Product Information for the User
Enbrel 25 mg Powder and Diluent for Injectable Solution
etanercept
Read this entire product information carefully before starting to use this medicine, as it contains important information for you.
|
The information inthisproduct information is organizedinthe following 7 sections:
1.What Enbrel is and for what it is used
2.What you need to know before starting to use Enbrel
3.How to use Enbrel
4.Possible side effects
5.Storage of Enbrel
6.Contents of the pack and additional information
7.Instructions for use
Enbrel is a medication made from two human proteins. It blocks the activity of another protein found in the body, which produces inflammation. Enbrel acts by reducing the inflammation associated with certain diseases.
Enbrel may be used in adults 18 years of age or older for the treatment ofmoderate to severe rheumatoid arthritis,psoriatic arthritis,axial spondyloarthritissevere, includingankylosing spondylitisandpsoriasismoderate to severe, usually, depending on each case, when other treatments have not been sufficiently effective or are not appropriate for you.
In the treatment of rheumatoid arthritis, Enbrel is usually used in combination with methotrexate, although it may also be used as a single medication, in the case that methotrexate treatment is not suitable for you. Enbrel may slow the damage caused by rheumatoid arthritis in your joints and improve your ability to perform daily activities, whether used alone or in combination with methotrexate.
In the case of patients with psoriatic arthritis with multiple joint involvement, Enbrel may improve your ability to perform normal daily activities.In the case of patients with multiple symmetrical, swollen, or painful joints (for example, in hands, wrists, and feet), Enbrel may delay the progression of structural damage to these joints caused by the disease.
Enbrel is also indicated for the treatment of children and adolescents with the following diseases:
No use Enbrel
Warnings and precautions
Consult your doctor before starting to use Enbrel.
Patients with severe rheumatoid arthritis, who have had the disease for a long time, may be at higher risk of developing lymphoma.
Children and adults taking Enbrel may be at increased risk of developing lymphoma or other cancer.
Some adolescent and child patients who have received Enbrel or other medications that work in the same way as Enbrel have developed cancers, including rare types, which sometimes resulted in death.
Some patients taking Enbrel have developed skin cancers. Inform your doctor if you or the child develop any changes in skin appearance or growths on the skin.
Children and adolescents
Vaccinations:If possible, children should have all vaccinations updated before using Enbrel. Some vaccines, such as the oral polio vaccine, should not be administered while using Enbrel. Consult with your doctor before using any vaccine.
Enbrel should not normally be used in children under 2 years with polyarthritis or oligoarthritis, in children under 12 years with arthritis related to enthesitis or psoriatic arthritis, or in children under 6 years with psoriasis.
Other medications and Enbrel
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 child should not use Enbrel with medications containing the active principles anakinra or abatacept.
Pregnancy and breastfeeding
Enbrel 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 Enbrel during pregnancy, your baby may be at increased risk of infection. Additionally, in one study, more birth defects were observed when the mother had received Enbrel during pregnancy, compared to mothers who had not received Enbrel or 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 Enbrel 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 Enbrel treatment. It is essential to inform the pediatrician and other healthcare professionals about the use of Enbrel during pregnancy and breastfeeding before your baby receives any vaccine.
Driving and operating machinery
It is not expected that Enbrel use will affect the ability to drive and operate machinery.
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 Enbrel is too strong or too weak, inform your doctor or pharmacist.
Dosage for 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 under the skin. However, your doctor may determine an alternative frequency for injecting Enbrel.
Plaque psoriasis
The usual dose is 25 mg twice a week or 50 mg once a week.
Alternatively, 50 mg can 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 take Enbrel and if you need a repeat treatment based on your response. If Enbrel 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 instruct you on how to prepare and measure the appropriate dose.
For extended oligoarthritis or polyarthritis in patients aged 2 years or older, or psoriatic arthritis related to enthesitis or psoriatic arthritis in patients aged 12 years or older, the usual dose is 0.4 mg of Enbrel per kg of body weight (up to a maximum of 25 mg) administered twice a week, or 0.8 mg of Enbrel per kg of body weight (up to a maximum of 50 mg) administered once a week.
For plaque psoriasis in patients aged 6 years or older, the usual dose is 0.8 mg of Enbrel per kg of body weight (up to a maximum of 50 mg) administered once a week. If Enbrel has no effect on the child's disease after 12 weeks, your doctor may instruct you to stop using this medication.
Form and route of administration
Enbrel is administered via a subcutaneous injection under the skin.
Enbrel can be administered with or without food or beverages.
The powder must be dissolved before use.Insection 7, “Instructions for use”, detailed instructions for preparing and injecting Enbrel are included.Enbrel 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 Enbrel.
If you use more Enbrel than you should
If you use more Enbrel than you should (either by injecting a high amount in one occasion or by using it too frequently), you should speak with a doctor or pharmacist immediately. Always carry the medication packaging with you, even if it is empty.
If you forget to inject Enbrel
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 you should administer the next dose, do not inject a double dose (two doses on the same day) to compensate for the missed dose.
If you interrupt Enbrel treatment
Your symptoms may return after interrupting treatment.
If you have any other questions about using this medication, ask your doctor or pharmacist.
Like all medications, this medication may cause side effects, although not everyone will experience them.
Allergic reactions
If you notice any of the following reactions, do not inject Enbrel again. Inform your doctor immediately or go to the nearest hospital emergency department.
Severe allergic reactions are rare. However, any of the above symptoms may be a sign of an allergic reaction to Enbrel, 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.
These side effects are rare or uncommon, but are serious conditions (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 Enbrel, grouped by decreasing frequency:
Infections (including colds, sinusitis, bronchitis, urinary tract infections, and skin infections); reactionsatthe 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 reactionatthe injection site that they had recently used); and headache.
