Erelzi 50 mg solution for injection in pre-filled pen
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Erelzi 50mg solution for injection in pre-filled pen
etanercept
Read the entire leaflet carefully before you start using this medicine, as it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- Your doctor will also provide you with a Patient Information Card, which contains important safety information you need to know 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 under your care and must not be given to other people, even if they have the same symptoms as you or the child under your care, as it may harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
Contents of the leaflet:
- What Erelzi is and what it is used for
- What you need to know before using Erelzi
- How to use Erelzi
- Possible side effects
- How to store Erelzi
- Contents of the pack and other information
- Instructions for using Erelzi in the 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 in the body that causes inflammation. Erelzi works by reducing the inflammation associated with certain diseases.
Erelzi can be used in adults aged 18 years and older for the treatment of moderate to severe rheumatoid arthritis, psoriatic arthritis, severe axial spondyloarthritis, including ankylosing spondylitis, and moderate to severe psoriasis, usually depending on the individual case, when other treatments have not been sufficiently effective or are not suitable for you.
In the treatment of rheumatoid arthritis, Erelzi is usually used in combination with methotrexate, although it may also be used alone if treatment with methotrexate is not suitable for you. Erelzi can slow down the joint damage caused by rheumatoid arthritis and improve your ability to perform daily activities, whether used alone or in combination with methotrexate.
In patients with psoriatic arthritis involving multiple joints, Erelzi can improve your ability to carry out normal daily activities.
In patients with multiple swollen or painful symmetric 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 treatment in children and adolescents with the following conditions:
- For the following types of juvenile idiopathic arthritis when treatment with methotrexate has not worked adequately or is not suitable:
- Polyarthritis (rheumatoid factor positive or negative) and extended oligoarthritis in patients aged 2 years and older with a body weight of at least 62.5 kg.
- Psoriatic arthritis in patients aged 12 years and older with a body weight of at least 62.5 kg.
- For enthesitis-related arthritis in patients aged 12 years and older with a body weight of at least 62.5 kg, when other commonly used treatments have not worked adequately or are not suitable for them.
- Severe psoriasis in patients aged 6 years and older with a body weight of at least 62.5 kg who have had an inadequate response to (or are unable to take) phototherapies or other systemic therapies.
2. What you need to know before using Erelzi
Do not use Erelzi
- if you or the child in your care are allergic to etanercept or any of the other components of Erelzi (listed in section 6). If you or the child experience allergic reactions such as chest tightness, wheezing, dizziness, or rash, do not inject any more Erelzi and contact your doctor immediately.
- if you or the child have or are at risk of developing a serious blood infection called sepsis. If you are unsure, consult your doctor.
- if you or the child have an infection of any type. If you are unsure, consult your doctor.
Warnings and precautions
Talk to your doctor before starting to use Erelzi.
•Allergic reactions: If you or the child experience allergic reactions such as chest tightness, wheezing, dizziness, or rash, do not inject any more Erelzi and contact your doctor immediately.
•Infections/surgery: If you or the child develop a new infection or are about to undergo major surgery, your doctor may consider monitoring or adjusting treatment with Erelzi.
•Infections/diabetes: Inform your doctor if you or the child have a history of recurrent infections or if you have diabetes or other disorders that increase the risk of infection.
•Infections/monitoring: Inform your doctor about any recent travel outside the European region. If you or the child develop symptoms of an infection such as fever, chills, or cough, notify your doctor immediately. Your doctor should decide whether continued monitoring for infections is needed even after you or the child stop treatment with Erelzi.
•Tuberculosis: Cases of tuberculosis have been reported in patients treated with Erelzi. Your doctor will examine for signs and symptoms of tuberculosis before starting Erelzi. This may include a thorough medical history, chest X-ray, and a tuberculosis test. Completion of these assessments must be recorded on the Patient Information Card. It is very important to tell your doctor if you or the child have had tuberculosis or have been in close contact with someone who has had tuberculosis. If symptoms of tuberculosis (such as persistent cough, weight loss, fatigue, 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 should test for hepatitis B before you or the child start treatment with Erelzi. Treatment with Erelzi may reactivate hepatitis B in patients previously infected with the hepatitis B virus. If this occurs, you must stop using Erelzi.
•Hepatitis C: Inform your doctor if you or the child have hepatitis C. Your doctor may want to monitor treatment with Erelzi in case the infection worsens.
