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 :
HUMIRA 80mg for S.C. Injection Pen 0.8mL
 Active ingredient:
Adalimumab(genetical recombination)
 Dosage form:
colorless, limpid or slightly opalescent injectable solution in a prefilled syringe contained inside a pen device
 Print on wrapping:

Effects of this medicine

This medicine suppresses function of TNF (tumor necrosis factor)-α which is one of possible primary causative substances in rheumatoid arthritis, psoriasis, ankylosing spondylitis, juvenile idiopathic arthritis, Crohn's disease and ulcerative colitis. TNF is one of cytokines existing inside of the body even in a healthy state, and involved in activities of immunity and development of inflammation or pain.
It is usually used to treat rheumatoid arthritis (including prevention of structural joint damage) and diseases described below with inadequate response to conventional therapies: psoriasis vulgaris, psoriasis arthritis or pustular psoriasis, ankylosing spondylitis, intestinal Behcet's disease, non-infectious intermediate/posterior uveitis and panuveitis and moderate to severe ulcerative colitis.
It is also used for inducing clinical remission and maintaining therapy in patient with moderately to severely active Crohn's disease.

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 or are suspected of having infections such as sepsis.
    If you have or have a history of tuberculosis or hematologic disease.
    If you have, or have a past medical or family history of demyelinating disease such as multiple sclerosis.
    If you are a hepatitis B virus carrier or have a history of hepatitis B virus infection.
    If you have just received live vaccine.
    If you have congestive heart failure.
  • 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 rheumatoid arthritis: In general, for adults, inject 40 mg of the active ingredient subcutaneously, once every two weeks. When its effect is insufficient, the dosage may be increased up to 80 mg at a time.
    For psoriasis vulgaris, psoriasis arthritis or pustular psoriasis: In general, for adults, inject 80 mg of the active ingredient subcutaneously as initial dose, followed by 40 mg, once every two weeks. When its effect is insufficient, the dosage may be increased up to 80 mg at a time.
    For ankylosing spondylitis: In general, for adults, inject 40 mg of the active ingredient subcutaneously, once every two weeks. When its effect is insufficient, the dosage may be increased up to 80 mg at a time.
    For Crohn's disease: In general, for adults, inject 160 mg of the active ingredient subcutaneously as initial dose. Inject 80 mg subcutaneously two weeks after the initial dose and thereafter 40 mg subcutaneously, once every two weeks. When its effect is diminished, the dosage may be increased up to 80 mg at a time.
    For intestinal Behcet's disease: In general, for adults, inject 160 mg of the active ingredient subcutaneously as initial dose. Inject 80 mg subcutaneously two weeks after the initial dose and thereafter 40 mg subcutaneously, once every two weeks.
    For ulcerative colitis: In general, for adults, inject 160 mg of the active ingredient subcutaneously as initial dose. Inject 80 mg subcutaneously two weeks after the initial dose and thereafter 40 mg subcutaneously, once every two weeks.
    For non-infectious intermediate/posterior uveitis and panuveitis: In general, for adults, inject 80 mg of the active ingredient subcutaneously as initial dose. Inject 40 mg subcutaneously one week after the initial dose and thereafter 40 mg subcutaneously, once every two weeks.
    This medicine contains 80 mg of the active ingredient in a pen.
    In any case, strictly follow the instructions.
  • Inject this medicine into the thighs, abdomen, or upper arms. Injection site should be rotated and be sure to choose a different injection site each time. Do not inject to the sensitive area of skin, the site with wound, rash and psoriasis. Do not rub the subcutaneous injection site.
  • Inject at least 3 cm apart from the previous injected site.
  • If you miss an injection, contact your doctor.
  • 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

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include nasopharyngitis, injection site reaction (erythema, itch, rash, bleeding, swelling), rash and upper respiratory tract infection. If any of these symptoms occur, consult with your doctor or pharmacist.
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, sudden high fever with shivering, cough/phlegm [serious infections such as sepsis and pneumonia]
  • prolonged slight fever/cough (2 weeks or longer), general malaise, weight loss [tuberculosis]
  • joint pain, muscle pain, skin eruption [lupus-like syndrome]
  • reduced visual acuity/double vision, numbness/pain/motor paralysis [demyelinating disease]
  • respiratory distress, hives, swelling around the eyes or lips [serious allergic reaction]
  • malaise, loss of appetite, yellow discoloration of the skin and the white of eyes [fulminant hepatitis, liver dysfunction, jaundice, liver failure]
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 the medicine out of the reach of children. Store away from light and avoid freezing. Store at temperature of 2 to 8℃.
  • Discard the remainder. Do not store them. Ask the pharmacist or medical institution how to discard.

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.

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