50 mg solution for injection in a pre-filled pen 
etanercept (etanerceptum)

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

  • Save this leaflet, you may need to read it again.
  • Your doctor will also provide you with a patient card that contains important safety information that you must be aware of before and during treatment with Erelzi.
  • If you have any further questions, ask your doctor, pharmacist, or nurse.
  • This medicine has been prescribed for you personally or for your child. Do not give it to others. It can harm them, even if they show signs of illness similar to yours or your child’s.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

This leaflet contains information about: 
1. What Erelzi is and what it is used for 
2. What you need to know before you use Erelzi 
3. How to use Erelzi 
4. Possible side effects 
5. How to store Erelzi 
6. Contents of the packaging and other information 

1. What Erelzi is and what it is used for

Erelzi is a drug made from two human proteins. It binds to another protein that causes inflammation and blocks its activity. This blockage reduces the inflammation associated with the disease.

In adults (18 and older) can Erelzi used for moderate or severe rheumatoid arthritis, psoriatic arthritis, severe axial spondyloarthritis including ankylosing spondylitis, and moderate or severe psoriasis – most often used when other widely used treatments have not worked well enough or are not suitable for you.

Erelzi is usually used in combination with methotrexate to treat rheumatoid arthritis, but it can also be used as the only medicine if treatment with methotrexate is unsuitable for you. Whether Erelzi is used alone or in combination with methotrexate, Erelzi can slow down the damage to your joints caused by rheumatoid arthritis and improve your ability to perform daily activities.

For patients who have multiple joints affected by psoriatic arthritis, Erelzi may increase the ability to perform daily activities.

For patients with multiple symmetrical aching or swollen joints (eg hands, ankles, and feet), Erelzi may delay the breakdown of the joint surfaces.

Erelzi is also used to treat the following diseases in children and adolescents:

  • For the following types of childhood rheumatism ( juvenile idiopathic arthritis ), when treatment with methotrexate has not given sufficient results or is not appropriate:
    • Inflammation of many joints (polyarthritis) (rheumatoid factor positive or negative) and inflammation affecting 5 or more joints (enlarged oligoarthritis) in patients from 2 years of age weighing 62.5 kg or more.
    • Arthritis is associated with the skin disease psoriasis (psoriatic arthritis) in patients from the age of 12 weighing 62.5 kg or more.
  • For patients from the age of 12 years, weighing 62.5 kg or more, with musculoskeletal and tendinitis ( arthritis-related arthritis ) when other standard treatments have not given sufficient results or are not suitable.
  • Severe psoriasis in children and adolescents from 6 years of age weighing 62.5 kg or more and which has had the insufficient effect of (or which can not be treated with) light therapy or other systemic treatments (drugs that affect the whole body).

2. What you need to know before using Erelzi

Do not use Erelzi

  • if you or your child are hypersensitive (allergic) to etanercept or any of the other ingredients of Erelzi (listed in section 6). If you or your child have allergic reactions, such as shortness of breath, wheezing, dizziness, or rash, stop injecting Erelzi and contact your doctor immediately.
  • if you or your child have, or are at risk of developing, a serious infection in the blood called sepsis. If you are not sure, talk to your doctor.
  • if you or your child have an infection of any kind. If you are not sure, talk to your doctor.

Warnings and cautions

Talk to your doctor before using Erelzi.