•Blood disorders: Immediately inform your doctor if you or the child have signs or symptoms such as persistent fever, sore throat, bruising, bleeding, or paleness. These symptoms may indicate a serious blood disorder that may require discontinuation of Erelzi treatment.
•Nervous system and vision disorders: Inform your doctor if you or the child have multiple sclerosis, optic neuritis (inflammation of the optic nerves), or transverse myelitis (inflammation of the spinal cord). Your doctor will decide whether Erelzi is an appropriate treatment.
•Congestive heart failure: Inform your doctor if you or the child have a history of congestive heart failure, as Erelzi must be used with caution in such cases.
•Cancer: Inform your doctor if you have or have had lymphoma (a type of blood cancer) or any other cancer before receiving Erelzi.
Patients with severe rheumatoid arthritis who have had the disease for a long time may have a higher than average risk of developing lymphoma.
Children and adults taking Erelzi may have an increased risk of developing lymphoma or other cancers.
Some adolescent and pediatric patients who have received Erelzi or other medicines that work similarly to Erelzi have developed cancers, including unusual types, which sometimes resulted in death.
Some patients receiving Erelzi have developed skin cancers. Inform your doctor if you or the child develop any changes in the appearance of the skin or skin growths.
•Chickenpox: Inform your doctor if you or the child are exposed to chickenpox while using Erelzi. Your doctor will determine whether preventive treatment for chickenpox is appropriate.
•Alcoholism: Erelzi should not be used to treat hepatitis related to alcoholism. Please inform your doctor if you or the child in your care have a history of alcoholism.
•Wegener’s granulomatosis: Erelzi is not recommended for the treatment of Wegener’s granulomatosis, a rare inflammatory disease. If you or the child in your care have Wegener’s granulomatosis, discuss this with your doctor.
•Antidiabetic medicines: Inform your doctor if you or the child have diabetes or are taking medicines to treat diabetes. Your doctor may decide that you or the child need a lower dose of antidiabetic medicine while using Erelzi.
Children and adolescents
The use of Erelzi is not indicated in children and adolescents weighing less than 62.5 kg.
•Vaccinations: Whenever possible, children should be up to date with all vaccinations before starting Erelzi. Some vaccines, such as oral polio vaccine, should not be administered while using Erelzi. Consult your doctor before you or the child receive any vaccine.
Erelzi is generally not to be used in children under 2 years of age or weighing less than 62.5 kg with polyarticular juvenile idiopathic arthritis or extended oligoarticular juvenile idiopathic arthritis, in children under 12 years of age or weighing less than 62.5 kg with enthesitis-related arthritis or psoriatic arthritis, or in children under 6 years of age or weighing less than 62.5 kg with psoriasis.
Other medicines and Erelzi
Inform your doctor or pharmacist if you or the child are taking, have recently taken, or might need to take any other medicines (including anakinra, abatacept, or sulfasalazine), even those not prescribed by your doctor.
You or the child must not use Erelzi together with medicines containing the active substances anakinra or abatacept.
Pregnancy and breastfeeding
Erelzi should only be used during pregnancy if clearly necessary. Consult your doctor if you are pregnant, think you might be pregnant, or plan to become pregnant.
If you have received Erelzi during pregnancy, your baby may have an increased risk of developing an infection. In addition, one study reported more birth defects when mothers had received etanercept during pregnancy compared to mothers who did not receive etanercept or other similar medicines (TNF antagonists), but there was no consistent pattern in the types of birth defects reported. Another study found no increased risk of congenital malformations when mothers received Erelzi during pregnancy. Your doctor will help you decide whether the benefits of treatment outweigh the potential risks to your baby.
Consult your doctor if you wish to breastfeed while being treated with Erelzi. It is important to inform the pediatrician and other healthcare professionals about the use of Erelzi during pregnancy and breastfeeding before your baby receives any vaccine.
Driving and using machines
Erelzi is not expected to affect the ability to drive or use machines.
Erelzi contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per 50 mg; essentially “sodium-free”.
3. How to use Erelzi
Follow exactly the instructions for administering this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.
If you think that the effect of Erelzi is too strong or too weak, tell your doctor or pharmacist.
You have been prescribed the 50 mg presentation of Erelzi. A 25 mg presentation 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 a week or 50 mg administered once a week, as a subcutaneous injection. However, your doctor may determine an alternative frequency for administering 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 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 whether treatment should be repeated based on your response. If Erelzi has no effect on your disease after 12 weeks, your doctor may instruct you to stop using this medicine.
