Enbrel 50 mg. 4 vials
Enbrel e medicine that is made from two human proteins. It blocks the activity of another protein in the body that causes inflammation. Enbrel works by reducing the inflammation associated with certain diseases.
In adults (over 18 years) Enbrel can be used for moderate or severe rheumatoid arthritis, psoriatic arthritis, severe ankylosing spondylitis and moderate or severe psoriasis - in each case usually when other widely used treatments have not good enough or they are not suitable for you.
In rheumatoid arthritis, Enbrel is usually used in combination with methotrexate, although can be used alone if the treatment with methotrexate is inappropriate for the search. Whether used alone or in combination with methotrexate, Enbrel can slow down the damage to your joints caused by rheumatoid arthritis, and improve your ability to do normal daily activities.
In patients with psoriatic arthritis with involvement of multiple joints Enbrel can improve your ability to perform normal daily activities. In patients with multiple symmetrical painful or swollen joints (eg. Hands, wrists and feet) Enbrel can slow down the structural damage to those joints caused by the disease.
Enbrel is also prescribed for the treatment of the following diseases in children and adolescents:
• The following types of juvenile idiopathic arthritis when treatment with methotrexate is given a good enough result or is not appropriate for them:
• Polyarthritis (positive or negative rheumatoid factor) and extended oligoarthritis in patients aged 2 years and more
• Psoriatic arthritis in patients aged 12 years and over
• For enthesitis-related arthritis in patients aged 12 years and over when other widely used treatments have not good enough or they are not suitable for them
• Severe psoriasis in patients aged six years and over who have had an inadequate response to (or are unable to accept) phototherapy or other systemic therapy.
2. What you should know before using Enbrel?
Do not use Enbrel
• If you or the child you are caring for, are allergic to etanercept or any of the other ingredients of Enbrel. If you or the child experience allergic reactions such as chest tightness, wheezing, dizziness or rash, do not inject more Enbrel and immediately contact your doctor.
• if you or your child have or are at risk of developing a serious blood infection called sepsis. If you are unsure, please contact your doctor.
• if you or your child have any kind of infection. If you are unsure, please talk to your doctor.
Warnings and Precautions
• Allergic reactions: If you or the child experience allergic reactions such as chest tightness, wheezing, dizziness or rash, do not inject more Enbrel and immediately contact your doctor.
• Infections / surgery: If you or the child develop a new infection or have any major surgery, your doctor may want to monitor the treatment with Enbrel.
• Infections / diabetes: Tell your doctor if you or your child have a history of recurrent infections or suffer from diabetes or other conditions that increase the risk of infection.
• Infections / track: Tell your doctor about any forthcoming travel outside the European region. If you or your child develop symptoms of infection such as fever, chills or cough, notify your doctor. Your doctor may decide to continue to monitor you or the child for the presence of infections after you or the child stop using Enbrel.
• Tuberculosis: As in patients treated with Enbrel, reported cases of tuberculosis, your doctor will check for signs and symptoms of tuberculosis before prescribing Enbrel. This may include a thorough medical history, chest X-ray and a tuberculin test. The conduct of these tests should be recorded in the Patient Alert Card. It is important to tell your doctor if you or the child have ever had tuberculosis, or if you have been in close contact with someone who has had tuberculosis. If during or after therapy symptoms of tuberculosis (eg persistent cough, weight loss, listlessness, mild fever), or any other infection, tell your doctor.
• Hepatitis B: Your doctor may decide to test for the presence of hepatitis B infection before you or the child begin treatment with Enbrel.
• Hepatitis C: Tell your doctor if you or the child have hepatitis C. Your doctor may wish to monitor the treatment with Enbrel, if the infection is deeper.
• Blood disorders: Seek medical advice if you or your child have any signs or symptoms such as persistent fever, sore throat, bruising, bleeding or paleness. Such symptoms may point to the existence of potentially life-threatening blood disorders, which may require discontinuation of Enbrel.
• Nervous system and eye: Tell your doctor if you or the child have multiple sclerosis, optic neuritis (inflammation of the nerves of the eyes) or transverse myelitis (inflammation of the spinal cord). Your doctor will determine if Enbrel is an appropriate treatment.
• Congestive heart failure: Tell your doctor if you or your child have a history of congestive heart failure, because Enbrel should be used with caution in these circumstances.
• Cancer: Tell your doctor if you have or have ever had lymphoma (a type of blood cancer) or any other cancer before you are given Enbrel.
Patients with severe rheumatoid arthritis who have long been suffering from this disease may be at higher than average risk of developing lymphoma.
