Menu
Hypersensitivity
If a systemic hypersensitivity reaction (immediate or delayed) occurs, administration of lebrikizumab should be discontinued and appropriate therapy initiated.1
Conjunctivitis
Patients treated with lebrikizumab who develop conjunctivitis that does not resolve following standard treatment should undergo ophthalmological examination.1
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.1
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.1
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).1
Pregnancy
There are limited amount of data from the use of lebrikizumab in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). As a precautionary measure, it is preferable to avoid the use of lebrikizumab during pregnancy.
Breast-feeding
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.
Fertility
Animal studies showed no impairment of fertility.1