Use in children and adolescents
The appropriate dose and dosing frequency will depend on the child's or adolescent's body weight and condition. Your doctor will determine the appropriate dose for the child and prescribe the most suitable etanercept formulation. Pediatric 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 single-dose prefilled syringe or prefilled pen.
Other etanercept medicines with doses appropriate for children are available.
For polyarticular or extended oligoarticular juvenile idiopathic arthritis in patients aged 2 years and older weighing 62.5 kg or more, or for enthesitis-related arthritis or psoriatic arthritis in patients aged 12 years and older weighing 62.5 kg or more, the usual dose is 25 mg twice a week or 50 mg once a week.
For psoriasis in patients aged 6 years and older 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 medicine.
Your doctor will provide precise instructions for preparing and calculating the correct dose.
Method and route of administration
Erelzi is administered by subcutaneous injection (injection under the skin).
Detailed instructions for injecting Erelzi are provided in section 7, “Instructions for use of Erelzi in the prefilled pen”.
The Erelzi solution must not be mixed with any other medicine.
To help you remember, it may be useful to write down 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 larger amount at one time or by using it too frequently), you should speak to a doctor or pharmacist immediately.
Always keep the medicine carton with you, even if it is empty.
If you forget to inject Erelzi
If you miss a dose, you should inject it as soon as you remember, unless the next dose is scheduled for the following day, in which case you should skip the missed dose. Then continue injecting the medicine on your usual day(s). If you do not remember until the day you are due to administer the next dose, do not inject a double dose (two doses on the same day) to make up for the missed dose.
If you stop using Erelzi
Your symptoms may return after stopping treatment.
If you have any further questions about how to use this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Allergic reactions
If you notice any of the following reactions, do not inject any more Erelzi. Contact your doctor immediately or go to the nearest hospital Emergency Department.
- Difficulty swallowing or breathing.
- Swelling of the face, throat, hands, and feet.
- Feeling nervous or anxious, palpitations, sudden redness of the skin and/or sensation of warmth.
- Severe rash, itching, or hives (prominent, red or pale welts on the skin, often accompanied by itching).
Severe allergic reactions are rare. However, any of the above symptoms may indicate an allergic reaction to Erelzi, so you must seek immediate medical attention.
Serious adverse effects
If you notice any of the following effects, you or the child may require urgent medical attention.
- Signs of serious infections, such as high fever which may be accompanied by cough, shortness of breath, chills, weakness, or a painful, tender, red and warm area on the skin or joints.
- Signs of blood disorders, such as bleeding, bruising, or paleness.
- Signs of nervous system disorders, such as numbness or tingling, changes in vision, eye pain, or sudden weakness in an arm or leg.
- Signs of heart failure or worsening heart failure, such as fatigue or shortness of breath during activity, swelling of the ankles, feeling of fullness in the neck or abdomen, shortness of breath at night or cough, bluish coloration of the nails or around the lips.
- Signs of cancer: cancer can affect any part of the body including the skin and blood, and possible signs depend on the type and location of the cancer. These signs may include weight loss, fever, swelling (with or without pain), persistent cough, or presence of lumps or thickening in the skin.
- Signs of autoimmune reactions (in which antibodies develop that may damage normal body tissues), such as pain, itching, weakness, and abnormal breathing, thinking, sensation, or vision.
- Signs of lupus or lupus-like syndrome, such as weight changes, persistent rash, fever, muscle or joint pain, or fatigue.
- Signs of inflammation of blood vessels, such as pain, fever, redness or warmth of the skin, or itching.
These adverse effects are rare or uncommon, but they are serious conditions (some of which, rarely, may be fatal). If any of these signs occur, inform your doctor immediately or go to the nearest hospital Emergency Department.
The following is a list of known adverse effects of Erelzi, grouped in decreasing order of frequency:
• Very common (may affect more than 1 in 10 people):
Infections (including colds, sinusitis, bronchitis, urinary tract infections, and skin infections); injection site reactions (including bleeding, bruising, redness, itching, pain, and swelling) occur less frequently after the first month of treatment; some patients have developed injection site reactions at sites they had recently used.
• Common (may affect up to 1 in 10 people):
Allergic reactions; fever; rash; itching; antibodies directed against normal tissues (formation of autoantibodies).
