くすりのしおり

Self-injection
Published: 2/2021

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 :
ADALIMUMAB BS Subcutaneous Injection 40mg Pen 0.8mL [FKB]
 Active ingredient:
Adalimumab(genetical recombination)[adalimumab biosimilar 1]
 Dosage form:
colorless to faintly yellowish brown and limpid or slightly white turbid 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 the possible primary causative substances in rheumatoid arthritis, psoriasis, ankylosing spondylitis, juvenile idiopathic arthritis, intestinal Behcet's disease and Crohn's disease. TNF is one of the 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; active polyarticular-juvenile idiopathic arthritis; and intestinal Behcet's disease. It is also used for inducing clinical remission and maintenance therapy in patients 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 diseases 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 juvenile idiopathic arthritis: In general, for patients weighing 15 kg to less than 30 kg, inject 20 mg of the active ingredient subcutaneously at a time, once every two weeks. For patients weighing 30 kg or over, inject 40 mg subcutaneously at a time, once every two weeks.
    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 injection and inject 40 mg subcutaneously once every two weeks from four weeks after the initial injection.
    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 injection and inject 40 mg subcutaneously once every two weeks from four weeks after the initial injection. When its effect is diminished, the dosage may be increased up to 80 mg at a time.
    This preparation contains 40 mg of the active ingredient in a pen. In any case, strictly follow the instructions.
  • Inject this medicine to the thighs, abdomen or arms. Injection site should be rotated and changed every time you inject this medicine. Do not inject this medicine to sensitive area of skin, wound site, rash or psoriasis. Do not massage the subcutaneous injection site.
  • Inject this medicine to the area at least 3 cm apart from the previously injected site.
  • Please use the whole amount at one time.
  • If you miss an injection, contact your doctor. You should never inject two doses at one time.
  • 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 headache, upper respiratory tract infection (nasopharyngitis, etc.), cough, diarrhea, rash, itch, eczema, tinea infection, fever and injection site reaction (erythema, bleeding, swelling, induration, etc.). 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.
  • rapid high fever with chills and trembling, 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]
  • dyspnea, hives, swelling around the eyes or lips [serious allergic reaction]
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 reach of children. Store away from light and moisture. Store at 2 to 8 degrees Celsius.
  • Discard the remainder. Do not store them. Seek advice of your pharmacy or medical institution about proper disposal of the unused medicines.

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.