くすりのしおり

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 I.V. infusion 120mg
 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 and children aged 5 years and older, this medicine is injected by intravenous infusion over a period of 1 hour or longer at a time as an initial dose, and administer the same dose at 2 weeks and 4 weeks after starting administration. Thereafter, administer once every 4 weeks.
  • The treatment duration with this medicine depends on your response to the treatment.
  • Ask the doctor about the treatment span.

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 rash 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

  • 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.