Active Ingredient: Emicizumab
Emicizumab is indicated for routine prophylaxis of bleeding episodes in patients with haemophilia A (congenital factor VIII deficiency):
Emicizumab can be used in all age groups.
For this indication, competent medicine agencies globally authorize below treatments:
Regimen A: Subcutaneous, 3 milligrams emicizumab per kilogram of body weight, once weekly, over the duration of 4 weeks. Afterwards, subcutaneous, 1.5 milligrams emicizumab per kilogram of body weight, once weekly.
Regimen B: Subcutaneous, 3 milligrams emicizumab per kilogram of body weight, once weekly, over the duration of 4 weeks. Afterwards, subcutaneous, 3 milligrams emicizumab per kilogram of body weight, once every 2 weeks.
Regimen C: Subcutaneous, 3 milligrams emicizumab per kilogram of body weight, once weekly, over the duration of 4 weeks. Afterwards, subcutaneous, 6 milligrams emicizumab per kilogram of body weight, once every 4 weeks.
Treatment (including routine prophylaxis) with bypassing agents (e.g. activated prothrombin complex concentrate [aPCC] and activated recombinant human FVII [rFVIIa]) should be discontinued the day before starting emicizumab therapy.
Factor VIII (FVIII) prophylaxis may be continued for the first 7 days of emicizumab treatment.
The recommended dose is 3 mg/kg once weekly for the first 4 weeks (loading dose), followed by a maintenance dose from week 5, of either 1.5 mg/kg once weekly, 3 mg/kg every two weeks, or 6 mg/kg every four weeks, all doses administered as a subcutaneous injection.
The loading dose regimen is the same, irrespective of the maintenance dose regimen.
The maintenance dose regimen should be selected based on physician and patient/caregiver dosing regimen preference to support adherence.
The patient dose (in mg) should be calculated as follows:
Different emicizumab concentrations should not be combined in the same syringe when making up the total volume to be administered.
Emicizumab is intended for long-term prophylactic treatment.
No dose adjustments of emicizumab are recommended.
If a patient misses a scheduled subcutaneous injection of emicizumab, the patient should be instructed to take the missed dose as soon as possible, up to a day before the day of the next scheduled dose. The patient should then administer the next dose on the usual scheduled dosing day. The patient should not take two doses on the same day to make up for a missed dose.
No dose adjustments are recommended in paediatric patients. There are no data in patients less than 1 year of age.
No dose adjustments are recommended in patients ≥65 years of age. There are no data in patients over 77 years old.
The injection should be restricted to the recommended injection sites: the abdomen, the upper outer arms and the thighs.
Administration of emicizumab subcutaneous injection in the upper outer arm should be performed by a caregiver or healthcare professional.
Alternating the site of injection may help prevent or reduce injection site reactions. Emicizumab subcutaneous injection should not be administered into areas where the skin is red, bruised, tender or hard, or areas where there are moles or scars.
During treatment with emicizumab, other medicinal products for subcutaneous administration should, preferably, be injected at different anatomical sites.
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