Prospect: information for the user

Erelzi 25mg pre-filled syringe solution

Erelzi 50mg pre-filled syringe solution

etanercept

Read this prospect carefully before starting to use this medication, because it contains important information for you.

•Keep this prospect, as you may need to read it again.

•Your doctor will also give you a Patient Information Leaflet, which contains important safety information that you need to know before and during treatment with Erelzi.

•If you have any questions, consult your doctor, pharmacist, or nurse.

•This medication has been prescribed to you or the child in your care and should not be given to others, even if they have the same symptoms as you or the child in your care, as it may harm them.

•If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section4.

1.What is Erelzi and what is it used for

2.What you need to know before starting to use Erelzi

3.How to use Erelzi

4.Possible adverse effects

5.Storage of Erelzi

6.Contents of the package and additional information

7.Instructions for use of the pre-filled syringe of Erelzi

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

Erelzi may be used in adults 18 years of age or older for the treatment ofmoderate to severe rheumatoid arthritis,psoriatic arthritis,axial spondyloarthritis, includingankylosing spondylitis, andpsoriasismoderate to severe, usually, depending on each case, when other treatments have not been sufficiently effective or are not appropriate for you.

In the treatment ofrheumatoid arthritis, Erelzi is usually used in combination with methotrexate, although it may also be used as a single medication, in the case where methotrexate treatment is not suitable for you. Erelzi may slow the damage caused by rheumatoid arthritis in your joints and improve your ability to perform daily activities, whether used alone or in combination with methotrexate.

In the case of patients withpsoriatic arthritiswith multiple joint involvement, Erelzi may improve your ability to perform normal daily activities.

In the case of patients withsymmetrically multiple, swollen, or painful joints(for example, in 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 in children and adolescents with the following diseases:

• For the following types of juvenile idiopathic arthritis when treatment with methotrexate has not worked adequately, or is not suitable for them:
• Polyarthritis (with positive or negative rheumatoid factor) and extended oligoarthritis in patients from 2years old and with a weight of 62.5kg or more.
• Psoriatic arthritis in patients from 12years old and with a weight of 62.5kg or more.
• Arthritis related to enthesitis in patients from 12years old and with a weight of 62.5kg or more for whom the use of other commonly used treatments has not worked adequately, or these treatments are not suitable for them.
• Severe psoriasis in patients from 6years old and with a weight of 62.5kg or more who have had an inadequate response to (or are unable to take) phototherapy or other systemic therapies.

No use Erelzi

•if you or the child in your care areallergic to etanerceptor to any ofthe other components of Erelzi(listed in section6). If you or the child experience allergic reactions, such as chest tightness, rapid breathing, dizziness, or rash, do not inject more Erelzi and immediately contact your doctor.

•if you or the child have or are at risk of developing aserious blood infectioncalled sepsis. If unsure, consult your doctor.

•if you or the child have anyinfection. If unsure, consult your doctor.

Warnings and precautions

Consult your doctor before starting to use Erelzi.

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

•Infections/surgery:If you or the child develop a new infection or are about to undergo major surgery, your doctor may be interested in controlling the treatment with Erelzi.

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

•Infections/monitoring:Inform your doctor of 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 to continue monitoring you or the child to see the presence of infections 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 the signs and symptoms of tuberculosis before starting Erelzi. This may include a detailed medical history, chest X-ray, and tuberculosis test. The performance of these tests should be recorded in the Patient Information Card. It is very important to tell your doctor if you or the child have had tuberculosis, or if they have been in direct contact with someone who has had tuberculosis. If symptoms of tuberculosis (such as persistent cough, weight loss, apathy, moderate 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 at any time. Your doctor should perform the hepatitis B test before you or the child start treatment with Erelzi. Treatment with Erelzi can reactivate hepatitis B in patients who have previously been infected with the hepatitis B virus. If this occurs, you should stop using Erelzi.

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

•Blood disorders:Inform your doctor immediately if you or the child have signs or symptoms such as persistent fever, sore throat, bruises, bleeding, or pallor. Such symptoms may indicate the presence of a serious blood disorder that requires interruption of treatment with Erelzi.

•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 if Erelzi is an appropriate treatment.

•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 circumstances.

•Cancer:Inform your doctor if you have or have had lymphoma (a type of blood cancer) or any other cancer before Erelzi is administered.

Patients with severe rheumatoid arthritis, who have had the disease for a long time, may be at a higher risk than average of developing lymphoma.

Children and adults taking Erelzi may be at an increased risk of developing lymphoma or other cancer.

Some patients, particularly adolescents and children, who have received Erelzi or other medications that work in the same way as Erelzi, have developed cancers, including rare types, which sometimes resulted in death.

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

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

•Alcoholism:Erelzi should not be used to treat alcohol-related hepatitis. Please inform your doctor if you or the child have a history of alcoholism.