Allergic reactions; fever; rash; itching; and autoantibodies directed against normal tissues (formation of autoantibodies).
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 multiple organs affecting blood vessels; increased liver enzymes in blood tests (in patients also receiving methotrexate treatment, the increase in liver enzymes is common); abdominal cramps and pain, diarrhea, weight loss, or blood in the stool (signs of intestinal problems).
Severe allergic reactions (including localized severe skin swelling and labored breathing); lymphoma (a type of blood cancer); leukemia (cancer affecting the blood and bone marrow); melanoma (a type of skin cancer); combined low red blood cell, white blood cell, and platelet count; neurological disorders (with severe muscle weakness and symptoms and signs similar to multiple sclerosis or inflammation of the optic nerves or spinal cord); tuberculosis; new-onset congestive heart failure; seizures; lupus or lupus-like syndrome (symptoms may include persistent rash, fever, joint pain, and fatigue); skin eruption that may lead to severe blistering and skin peeling; lichenoid reactions (pruritic, red-brown skin eruption and/or thick white-gray lines on mucous membranes); autoimmune hepatitis caused by the immune system (in patients also receiving methotrexate treatment, the frequency is uncommon);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); damage to the small filters within the kidneys that lead to impaired kidney function (glomerulonephritis).
Failure of the bone marrow to produce critical blood cells.
Merkel cell carcinoma (a type of skin cancer);Kaposi's sarcoma, a rare cancer related to human herpesvirus 8 infection. Kaposi's sarcoma usually manifests as purple skin lesions; excessive activation of white blood cells associated with inflammation (macrophage activation syndrome); reactivation of hepatitis B (a liver infection);worsening of a disease called dermatomyositis (inflammation and weakness of muscles accompanied by skin eruption).
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 or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Vigilance of Medicinal Products for Human Use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.
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 label after “EXP.” The expiration date is the last day of the month indicated.
Store in the refrigerator (2 °C - 8 °C).Do not freeze.
Before preparing the Enbrel solution, Enbrel can be stored outside the refrigerator at a maximum temperature of 25 °C, and for a single period of up to 4 weeks; after which, the medication cannot be refrigerated again. Enbrel must be discarded if not used within 4 weeks following its removal from the refrigerator. It is recommended that you note the date when Enbrel is removed from the refrigerator and the date from which Enbrel must be discarded (not exceeding 4 weeks from the removal of the packaging from the refrigerator).
After preparing the Enbrel solution, immediate use is recommended. However, the solution can be used within the 6 hours following reconstitution when stored at temperatures not exceeding 25 °C.
Do not use this medication if you observe that the solution is not transparent or contains particles. The solution must be transparent, colorless to pale yellow or pale brown, without lumps, scales, or particles.
Properly discard any Enbrel solution that has not been injected within 6 hours.
Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. In this way, you will help protect the environment.
Enbrel Composition
The active ingredient of Enbrel is etanercept. Each vial of Enbrel 25 mg contains 25 mg of etanercept.
The other components are:
Powder: Mannitol (E421), sucrose, and tromethamine
Vehicle: Water for injection
Appearance of the product and contents of the pack
Enbrel 25 mg is presented as a white powder and a vehicle for injectable solution (powder for injection). Each pack contains 4, 8, or 24 vials of single dose, 4, 8, or 24 pre-filled syringes with water for injection, 4, 8, or 24 needles, 4, 8, or 24 vial adapters, and 8, 16, or 48 cotton balls with alcohol. Some pack sizes may not be marketed.
Marketing Authorization Holder: Pfizer Europe MA EEIG Boulevard de la Plaine 17 1050 Bruxelles Belgium | |
Manufacturer: Pfizer Manufacturing Belgium NV Rijksweg 12, 2870 Puurs-Sint-Amands Belgium |
For further information about this medicinal product, please consult the representative of the marketing authorization holder in your country.
Spain
Pfizer, S.L.
Tel: +34 91 490 99 00
Last update of the leaflet:
The detailed information on this medicinal product is available on the website of the European Medicines Agency:http://www.ema.europa.eu.
7.Instructions for use
This section is divided into the following subsections:
a.Introduction
The following instructions explain how to prepare and inject Enbrel. Read these instructions carefully and follow them step by step. Your doctor or nurse will teach you the self-injection or injection administration techniques for children. Do not attempt to administer an injection until you are sure you understand how to prepare the injection and administer it.
This injection should not be mixed with another medicine.
b.Preparing for an injection
1 Vial of Enbrel
1 Syringe pre-filled with transparent colorless vehicle (water for injection)
1 Needle
1 Vial adapter
2 Cotton balls with alcohol
c.Preparing the Enbrel dose for injection
Figure 1
Figure 2 | Figure 3 | Figure 4 |
CORRECT | INCORRECT |
Figure 5
Figure 6
Figure 7
d.Adding the vehicle
Figure 8
Figure 9
e.Extracting the Enbrel solution from the vial
Figure 10
Figure 11
Figure 12
(Note: After completing these steps, a small amount of liquid may remain in the vial. This is normal.)
f.Placing the needleinthe syringe
Figure 13
Figure 14
Figure 15
Figure 16
g.Choosing an injection site
Figure 17
h.Preparing the injection site and injecting the Enbrel solution
Figure 18
Figure 19
If you have any questions, consult a doctor, nurse, or pharmacist who is familiar with the use of Enbrel.
Есть вопросы по этому лекарству или вашим симптомам? Свяжитесь с лицензированным врачом для получения помощи и персонализированного ухода.