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 40mg for S.C. Injection Pen 0.4mL
 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 in the treatment of rheumatoid arthritis (including prevention of structural joint damage) and used in the treatment of the following diseases with inadequate response to conventional therapies: psoriasis vulgaris, psoriasis arthritis or pustular psoriasis, ankylosing spondylitis, active polyarticular-juvenile idiopathic arthritis, 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: 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))
  • For rheumatoid arthritis: In general, for adults, subcutaneously inject 1 pen (40 mg of the active ingredient) per dose, every two weeks. The dosage may be increased up to 2 pens (80 mg) per dose if the effect is insufficient.
    For psoriasis vulgaris, psoriasis arthritis or pustular psoriasis: : In general, for adults, subcutaneously inject initial dose of 2 pens (80 mg of the active ingredient), followed by 1 pen (40 mg of the active ingredient) per dose, every two weeks and onwards. The dosage may be increased up to 2 pens (80 mg) per dose if the effect is insufficient.
    For ankylosing spondylitis: In general, for adults, subcutaneously inject 1 pen (40 mg of the active ingredient) per dose, every two weeks. The dosage may be increased up to 2 pens (80 mg) per dose if the effect is insufficient.
    For juvenile idiopathic arthritis: In general, if the patient weight is 30 kg or more, inject subcutaneously 1 pen (40 mg of the active ingredient) per dose, every two weeks.
    For Crohn's disease: In general, for adults, subcutaneously inject initial dose of 4 pens (160 mg of the active ingredient). Two weeks after the initial dose, subcutaneously inject 2 pens (80 mg of the active ingredient). After another two weeks, subcutaneously inject 1 pen (40 mg of the active ingredient) per dose, and continue every two weeks and onwards. The dosage may be increased up to 2 pens (80 mg) per dose if the effect is diminished.
    For intestinal Behcet's disease: In general, for adults, subcutaneously inject initial dose of 4 pens (160 mg of the active ingredient). Two weeks after the initial dose, subcutaneously inject 2 pens (80 mg of the active ingredient). After another two weeks, subcutaneously inject 1 pen (40 mg of the active ingredient) per dose, and continue every two weeks and onwards.
    For ulcerative colitis: In general, for adults, subcutaneously inject initial dose of 4 pens (160 mg of the active ingredient). Two weeks after the initial dose, subcutaneously inject 2 pens (80 mg of the active ingredient). After another two weeks, subcutaneously inject 1 pen (40 mg of the active ingredient) per dose, and continue every two weeks and onwards.
    For non-infectious intermediate/posterior uveitis and panuveitis: In general, for adults, subcutaneously inject initial dose of 2 pens (80 mg of the active ingredient). One week after the initial dose, subcutaneously inject 1 pen (40 mg of the active ingredient). After another two weeks, subcutaneously inject 1 pen (40 mg of the active ingredient) per dose, and continue every two weeks and onwards.
    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 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.
  • Inject to the area at least 3 cm apart from the previously injected site.
  • 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. 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.
  • chill, sudden high fever with shiver, 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]
  • respiratory distress, 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 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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