•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, please discuss this with your doctor.

•Antidiabetic medications:Inform your doctor if you or the child have diabetes or are taking medications to treat diabetes. Your doctor may decide if you or the child need less antidiabetic medication while using Erelzi.

Children and adolescents

Erelzi is not indicated for use in children and adolescents with a weight of less than 62.5 kg.

•Vaccinations:If possible, children should have all vaccinations updated before using Erelzi. Some vaccines, such as the oral polio vaccine, should not be administered while using Erelzi. Consult with your doctor before using any vaccine.

Normally, Erelzi should not be used in children under 2 years or with a weight of less than 62.5 kg with polyarthritis or oligoarthritis, in children under 12 years or with a weight of less than 62.5 kg with arthritis related to enthesitis or psoriatic arthritis, or in children under 6 years or with a weight of less than 62.5 kg with psoriasis.

Other medications and Erelzi

Inform your doctor or pharmacist if you or the child are using, have used recently, or may need to use any other medication (including anakinra, abatacept, or sulfasalazine), even those not prescribed by your doctor.

You or the childshould not useErelzi with medications containing the active principles 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 intend to become pregnant.

If you have received Erelzi during pregnancy, your baby may be at a higher risk of contracting an infection. Additionally, in one study, more birth defects were observed when the mother had received etanercept during pregnancy, compared to mothers who had not received etanercept or other similar medications (TNF antagonists), but no pattern was observed in the types of birth defects reported. Another study found no increased risk of congenital defects when the mother had received Erelzi during pregnancy. Your doctor will help you decide if the benefits of treatment outweigh the potential risk to your baby.

Consult your doctor if you wish to breastfeed while on treatment with Erelzi. It is essential 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 operating machinery

No impairment of the ability to drive and operate machinery is expected with the use of Erelzi.

Erelzi contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per 25 mg or 50 mg; essentially "sodium-free".

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

If you estimate that the action of Erelzi is too strong or too weak, inform your doctor or pharmacist.

Erelzi is available in presentations of 25 mg and 50 mg.

Use in adult patients (18 years of age or older)

Rheumatoid arthritis, psoriatic arthritis, and axial spondyloarthritis, including ankylosing spondylitis

The usual dose is 25 mg administered twice a week or 50 mg administered once a week, in the form of a subcutaneous injection. However, your doctor may determine an alternative frequency for injecting Erelzi.

Plaque psoriasis

The usual dose is 25 mg twice a week or 50 mg once a week.

Alternatively, 50 mg may be administered twice a week for a maximum of 12 weeks, followed by 25 mg twice a week or 50 mg once a week.

Your doctor will decide how long you should use Erelzi and if you need a repeat of the treatment based on your response. If Erelzi has no effect on your disease after 12 weeks, your doctor may instruct you to stop using this medication.

Use in children and adolescents

The appropriate dose and dosing frequency will depend on the child's or adolescent's body weight and disease. Your doctor will determine the appropriate dose for the child and prescribe the most suitable presentation of etanercept. Patients weighing 62.5 kg or more may be prescribed a dose of 25 mg twice a week or 50 mg once a week using a pre-filled syringe or a fixed-dose pen.

Other etanercept medications are available with doses suitable for children.

For extended oligoarthritis or polyarthritis in patients aged 2 years or older and weighing 62.5 kg or more, or psoriatic arthritis related to enthesitis or psoriatic arthritis in patients aged 12 years or older and weighing 62.5 kg or more, the usual dose is 25 mg twice a week or 50 mg once a week.

For plaque psoriasis in patients aged 6 years or older and weighing 62.5 kg or more, the usual dose is 50 mg once a week. If Erelzi has no effect on the child's disease after 12 weeks, your doctor may instruct you to stop using this medication.

Your doctor will give you precise instructions for preparing and calculating the correct dose.

Form and route of administration

Erelzi is administered via a subcutaneous injection.

In section 7, “Instructions for use of the Erelzi pre-filled syringe”, detailed instructions for injecting Erelzi are included.

The Erelzi solution should not be mixed with any other medication.

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

If you use more Erelzi than you should

If you use more Erelzi than you should (either by injecting a high amount on a single occasion or by using it too frequently), you should speak with a doctor or pharmacist immediately.

Always carry the medication packaging with you, even if it is empty.

If you forget to inject Erelzi

If you forget a dose, you should inject it as soon as you remember, unless the next dose is due the following day, in which case you should omit the missed dose. Then, continue injecting the medication on the usual day(s). If you do not remember until the day when the next dose is due, do not inject a double dose (two doses on the same day) to compensate for the missed dose.

If you interrupt treatment with Erelzi

Your symptoms may return after interrupting treatment.

If you have any other doubts about using this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Allergic reactions

If you notice any of the following reactions, do not inject Erelzi again. Inform your doctor immediately or go to the nearest hospital emergency department.

