25 mg injection solution in a prefilled pen
Read all of this leaflet carefully (both sides) 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 you start and during treatment with Enbrel.
– 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 Enbrel is and what it is used for
2. What you need to know before you use Enbrel
3. How to use Enbrel
4. Possible side effects
5. How to store Enbrel
6. Contents of the packaging and other information
1. What Enbrel is and what it is used for
Enbrel 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 years and older), Enbrel can be used for moderate or severe rheumatoid arthritis, psoriatic arthritis, severe axial spondylarthritis including ankylosing spondylitis, and moderate or severe psoriasis – usually when other commonly used treatments have not worked well enough or are inappropriate for you.
Enbrel 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 Enbrel is used as a single medicine or in combination with methotrexate, Enbrel 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, Enbrel may increase the ability to perform daily activities. For patients with multiple symmetrical aching or swollen joints (eg hands, ankles, and feet), Enbrel may delay the breakdown of joint surfaces.
Enbrel 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.
- Arthritis is associated with the skin disease psoriasis (psoriatic arthritis) in patients from 12 years of age.
- For patients from the age of 12 with musculoskeletal and tendonitis (enthesitis-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 who have had an insufficient effect of (or who cannot be treated with) light therapy or other systemic treatments (drugs that affect the whole body).
2. What you need to know before you use Enbrel
Do not use Enbrel
- if you or your child are hypersensitive (allergic) to etanercept or any of the other ingredients of Enbrel (listed in section 6). If you or your child have allergic reactions, such as shortness of breath, wheezing, dizziness, or rash, stop injecting Enbrel 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, contact your or your child’s 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 Enbrel.
- Allergic reactions: If you or your child have allergic reactions, such as shortness of breath, wheezing, dizziness, or rash, stop injecting Enbrel 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 Enbrel.
- Infections / Diabetes: Tell your or your child’s doctor if you or your child has had a recurrent infection or has 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 Enbrel.
- Tuberculosis: As cases of tuberculosis have been reported in patients treated with Enbrel, your doctor will examine to see if there are any signs of tuberculosis before starting treatment with Enbrel. 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 occur 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 test for hepatitis B before you or your child start treatment with Enbrel. Treatment with Enbrel 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 Enbrel 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 Enbrel 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, which requires discontinuation of Enbrel.
- 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 Enbrel is the right treatment.
- Heart failure: Tell your doctor if you or your child have a history of heart failure, as Enbrel 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 taking Enbrel. 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 Enbrel may be at greater risk of developing lymphoma or other cancers. Some children and teens who have received Enbrel or other medicines that work in a similar way to Enbrel have developed cancer, including unusual types that sometimes lead to death. Some patients who have received Enbrel 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 Enbrel. Your doctor will decide if prophylactic treatment for chickenpox needs to be prescribed to you.
- Latex: The needle cover on the MYCLIC pen is made of latex (dry natural rubber). Contact your doctor before using Enbrel if the needle guard will be handled by, or Enbrel is given to, someone with a known or possible hypersensitivity ( allergy ) to latex.
- Alcohol abuse: Enbrel should not be used for the treatment of hepatitis-related to alcohol abuse. Tell your doctor if you or your child have a history of alcohol abuse.
- Wegener’s granulomatosis: Enbrel 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 Enbrel.
Children and young people
- Vaccinations: If possible, children should have received all vaccinations according to the vaccination program before starting treatment with Enbrel. Some vaccines, such as the oral polio vaccine, should not be taken while taking Enbrel. Check with your or your child’s doctor before you or your child receive any vaccination.
Enbrel should not normally be used in children under 2 years of age with polyarthritis or extended oligoarthritis, or children under 12 years of age with encephalitis-related arthritis or psoriatic arthritis, or children under 6 years of age with psoriasis.
Other medicines and Enbrel
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 Enbrel at the same time as medicines containing anakinra or abatacept as an active substance.
Pregnancy, breastfeeding, and fertility
Enbrel should only be used during pregnancy if clearly necessary. Contact your doctor if you become pregnant, think you may be pregnant, or are planning to have a baby.
