Posology : מינונים

4.2    Posology and method of administration

Treatment should be initiated by healthcare professionals experienced in the diagnosis and treatment of atopic dermatitis.

Posology

The recommended dose of lebrikizumab is 500 mg (two 250 mg injections) at both week 0 and week 2, followed by 250 mg administered subcutaneously every other week up to week 16.

Consideration should be given to discontinuing treatment in patients who have shown no clinical response after 16 weeks of treatment. Some patients with initial partial response may further improve with continued treatment every other week up to week 24.

Once clinical response is achieved, the recommended maintenance dose of lebrikizumab is 250 mg every fourth week.

Lebrikizumab can be used with or without topical corticosteroids (TCS). Topical calcineurin inhibitors (TCI) may be used, but should be reserved for problem areas only, such as the face, neck, intertriginous and genital areas.



Missed dose

If a dose is missed, the dose should be administered as soon as possible. Thereafter, dosing should be resumed at the regular scheduled time.

Special populations

Elderly (≥ 65 years)
No dose adjustment is recommended for elderly patients (see section 5.2).
Renal and hepatic impairment
No dose adjustment is recommended for patients with renal or hepatic impairment (see section 5.2).

Body weight
No dose adjustment for body weight is recommended (see section 5.2).

Paediatric population
The safety and efficacy of lebrikizumab in children <12 years or adolescents 12 to 17 years of age and weighing less than 40 kg have not yet been established. No data are available.

Method of administration

Subcutaneous use.
Lebrikizumab is administered by subcutaneous injection into the thigh or abdomen, except for 5 cm around the navel. If somebody else administers the injection, the upper arm can also be used.

For the initial 500 mg dose, two 250 mg injections should be administered consecutively in different injection sites.

It is recommended to rotate the injection site with each injection. Lebrikizumab should not be injected into skin that is tender, damaged or has bruises or scars.

A patient may self-inject lebrikizumab or the patient’s caregiver may administer lebrikizumab if their healthcare professional determines that this is appropriate. Proper training should be provided to patients and/or caregivers on the administration of lebrikizumab prior to use. Detailed instructions for use are included at the end of the package leaflet.