Active Ingredient: Bulevirtide
Bulevirtide is indicated for the treatment of chronic hepatitis delta virus (HDV) infection in plasma (or serum) HDV-RNA positive adult and paediatric patients 3 years of age and older weighing at least 10 kg with compensated liver disease.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Subcutaneous, 2 milligrams bulevirtide, once daily.
Bulevirtide should be administered once daily (every 24 hours ± 4 hours) by subcutaneous injection as monotherapy or in co-administration with a nucleoside/nucleotide analogue for treatment of underlying hepatitis B virus (HBV) infection.
The recommended dose of bulevirtide in adult patients is 2 mg once daily.
The optimal treatment duration is unknown. Treatment should be continued as long as associated with clinical benefit.
Consideration to discontinue the treatment should be given in case of sustained (6 months) HBsAg seroconversion or loss of virological and biochemical response.
If an injection has been omitted and less than 4 hours have elapsed since the scheduled time, the injection must be performed as soon as possible. The time of the next injection will not be calculated from the time of the “rescue” injection, but according to the injection schedule previously established. It is, therefore, necessary to return to the usual pattern of administration, at the appointed time, the following day.
If an injection has been missed and more than 4 hours have elapsed since the scheduled time, the missed dose should not be administered.
The next injection will take place according to the usual schedule (injection of the prescribed dose without doubling), at the appointed time the next day.
If the injection has been made by mistake more than 4 hours after the scheduled time, the next administration must take place in the usual way (i.e. in accordance with the original schedule).
Bulevirtide may be injected into sites such as the upper thigh, or abdomen.
For:
Regimen A: In case that patient age in years is ≥ 3 and patient weight is ≥ 10 kg and patient weight is < 25 kg, subcutaneous, 1 milligrams bulevirtide, once daily.
Regimen B: In case that patient age in years is ≥ 3 and patient weight is ≥ 25 kg and patient weight is < 35 kg, subcutaneous, 1.5 milligrams bulevirtide, once daily.
Regimen C: In case that patient age in years is ≥ 3 and patient weight is ≥ 35 kg, subcutaneous, 2 milligrams bulevirtide, once daily.
Bulevirtide should be administered once daily (every 24 hours ± 4 hours) by subcutaneous injection as monotherapy or in co-administration with a nucleoside/nucleotide analogue for treatment of underlying hepatitis B virus (HBV) infection.
The recommended dose of bulevirtide in paediatric patients is based on weight as detailed in the table below.
Dosing for paediatric patients:
| Body Weight (kg) | Bulevirtide Daily Dose |
|---|---|
| 10 kg to <25 kg | 1 mg |
| 25 kg to <35 kg | 1.5 mg |
| 35 kg and above | 2 mg |
The optimal treatment duration is unknown. Treatment should be continued as long as associated with clinical benefit.
Consideration to discontinue the treatment should be given in case of sustained (6 months) HBsAg seroconversion or loss of virological and biochemical response.
If an injection has been omitted and less than 4 hours have elapsed since the scheduled time, the injection must be performed as soon as possible. The time of the next injection will not be calculated from the time of the “rescue” injection, but according to the injection schedule previously established. It is, therefore, necessary to return to the usual pattern of administration, at the appointed time, the following day.
If an injection has been missed and more than 4 hours have elapsed since the scheduled time, the missed dose should not be administered.
The next injection will take place according to the usual schedule (injection of the prescribed dose without doubling), at the appointed time the next day.
If the injection has been made by mistake more than 4 hours after the scheduled time, the next administration must take place in the usual way (i.e. in accordance with the original schedule).
Bulevirtide may be injected into sites such as the upper thigh, or abdomen.
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