If you have been given Enbrel during pregnancy, your baby may be at greater risk of getting an infection. One study also found more malformations when the mother had received Enbrel during pregnancy, compared to mothers who had not received Enbrel or other similar drugs ( TNF – antagonist), but no specific type of malformation was reported. Another study did not show an increased risk of malformations when the mother received Enbrel during pregnancy. Your doctor will help you determine if the benefits of treatment outweigh the potential risks to your child. You must tell your infant’s physician or another healthcare professional that Enbrel has been used during pregnancy before the infant receives any vaccination (see section 2, “Vaccinations” for more information).
You should not breast-feed while using Enbrel as Enbrel passes into breast milk.
Driving and using machines
The use of Enbrel is not expected to affect your ability to drive or use machines.
Important information about latex
Contact your doctor before using Enbrel, Enbrel will be handled by, or given to anyone with an allergy to latex, since the needle cover to the MYCLIC pen is made from latex.
3. How to use Enbrel
Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
If you have the impression that the effect of Enbrel is too strong or too weak, talk to your doctor or doctor
You have been prescribed Enbrel 25 mg. There is also Enbrel 50 mg if you are prescribed a dose of 50 mg.
Dosage for adult patients (over 18 years)
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.
The recommended dose is 25 mg given twice a week or 50 mg given once a week.
Alternatively, 50 mg may 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 to take Enbrel and if resuming treatment is needed based on the treatment results. If Enbrel 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. Your doctor will determine the correct dose for your child and prescribe Enbrel with the appropriate strength (10 mg, 25 mg, or 50 mg).
For patients from 2 years of age with polyarthritis or extended oligoarthritis or patients from 12 years of age with encephalitis-related arthritis or psoriatic arthritis, the usual dose is 0.4 mg Enbrel per kilogram body weight (up to a maximum of 25 mg per dose ) given two times. times a week, or 0.8 mg Enbrel per kilogram body weight (up to a maximum of 50 mg per dose ) given once a week.
For patients from 6 years of age with psoriasis, the usual dose is 0.8 mg Enbrel per kilogram body weight (up to a maximum of 50 mg per dose ) given once a week. If Enbrel 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
Enbrel is injected under the skin ( subcutaneous injection ).
Enbrel can be taken with or without food or drink.
Detailed instructions on how to inject Enbrel are provided in section 7 “Using MYCLIC pen to inject Enbrel”. Do not mix the Enbrel 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 Enbrel should be taken.
If you take more Enbrel than you should
If you have injected more Enbrel than your doctor has 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 use Enbrel
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 Enbrel
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.
If any of the following symptoms occur, do not inject more Enbrel, but contact your doctor or your doctor immediately 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 Enbrel, 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,g or pallor.
- Symptoms of any neurological disease, such as loss of sensation and a stinging sensation, vision changes, or muscle weakness in the arms or legs.
- Symptoms of heart failure or worsening heart failure, such as fatigue or difficulty breathing exertion, swollen ankles, a feeling of swollen neck and abdomen, difficulty breathing at night, cough 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, sensations, 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 any of the above symptoms occur, contact your or your child’s physician or the emergency department at the nearest hospital immediately.
Known side effects of Enbrel are the following, 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 (such as bleeding, bruising, redness, itching, pain, swelling) (these often subside after the first month of treatment, some patients develop a reaction at an injection site that has recently used) and headache.
• Common (may affect up to 1 in 10):
Allergic reactions, fever, rash, itching, antibody are directed against normal tissue(autoantibody formation).
• Uncommon (may affect up to 1 in 100 people):
Severe infections (including pneumonia, deep skin infections, joint infections, sepsis, and infections in various places), worsening chronic heart failure, low red blood cell count, low white blood cell count, low neutrophil count (a type of white blood cell count ), low number platelets, 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 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 ), inflammation of the liver caused by the body’s own immune system ( autoimmune hepatitis , in patients who also receive methotrexate the frequency is “less common”), immune disease that can affect the lungs, skin and lymph nodes ( sarcoidosis ), inflammation or fibrosis in the lungs (in patients who also get methotrexate is the frequency of inflammation or fibrosis in the lungs “less common”).
• Very rare (may affect up to 1 in 10,000 people):
The 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). Kaposi’s sarcoma, rare cancer associated with infection with human herpesvirus 8 Kaposi sarcoma occurs most often as purple spots on the skin. 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).
