Prevention of recurrent attacks of hereditary angioedema (HAE)

Active Ingredient: Lanadelumab

Indication for Lanadelumab

Population group: only children (1 year - 12 years old) , adolescents (12 years - 18 years old) , adults (18 years old or older)
Therapeutic intent: Preventive action

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:

300 mg once every 2 weeks

For:

Dosage regimens

Subcutaneous, 300 milligrams lanadelumab, once every 2 weeks.

Detailed description

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.

Missed doses

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:

  • at least 10 days between doses for patients on every 2 weeks dosing regimen,
  • at least 17 days between doses for patients on every 3 weeks dosing regimen,
  • at least 24 days between doses for patients on every 4 weeks dosing regimen.

Dosage considerations

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.

150 mg every 2 or 4 weeks, or 300 mg every 2 weeks based on body weight

For:

Dosage regimens

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.

Detailed description

Children 2 to less than 12 years of age

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 weeksA 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 weeksA 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 weeksA 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.

Missed doses

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:

  • at least 10 days between doses for patients on every 2 weeks dosing regimen,
  • at least 17 days between doses for patients on every 3 weeks dosing regimen,
  • at least 24 days between doses for patients on every 4 weeks dosing regimen.

Dosage considerations

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.

Active ingredient

Lanadelumab

Lanadelumab is a fully human, monoclonal antibody (IgG1/κ-light chain). Lanadelumab inhibits active plasma kallikrein proteolytic activity. Lanadelumab provides sustained control of plasma kallikrein activity and thereby limits bradykinin generation in patients with HAE.

Read more about Lanadelumab

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