Children and adults taking Enbrel, may have an increased risk of developing lymphoma or other cancers.
Some children and adolescent patients who have received Enbrel or other medicines affecting the same way as Enbrel, have developed various types of cancers, including unusual types, which sometimes lead to death.
Some patients receiving Enbrel, have developed skin cancer. Tell your doctor if you or your child get any change in the appearance of the skin or growths on the skin.
• Chickenpox: Tell your doctor if you or the child are exposed to chickenpox when using Enbrel. Your doctor will determine whether it is appropriate preventive treatment for chickenpox.
• Latex: The needle cover is made from latex (dry natural rubber). Contact your doctor before using Enbrel, if that works to cover the needle, or the one who will apply Enbrel, have a known or possible hypersensitivity (allergy) to latex.
• Alcohol abuse: Enbrel should not be used for the treatment of hepatitis related to alcohol abuse. Please tell your doctor if you or the child you are caring, have a history of alcohol abuse.
• Wegener's granulomatosis: Enbrel is not recommended for the treatment of Wegener's granulomatosis, a rare inflammatory disease. If you or the child in your care, you have Wegener's granulomatosis, talk to your doctor.
• Antidiabetic drugs: Tell your doctor if you or the child have diabetes or are taking medicines to treat diabetes. Your doctor can decide whether you or the child need less anti-diabetes medicines while taking Enbrel.
Children and adolescents
• Vaccinations: If possible, children should be held all vaccinations before using Enbrel. Some vaccines, such as oral polio vaccine should not be administered while using Enbrel. Please consult your doctor before you or your child to take any vaccines.
• Inflammatory bowel disease (IBD): In patients with juvenile idiopathic arthritis (JIA) treated with Enbrel, there are cases of IBD. Tell the doctor if the child has abdominal cramps and pain, diarrhea, weight loss or blood in the stool.
Usually Enbrel should not be used in children with arthritis or extended oligoarthritis under 2 years of age or in children with enthesitis-related arthritis or psoriatic arthritis under 12 years of age or in children with psoriasis below the age of 6.
Other medicines and Enbrel
Tell your doctor or pharmacist if you or your child are taking or have recently taken any other medicines (including anakinra, abatacept or sulfasalazine), even those not prescribed by a doctor. You or the child should not use Enbrel with medicines containing the active substance anakinra or abatacept.
Pregnancy and lactation
The effects of Enbrel in pregnant women are not known, so it is not recommended the use of Enbrel during pregnancy. Women using Enbrel, should not become pregnant. If the patient becomes pregnant, you should consult a doctor.
Women using Enbrel, should not breastfeed, because Enbrel passes into human milk.
Driving and using machines
Do not expect the use of Enbrel affect the ability to drive and use machines. 3. How to use Enbrel
Always use Enbrel exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
If you feel that the effect of Enbrel is too strong or too weak, talk to your doctor or pharmacist.
Dosing for adult patients (aged 18 years)
Rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis
The usual dose is 25 mg, administered twice weekly or 50 mg once weekly as a subcutaneous injection. However, your doctor may determine an alternative frequency at which to inject Enbrel.
The usual dose is 25 mg twice a week or 50 mg once a week.
In other cases, 50 mg may be administered twice a week for a maximum of 12 weeks followed by 25 mg twice a week or 50 mg once a week.
Your doctor will decide how long you should take Enbrel and whether retreatment is needed based on your response. If Enbrel has no effect on your condition after 12 weeks, your doctor may tell you to stop taking this medicine.
Use in children and adolescents
The appropriate dose and frequency of administration for the child or adolescent will depend on body weight and disease. The doctor will provide detailed directions for preparing and measuring the appropriate dose.
For arthritis and extended oligoarthritis in patients aged 2 years or more and enthesitis-related arthritis or psoriatic arthritis in patients aged 12 years and older, the usual dose is 0,4 mg Enbrel per kg bodyweight (up to 25 mg) administered twice weekly or 0,8 mg Enbrel per kg body weight (up to 50 mg) administered once a week.
For psoriasis in patients older than 6 years and over, the usual dose is 0,8 mg Enbrel per kg body weight (up to a maximum of 50 mg), and should be administered once a week. If Enbrel has no effect on the child's condition after 12 weeks, your doctor may tell you to stop using this medicine.
Method and route of administration
Enbrel is given by injection under the skin (subcutaneous injection). Enbrel can be taken with or without food or drink.
