くすりのしおり

Self-injection
Revised: 8/2021

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 SYRINGE 0.8mL "DAIICHI SANKYO"
 Active ingredient:
Adalimumab (genetical recombination) [adalimumab biosimilar 2]
 Dosage form:
injection
 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 and juvenile idiopathic arthritis. 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: active polyarticular-juvenile idiopathic arthritis; psoriasis vulgaris, psoriasis arthritis or pustular psoriasis; ankylosing spondylitis; intestinal Behcet's disease; and moderate to severe ulcerative colitis.
It is also used for inducing clinical remission and maintenance 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 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 with body weight of 15 kg to less than 30 kg, inject 20 mg of the active ingredient subcutaneously, once every two weeks. For patients with body weight of more than 30 kg, inject 40 mg of the active ingredient subcutaneously, 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 thereafter 40 mg subcutaneously, once every two weeks.
    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 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 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 injection and thereafter 40 mg subcutaneously, once every two weeks.
    This preparation contains 40 mg of the active ingredient in a syringe.
    In any case, strictly follow the instructions.
  • Inject this medicine to the thighs, abdomen or upper 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 a cutaneous lesion. 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 upper respiratory tract infection (such as nasopharyngitis), injection site reaction (erythema, itch, rash, bleeding, swelling) and rash. 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]
  • 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]
  • general dullness, fever, prolonged bleeding, bleeding tendency, nose bleeding, blue spot, shortness of breath  [serious blood disorder]
  • fever, dry cough, breathing difficulty, shortness of breath [interstitial pneumonia]
  • malaise, loss of appetite, yellowing 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 out of the reach of children. Store away from light. Store at temperature of 2 to 8℃.
  • 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.