くすりのしおり

Self-injection
Published: 5/2016

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 :
ORENCIA SC 125mg Autoinjector 1mL
 Active ingredient:
Abatacept (genetical recombination)
 Dosage form:
injection
 Print on wrapping:

Effects of this medicine

This medicine blocks co-stimulatory signal between antigen presenting cells and T cells, resulting in blocking T-cell activation and cytokine production related to rheumatoid arthritis. It is usually used to treat rheumatoid arthritis which conventional treatments showed insufficient results.

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 serious infectious disease.
  • 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, administer abatacept (genetical recombination) by intravenous infusion as an initial dose and subcutaneously inject 1 syringe (125 mg of the active ingredient) of this medicine on the same day. Then subcutaneously inject 1 syringe at a
    time once a week. The treatment might be started with 1 syringe injected subcutaneously once a week. Strictly follow the instructions.
  • Allow ORENCIA prefilled syringe to reach room temperature before use.
  • Check the liquid in this medicine before use. This medicine is colorless to pale yellow clear solution. Do not use the medicine if the liquid is cloudy, discolored, or has lumps or particles in it.
  • Inject this medicine into left or right abdomen avoiding about 5 cm diameter area around the naval, or into thighs or upper arms. Injection site should be at least 3 cm apart from the previously injected site, and should be rotated and changed every time you inject the medicine. Do not inject to wound site or skin rash lesion.
  • You can inject this medicine by yourself only if you have received training in how to give the injection at the medical facility and your doctor has judged you are able to give the injection properly. Receive an explanation to fully understand how to give the injection and how to properly discard syringes and needles (used needles and syringes should not be re-used). Strictly follow the instructions.
  • This medicine should be self-injected after training by your medical doctor at hospital and you might be judged your self-injection.
  • If you missed an injection or could not inject on a scheduled date, 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 change the amount of your dosage unless your doctor instructs you to do so.

Precautions while taking this medicine

  • If you feel something wrong such as breathlessness or itch during or after administration, consult with your doctor or nurse immediately.
  • Chest X-ray or other examination should be done periodically in order to prevent severe adverse drug reaction during or after administration. However, if you have prolonged cough or fever, contact with your doctor before the next consultation day and see your doctor as soon as possible.
  • Wash hands and gargle and regulate your daily life to prevent infectious disease. If you notice any unusual signs with your physical condition such as sputum, sore throat, nasal discharge, congested nose, lassitude, rash, itching of skin, shortness of breath or breathlessness, consult with your doctor, nurse or pharmacist.
  • If you notice any unusual signs other than those above or notice any changes in your physical conditions, consult with your doctor, nurse or pharmacist.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include headache, blood pressure elevation, decreased blood pressure, hypertension, upper respiratory infection (including nasopharyngitis), upper respiratory tract inflammation, nausea, stomatitis, rash (including eczema, prurigo, erythema) and sore throat. 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.
  • sputum, sore throat, nasal discharge, congested nose, lassitude [serious infection disease (sepsis, pneumonia, bronchitis, cellulitis, urinary-tract infection)]
  • lassitude, rash, itching of skin, shortness of breath, breathlessness [serious hypersensitivity (shock, anaphylactoid symptoms)]
  • fever, dry cough, breathlessness, shortness of breath [interstitial pneumonia]
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 refrigerator (2-8C), avoid freezing and light.
  • Discard the remainder. Do not store them. Ask the pharmacist and the medical institution how to discard them.
  • Throw away used syringes in biohazrd container made specifically for disposing of used syringes.
  • If you feel you are not able to continue self-injections, consult with your doctor immediately.
  • Consult with your doctor before you receive vaccination.

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.