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Treatment should be initiated by healthcare professionals experienced in the diagnosis and treatment of atopic dermatitis. 3 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. 2). 2). 2). Paediatric population The safety and efficacy of lebrikizumab in children aged 6 months to <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. 4

4%). Tabulated list of adverse reactions Across all clinical studies in atopic dermatitis, a total of 1720 patients were administered lebrikizumab, of which, 891 patients were exposed to lebrikizumab for at least one year. Unless otherwise stated, the frequencies are based on a pool of 4 randomised, double-blind studies in patients with moderate-to- severe atopic dermatitis where 783 patients were treated with subcutaneous lebrikizumab during the placebo-controlled period (first 16 weeks of treatment).

6 Listed in Table 1 are adverse reactions observed from clinical trials presented by system organ class and frequency, using the following categories: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1 000 to < 1/100); rare (≥ 1/10 000 to < 1/1 000); very rare (< 1/10 000).

Within each frequency grouping the adverse reactions are presented in the order of decreasing seriousness. Table 1. 3%). 9% respectively. 3% of cases, respectively. 2% of cases, respectively. 72% of patients recovered, of those 57% recovered within 90 days.

Eosinophilia Lebrikizumab-treated patients had a greater mean increase from baseline in eosinophil count compared to patients treated with placebo. 7% with placebo. In general, the increase in the lebrikizumab-treated patients was mild or moderate and transient.

4% lebrikizumab-treated patients and none of the placebo-treated patients. 6% of patients treated with lebrikizumab and with a similar rate in patients treated with placebo during the initial treatment period. Eosinophilia did not result in treatment discontinuation and no eosinophil-related disorders were reported.

5%). 5%) discontinued lebrikizumab treatment. 6% of the patients treated with lebrikizumab and none of the patients in the placebo group. All herpes zoster events reported were mild or moderate in severity and none led to permanent discontinuation of treatment.

Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Hypersensitivity If a systemic hypersensitivity reaction (immediate or delayed) occurs, administration of lebrikizumab should be discontinued and appropriate therapy initiated.

8). Helminth infection Patients with known helminth infections were excluded from participation in clinical studies. It is unknown if lebrikizumab will influence the immune response against helminth infections by inhibiting IL-13 signalling.

Patients with pre-existing helminth infections should be treated before initiating treatment with lebrikizumab. If patients become infected while receiving lebrikizumab and do not respond to antihelminth treatment, treatment with lebrikizumab should be discontinued until infection resolves.

Vaccinations Prior to initiating therapy with lebrikizumab, it is recommended that patients are brought up to date with all age-appropriate immunisations according to current immunisation guidelines. Live and live attenuated vaccines should not be given concurrently with lebrikizumab as clinical safety and efficacy has not been established.

5). 3 mg/mL. Polysorbates may cause allergic reactions.

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