くすりのしおり

Self-injection
Revised: 5/2021

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 :
Nucala solution for s.c. injection 100mg Pen
 Active ingredient:
Mepolizumab(genetical recombination)
 Dosage form:
injection
 Print on wrapping:

Effects of this medicine

This medicine inhibits interleukin-5 (IL-5) to reduce the increasing number of eosinophil which is one of the causes of bronchial asthma and eosinophilic granulomatosis with polyangiitis. As a result, it suppresses inflammation and helps to prevent symptoms.
It is usually used to treat refractory bronchial asthma whose symptoms are not able to be controlled with conventional therapy and eosinophilic granulomatosis with polyangiitis with insufficient efficacy of conventional therapy. It should not be used in bronchial asthma patients to relieve their asthma attack that has already begun.

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 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))
  • For bronchial asthma: In general, for adults and children aged 12 years and older, inject 1 syringe (100 mg of the active ingredient) subcutaneously, at a time, once every 4 weeks.
    For eosinophilic granulomatosis with polyangiitis: In general, for adults, inject 3 syringes (300 mg) subcutaneously, at a time, once every 4 weeks.
    In any case, strictly follow the instructions.
  • Before injection, leave the syringe at room temperature for 30 minutes or more.
  • Once you open the package, use this medicine within 8 hours. If you have not used it for more than 8 hours, discard it.
  • Inject this medicine into your upper arms, thighs or abdomen. Be sure that individual injection sites are separated by at least 5 cm if you inject 3 syringes at once.
  • 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 unless your doctor instructs you to do so.

Precautions while taking this medicine

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include injection site reaction (pain, erythema, swelling, itch, burning sensation) and headache. 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.
  • respiratory distress, general malaise, hot flush [anaphylaxis]
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 in a refrigerator (2 to 8 degrees Celsius) and avoid freezing. After taking this medicine out of a refrigerator, keep it in the outer carton, store at room temperature (below 30 degrees Celsius) and use within 7 days. Once you open the outer carton, store this medicine away from light.
  • 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.

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.