplied as an injectable solution in a pre-filled pen. The pre-filled pen contains a solution for injection (injectable preparation) that ranges from clear to slightly opalescent and from colourless to slightly yellowish. The pre-filled syringes are Type I glass syringes with a rubber plunger stopper (bromobutyl rubber), plunger, attached 29 G stainless steel needle and needle cap (thermoplastic elastomer).
Each carton contains 1, 2 or 4 pens. Multi-pack cartons contain 12 pens (3 packs of 4).
Not all pack sizes may be marketed.

Marketing Authorisation 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 further information about this medicine, please contact the local representative of the Marketing Authorisation Holder.

België/Belgique/Belgien Lietuva
Sandoz nv/sa Sandoz Pharmaceuticals d.d filialas
Tél/Tel: +32 2 722 97 97 Tel: +370 5 2636 037
България Luxembourg/Luxemburg
Сандоз България КЧТ Sandoz nv/sa
Тел.: +359 2 970 47 47 Tél/Tel.: +32 2 722 97 97
Česká republika Magyarország
Sandoz s.r.o. Sandoz Hungária Kft.
Tel: +420 225 775 111 Tel.: +36 1 430 2890
Danmark/Norge/Ísland/Sverige Malta
Sandoz A/S Sandoz Pharmaceuticals d.d.
Tlf/Sími/Tel: +45 63 95 10 00 Tel: +35699644126
Deutschland Nederland
Hexal AG Sandoz B.V.
Tel: +49 8024 908 0 Tel: +31 36 52 41 600
Eesti Österreich
Sandoz d.d. Eesti filiaal Sandoz GmbH
Tel: +372 665 2400 Tel: +43 5338 2000
Ελλάδα Polska
SANDOZ HELLAS ΜΟΝΟΠΡΟΣΩΠΗ Α.Ε. Sandoz Polska Sp. z o.o.
Τηλ: +30 216 600 5000 Tel.: +48 22 209 70 00
España Portugal
Sandoz Farmacéutica, S.A. Sandoz Farmacêutica Lda.
Tel: +34 900 456 856 Tel: +351 21 000 86 00
France România
Sandoz SAS Sandoz Pharmaceuticals SRL
Tél: +33 1 49 64 48 00 Tel: +40 21 407 51 60
Hrvatska Slovenija
Sandoz d.o.o. Sandoz farmacevtska družba d.d.
Tel: +385 1 23 53 111 Tel: +386 1 580 29 02
Ireland Slovenská republika
Rowex Ltd. Sandoz d.d. - organizačná zložka
Tel: +353 27 50077 Tel: +421 2 48 20 0600
Italia Suomi/Finland
Sandoz S.p.A. Sandoz A/S
Tel: +39 02 96541 Puh/Tel: +358 10 6133 400
Κύπρος United Kingdom (Northern Ireland)
SANDOZ HELLAS ΜΟΝΟΠΡΟΣΩΠΗ Α.Ε. Sandoz GmbH
Τηλ: +30 216 600 5000 Tel: +43 5338 2000
Latvija
Sandoz d.d. Latvia filiāle
Tel: +371 67 892 006

More detailed information on this medicine is available on the European Medicines Agency website: https://www.ema.europa.eu.

7. Instructions for use of Erelzi pre-filled pen

READ THESE INSTRUCTIONS IN FULL BEFORE ADMINISTERING THE INJECTION.
These instructions are intended to assist you in correctly administering the injection
using the Erelzi pre-filled pen.
It is important not to attempt to administer the injection by yourself until you have
been properly trained by your doctor, nurse, or pharmacist.
Appearance of the Erelzi pre-filled pen:

Store the unopened pen in the refrigerator at
Needle
2 °C – 8 °C and keep it out of the reach of
children.

• Do not freeze the pen. Needle cap – Do not shake the pen.
• Do not use the pen if it has been dropped without the needle cap. Inner needle cover The Erelzi pre-filled pen shown with the cap removed. For a more comfortable injection, remove the pen from the refrigerator 15–30 minutes before injection to allow it to reach room temperature. Do not remove the cap until you are ready to inject.

What you need for the injection:
Included in the package: Not included in the package:
One new, unused Erelzi pre-filled pen  Alcohol swab
 Cotton ball or gauze pad

• Sharps disposal container

Before the injection:

1. Important safety checks before injection:

The solution should be from clear to slightly opalescent,
colorless to slightly yellowish, and may contain small white or
almost translucent protein particles. This is the normal appearance of
Erelzi.
Do not use if the liquid is cloudy, shows changes in color,
or contains clumps, flakes, or colored particles.
Do not use the pen after the expiry date.
Do not use if the tamper-evident seal has been opened.
Contact your pharmacist if the pen fails to meet any of
these checks.

2a. Choosing the injection site:

• The recommended site is the front of the thighs. You may also use the lower abdomen, but not the area within 5 centimeters around the navel.
• Select a different site for each new injection.
• Do not inject in areas where the skin is tender, bruised, red, scaly, or hard. Avoid areas with scars or stretch marks. If you have psoriasis, the injection must not be administered directly into areas or lesions where the skin appears raised, thick, red, or scaly (“psoriatic skin lesions”).

2b. For caregivers and healthcare professionals only:

• If the injection is administered by a caregiver or by healthcare professionals, it may also be given in the upper outer area of the arms.

3. Cleaning the injection site:

• Wash your hands with soap and warm water.
• Using a circular motion, clean the injection site with an alcohol swab. Allow it to dry before administering the injection.
• Do not touch the cleaned area again before giving the injection.

Injection:

4. Removing the cap:

• Remove the cap only when you are ready to use the pen.
• Unscrew the cap in the direction of the arrows.
• Discard the cap. Do not attempt to reattach the cap.
• Use the pen within 5 minutes after removing the cap.

5. Position of the pen:

• Hold the pen at a 90-degree angle to the cleaned injection site.

Correct Incorrect

READ BEFORE PERFORMING THE INJECTION.
During the injection, you will hear two audible clicks.
The first click indicates that the injection has started. Several seconds later, a
second click indicates that the injection is almost complete.
You must continue to hold the pen firmly against the skin until the
green indicator fills the window and stops moving.

6. Start the injection:

• Press the pen firmly against the skin to start the injection.
• The first click indicates that the injection has started.
• Continue to keep the pen firmly pressed against the skin.
• The green indicator shows the progress of the injection.

7. Completing the injection:

• Wait for the sound of the second click. This indicates that the injection is almost complete.
• Check that the green indicator has filled the window and has stopped moving.
• The pen can now be removed.

After the injection:

8. Check that the green indicator fills the window:

• This means the medicine has been administered. Contact the doctor if the green indicator is not visible.
• Mild bleeding at the injection site may occur. If so, press a cotton ball or gauze pad against the injection site for 0 seconds. Do not rub the injection site. If needed, the injection site may be covered with a small plaster.

9. Disposal of the Erelzi pre-filled pen:

• Dispose of the used pen by placing it in a designated sharps container (e.g. a puncture-resistant, closable container or similar).
• Never attempt to reuse the pen.

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