• Uncommon (may affect up to 1 in 100 people):
Serious infections (including pneumonia, non-superficial skin infections, joint infections, blood infection, and systemic infections); worsening of congestive heart failure; low red blood cell count, low white blood cell count, low neutrophil count (a type of white blood cell); low platelet count; skin cancer (excluding melanoma); localized swelling of the skin (angioedema); hives (prominent, red or pale welts on the skin, 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, increased liver enzymes are common); abdominal cramps and pain, diarrhea, weight loss, or blood in stools (signs of intestinal problems).
• Rare (may affect up to 1 in 1,000 people):
Severe allergic reactions (including severe localized skin swelling and wheezing); lymphoma (a type of blood cancer); leukemia (cancer affecting blood and bone marrow); melanoma (a type of skin cancer); combined low counts of red blood cells, white blood cells, and platelets; nervous system disorders (with severe muscle weakness and signs and symptoms similar to multiple sclerosis or inflammation of the optic nerves or spinal cord); tuberculosis; new onset or worsening of congestive heart failure; seizures; lupus or lupus-like syndrome (symptoms may include persistent rash, fever, joint pain, and fatigue); skin rash that may lead to severe blistering and peeling of the skin; lichenoid reactions (itchy, reddish-purple rash and/or thick white-grey lines on mucous membranes); liver inflammation caused by the immune system (autoimmune hepatitis; in patients also receiving methotrexate, this is uncommon); an immune disorder that may affect the lungs, skin, and lymph nodes (sarcoidosis); lung inflammation or scarring (in patients also receiving methotrexate, the frequency of lung inflammation or scarring is uncommon).
• Very rare (may affect up to 1 in 10,000 people):
Failure of the bone marrow to produce essential blood cells.
• Frequency not known (cannot be estimated from available data):
Merkel cell carcinoma (a type of skin cancer); excessive activation of white blood cells associated with inflammation (macrophage activation syndrome); reactivation of hepatitis B (a liver infection); damage to the small filters in the kidneys leading to impaired kidney function (glomerulonephritis); worsening of a condition called dermatomyositis (inflammation and weakness of muscles accompanied by skin rash).
Other adverse effects in children and adolescents
Adverse effects observed in children and adolescents, as well as their frequencies, are similar to those described above.
Reporting of adverse effects
If you experience any adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system listed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Erelzi
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging and on the pre-filled pen label after “CAD”/“EXP”. The expiry date refers to the last day of the month indicated.
Store in a refrigerator (2 °C – 8 °C). Do not freeze.
Keep the pre-filled pens in their outer packaging to protect them from light.
After removing the pre-filled pen from the refrigerator, wait approximately 15–30 minutes for the Erelzi solution to reach room temperature. Do not heat it in any other way. Immediate use is then recommended.
Erelzi may be stored outside the refrigerator at a maximum temperature of 25 °C for a single period of up to 4 weeks; after this time, the medicine must not be refrigerated again. Erelzi must be discarded if not used within 4 weeks of removal from the refrigerator. It is advisable to record the date when Erelzi was removed from the refrigerator and the date after which Erelzi must be discarded (no more than 4 weeks after removal from the refrigerator packaging).
Inspect the solution in the pen by looking through the transparent inspection window. The solution should be transparent or slightly opalescent, colourless 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 discoloured or cloudy, or if it contains particles different from those described above. If you have concerns about the appearance of the solution, contact your pharmacist for assistance.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Erelzi
The active substance is etanercept.
Each pre-filled 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.
Presentation of the product and contents of the container
Erelzi is presented as an injectable solution in a pre-filled pen. The pre-filled pen contains a clear or slightly opalescent, colourless to slightly yellowish injectable solution (injection). The pre-filled syringes are made of Type I glass, a rubber plunger stopper (bromobutyl rubber), a plunger rod, a 29-gauge stainless steel needle, and a needle cap (thermoplastic elastomer). Each pack contains 1, 2 or 4 pens; multiple packs contain 12 (3 packs of 4) pens.
Only certain pack sizes may be marketed.
