Download Drug Information Sheet("Kusuri-no-Shiori") Injection Revised: 05

Drug Information Sheet("Kusuri-no-Shiori")
Injection
Revised: 05/2016
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:REMICADE for I.V. Infusion 100
Active ingredient:Infliximab (genetical recombination)
Dosage form:injection
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Effects of this medicine
This medicine relieves inflammation and improves symptoms, by suppressing the action of TNFα as cause of
abnormal immunity in various diseases.
It is usually used for treatment of rheumatoid arthritis, refractory retinouveitis associated with Behcet’s disease,
psoriasis, ankylosing spondylitis, entero-/neuro-/vasculo-Behcet’s disease, acute Kawasaki's disease, Crohn’s
disease and ulcerative colitis.
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 internal medicines or injections.
If you have: infection (sepsis, etc.), tuberculosis or a history of it, congestive heart failure.
If you or your family have/has demyelinating disease (multiple sclerosis, etc.) or a history of it.
・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, this medicine is given by intravenous drip infusion. After the first infusion,
additional doses are given at 2 and 6 weeks, and then every 8 weeks thereafter. After the additional dose at week
6, shorter dosing intervals can be given if inadequate response is observed.
For refractory retinouveitis associated with Behcet’s disease: In general, this medicine is given by intravenous drip
infusion. After the first infusion, additional doses are given at 2 and 6 weeks, and then every 8 weeks thereafter.
For psoriasis: In general, this medicine is given by intravenous drip infusion. After the first infusion, additional
doses are given at 2 and 6 weeks, and then every 8 weeks thereafter. After the additional dose at week 6, shorter
dosing intervals can be given if inadequate response is observed.
For ankylosing spondylitis: In general, this medicine is given by intravenous drip infusion. After the first infusion,
additional doses are given at 2 and 6 weeks, and then every 6 to 8 weeks thereafter.
For entero-/neuro-/vasculo-Behcet’s disease: In general, this medicine is given by intravenous drip infusion.
After the first infusion, additional doses are given at 2 and 6 weeks, and then every 8 weeks thereafter.
For acute Kawasaki's disease: In general, this medicine is given once by intravenous drip infusion.
For Crohn’s disease: In general, this medicine is given by intravenous drip infusion. After the first infusion,
additional doses are given at 2 and 6 weeks, and then every 8 weeks thereafter.
For ulcerative colitis: In general, this medicine is given by intravenous drip infusion. After the first infusion,
additional doses are given at 2 and 6 weeks, and then every 8 weeks thereafter.
・In any case, this medicine is intravenously infused over a period of not less than 2 hours.
・The dosing interval and treatment duration depend on your symptoms.
Precautions while taking this medicine
・The effect of this medicine persists for a long time and compromises the immune system, which may lead to
susceptibility to infections. Do not overload and get enough sleep in your daily life. If you feel cold-like symptoms
or have persistent cough or sputum, make sure you consult with your doctor.
・Avoid administration of live vaccines during treatment with this medicine. Administration of live vaccines may
increase the risk of infections. If you want to get a vaccination, make sure you consult with your doctor.
Possible adverse reactions to this medicine
The most commonly reported adverse reactions include laryngopharyngitis, fever, rash, headache, and infusion
related reaction. 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.
・fever, headache, vomiting, cough/sputum, shortness of breath/respiratory distress, muscle/joint pain [infections]
・general malaise, slight fever, persistent cough [tuberculosis]
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・respiratory distress, wheezing, headache, dizziness, lassitude, swelling of eyelids/lips/tongue, fever, hives [serious
infusion reactions]
・numbness/paralysis of feet, lassitude, restricted eye movement [demyelinating diseases]
・fever, cough, respiratory distress [interstitial pneumonia]
・rash, fever, pruritus, edema of hands/face, hives [delayed hypersensitivity reaction]
・joint pain, muscle pain, eruption [lupus-like syndrome accompanied by positive for antibodies against dsDNA]
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
・Consult with your doctor about vaccination.
・Bovine-derived materials are used during the manufacturing process of this medicine. Although no transmission of
transmissible spongiform encephalopathy (TSE) to humans caused by administration of this medicine has been
reported to date, the theoretical risk of transmission of TSE through this medicine cannot be completely ruled out.
For healthcare professional use only
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For further information, talk to your doctor or pharmacist.
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