くすりのしおり

Self-injection
Revised: 8/2021

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 :
Benlysta for S.C. injection 200mg Syringe
 Active ingredient:
Belimumab (genetical recombination)
 Dosage form:
injection
 Print on wrapping:

Effects of this medicine

This medicine exerts its treatment effect through suppressing B cell proliferation by inhibiting activity of B-lymphocyte stimulator which relates to pathology of systemic lupus erythematosus.
It is usually used in systematic lupus erythematosus patients with insufficient efficacy of existing medications, such as steroids and immunosuppressive drugs.

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 or are suspected of having bacterial/viral infection.
    If you have or have a history of tuberculosis. If anyone who has close contact with you (anyone in your household, etc.) has tuberculosis.
  • 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, once a week. Strictly follow the instructions.
  • Before injection, leave the syringe at room temperature for about 30 minutes.
  • Inject this medicine into the abdomen or thighs. Be sure to choose a different injection site each time if you use the same area of your body. Avoid injecting into the site with sensitive skin, internal bleeding, redness or hardening.
  • 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), and follow the instructions.
  • Read the instruction leaflet included in the package of this medicine carefully before use.
  • If you miss an injection or cannot 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

  • Chest X-ray or other examinations such as blood test may be done periodically in order to prevent severe adverse reactions 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.
  • Use an effective contraceptive method during the treatment and at least for 4 months after stop using this medicine if you are a woman with possibility of pregnancy.
  • Psychotic or behavioral symptoms may appear, including depression, suicidal ideation or suicide attempt. If any changes in your mental state such as insomnia or feeling anxiety occur, contact your doctor immediately.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include injection site reaction and fever. 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.
  • blood pressure falling, hives, angioedema [serious hypersensitivity]
  • fever, cold-like symptoms, general malaise [infection]
  • consciousness disorder, cognitive impairment, paralytic symptoms (hemiparesis, paralysis of limbs) [progressive multifocal leukoencephalopathy]
  • fever, cough, respiratory distress [interstitial pneumonia]
  • insomnia, loss of interest, attempt suicide [depression, suicidal ideation, suicide attempt]
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 reach of children. Store at 2 to 8 degrees Celsius, away from light and avoid freezing.
  • Discard the remainder. Do not store them. Ask the pharmacy or medical institution on how to discard them.
  • If any symptoms suspected of 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 while using this medicine.
  • [To family members] You need to be informed about the possible change in the patient's mood or behavior such as depression, suicidal ideation or suicide attempt. Please receive enough explanation from the doctor until you fully understand it, and monitor the patient's condition. If you notice any changes in behavior or symptoms in the patient such as insomnia or feeling anxiety, contact the doctor immediately.

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.