Marketing Authorization Holder
Sandoz GmbH
Biochemiestrasse 10
6250 Kundl
Austria
Manufacturer
Sandoz GmbH Schaftenau
Biochemiestrasse 10
6336 Langkampfen
Austria
Novartis Pharmaceutical Manufacturing GmbH
Biochemiestrasse 10
6336 Langkampfen
Austria
For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:
Belgium/Belgium/Belgium Sandoz nv/sa Tel/Tel: +32 2 722 97 97 | Lithuania Sandoz Pharmaceuticals d.d. branch Tel: +370 5 2636 037 |
| Luxembourg/Luxembourg Sandoz nv/sa (Belgium/Belgium) Tel/Tel: +32 2 722 97 97 |
Czech Republic Sandoz s.r.o. Tel: +420 234 142 222 | Hungary Sandoz Hungária Kft. Tel.: +36 1 430 2890 |
Denmark/Norway/Iceland/Sweden Sandoz A/S Tlf/Sími/Tel: +45 63 95 10 00 | Malta Sandoz Pharmaceuticals d.d. Tel: +35699644126 |
Germany Hexal AG Tel: +49 8024 908 0 | Netherlands Sandoz B.V. Tel: +31 36 52 41 600 |
Estonia Sandoz d.d. Estonian branch Tel: +372 665 2400 | Austria Sandoz GmbH Tel: +43 5338 2000 |
Greece SANDOZ HELLAS MONOPROSOPHI S.A. Tel: +30 216 600 5000 | Poland Sandoz Polska Sp. z o.o. Tel.: +48 22 209 70 00 |
Spain Sandoz Farmacéutica, S.A. Tel: +34 900 456 856 | Portugal Sandoz Farmacêutica Lda. Tel: +351 21 000 86 00 |
France Sandoz SAS Tél: +33 1 49 64 48 00 | Romania Sandoz Pharmaceuticals SRL Tel: +40 21 407 51 60 |
Croatia Sandoz d.o.o. Tel: +385 1 23 53 111 | Slovenia Sandoz farmacevtska družba d.d. Tel: +386 1 580 21 11 |
Ireland Rowex Ltd. Tel: +353 27 50077 | Slovak Republic Sandoz d.d. - organizational unit Tel: +421 2 48 20 0600 |
Italy Sandoz S.p.A. Tel: +39 02 81280696 | Finland/Finland Sandoz A/S Puh/Tel: +358 10 6133 400 |
Cyprus Sandoz Pharmaceuticals d.d. (Greece) Tel: +357 22 69 0690 | United Kingdom (Northern Ireland) Sandoz GmbH Tel: +43 5338 2000 |
Latvia Sandoz d.d. Latvia branch Tel: +371 67 892 006 |
Date of the most recent review of this leaflet:
Detailed information about this medicine is available on the website of the European Medicines Agency: http://www.ema.europa.eu.
- Instructions for use of Erelzi in prefilled pen
| READ ALL INSTRUCTIONS BEFORE INJECTING THE MEDICATION These instructions will help you properly administer Erelzi with the SensoReady pen. It is important that you do not attempt to inject the medication until your doctor, nurse, or pharmacist has shown you how to do it. |
Your Erelzi pre-filled pen:
Erelzi in prefilled pen without cap. Do not remove the cap until you are ready to administer the injection. | Store the carton with the pen in the refrigerator at 2°C to 8°C and out of sight and reach of children.
For a more comfortable injection, remove the pen from the refrigerator 15–30 minutes before administration to allow it to reach room temperature. |
What else you need for the injection:
Contents in the box: New, unused Erelzi pre-filled pen. | Not included in the box:
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Before injection:
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The solution should be clear or slightly opalescent, colorless to slightly yellowish, and may contain small particles of white or nearly translucent proteins. This is the normal appearance of Erelzi. Do not use if the liquid is cloudy, discolored, or contains large clumps, flakes, or colored particles. Do not use the pen if the expiry date has passed. Do not use if the safety seal is broken. Contact your pharmacist if the pen does not meet any of these requirements. |
| 2a. Choose an injection site:
You may also use the lower abdomen, but not within a 5 cm radius around the navel.
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| 2b. For caregivers or healthcare professionals only:
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The injection:
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Correct Incorrect |
| YOU SHOULD READ THE FOLLOWING BEFORE INJECTING. During the injection, you will hear 2 loud clicks. The 1st click indicates the start of the injection. A few seconds later, the 2nd click indicates that the injection is about to finish. Keep the pen firmly pressed against the skin until the green indicator fills the window and has stopped moving. |
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After the injection:
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If you have any questions, consult a doctor, nurse, or pharmacist who is familiar with Erelzi.