  • Allergic reactions: If you or your child have allergic reactions, such as shortness of breath, wheezing, dizziness, or rash, stop injecting Erelzi and contact your or your child’s doctor immediately.
  • Infections/operations: If you or your child develops a new infection or is facing a major operation. Your doctor may then want to monitor your treatment with Erelzi.
  • Infections / Diabetes: Tell your doctor if you or your child have had a recurring infection or have diabetes or any other condition that increases the risk of infection.
  • Infections/follow-up: Tell your or your child’s doctor if you or your child have recently been traveling outside of Europe. If you or your child develops symptoms of an infection such as fever, chills, or cough, consult a doctor immediately. Your doctor may want to continue to monitor you for the presence of infection after you or your child has stopped taking Erelzi.
  • Tuberculosis: As cases of tuberculosis have been reported in patients treated with Erelzi, your doctor will examine to see if there are any signs of tuberculosis before starting treatment with Erelzi. This may include a thorough review of your medical history, a chest x-ray, and a tuberculin test. The results of these examinations must be entered on the patient card. You must tell your doctor if you or your child have ever had tuberculosis or had close contact with a person who has had tuberculosis. If symptoms of tuberculosis (eg persistent cough, weight loss, worsening of the general condition, or mild fever) or any other infection occurs during treatment, contact your doctor immediately.
  • Hepatitis B: Tell your doctor if you or your child have or have ever had hepatitis B. Your doctor should take a test for hepatitis B before you or your child start treatment with Erelzi. Treatment with Erelzi may result in the reactivation of hepatitis B in patients who have previously been infected with the hepatitis B virus. If this happens, treatment with Erelzi should be stopped.
  • Hepatitis C: Tell your doctor if you or your child have hepatitis C. Your doctor may want to check your treatment with Erelzi if the infection worsens.
  • Blood disorders: Seek immediate medical attention if you or your child have symptoms such as persistent fever, sore throat, bruising, bleeding, and/or paleness. Such symptoms may indicate a potentially life-threatening disorder of the blood picture, requiring discontinuation of Erelzi.
  • Nervous system and eye diseases: Tell your doctor if you or your child have multiple sclerosis, optic neuritis ( inflammation of the nerves in the eye), or transverse myelitis ( inflammation of the spinal cord). Your doctor will decide if Erelzi is the right treatment.
  • Heart failure: Tell your doctor if you or your child have a history of heart failure, as Erelzi must be used with caution in such circumstances.
  • Cancer: Tell your doctor if you have or have ever had lymphoma (a type of blood cancer) or any other type of cancer before you get Erelzi.
  • Patients with severe rheumatoid arthritis who have had the disease for a long time may have a higher-than-average risk of developing lymphoma.
  • Children and adults who use Erelzi may be at greater risk of developing lymphoma or other cancers. Some children and teens who have received Erelzi or other medicines that work similarly to Erelzi have developed cancer, including unusual types that sometimes lead to death. Some patients who have received Erelzi have developed skin cancer. Tell your doctor if you or your child develops any type of skin change or growth on the skin.
  • Chickenpox: Tell your doctor if you or your child have been exposed to chickenpox during treatment with Erelzi. Your doctor will decide if prophylactic treatment for chickenpox needs to be prescribed to you.
  • Alcohol abuse: Erelzi should not be used to treat hepatitis related to alcohol abuse. Tell your doctor if you or your 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. Talk to your or your child’s doctor if you or your child have Wegener’s granulomatosis 
  • Medicines for diabetes: Tell your doctor if you or your child have diabetes or are taking medicines to treat diabetes. Your doctor will decide if you or your child needs a smaller dose of the drug for diabetes during treatment with Erelzi.

Children and young people

Erelzi is not intended for use in children and adolescents weighing less than 62.5 kg.

  • Vaccinations: If possible, children should have received all vaccinations according to the vaccination program before starting treatment with Erelzi. Some vaccines, such as the oral polio vaccine, should not be taken while Erelzi is being treated. Check with your or your child’s doctor before you or your child receive any vaccination.
  • Inflammatory bowel disease (IBD): There have been cases of IBD in patients with juvenile idiopathic arthritis (JIA) treated with Erelzi. Tell your doctor if your child has abdominal pain or stomach cramps, diarrhea, weight loss, or blood in the stool.

Erelzi should not normally be used in children younger than 2 years or weighing less than 62.5 kg, with polyarthritis or enlarged oligoarthritis, or in children younger than 12 years, or weighing less than 62.5 kg, with enthesitis-related arthritis or psoriatic arthritis, or in children younger than 6 years, or weighing less than 62.5 kg, with psoriasis.

Other medicines and Erelzi

Tell your doctor or pharmacist if you or your child are taking, have recently taken, or might take any other medicines (including anakinra, abatacept, and sulfasalazine), including over-the-counter medicines. Do not use Erelzi at the same time as medicines containing anakinra or abatacept as an active substance.

Pregnancy and breastfeeding

Erelzi should only be used during pregnancy if clearly needed. Contact your doctor if you become pregnant, think you may be pregnant, or are planning to have a baby.

If you have had Erelzi during pregnancy, your baby may be at greater risk of getting an infection. In one study, more malformations were found when the mother had received etanercept during pregnancy, compared with mothers who had not received etanercept or other similar drugs ( TNF – antagonist), but no specific type of malformation was reported. Another study again found an increased risk of malformations when the mother had received etanercept during pregnancy. Your doctor will help you decide if the benefits of treatment outweigh the potential risk to your child. You must tell the infant’s doctor or another healthcare professional that Erelzi has been used during pregnancy before the infant receives any vaccination (for more information, see section 2, “Vaccinations”).

You should not breast-feed while using Erelzi as Erelzi will pass into breast milk.

Driving and using machines

The use of Erelzi is not expected to affect your ability to drive or use machines.

Erelzi contains sodium

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

3. How to use Erelzi

Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

If you have the impression that the effect of Erelzi is too strong or too weak, talk to your doctor or pharmacist.

You have been prescribed Erelzi in a strength of 50 mg. Erelzi is available in 25 mg strengths for doses of 25 mg.