Side effects are 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 Enbrel
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 the label 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 the Enbrel pre-filled pen from the refrigerator, wait 15-30 minutes for the Enbrel solution to reach room temperature, do not heat Enbrel in any other way. Immediate use is then recommended.
Enbrel can be stored outside the refrigerator at temperatures up to a maximum of 25 ºC for a single period of up to four weeks, after which it should not be stored in the refrigerator again. Enbrel should be discarded if not used within four weeks of removal from the refrigerator. It is recommended that you note the date that Enbrel is removed from the refrigerator and the date when Enbrel is to be discarded (no longer than 4 weeks after removal from the refrigerator).
Inspect the solution in the pre-filled pen by looking through the transparent inspection window. It should be clear or slightly opalescent, colorless to pale yellow or light brown, and may contain small white or almost transparent particles of protein. This appearance is normal for Enbrel. Do not use the solution if it is discolored, cloudy or if particles other than those described above are present. 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
The active substance in Enbrel is etanercept. Each MYCLIC prefilled pen contains 25 mg etanercept.
Other ingredients are:
Sucrose, sodium chloride, L-arginine hydrochloride, sodium dihydrogen phosphate dihydrate, disodium phosphate dihydrate, and water for injections
What the medicine looks like and the contents of the pack
Enbrel is supplied as an injection solution, in a pre-filled pen (MYCLIC) (Solution for injection ). MYCLIC pen contains a clear, colorless to pale yellow or light brown injection. Each pack contains 4, 8, or 24 pre-filled pens and 4, 8, or 24 compresses of alcohol for use before injection.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Pfizer Europe MA EEIG
Boulevard de la Plaine 17
Pfizer Manufacturing Belgium NV
Contact the representative of the marketing authorization holder to find out more about this medicine:
|Belgium / Belgique / BelgienLuxembourg / LuxemburgPfizer SA / NVTel: +32 (0) 2 554 62 11||ΎπροςPFIZER EAA AE (CYPRUS BRANCH).Tηλ: +357 22 817690|
|Czech RepublicPfizer spol. sroTel: + 420-283-004-111||HungaryPfizer Kft.Tel: +36 1 488 3700|
|DenmarkPfizer ApSTel: +45 44 201 100||MaltaVivian Corporation Ltd.Tel: +35621 344610|
|GermanyPfizer Pharma GmbHTel: +49 (0) 30 550055-51000||The NetherlandsPfizer bvTel: +31 (0) 10 406 43 01|
|Bulgaria Pfizer of Luxembourg, Clone of BulgariaTel: +359 2 970 4333||NorwayPfizer ASTel: +47 67 52 61 00|
|EestiPfizer Luxembourg SARL, Estonian branchTel: +372 666 7500||AustriaPfizer Corporation Austria Ges.mbHTel: +43 (0) 1 521 15-0|
|GreecePFIZER EΛΛAΣ AE.:Ηλ .: +30 210 6785 800||PolandPfizer Polska Sp. z ooTel .: +48 22 335 61 00|
|SpainPfizer, SLTel: +34 91 490 99 00||PortugalPfizer Laboratories, Lda.Tel: +351 21 423 5500|
|FrancePfizerPhone +33 (0) 1 58 07 34 40||RomaniaPfizer Romania SRLTel: +40 (0) 21 207 28 00|
|CroatiaPfizer Croatia dooTel: +385 1 3908 777||SloveniaPfizer Luxembourg SARL, Pfizer, underwriter for cleaning and pharmaceutical pharmaceuticalsdejavnosti, LjubljanaTel: +386 (0) 1 52 11 400|
|IrelandPfizer Healthcare IrelandTel: +1800 633 363 (toll free)Tel: +44 (0) 1304 616161||Slovak RepublicPfizer Luxembourg SARL, organizerTel: +421 2 3355 5500|
|IcelandIcepharma hf.Tel: +354 540 8000||Finland / FinlandPfizer OyPuh / Tel: +358 (0) 9 430 040|
|LatviaPfizer Luxembourg SARL subsidiary LatvijāTel. +371 67035775||United KingdomPfizer LimitedTel: +44 (0) 1304 616161|
|LithuaniaPfizer Luxembourg SARL branches in LithuaniaTel. +3705 2514000|