Active Ingredient: Lanadelumab
Lanadelumab is indicated for routine prevention of recurrent attacks of hereditary angioedema (HAE) in patients aged 2 years and older.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Subcutaneous, 300 milligrams lanadelumab, once every 2 weeks.
The recommended starting dose is 300 mg lanadelumab every 2 weeks. In patients who are stably attack free on treatment, a dose reduction to 300 mg lanadelumab every 4 weeks may be considered, especially in patients with low weight.
In patients with a body weight less than 40 kg, a starting dose of 150 mg lanadelumab every 2 weeks may also be considered. In patients who are stably attack free on treatment, a dose reduction to 150 mg lanadelumab every 4 weeks may be considered.
Lanadelumab is not intended for treatment of acute HAE attacks.
If a dose of lanadelumab is missed, the patient or caregiver should be instructed to administer the dose as soon as possible. The subsequent dosing schedule may need adjustment according to the intended dosing frequency to ensure:
The injection should be restricted to the recommended injection sites: the abdomen, the thighs, and the upper outer arms. Rotation of the injection site is recommended.
Lanadelumab may be self-administered or administered by a caregiver only after training on subcutaneous injection technique by a healthcare professional.
For:
Regimen A: In case that patient age in years is ≥ 2 and patient weight is ≥ 10 kg and patient weight is < 20 kg, subcutaneous, 150 milligrams lanadelumab, once every 4 weeks.
Regimen B: In case that patient age in years is ≥ 2 and patient weight is ≥ 20 kg and patient weight is < 40 kg, subcutaneous, 150 milligrams lanadelumab, once every 2 weeks.
Regimen C: In case that patient age in years is ≥ 2 and patient weight is ≥ 40 kg, subcutaneous, 300 milligrams lanadelumab, once every 2 weeks.
The recommended dose of lanadelumab for children 2 to less than 12 years of age is based on body weight (see table below).
Patients with a body weight of 20 to less than 40 kg who are stably attack free may continue with the same dose when reaching 12 years of age.
Recommended dose in children 2 to less than 12 years of age:
Body Weight (kg) | Recommended Starting Dose | Dose Adjustment |
---|---|---|
10 to less than 20 kg | 150 mg lanadelumab every 4 weeks | A dose increase to 150 mg lanadelumab every 3 weeks may be considered in patients with insufficient control of attacks |
20 to less than 40 kg | 150 mg lanadelumab every 2 weeks | A dose reduction to 150 mg lanadelumab every 4 weeks may be considered in patients who are stably attack free on treatment |
40 kg or more | 300 mg lanadelumab every 2 weeks | A dose reduction to 300 mg lanadelumab every 4 weeks may be considered in patients who are stably attack free on treatment |
Lanadelumab is not intended for treatment of acute HAE attacks.
If a dose of lanadelumab is missed, the patient or caregiver should be instructed to administer the dose as soon as possible. The subsequent dosing schedule may need adjustment according to the intended dosing frequency to ensure:
The injection should be restricted to the recommended injection sites: the abdomen, the thighs, and the upper outer arms. Rotation of the injection site is recommended.
Lanadelumabshould only be administered by a caregiver after training on subcutaneous injection technique by a healthcare professional.
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