Use in adult patients (over 18 years of age)

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

The recommended dose is 25 mg twice a week or 50 mg once a week as an injection under the skin. Your doctor may determine a different frequency for your injections.

Plaque psoriasis

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

Alternatively, 50 mg can be given twice a week for up to 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 the resumption of treatment is needed based on the treatment results. If Erelzi has not had any effect on your condition after 12 weeks, your doctor may ask you to stop treatment.

Use for children and adolescents

The appropriate dose and how often it should be given to your child or adolescent depends on body weight and illness. The doctor determines the correct dose for the child and prescribes etanercept with appropriate strength. Pediatric patients weighing 62.5 kg or more may be given 25 mg twice a week or 50 mg once a week with a fixed-dose in a pre-filled syringe or pre-filled pen.

Other etanercept preparations with suitable dosage forms for children are available.

For patients from 2 years of age weighing 62.5 kg or more, with polyarthritis or enlarged oligoarthritis, or for patients from 12 years of age weighing 62.5 kg or more, with enthesitis-related arthritis or psoriatic arthritis, the usual dose is one 25 mg twice a week or 50 mg once a week.

For patients from 6 years of age with psoriasis weighing 62.5 kg or more, the usual dose is 50 mg once a week. If Erelzi does not show any effect after 12 weeks, your doctor may ask you to stop treatment with this medicine.

Your doctor will provide you with detailed instructions for preparing and measuring the correct dose.

Method and route of delivery

Erelzi is injected under the skin (via subcutaneous injection ).

Erelzi can be taken with or without food or drink.

Detailed instructions on how to inject Erelzi can be found in section 7 “Instructions for using the Erelzi SensoReady pen”.

Do not mix the Erelzi solution with any other medicine.

To make it easier for you to remember, it can be helpful to write in a calendar which days of the week Erelzi should be taken.

If you take more Erelzi than you should

If you have injected more Erelzi than your doctor prescribed (either by injecting too much at one time or taking one dose too much) you should contact your doctor or pharmacist immediately. Always carry the labeled outer packaging of the medicine, even if it is empty.

If you forget to take Erelzi

If you miss a dose, you should inject one as soon as you remember, unless the next scheduled dose is to be taken the next day, then skip the missed dose. Then continue to inject the medicine on the usual scheduled day. If you do not remember a dose until the day of the usual injection, do not take a double dose (two doses on the same day) to make up for a forgotten dose.

If you stop using Erelzi

Your symptoms may return if treatment is stopped.

If you have any further questions on the use of this product, ask 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 symptoms occur, do not inject more Erelzi without contacting your or your child’s doctor or the emergency department at the nearest hospital.

  • Difficulty swallowing or breathing
  • Swelling of the face, neck, hands, or feet
  • Feeling of nervousness or anxiety, throbbing sensation, sudden redness of the skin with or without feeling hot
  • Severe rash, itching, or hives (red spots or pale skin that often itches)

Severe allergic reactions are rare, but one or more of the above symptoms may indicate an allergic reaction caused by Erelzi and medical attention should be sought immediately.

Serious side effects are

If you or your child observes any of the following symptoms, seek medical attention immediately.

  • Symptoms of a serious infection, such as a high fever that may be associated with coughing, difficulty breathing, feeling weak, or a hot, red, and tense surface in the skin or at a joint.
  • Symptoms of any blood disease, such as bleeding, bruising, or pallor.
  • Symptoms of any neurological disease, such as loss of sensation and a stinging sensation, changes in vision, or muscle weakness in the arms or legs.
  • Symptoms of heart failure or worsening heart failure, such as fatigue or difficulty breathing during exertion, swollen ankles, a feeling of swollen neck and abdomen, difficulty breathing at night, coughing, or bluish color on nails or lips.
  • Symptoms of cancer: cancer can affect all parts of the body, including the skin and blood, and the symptoms depend on the type of cancer and its location. These symptoms may include weight loss, fever, swelling (with or without pain), persistent cough, lumps, or growths on the skin.
  • Symptoms of autoimmune reactions (when antibodies are formed that can damage the body’s normal tissues ) such as pain, itching, weakness, abnormal breathing, thoughts, sensation,s or vision.
  • Symptoms of inflammatory bowel disease (lupus) or lupus-like syndromes such as weight change, persistent rash, fever, joint or muscle aches, or fatigue.
  • Symptoms of inflammation of the blood vessels such as pain, fever, redness or feeling of warmth in the skin, or itching.

These are rare or unusual side effects, but serious (some of them can be fatal). If these signs occur, contact your or your child’s physician or the emergency department of the nearest hospital immediately.

