Active Ingredient: Donidalorsen
Donidalorsen is indicated for routine prevention of recurrent attacks of hereditary angioedema (HAE) in adults and adolescents aged 12 years and older.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Subcutaneous, 80 milligrams donidalorsen, once monthly.
The recommended starting dose in adult and adolescent patients aged 12 years and older is 80 mg donidalorsen by subcutaneous injection once monthly.
A dosing interval of 80 mg once every 2 months may be considered if the patient is well controlled (e.g., attack free) for at least 3 months while receiving donidalorsen.
Based on the clinical data, a gradual reduction in attack rate is seen as early as Week 1 after the initial dose of donidalorsen with an expected maximum effect after 1 month.
Consideration should be given to discontinuing treatment in patients with normal C1-INH HAE (nC1-INH) who have shown insufficient reduction in attacks after 4 months of treatment.
Donidalorsen is not intended for the treatment of acute HAE attacks.
No dose adjustment is required for patients above 65 years of age.
If a dose is missed, the patient or caregiver should be instructed to administer the dose as soon as possible. Thereafter, dosing should be resumed at the prescribed dosing frequency (once monthly or once every 2 months) from the date of the most recently administered dose.
The following treatment schedules (Table 1) are recommended for patients that are changing their HAE prophylactic therapy from berotralstat, a C1 esterase inhibitor, or lanadelumab to donidalorsen.
Table 1. Treatment schedule for patients changing from other prophylactic therapy to donidalorsen:
| Other prophylactic therapy | Recommended treatment schedule when changing to donidalorsen |
| Berotralstat | Continue taking the current dose of berotralstat for 14 days after initiating treatment with donidalorsen. |
| C1 esterase inhibitor | Continue taking the current dose of C1 esterase inhibitor for 14 days after initiating treatment with donidalorsen. |
| Lanadelumab | Administer last dose of lanadelumab 14 days prior to initiating treatment with donidalorsen. |
Donidalorsen is to be administered as a subcutaneous injection in the abdomen, upper thigh region, or for caregivers only, the back of the upper arm. Rotation of the injection site is recommended.
Donidalorsen must not be injected into areas where the skin is tender, bruised, red, hard, infected or discoloured.
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