•Difficulty swallowing or breathing.

•Swelling of the face, throat, hands, and feet.

•Feeling of nervousness or anxiety, palpitations, sudden redness of the skin, and/or feeling of heat.

•Severe rash, itching, or urticaria (prominent skin rashes, red or pale, often accompanied by itching).

Severe allergic reactions are rare. However, any of the above symptoms may be a sign of an allergic reaction to Erelzi, so you must seek urgent medical attention immediately.

Severe side effects

If you notice any of the following side effects, you or the child may need emergency medical attention.

•Signs ofserious infections, such as high fever that may be accompanied by cough, shortness of breath, chills, weakness, or a painful, sensitive, red, and warm area on the skin or joints.

•Signs ofblood disorders, such as bleeding, bruising, or paleness.

•Signs ofnervous system disorders, such as numbness or tingling, visual disturbances, eye pain, or weakness in an arm or leg.

•Signs ofheart failureorworsening of heart failure, such as fatigue or shortness of breath with activity, swelling of the ankles, feeling of fullness in the neck or abdomen, shortness of breath at night, or cough, blue discoloration of the nails or around the lips.

•Signs ofcancer: cancer can affect any part of the body, including the skin and blood, and the possible signs will depend on the type and location of the cancer. These signs may include, among others, weight loss, fever, swelling (with or without pain), persistent cough, presence of lumps or thickening in the skin.

•Signs ofautoimmune reactions(in which antibodies may be formed that can damage normal body tissues) such as pain, itching, weakness, and abnormal breathing, thinking, sensation, or vision.

•Signs oflupus or lupus-like syndromesuch as weight changes, persistent rash, fever, joint pain, or fatigue.

•Signs ofvasculitissuch as pain, fever, redness, or warmth of the skin, or itching.

These side effects are rare or uncommon, but are serious (some of them may be fatal in rare cases). If these signs occur, inform your doctor immediately or go to the nearest hospital emergency department.

The following are known side effects of Erelzi, grouped by decreasing frequency:

•Very common(may affect more than 1 in 10people):

Infections (including colds, sinusitis, bronchitis, urinary tract infections, and skin infections); reactions at the injection site (including bleeding, bruising, redness, itching, pain, and swelling).(These are not as common after the first month of treatment; some patients have developed a reaction at the injection site that they had recently used); and headache.

•Common(may affect up to 1 in 10people):

Allergic reactions; fever; rash; itching; antibodies directed against normal tissues (autoantibody formation).

•Uncommon(may affect up to 1 in 100people):

Severe infections (including pneumonia, non-superficial skin infections, joint infections, blood infections, and generalized infections); worsening of congestive heart failure; low red blood cell count, low white blood cell count, low neutrophil count (a type of white blood cell);low platelet count; skin cancer (excluding melanoma); localized skin swelling (angioedema); urticaria (prominent skin rashes, red or pale, often accompanied by itching); eye inflammation, psoriasis (new or worsening); inflammation of blood vessels affecting multiple organs; increased liver enzymes in blood tests (in patients also receiving methotrexate treatment, the frequency is uncommon); abdominal cramps and pain, diarrhea, weight loss, or blood in the stool (signs of intestinal problems).

•Rare(may affect up to 1 in 1,000people):

Severe allergic reactions (including localized severe skin swelling and labored breathing); lymphoma (a type of blood cancer);leukemia (cancer affecting the blood and bone marrow);melanoma (a type of skin cancer); low counts of red blood cells, white blood cells, and platelets combined; 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; congestive heart failureof new onset; seizures; lupus or lupus-like syndrome (symptoms may include persistent rash, fever, joint pain, or fatigue); skin rash that may lead to severe blistering and skin peeling; lichenoid reactions (pruritic, red-brown skin rash and/or thick white-gray lines on mucous membranes); autoimmune hepatitis(in patients also receiving methotrexate treatment, the frequency is uncommon); immune disorder that may affect the lungs, skin, and lymph nodes (sarcoidosis);inflammation or scarring of the lungs (in patients also receiving methotrexate treatment, the frequency of lung inflammation or scarring is uncommon).

•Very rare(may affect up to 1 in 10,000people):

Bone marrow failure to produce critical blood cells.

•Unknown frequency(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 hepatitisB (a liver infection); damage to the small filters within the kidneys that lead to impaired kidney function (glomerulonephritis); worsening of a disease called dermatomyositis (inflammation and weakness of the muscles accompanied by skin rash).

Other side effects in children and adolescents

The side effects observed in children and adolescents, as well as their frequencies, are similar to those previously described.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through thenational notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging and the pre-filled syringe label after “CAD”/”EXP”. The expiration date is the last day of the month indicated.

Store in refrigerator (2°C–8°C). Do not freeze.

Store pre-filled syringes in the outer packaging to protect them from light.

