Posology : מינונים

4.2     Posology and method of administration

This medicinal product should be initiated under the supervision of a physician experienced in the management of patients with hereditary angioedema (HAE).

Posology

Adults
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.

Adolescents 12 to less than 18 years of age
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.
Children 6 to less than 12 years of age
The recommended starting dose is 150 mg lanadelumab every 2 weeks. In patients who are stably attack free on treatment, a dose reduction to 150 mg lanadelumab every 4 weeks, may be considered.

Children 2 to less than 6 years of age
The recommended dose is 150 mg lanadelumab every 4 weeks.

TAKHZYRO is not intended for treatment of acute HAE attacks (see section 4.4) 
Missed doses
If a dose of TAKHZYRO 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 24 days between doses for patients on every 4 weeks dosing regimen.


Special populations
Elderly

Age is not expected to affect exposure to lanadelumab. No dose adjustment is required for patients above 65 years of age (see section 5.2).

Hepatic impairment

No studies have been conducted in patients with hepatic impairment. Hepatic impairment is not expected to affect exposure to lanadelumab. No dose adjustment is required in patients with hepatic impairment (see section 5.2).

Renal impairment

No studies have been conducted in patients with severe renal impairment. Renal impairment is not expected to affect exposure to lanadelumab or the safety profile. No dose adjustment is required in patients with renal impairment. (see section 5.2).

Paediatric population

The safety and efficacy of TAKHZYRO in children aged less than 2 years have not been established.
No data are available.
Method of administration

TAKHZYRO is intended for subcutaneous (SC) administration only.

Each TAKHZYRO unit (pre-filled syringe or vial) is intended for single use only (see section 6.6).
The injection should be restricted to the recommended injection sites: the abdomen, the thighs, and the upper outer arms (see section 5.2). Rotation of the injection site is recommended.

For adults and adolescents (12 to less than 18 years of age), TAKHZYRO may be self-administered or administered by a caregiver only after training on subcutaneous injection technique by a healthcare professional.

For children (2 to less than 12 years of age), TAKHZYRO should only be administered by a caregiver after training on subcutaneous injection technique by a healthcare professional.