Active Ingredient: Concizumab
Concizumab is indicated for routine prophylaxis of bleeding in patients with haemophilia B (congenital factor IX deficiency) with FIX inhibitors and of 12 years of age or more.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Subcutaneous, 1 milligrams concizumab per kilogram of body weight, one dose, over the duration of 1 day. Afterwards, subcutaneous, 0.2 milligrams concizumab per kilogram of body weight, once daily, over the duration of 4 weeks. Afterwards, subcutaneous, between 0.15 milligrams concizumab per kilogram of body weight and 0.25 milligrams concizumab per kilogram of body weight, once daily.
Treatment should be initiated in a non-bleeding state.
Treatment with rFVIIa should be discontinued at least 12 hours before starting concizumab therapy and treatment with aPCC should be discontinued at least 48 hours before.
The recommended dosing regimen is
Table 1. Individual maintenance dose based on concizumab plasma concentration:
| Concizumab plasma concentration | Once daily dose concizumab |
|---|---|
| <200 ng/mL | 0.25 mg/kg |
| 200−4 000 ng/mL | 0.20 mg/kg |
| >4 000 ng/mL | 0.15 mg/kg |
Individual maintenance dose setting should be performed at the earliest convenience (after concizumab plasma concentration result is available) and recommended no later than 8 weeks after initiation of treatment. Additional concizumab plasma concentration measurement(s) can be taken after 8 weeks on the same maintenance dose according to the patient’s medical condition. For example, this should be considered if a patient experiences an increased bleeding frequency, a large change in body weight, has missed doses before maintenance dose setting, or acquires a comorbidity, which can lead to an increase in the overall thromboembolic risk.
Since concizumab is dosed per body weight (mg/kg), it is important to recalculate the dose (mg) when the body weight changes.
Concizumab is intended for long-term prophylactic treatment.
Concizumab can be administered any time during the day.
It is important that each patient adheres to their daily dosing. Adherence is particularly important during the initial 4 weeks to ensure a correct maintenance dose is properly established based on the week 4 concizumab plasma concentration. Patients who miss doses before the maintenance dose has been established should resume treatment as soon as possible at the initial 0.2 mg/kg daily dose and inform their healthcare professional.
The following dosing guidelines should apply ONLY when a patient has forgotten to or neglected to take their once daily maintenance dose.
When in doubt, the patient should contact their healthcare professional.
No dose adjustment of concizumab should be done in case of breakthrough bleeds.
Physicians should discuss with the patient and/or caregiver about the dose and schedule of bypassing agents, if required while receiving concizumab prophylaxis.
Treatment with bypassing agents (e.g., rFVIIa or aPCC) can be used for breakthrough bleeds, and the dose and duration will depend on the location and severity of the bleed.
For mild and moderate bleeds that require additional treatment with bypassing agents (e.g., rFVIIa or aPCC), the lowest approved dose and the dose interval as in the approved label is recommended. Furthermore, for aPCC a maximum dose of 100 U/kg body weight within 24 hours is recommended.
For severe bleeds it is recommended to follow the dosing scheme provided in the approved label for the specific product based on clinical judgement.
No dose adjustment of concizumab is needed in case of minor surgeries.
Before major surgery, a healthcare professional experienced in treatment of haemophilia and/or bleeding disorders should be consulted. As there is limited clinical experience in using concizumab during major surgeries, it is generally recommended to pause concizumab at least 4 days prior to elective major surgery. Concizumab therapy can be resumed 10-14 days after surgery on the same maintenance dose without a new loading dose, considering the overall clinical picture of the patient. The criteria for major surgery are any invasive operative procedure that requires ≥3 doses of bypassing therapy and/or where any one or more of the following occur:
The safety and efficacy of concomitant use with concizumab in patients receiving ongoing ITI, a desensitisation strategy for eradication of inhibitors, have not been established. No data is available. Careful assessment of potential benefits and risks should be performed if continuation or initiation of concizumab during ITI is considered.
Concizumab should be administered daily, at any time point of the day, not necessarily the same time point every day.
Concizumab may be self-administered, or administered by a caregiver, after receiving appropriate training by a health care professional and reading the Instructions for Use.
Concizumab should be administered by subcutaneous injection to the abdomen or thigh with rotation of injection site every day. Subcutaneous injections should not be given in areas where the skin is tender, bruised, red or hard, or areas where there are moles or scars.
A new needle should always be used for each injection.
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