After removing the syringe from the refrigerator,wait approximately 15‑30minutes for the Erelzi solution to reach room temperature. Do not heat it in any other way. It is then recommended to use it immediately.

Erelzi can be stored at room temperature up to a maximum of 25°C, and for a single period of up to 4weeks; after which, the medication cannot be refrigerated again. Erelzi must be discarded if it has not been used within 4weeks following its removal from the refrigerator. It is recommended to note the date on which Erelzi was removed from the refrigerator and the date from which Erelzi must be discarded (not exceeding 4weeks from the removal of the packaging from the refrigerator).

Inspect the solution in the syringe. It should be transparent or 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 the solution if it is discolored or turbid, or if it presents different particles. If you are concerned about the appearance of the solution, contact your pharmacist for any assistance you may need.

Medicines should not be thrown down the drain or in the trash. Ask your pharmacist how to dispose of the packaging and medicines that you no longer need. In this way, you will help protect the environment.

Composition of Erelzi

The active ingredient 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-histidine hydrochloride, sodium hydroxide, hydrochloric acid, and water for injection.

Appearance of the product and contents of the pack

Erelzi is presented as a pre-filled syringe containing a transparent or slightly opalescent, colourless to slightly yellowish solution for injection.The pre-filled syringes are made of type I glass, a bromobutyl rubber stopper for the plunger, a plunger rod, a stainless steel needle of gauge 29, and a needle cap (thermoplastic elastomer). The syringes are provided with an automatic needle guard.Each pack contains 1, 2, or 4 pre-filled syringes with a needle guard; the multiple packs contain 12 (3 packs of 4) pre-filled syringes of 25 mg or 50 mg with a needle guard or 8 (2 packs of 4) or 24 (6 packs of 4) pre-filled syringes of 25 mg with a needle guard. Some pack sizes may only be marketed.

Marketing authorisation holder

Sandoz GmbHBiochemiestrasse10

6250 Kundl

Austria

Manufacturer

Sandoz GmbH Schaftenau

Biochemiestrasse10

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 authorisation holder:

Last update of this leaflet:{MM/AAAA}

For more detailed information on this medicinal product, please consult the website of the European Medicines Agency:http://www.ema.europa.eu.

7.Instructions for use of the Erelzi pre-filled syringe

Read all the instructions before injecting the medicinal product.This information is also available on www.erelzi.eu and in the following code.

“Include QR code”+ www.erelzi.eu

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

Your Erelzi pre-filled syringe with needle guard and finger grip

Once the medicinal product has been injected, the needle guard will activate to cover the needle. This is designed to protect healthcare professionals, patients who self-inject the medicinal product prescribed by a doctor, and individuals who assist patients in self-injecting the medicinal product from needlestick injuries.

What else do you need for the injection:

Important safety information

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

1.Do not open the pack until you are ready to administer this medicinal product.

2.Do not use this medicinal product if the blister seal is broken, as it may not be safe to use.

3.Do not shake the pre-filled syringe.

4.Never leave the pre-filled syringe in places where others may touch it.

5.The pre-filled syringe has a needle guard that will activate to cover the needle after administration of the injection. The needle guard will help to prevent needlestick injuries to anyone using the pre-filled syringe.

Be very careful not to touch the activation clips of the needle guard before use. If you do, the needle guard will activate prematurely.

6.Do not remove the needle cap until just before administering the injection.

7.The pre-filled syringe cannot be reused. Once used, dispose of the pre-filled syringe immediately in a sharps container.

8.Do not use if the pre-filled syringe has fallen onto a hard surface or has been dropped after removing the needle cap.

Storage of the Erelzi pre-filled syringe

1.Store this medicinal product in the closed pack to protect it from light. Store in a refrigerator at 2°C to 8°C. DO NOT FREEZE.

2.Remember to take the blister out of the refrigerator to allow it to come to room temperature before preparing the injection (15‑30minutes).

3.Do not use the pre-filled syringe after the expiry date that appears on the pack or on the label of the pre-filled syringe after “CAD”/”EXP”. If it has expired, return the pack to the pharmacy.

Injection sites

Preparing the Erelzi pre-filled syringe

1.Take the blister with the pre-filled syringe out of the refrigerator and let it come to room temperature for 15‑30minutes.

2.When you are ready to use the pre-filled syringe, open the blister and wash your hands thoroughly with water and soap.

3.Disinfect the injection site thoroughly with a moist towelette in alcohol.

4.Remove the pre-filled syringe from the blister.

5.Inspect the pre-filled syringe. The liquid should be transparent or slightly opalescent, colourless 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, discoloured, or contains large lumps, scales, or coloured particles. Do not use if the pre-filled syringe is broken or the needle guard is activated. In all these cases, return the pack to the pharmacy.

How to use the Erelzi pre-filled syringe

Disposal instructions

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