くすりのしおり

Injection
Revised: 6/2019

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 :
ACTEMRA 200mg for Intravenous Infusion
 Active ingredient:
Tocilizumab(genetical recombination)
 Dosage form:
injection
 Print on wrapping:

Effects of this medicine

This medicine improves joint pain/swelling and general symptoms associated with rheumatoid arthritis, polyarticular-course juvenile idiopathic arthritis (pJIA), systemic juvenile idiopathic arthritis (sJIA) and prevents progression of joint destruction in rheumatoid arthritis, by suppressing the actions of Interleukin-6 (IL-6). This medicine improves fever, joint pain/swelling and rash associated with Adult Still's disease, conditions (e.g. general malaise) and laboratory findings (e.g. increased C-reactive protein, anemia) associated with Castleman's disease, also improves fever and general dullness symptoms associated with cytokine release syndrome (CRS).
It is usually used for treatment of rheumatoid arthritis, polyarticular-course juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, Adult Still's disease, Castleman's disease and cytokine release syndrome induced by tumor-specific T cell infusion 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 bacterial/viral infection.
    If you have tuberculosis or have a history of it.
    If anyone who has close contact with you (anyone in your household, etc.) has tuberculosis.
    If you have interstitial pneumonia or have a history of it.
    If you have a macrophage activation syndrome (MAS).
    If you have intestinal diverticulum.
    If you have leukopenia, neutropenia or thrombopenia.
  • 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))
  • Rheumatoid arthritis, polyarticular-course juvenile idiopathic arthritis (pJIA): In general, you are administered with intravenous infusion once every four weeks.
    Systemic juvenile idiopathic arthritis (sJIA), Adult Still's disease, Castleman's disease: In general, you are administered with intravenous infusion once every two weeks.
    Cytokine release syndrome (CRS): In general, you are administered with intravenous infusion once.
  • It will take about one hour for one intravenous infusion.
  • The treatment period with this medicine depends on your response to the treatment.
  • Blood test and/or ECG test may be performed before and during the treatment with this medicine.

Precautions while taking this medicine

  • You should receive blood test, chest X-ray test, and ECG test regularly during the treatment with this medicine. Receive these tests according to instructions of your doctor.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include upper respiratory infection, rash, gastroenteritis, pneumonia, tinea and periodontal disease. 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.
  • generalized itching, hives, itchy throat, lightheadedness, dizziness, palpitation, breathing difficulty, cold sweat, pale face, cold hands/feet [anaphylactic shock, anaphylaxis]
  • chills, general dullness, fever, cough, small blisters appearing in a belt-like shape, red swelling with pain and fever, joint pain [infections]
  • fever, cough, breathing difficulty, shortness of breath [interstitial pneumonia]
  • nausea, vomiting, severe abdominal pain, chills, fever, lightheadedness, shortness of breath, decreased consciousness [intestinal perforation]
  • sudden high fever, chills, sore throat [agranulocytosis, leukopenia, neutropenia]
  • nose/gum bleeding, bruise, bleeding tendency [thrombopenia]
  • easy fatigability, edema, breathing difficulty, shortness of breath, increase in body weight [cardiac 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

  • Do not receive live vaccines during the treatment with this medicine.

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.

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