くすりのしおり

Self-injection
Revised: 11/2016

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 20mg for S.C. Injection Syringe 0.4mL
 Active ingredient:
Adalimumab (genetical recombination)
 Dosage form:
colorless limpid or slightly opalescent injectable solution in prefilled syringe
 Print on wrapping:

Effects of this medicine

This medicine suppresses function of TNF-α which is the major causative substance of juvenile idiopathic arthritis. TNF (tumor necrosis factor) is one of cytokines existing inside of the body even in a healthy one, and involved in activities of immunity and development of inflammation or pain.
It is usually used in the treatment of patients with active, polyarticular-course juvenile idiopathic arthritis who had insufficient response to conventional therapy.

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: infections such as sepsis or suspected of them, tuberculosis or a history of it, demyelinating disease such as multiple sclerosis or a personal/family history of it, hematologic disease or a history of it, a history of hepatitis B virus infection, congestive heart failure.
    If you are a hepatitis B virus carrier.
    If you have just received live vaccine.
  • 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))
  • In general, if the patient weight is 15 kg to less than 30 kg, inject 1 syringe (20 mg of the active ingredient) subcutaneously at a time, every two weeks. Strictly follow the instructions.
  • Inject this medicine to the thighs, abdomen or arms. Injection site should be rotated and changed every time you inject the medicine. Do not inject to sensitive area of skin, wound site, skin rash or a psoriasis lesion. Do not massage the subcutaneous injection site.
  • You need to inject in the area of at least 3 cm apart from the last injection site.
  • Please use the whole amount at one time.
  • If you miss an injection, consult with 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.
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.
  • chill, sudden high fever with shivering, cough, sputum  [severe infections such as sepsis or pneumonia]
  • prolonged slight fever or cough (2 weeks or over), general malaise, weight loss  [tuberculosis]
  • joint pain, muscular pain, skin eruption  [lupus-like syndrome]
  • reduced vision, double vision, numbness, pain, paralysis  [demyelinating disease]
  • breathing difficulty, hives, swelling around the eye or lip  [severe allergic reaction]
  • malaise, loss of appetite, yellowness in the skin and/or the white of the eye  [fulminant hepatitis, hepatic dysfunction, jaundice, hepatic insufficiency]
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 it away from light and freeze, 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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