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 :
HEMLIBRA for subcutaneous injection 60mg
 Active ingredient:
Emicizumab(genetical recombination)
 Dosage form:
injection
 Print on wrapping:

Effects of this medicine

This medicine improves the symptom of prolonged bleeding by promoting the activation of blood-clotting protein in the blood.
It is usually used to suppress a bleeding tendency in patients with congenital blood coagulation factor VIII deficiency who have coagulation factor VIII inhibitors.

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))
  • In general, inject 3 mg of the active ingredient per kilogram of the body weight subcutaneously, at an interval of 1 week for 4 times, then inject subcutaneously according to any one of the following dosing schedule. Strictly follow the instructions.
    - 1.5 mg of the active ingredient per kilogram of body weight, at an interval of 1 week
    - 3 mg of the active ingredient per kilogram of body weight, at an interval of 2 weeks
    - 6 mg of the active ingredient per kilogram of body weight, at an interval of 4 weeks
  • Inject this medicine into the abdomen, upper arms, or thighs. Avoid injecting into the same area of your body repeatedly.
  • 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. You should be thoroughly instructed regarding preparation procedures, injection procedures, not to reuse needles or syringes, and their disposal methods. Strictly follow the instructions
  • If you miss a dose, consult with your doctor or pharmacist. You should never use two doses at one time.
  • If you accidentally use more than your prescribed dose, consult with your doctor.
  • Do not stop using this medicine or adjust the dose 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. 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, see your doctor immediately.
  • vomiting, nausea, lassitude, paralysis, severe headache, chest pain, constrictive chest pain, sudden shortness of breath, severe abdominal pain, abdominal bloating, severe leg pain [thromboembolism]
  • bleeding tendency, nasal bleeding, gum bleeding, bruise, bloody urine [thrombotic microangiopathy]
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

  • Store the vial in the outer case and in a refrigerator (2 to 8℃) to avoid light and freezing. If stored at room temperature (below 30℃) for any reason, use within the room temperature cumulative storage time of 7 days.
  • Keep out of the reach of children.
  • Discard the remainder. Do not store them. Ask the pharmacist or healthcare facility 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 use activated prothrombin complex concentrate (anti-inhibitor coagulant complex) including activated blood coagulation factor IX and blood coagulation factor X or freeze-dried activated human blood coagulation factor VII concentrate containing factor X during treatment and for 6 months after withdrawal of treatment.
  • When you need to self-inject activated blood coagulation factor VII (eptacog alfa [activated] [genetical recombination]) at home during treatment with this medicine, ask your doctor in advance about how to assess the needs for medication and the dosage. If single self-injection does not stop your bleeding, consult with the medical institution.
  • For bleeding episodes while use of this medicine, ask your doctor in advance about the need for, types of, and dosage of blood coagulation factor VIII self-injection at home.

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.

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