くすりのしおり

Self-injection
Revised: 4/2018

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 :
LUMICEF Subcutaneous Injection 210mg Syringe
 Active ingredient:
Brodalumab (genetical recombination)
 Dosage form:
injection
 Print on wrapping:

Effects of this medicine

This medicine selectively binds to Interleukin-17 (IL-17) receptor A to suppress IL-17 activity. It consequently improves psoriasis symptoms.
It is usually used to treat psoriasis vulgaris, psoriatic arthritis, pustular psoriasis, psoriatic erythroderma with inadequate response to 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 infections or are suspected of them.
    If you have active tuberculosis or have a history of tuberculosis.
    If you have depression/state of depression or have a history of them.
    If you have a history of suicidal thought (considering suicide on impulse) or suicide attempt.
    If you have active Crohn's Disease.
    If you are scheduled for vaccination with a live virus vaccine.
  • 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 (210 mg of the active ingredient) at a time, subcutaneously at weeks 0, 1, and 2 followed by every 2 weeks. Strictly follow the instructions.
  • When your doctor confirms that you are able to reliably self-inject after the start of treatment, you can start self-injection.
  • This medicine may be used for a long period of time depending on your response to treatment.
  • Allow this medicine to reach room temperature before use.
  • Do not inject areas of the skin that are sensitive or abnormal [scratch, redness, sclerosis, thickness, scaling (peeled surface skin), or other abnormalities], or sites of psoriasis.
  • Inject this medicine into the thighs, abdomen, or upper arms. You should change the injection site every time and inject the medicine at least 3 to 5 cm apart from the previous site.
  • Do not massage the injected site after injection.
  • If you missed an injection, or were unable to inject on the 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 unless your doctor instructs you to do so.

Precautions while taking this medicine

  • To pay attention to infections such as tuberculosis, periodical chest X-ray test and other tests are required while using this medicine. If you have symptoms suggestive of tuberculosis (persistent cough, weight loss, fever, etc.), immediately consult with your doctor.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include upper respiratory infection, nasopharyngitis, headache, joint pain, itch, fatigue, and oral candidosis. 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.
  • general malaise, fever, vomiting [serious infections]
  • fever, sore throat [decreased neutrophil count]
  • hives, light headedness, breathing difficulty [serious hypersensitivity]
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 and avoid light and freezing.
  • Discard the remainder. Do not store them. Ask the pharmacist and the medical institution how to discard them.

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.