Drug Information Sheet("Kusuri-no-Shiori")
Self-injection
Revised: 07/2013
The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval
details may vary by country. Medicines have adverse effects (risks) as well as efficacies (benefits). It is
important to minimize adverse effects and maximize efficacy. To obtain a better therapeutic response, patients
should understand their medication and cooperate with the treatment.
Brand name:ACTEMRA 162mg Syringe for SC Injection
Active ingredient:Tocilizumab(genetical recombination)
Dosage form:injectable preparation
Print on wrapping:
Effects of this medicine
This medicine improves joint pain/swelling and general symptoms accompanied by rheumatoid arthritis, and prevents
progression of joint destruction, by suppressing actions of interleukin-6 (IL-6).
It is usually used to treat rheumatoid arthritis.
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 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>>
・In general, for adults, inject 1 syringe subcutaneously at a time, at an interval of 2 weeks. Strictly follow the
instructions.
・Inject this medicine into the abdomen, thighs, or upper arms. Injection site should be rotated and changed every
time you inject the medicine. Inject to the area at least 3 cm apart from the previously injected site. Avoid
injecting this medicine into the skin with wound or rash.
・Blood test and/or ECG test may be performed before and during the treatment with this medicine.
・Only if you have received proper training at a medical facility and your doctor has judged you are capable of it, this
medicine may be self-injected. Receive an explanation to fully understand how to self-inject and how to discard
syringes and needles properly (used syringes and needles must never be re-used). Strictly follow the instructions.
・If you missed an injection, consult with 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 or not adjust the dosage unless your doctor instructs you to do so.
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 effects of this medicine
The most commonly reported adverse reactions include injection site reaction and upper respiratory 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 effects indicated in
brackets. If any of these symptoms occur, stop taking this medicine and see your doctor immediately.
・lassitude, lightheadedness, decreased consciousness, impaired mind/judgment, glow, pale face, swelling around the
eye/lip, hoarseness, breathlessness, shortness of breath, palpitation, urticaria [anaphylactic shock, anaphylactoid
symptoms]
・cold-like symptoms, lassitude, fever, vomiting, shortness of breath, cough, sore throat, rash with pain, joint pain,
pain on urination [infections]
・fever, dry cough, breathlessness, shortness of breath [interstitial pneumonia]
1/4
・nausea, vomiting, severe abdominal pain [intestinal perforation]
・fever, sore throat [agranulocytosis, leukopenia, neutropenia]
・nose/gum bleeding, continuous bleeding, blue spot, subcutaneous bleeding [thrombopenia]
・lassitude, body swelling, easy breathing in upright position than when lying down, breathlessness, shortness of
breath, palpitation on exertion [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
・Keep out of the reach of children. Store in a box, keep in the refrigerator (2 to 8℃) to avoid light and freezing.
・Discard the remainder. Do not store them. Ask the pharmacist or healthcare facility how to discard them.
・If any symptoms suspected adverse reactions appear at the time of self-injection, consult with your doctor or
pharmacist immediately.
If you feel you are not able to continue self-injections, consult with your doctor immediately.
・Do not receive live vaccines during the treatment with this medicine.
For healthcare professional use only
/
/
For further information, talk to your doctor or pharmacist.
2/4
Drug Information Sheet("Kusuri-no-Shiori")
Self-injection
Revised: 07/2013
The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval
details may vary by country. Medicines have adverse effects (risks) as well as efficacies (benefits). It is
important to minimize adverse effects and maximize efficacy. To obtain a better therapeutic response, patients
should understand their medication and cooperate with the treatment.
Brand name:ACTEMRA 162mg Auto-Injector for SC Injection
Active ingredient:Tocilizumab(genetical recombination)
Dosage form:injectable preparation
Print on wrapping:
Effects of this medicine
This medicine improves joint pain/swelling and general symptoms accompanied by rheumatoid arthritis, and prevents
progression of joint destruction, by suppressing actions of interleukin-6 (IL-6).
It is usually used to treat rheumatoid arthritis.
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 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>>
・In general, for adults, inject 1 syringe subcutaneously at a time, at an interval of 2 weeks. Strictly follow the
instructions.
・Inject this medicine into the abdomen, thighs, or upper arms. Injection site should be rotated and changed every
time you inject the medicine. Inject to the area at least 3 cm apart from the previously injected site. Avoid
injecting this medicine into the skin with wound or rash.
・Blood test and/or ECG test may be performed before and during the treatment with this medicine.
・Only if you have received proper training at a medical facility and your doctor has judged you are capable of it, this
medicine may be self-injected. Receive an explanation to fully understand how to self-inject and how to discard
syringes and needles properly (used syringes and needles must never be re-used). Strictly follow the instructions.
・If you missed an injection, consult with 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 or not adjust the dosage unless your doctor instructs you to do so.
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 effects of this medicine
The most commonly reported adverse reactions include injection site reaction and upper respiratory 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 effects indicated in
brackets. If any of these symptoms occur, stop taking this medicine and see your doctor immediately.
・lassitude, lightheadedness, decreased consciousness, impaired mind/judgment, glow, pale face, swelling around the
eye/lip, hoarseness, breathlessness, shortness of breath, palpitation, urticaria [anaphylactic shock, anaphylactoid
symptoms]
・cold-like symptoms, lassitude, fever, vomiting, shortness of breath, cough, sore throat, rash with pain, joint pain,
pain on urination [infections]
・fever, dry cough, breathlessness, shortness of breath [interstitial pneumonia]
3/4
・nausea, vomiting, severe abdominal pain [intestinal perforation]
・fever, sore throat [agranulocytosis, leukopenia, neutropenia]
・nose/gum bleeding, continuous bleeding, blue spot, subcutaneous bleeding [thrombopenia]
・lassitude, body swelling, easy breathing in upright position than when lying down, breathlessness, shortness of
breath, palpitation on exertion [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
・Keep out of the reach of children. Store in a box, keep in the refrigerator (2 to 8℃) to avoid light and freezing.
・Discard the remainder. Do not store them. Ask the pharmacist or healthcare facility how to discard them.
・If any symptoms suspected adverse reactions appear at the time of self-injection, consult with your doctor or
pharmacist immediately.
If you feel you are not able to continue self-injections, consult with your doctor immediately.
・Do not receive live vaccines during the treatment with this medicine.
For healthcare professional use only
/
/
For further information, talk to your doctor or pharmacist.
4/4