Ebglyss

/ Eli Lilly

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.
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.

Indicated for the treatment of moderate-to-severe atopic dermatitis in adults and adolescents 12 years and older with a body weight of at least 40 kg who are candidates for systemic therapy.

Hypersensitivity to the active substance or to any of the excipients

Hypersensitivity
If a systemic hypersensitivity reaction (immediate or delayed) occurs, administration of lebrikizumab should be discontinued and appropriate therapy initiated.
Conjunctivitis
Patients treated with lebrikizumab who develop conjunctivitis that does not resolve following standard treatment should undergo ophthalmological examination.
Helminth infection
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. Immune responses to non-live vaccines were assessed in a combined tetanus, diphtheria and acellular pertussis vaccine (TdaP) and a meningococcal polysaccharide vaccine.

Common: Conjunctivitis, Injection site reaction
See prescribing information for full details.

No interaction studies have been performed.
See prescribing information for full details.

Pregnancy: There are limited amount of data from the use of lebrikizumab in pregnant women. As a precautionary measure, it is preferable to avoid the use of lebrikizumab during pregnancy.
Lactation: It is unknown whether lebrikizumab is excreted in human milk or absorbed systemically after ingestion.
Maternal IgG is known to be present in human milk. A risk to the newborns/infants cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue from lebrikizumab therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.

Single intravenous doses up to 10 mg per kg of body weight and multiple subcutaneous doses up to 500 mg have been administered to humans in clinical trials without dose-limiting toxicity. There is no specific treatment for lebrikizumab overdose. In the event of overdose, the patient should be monitored for any signs
or symptoms of adverse reactions and institute appropriate symptomatic treatment immediately.

After removal from the refrigerator, this medical product must be used within 7 days (at a temperature up to 30°C) or discarded. Once stored out of refrigeration, do not place back in the refrigerator.