Product Information for the User

Erelzi 50mg pre-filled syringe solution

etanercept

Read this entire product information carefully before starting to use this medication, as it contains important information for you.

•Keep this product information, 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 product information. 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 Erelzi pre-filled syringe

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 can 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 can also be used as a single medication, in the case where methotrexate treatment is not suitable for you. Erelzi can slow down 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 can 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 can 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 methotrexate treatment 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.

Do not use Erelzi

•If you or the child in your care areallergic to etanerceptor to any of the 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 with 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 may 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 experience 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 higher risk of developing lymphoma.

Children and adolescents taking Erelzi may be at increased risk of developing lymphoma or other cancers.

Some patients, 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, inform 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 children and adolescents with a weight below 62.5 kg.

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

Normally, Erelzi should not be used in children under 2 years or with a weight below 62.5 kg with polyarthritis or oligoarthritis, in children under 12 years or with a weight below 62.5 kg with arthritis related to enthesitis or psoriatic arthritis, or in children under 6 years or with a weight below 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 increased risk of infection. Additionally, in a 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 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.

You have been prescribed a 50 mg presentation of Erelzi. A 25 mg presentation of Erelzi is available for 25 mg doses.

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 at which to inject 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 pre-filled pen with a fixed dose.

Other etanercept medications with suitable doses for children are available.

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.

See section 7, “Instructions for use of Erelzi in pre-filled pen”, for detailed instructions for injecting Erelzi.

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

To help you remember, it may be helpful 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 at one time 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 scheduled for 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 questions 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 of the skin or joints.

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

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

•Signs of heart failure orworsening 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 of 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) do not occur as frequently after the first month of treatment; some patients have developed a reaction at the injection site that they had recently used.

•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 that affects the blood and bone marrow);melanoma (a type of skin cancer); combined low red blood cell, white blood cell, and platelet count; neurological disorders (with severe muscle weakness and signs and symptoms similar to multiple sclerosis or inflammation of the optic nerves or spinal cord); tuberculosis; worsening of 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 (inflammation of the liver caused by the immune system); immunological 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 inflammation or scarring of the lungs 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 pen label after “CAD”/”EXP”. The expiration date is the last day of the month indicated.

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

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

After removing the pre-filled pen 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 after 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 of the pen by looking through the transparent inspection window. The solution must 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 away through the drains or in the trash. Ask your pharmacist how to dispose of the packaging and the 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 50 mg of etanercept.

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

Appearance of the product and contents of the pack

Erelzi is presented as a ready-to-use injection in a pre-filled syringe. The pre-filled syringe contains a transparent or slightly opalescent, colorless to slightly yellowish solution.The pre-filled syringes are made of type I glass, a rubber stopper (bromobutyl rubber), a plunger rod, a stainless steel needle of caliber 29, and a needle cap (thermoplastic elastomer).Each pack contains 1, 2, or 4 syringes; the multiple packs contain 12 (3 packs of 4) syringes.

Only some pack sizes may be marketed.

Marketing Authorization Holder

Sandoz GmbHBiochemiestrasse 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 medicine, please contact the local representative of the marketing authorization holder:

Date of the last revision of this leaflet:{MM/AAAA}

For more detailed information about this medicine, please visit the website of the European Medicines Agency:http://www.ema.europa.eu.

7.Instructions for use of Erelzi in a pre-filled syringe

Your Erelzi in a pre-filled syringe:

What else you need for the injection:

Before the injection:

The injection:

After the injection:

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