The powder must be dissolved before use. Detailed instructions on how to prepare and inject Enbrel are provided in section 7, "Instructions for preparation and injection of Enbrel". Do not mix the Enbrel solution with any other medicine.
To remember more easily, it may be helpful to write in a diary which day (which days) of the week should be used Enbrel.
If you use more than the required dose of Enbrel
If you use more than the amount of Enbrel (either by injecting too much dose once or too frequent use), talk immediately to a doctor or pharmacist. Always store carton of medicine with you, even if it is empty.
If you forget to inject Enbrel
If you miss a dose, you should inject as soon as possible after you remember, unless the next scheduled dose is not the next day, in which case you should skip the missed dose. Then continue to inject the medicine on the usual day (s). If you do not remember until the day the next injection, do not take a double dose (two doses on the same day) to make up the missed dose.
If you stop using Enbrel
Your symptoms may reappear after stopping.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Enbrel can cause side effects, although not everybody gets them.
There may be other side effects not listed in this leaflet. If you are worried about any side effects or you notice other effects not listed in this leaflet, please tell your doctor or pharmacist.
The most common side effects with Enbrel are injection site reactions, infections, allergic reactions, formation of autoantibodies, itching and fever. For more details please see below.
If anything of the following, do not inject more Enbrel. Tell your doctor or go to the casualty department at your nearest hospital:
• Difficulty swallowing or breathing.
• Swelling of the face, throat, hands, or feet.
• Feeling nervous or anxious, heart palpitations, sudden reddening of the skin and / or a warm feeling.
• Severe rash, itching or hives (raised red or white areas of the skin that often itch).
Serious allergic reactions are rare. However, any of the above symptoms may indicate an allergic reaction to Enbrel, so you should seek immediate medical attention.
Serious side effects
If you notice any of the following, you or the child may need urgent medical attention:
• Signs of serious infections, such as high fever that may be accompanied by cough, shortness of breath, chills, weakness, or a hot, red, painful inflamed area of skin or joints
• Signs of blood disorders, such as bleeding, bruising, or paleness
• Signs of nerve disorders, such as numbness, tingling, changes in vision, eye pain, or onset of weakness in an arm or leg
• Signs of worsening heart failure, such as fatigue or shortness of breath on exertion, swelling of the ankles, a feeling of fullness in the neck or abdomen, night shortness of breath or coughing, bluish color of the nails or lips
• Signs of cancer: Cancer may affect, to any part of the body, including skin and blood and possible signs depend on the type and location of the cancer. These symptoms may include weight loss, fever, swelling (with or without pain), persistent cough, presence of sores or bumps on the skin
• Signs of autoimmune reactions (formation of antibodies that can damage normal tissues in the body) such as pain, itching, weakness and disturbances of breathing, thinking, feeling or vision
• Signs of lupus or lupus-like syndrome, such as weight changes, persistent rash, fever, pain in the joints or muscles or fatigue
• Signs of inflammation of blood vessels such as pain, fever, redness or heat the skin or itching.
These are rare or uncommon side effects, but are serious conditions (some of which may rarely be fatal). If these signs occur, tell your doctor or visit the emergency department at your nearest hospital.
There are the following side effects with Enbrel, grouped in order of decreasing incidence:
• Very common (may affect more than 1 in 10 patients):
Infections (including colds, sinusitis, bronchitis, urinary tract infections and skin infections); injection site reactions (including bleeding, bruising, redness, itching, pain and swelling). Injection site reactions (they do not occur as often after the first month of treatment). Some patients develop reactions at the injection site that was used before.
• Common (may affect up to 1 in 10 patients):
Allergic reactions, fevers, itching, antibodies directed against normal tissue (autoantibody formation).
• Uncommon (may affect up to 1 in 100 patients):
Serious infections (including pneumonia, deep skin infections, joint infections, and blood infections at different sites); low blood platelet count; skin cancer (excluding melanoma); localized swelling of the skin (angioedema); urticaria (raised red or white areas of the skin that often itch); eye irritation; psoriasis (new or worsening); rash; inflammation or calcification of the lungs; inflammation of the blood vessels affecting multiple organs.
• Rare (may affect up to 1 in 1000 patients):
Serious allergic reactions (including severe localized swelling of the skin and wheezing); lymphoma (a type of blood cancer); melanoma (a type of skin cancer); combined low platelet, red blood cells and leukocytes; nervous system disorders (severe muscle weakness and signs and symptoms similar to those of multiple sclerosis, or inflammation of nerves of the eye, or spinal cord); tuberculosis; worsening congestive heart failure; seizures;
Keep out of reach of children.
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