Enbrel

Enbrel 50 mg Pre-Filled Syringe 4 pcs (Refrigerator)

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Etanercept Solution for injection 50 mg     

What Etanercept is and what it is used for:
  • Etanercept is a medicine that is made from two human proteins.
  • It blocks the activity of another protein in the body that causes inflammation.
  • Etanercept works by reducing the inflammation associated with certain diseases.
  • In adults (aged 18 and over), Etanercept can be used for moderate or severe rheumatoid arthritis, psoriatic arthritis, severe axial spondyloarthritis including ankylosing spondylitis, and moderate or severe psoriasis – in each case usually when other widely used treatments have not worked well enough or are not suitable for you. 
  • Etanercept is also prescribed for the treatment of the following diseases in children and adolescents
  • For the following types of juvenile idiopathic arthritis when treatment with methotrexate has not worked well enough or is not suitable for them:
  • Polyarthritis (rheumatoid factor positive or negative) and extended oligoarthritis in patients from the age of 2 years
  • Psoriatic arthritis in patients from the age of 12 years
  • For enthesitis-related arthritis in patients from the age of 12 years when other widely used treatments have not worked well enough or are not suitable for them
  • Severe psoriasis in patients from the age of 6 years who have had an inadequate response to (or are unable to take) phototherapies or other systemic therapies
Do not use Etanercept:
  • Tell your doctor if you:
  • if you, or the child you are caring for, are allergic to etanercept or any of the other ingredients of Etanercept
  • If you or the child experience allergic reactions such as chest tightness, wheezing, dizziness or rash, do not inject more Etanercept, 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 not sure, please contact your doctor.
  • if you or the child have an infection of any kind. If you are not sure, please talk to your doctor
Warnings and precautions:
  • You should let your doctor know:
  • Allergic reactions: If you or the child experience allergic reactions such as chest tightness, wheezing, dizziness or rash, do not inject more Etanercept, and contact your doctor immediately.
  • Infections/surgery: If you or the child develop a new infection, or are about to have any major surgery, your doctor may wish to monitor the treatment with Etanercept.
  • Infections/diabetes: Tell your doctor if you or the child have a history of recurrent infections or suffer from diabetes or other conditions that increase the risk of infection.
  • Infections/monitoring: Tell your doctor of 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 may decide to continue to monitor you or the child for the presence of infections after you or the child stop using Etanercept.
  • Tuberculosis: As cases of tuberculosis have been reported in patients treated with Etanercept, your doctor will check for signs and symptoms of tuberculosis before starting Etanercept.
  • This may include a thorough medical history, a chest X-ray and a tuberculin test.
  • The conduct of these tests should be recorded on the Patient Card. It is very important that you tell your doctor if you or the child have ever had tuberculosis, or have been in close contact with someone who has had tuberculosis.
  • If symptoms of tuberculosis (such as persistent cough, weight loss, listlessness, mild fever), or any other infection appear during or after therapy, tell your doctor immediately
  • Hepatitis B: Tell your doctor if you or the child have or have ever had hepatitis B.
  • Your doctor should test for the presence of hepatitis B infection before you or the child begin treatment with Etanercept.
  • Treatment with Etanercept may result in reactivation of hepatitis B in patients who have previously been infected with the hepatitis B virus. If this occurs, you should stop using Etanercept
  • Hepatitis C: Tell your doctor if you or the child have hepatitis C.
  • Your doctor may wish to monitor the treatment with Etanercept in case the infection worsens.
  • Blood disorders: Seek medical advice immediately if you or the 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 Etanercept.
  • Nervous system and eye disorders: 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 Etanercept is an appropriate treatment.
  • Congestive heart failure: Tell your doctor if you or the child have a history of congestive heart failure, because Etanercept needs to be used with caution under 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 Etanercept. Patients with severe rheumatoid arthritis, who have had the disease for a long time, may be at higher than average risk of developing lymphoma. Children and adults taking Etanercept may have an increased risk of developing lymphoma or another cancer. Some children and teenage patients who have received Etanercept or other medicines that work the same way as Etanercept have developed cancers, including unusual types, which sometimes resulted in death. Some patients receiving Etanercept have developed skin cancers. Tell your doctor if you or the child develop 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 Etanercept. Your doctor will determine if preventive treatment for chickenpox is appropriate.
