くすりのしおり

Self-injection
Revised: 12/2018

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 :
KEVZARA 200mg Syringe for S.C. Injection
 Active ingredient:
Sarilumab(genetical recombination)
 Dosage form:
colorless to faint yellow limpid solution (injection)
 Print on wrapping:

Effects of this medicine

This medicine is human anti-Interleukin (IL)-6 monoclonal antibody preparation. IL-6 is excessively present in synovial fluid and blood. This medicine binds to IL-6 receptors instead of IL-6, to suppress the activity of IL-6. Thereby it improves symptoms of rheumatoid arthritis.
It is usually used to treat rheumatoid arthritis with insufficient efficacy of existing 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 infection or are susceptible to 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 are a hepatitis virus carrier.
    If you have just received a vaccination.
    If you have a history of interstitial pneumonia.
    If you have intestinal diverticulum (pouch-like cavity formed in the intestine).
  • 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 200 mg of the active ingredient at a time subcutaneously once every two weeks. The dosage may be reduced to 150 mg at a time according to the condition. This medicine contains 200 mg of the active ingredient in a syringe. Strictly follow the instructions.
  • Take the medicine out of a refrigerator. Leave it in the original box, at room temperature, for at least 30 minutes before use.
  • Do not use if the solution is cloudy, discolored or contains particles, or if any part of the syringe appears to be damaged.
  • Inject this medicine into the abdomen (avoiding at least 5 cm area around your navel), thigh or upper arm. Change the injection site each time you inject and inject at least 3 cm apart from the previous injection site. Do not inject to areas that are sensitive/wounded/reddened or with rash/induration (hard lump).
  • Do not massage the injection site to prevent itch, swelling, bleeding, pain, etc.
  • The treatment period with this medicine depends on your symptoms. However, if treatment response is not obtained within 12 weeks, whether to continue the current treatment will be considered.
  • If you miss a dose and you notice it within 3 days, inject the missed dose as soon as possible. If you notice after 4 days or more have passed, consult with your doctor, pharmacist or nurse. 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 unless your doctor instructs you to do so.

Precautions while taking this medicine

  • Blood tests are periodically performed in order to confirm infection. If infection is suspected, chest X-ray, CT, etc. are performed. If you have symptoms suspected of infection (shortness of breath, cough, sore throat, skin abnormality, pain during urination, etc.), immediately consult with your doctor.
  • While using this medicine, chest X-ray and others are periodically performed in order to confirm tuberculosis. If you have symptoms suspected of tuberculosis (persistent cough, fever, etc.), immediately consult with your doctor.
  • As a guide, lipid tests are performed 3 months after the initial injection, and thereafter, as necessary.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include nasopharyngitis, injection site erythema (injection site becomes reddened) and stomatitis. 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, general malaise, cold-like symptoms [infection]
  • sore throat, fever, nose/gum bleeding [agranulocytosis, leukopenia, neutropenia, thrombocytopenia]
  • abdominal pain, fever, nausea [intestinal tract perforation]
  • reduction of blood pressure, respiratory distress, unconsciousness [shock, anaphylaxis]
  • fever, dry cough, respiratory distress [interstitial pneumonia]
  • general malaise, loss of appetite, nausea [liver dysfunction]
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 at 2 to 8 degrees Celsius (refrigerator) in the original case, away from light and avoid freezing.
  • Discard the remainder. Do not store them. Consult with your pharmacy or medical institution how to discard.
  • If you wish to receive a vaccination, consult with your doctor.

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.

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