Known side effects of Erelzi are as follows, divided into groups according to decreasing frequency:

  • Very common (may affect more than 1 user in 10): Infections, including upper respiratory tract infections, bronchitis, urinary tract infections, skin infections, injection site reactions including bleeding, bruising, redness, itching, pain, swelling. Injection site reactions (these often subside after the first month of treatment). Some patients develop a reaction at an injection site that has been used before.
  • Common (may affect up to 1 in 10 people): Allergic reactions, fever, rash, itching, antibody are directed against normal tissue(autoantibody formation).
  • Less common (may affect up to 1 in 100): Serious infections (including pneumonia, deep skin infections, joint infections, blood infections, and infections in various places), worsening heart failure, low red blood cell count, low white blood cell count, low neutrophil count (a type of white blood cell count ), low platelet count, skin cancer (excluding melanoma ), local swelling of the skin ( angioedema ), hives (red spots or pale skin that often itches), eye inflammation, psoriasis (new onset or worsening), inflammation in the blood vessels that can affect several organs, elevated liver values ​​in blood tests (in patients who also receive methotrexate, the frequency of elevated liver values ​​is “normal”), cramps and pain in the stomach, diarrhea, weight loss or blood in the stool (signs of intestinal disease).
  • Rare (may affect up to 1 in 1,000 people) :Severe allergic reactions (including severe local swelling of the skin and wheezing), lymphoma (a type of blood cancer), leukemia (cancer affecting the blood and bone marrow ), melanoma (a type of skin cancer), a combination of low platelet counts , redness and white blood cells , effects on the nervous system (with severe muscle weakness and signs and symptoms similar to those of multiple sclerosis or inflammation of the nerves or spinal cord of the eye), tuberculosis , new onset of worsening heart failure, seizures, lupus or lupus-like symptoms (symptoms include persistent rash, fever, joint pain and fatigue), skin rash that may lead to severe blistering and flaking of the skin, lichenoid reactions (itchy red-purple skin rash and / or thread-like white-gray lines on mucous membranes ), inflammationof the liver caused by the body’s own immune system ( autoimmune hepatitis , in patients who also received treatment with methotrexate the frequency is “less common”), immune disease that can affect the lungs, skin and lymph nodes ( sarcoidosis ), inflammation or fibrosis of the lungs (in patients who also received methotrexate treatment, the frequency is “less common”).
  • Very rare (may affect up to 1 in 10,000 people): Inability of bone marrow to produce blood cells ( aplastic anemia ).
  • No known frequency (cannot be calculated from the available data): Merkel cell cancer (a type of skin cancer), overactivation of white blood cells associated with inflammation (macrophage activation syndrome), reactivation of hepatitis B (a liver infection), worsening of a condition called dermatomyositis(muscle inflammation and weakness accompanied by skin rash)).

Additional side effects in children and adolescents

Side effects and frequency of side effects in children and adolescents are the same as in adults, see the description above.

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 which is stated on the carton and label it on the pre-filled SensoReady pen after EXP. The expiration date is the last day of the specified month.

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

Store the pre-filled pens in the outer carton. Sensitive to light.

After removing Erelzi from the refrigerator, wait approximately 15-30 minutes for the Erelzi solution in the pen to reach room temperature. Do not heat Erelzi in any other way. Thereafter, immediate use is recommended.

Erelzi can be stored outside the refrigerator at temperatures up to a maximum of 25 ° C for a single period of up to four weeks, after which it should not be stored in the refrigerator again. Erelzi should be discarded if not used within four weeks of removal from the refrigerator. It is recommended that you note the date that Erelzi is removed from the refrigerator and the date when Erelzi is to be discarded (no longer than 4 weeks after removal from the refrigerator).

Inspect the solution in the pen through the clear window. The solution should be clear or slightly opalescent, colorless to slightly yellowish, and may contain small white or almost transparent particles of protein. This appearance is normal for Erelzi. Do not use the solution if it is discolored, cloudy or if particles other than those described above occur. If you have any further questions on the use of this solution, ask your pharmacist for help.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

The active substance is etanercept.

Each pre-filled pen contains 50 mg etanercept.

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

What the medicine looks like and the contents of the pack

Erelzi was delivered as an injection solution in a pre-filled pen (SensoReady). The SensoReady pen contains a clear or slightly opalescent, colorless to slightly yellowish solution for injection ( injection ). Each pack contains 1, 2, or 4 pens, multi-pack contains 12 (3 packs of 4) pre-filled pens. Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Sandoz GmbH

Biochemistry. 10

A ‑ 6250 Kundl

Austria

Manufacturer

Sandoz GmbH Schaftenau

Biochemiestr. 10

A ‑ 6336 Langkampfen

Austria

Muhammad Nadeem

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