くすりのしおり

Self-injection
Published: 7/2018

The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval details may vary by country. Medicines have adverse reactions (risks) as well as efficacies (benefits). It is important to minimize adverse reactions and maximize efficacy. To obtain a better therapeutic response, patients should understand their medication and cooperate with the treatment.
Brand name :
Etanercept BS 10mg for S.C. Inj. MA
 Active ingredient:
(Etanercept (genetical recombination)[Etanercept Biosimilar 1])
 Dosage form:
white freeze-dry powder injectable preparation
 Print on wrapping:

Effects of this medicine

This medicine suppresses action of TNF, which is considered to be a primary factor of inflammation and pain associated with rheumatoid arthritis, improves the symptoms and prevents the damage of joints and bones.
It is usually used for treatment of rheumatoid arthritis and active, polyarticular-course juvenile idiopathic arthritis.

Before using this medicine, be sure to tell your doctor and pharmacist

  • If you have previously experienced any allergic reactions (itch, rash, etc.) to any medicines.
  • If you have infection, tuberculosis, demyelinating disorders such as multiple sclerosis, optic nerve inflammation or its past history, congestive heart failure, blood disorders or its past history, a history of interstitial pneumonia, cancer or its past history.
    If you have received live vaccines (such as rubella/mumps vaccines) just before use of the medicine.
  • If you have infection, tuberculosis, demyelinating disorders such as multiple sclerosis, optic nerve inflammation or its past history, congestive heart failure, blood disorders or its past history, a history of interstitial pneumonia, cancer or its past history.
  • If you have received live vaccines (such as rubella/mumps vaccines) just before use of the medicine.
  • If you are pregnant or breastfeeding.
  • If you are taking any other medicinal products. (Some medicines may interact to enhance or diminish medicinal effects. Beware of over-the-counter medicines and dietary supplements as well as other prescription medicines.)

Dosing schedule (How to take this medicine)

  • Your dosing schedule prescribed by your doctor is ((        to be written by a healthcare professional))
  • For treatment of rheumatoid arthritis: In general, for adults, dissolve 10 to 25 mg of the active ingredient into 1 mL of water for injection at a time and subcutaneously inject once a day on two different days (3 or 4 days apart) in the same week, or dissolve 25 to 50 mg into 1 mL of water for injection at a time and subcutaneously inject once a day, once a week.
    For treatment of active, polyarticular-course juvenile idiopathic arthritis: In general, for children, inject subcutaneously 0.2 to 0.4 mg/kg of the active ingredient at a time, once a day on two different days (3 or 4 days apart) in the same week. Each dose for children should not exceed 25 mg.
    Strictly follow the instructions in either case.
  • Avoid injection to the site overlapped to previously injected sites (Inject the medicine at least 3 cm apart from the previous injected site).
    Do not massage the injected site after giving the injection. You (patient) may self-inject this medicine (self-injection), only if you want to and the doctor has confirmed that patient meets certain criteria for the self-injection.
  • If you miss a dose, consult with your doctor or pharmacist.
  • If you accidentally inject more than your prescribed dose, consult with your doctor or pharmacist.
  • Do not stop injecting this medicine unless your doctor instructs you to do so.

Precautions while taking this medicine

  • This medicine suppresses your immune response. Take care of yourself to prevent infections: Stay away from a crowd, wash your hands and gargle.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include interstitial lung disease, upper respiratory tract inflammation, oropharyngeal pain, dizziness, anemia, infections (nasopharyngitis, bronchitis, etc.), injection site reactions (erythema, swelling, pain, itching), rash, itching, headache, diarrhea, constipation, abdominal pain and fever.
If any of these symptoms occur, consult with your doctor or pharmacist. Do not scratch or touch the injection site.
The symptoms described below are rarely seen as initial symptoms of the adverse reactions indicated in brackets. If any of these symptoms occur, stop taking this medicine and see your doctor immediately.
  • chills, fever, dullness (general) [sepsis, pneumonia (including pneumocystis pneumonia), opportunistic infections such as fungal infection]
  • persistent slight fever, persistent cough (for more than 2 weeks), dullness (general) [tuberculosis]
  • redness (general), swelling (general), breathlessness [serious allergic reactions]
  • persistent fever, sore throat, paleness of the face [serious blood disorders]
  • decreased vision/diplopia, numbness/pain/motor paralysis [demyelinating disorders]
The above symptoms do not describe all the adverse reactions to this medicine. Consult with your doctor or pharmacist if you notice any symptoms of concern other than those listed above.

Storage conditions and other information

  • Keep out of the reach of children. Store at 2 to 8 degrees Celsius and avoid light and freezing.
  • Discard the remainder. Do not store them. If you dispose of unused medicines, seek advice of your pharmacist or medical institution about proper disposal of medicines.
  • If you wish to receive vaccination, certainly inform the doctor that you are using this medicine and consult with him or her. DO NOT receive live vaccines (such as rubella/mumps vaccines) while using this medicine because of infection risk of the virus. If you wish to receive vaccination, consult your doctor and receive it before initiation of this medicine.

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.

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