  • Latex: The needle cap of the MYCLIC pen is made from latex (dry natural rubber). Contact your doctor before using Etanercept if the needle cap will be handled by, or Etanercept will be given to, someone with a known or possible hypersensitivity (allergy) to latex.
  • Alcohol abuse: Etanercept should not be used for the treatment of hepatitis related to alcohol abuse. Please tell your doctor if you or the child in your care have a history of alcohol abuse.
  • Wegener’s granulomatosis: Etanercept 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, talk to your doctor.
  • Anti-diabetic medicines: Tell your doctor if you or the child have diabetes or are taking medicines to treat diabetes. Your doctor may decide if you or the child need less anti-diabetic medicine while taking Etanercept.
Other medicines and Etanercept:
  • Tell the doctor or pharmacist if you or the child are taking, have recently taken or might take any other medicines (including anakinra, abatacept or sulfasalazine), even those not prescribed by the doctor.
  • You or the child should not use Etanercept with medicines that contain the active substance anakinra or abatacept.
How to use Etanercept:
  • Your doctor will decide the correct dose for you and how long you should take it.
  • Dosing for adult patients (aged 18 years or over)
  • Rheumatoid arthritis, psoriatic arthritis, and axial spondyloarthritis including ankylosing spondylitis
  • The usual dose is 25 mg given twice a week or 50 mg once a week as an injection under the skin.
  • However, your doctor may determine an alternative frequency at which to inject Etanercept. 
  • Plaque psoriasis 
  • The usual dose is 25 mg twice a week or 50 mg 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 you should take Etanercept and whether retreatment is needed based on your response.
  • If Etanercept 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 dosing for the child or adolescent will depend on body weight and disease.
  • Your doctor will determine the correct dose for the child and will prescribe an appropriate strength of Etanercept (10 mg, 25 mg or 50 mg)
  • For polyarthritis or extended oligoarthritis in patients from the age of 2 years, or enthesitis-related arthritis or psoriatic arthritis in patients from the age of 12 years, the usual dose is 0.4 mg of Etanercept per kg bodyweight (up to a maximum of 25 mg) given twice weekly, or 0.8 mg of Etanercept per kg of bodyweight (up to a maximum of 50 mg) given once weekly. 
  • For psoriasis in patients from the age of 6 years, the usual dose is 0.8 mg of Etanercept per kg bodyweight (up to a maximum of 50 mg), and should be given once weekly. 
  • If Etanercept has no effect on the child’s condition after 12 weeks, your doctor may tell you to stop using this medicine. 
  • The doctor will provide you with detailed directions for preparing and measuring the appropriate dose.
  • Method and route of administration 
  • Etanercept is administered by an injection under the skin (by subcutaneous injection)
Possible side effects:
  • Stop using the product and seek immediate medical attention if 
  • Signs of allergic reaction, such as swelling of the face, lips, tongue or throat which may cause difficulty in breathing   or swallowing 
  • Signs of serious infections, such as high fever that may be accompanied by cough, shortness of breath, chills, weakness, or a hot, red, tender, sore area on the skin or joints
  • Signs of blood disorders, such as bleeding, bruising, or paleness
  • Signs of nerve disorders, such as numbness or tingling, changes in vision, eye pain, or onset of weakness in an arm or leg 
  • Signs of heart failure or worsening heart failure, such as fatigue or shortness of breath with activity, swelling in the ankles, a feeling of fullness in the neck or abdomen, night-time shortness of breath or coughing, bluish colour of the nails or the lips
  • Signs of cancers: Cancers may affect any part of the body including the skin and blood, and possible signs will depend on the type and location of the cancer. These signs may include weight loss, fever, swelling (with or without pain), persistent cough, presence of lumps or growths on the skin
  • Signs of autoimmune reactions (where antibodies are made that may harm normal tissues in the body) 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, joint or muscle pain, or fatigue
  • Signs of inflammation of the blood vessels such as pain, fever, redness or warmth of the skin, or itching.
How to store Etanercept:
  • 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 on the MYCLIC prefilled pen after EXP.
  • The expiry date refers to the last day of that month.
  • Store in a refrigerator (2° – 8°C). Do not freeze.
  • Keep the pre-filled pens in the outer carton in order to protect from light. 
  • After taking a pre-filled pen from the refrigerator, wait approximately 15-30 minutes to allow the Etanercept solution in the pen to reach room temperature. Do not warm in any other way. Immediate use is then recommended.
*Dosage form and route of administration of Etanercept should be prescribed according to therapeutic indication and disease severity of each individual patient.

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  • Manufacturer: Enbrel
  • Product form: Syringe
  • Ingredients: Etanercept