Ebglyss · 4.1 Therapeutic indications · 1

HOS-100233 · has-adverse-reaction-information · PDF-Seite 5

Summary of the safety profile The most common adverse reactions are conjunctivitis (6.9%), injection site reactions (2.6%), conjunctivitis allergic (1.8%) and dry eye (1.4%). 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). 5 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. List of adverse reactions MedDRA System Frequency Adverse reaction Organ Class Infections and Common Conjunctivitis infestations Uncommon Herpes zoster Blood and lymphatic Uncommon Eosinophilia system disorders Eye disorders Common Conjunctivitis allergic Dry eye Uncommon Keratitis Blepharitis General disorders and Common Injection site reaction administration site conditions Description of selected adverse reactions Conjunctivitis and related events During the first 16 weeks of treatment conjunctivitis, conjunctivitis allergic, blepharitis and keratitis were reported more frequently in patients treated with lebrikizumab (6.9%, 1.8%, 0.8% and 0.6% respectively) compared to placebo (1.8%, 0.7%, 0.2% and 0.3%). During maintenance treatment period (16-52 weeks) the incidence of conjunctivitis and conjunctivitis allergic with lebrikizumab was 5.0% and 5.9% respectively. Across all clinical studies, among lebrikizumab-treated patients treatment discontinuation due to conjunctivitis and conjun

Auszug; vollständigen Abschnitt im Original lesen.

HOS-100229 · has-contraindication-information · PDF-Seite 4

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

HOS-100228 · has-indication-information · PDF-Seite 2

Ebglyss is 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.

HOS-100231 · has-interaction-information · PDF-Seite 4

No interaction studies have been performed. Live vaccines The safety and efficacy of concurrent use of lebrikizumab with live and live attenuated vaccines has not been studied. Live and live attenuated vaccines should not be given concurrently with lebrikizumab. 4 Non-live vaccines Immune responses to non-live vaccines were assessed in a study (ADopt-VA) in which adult patients with atopic dermatitis were treated with lebrikizumab 500 mg at weeks 0 and 2 followed by lebrikizumab 250 mg every other week. After 12 weeks of lebrikizumab administration, patients were vaccinated with a combined tetanus, diphtheria, and acellular pertussis vaccine TdaP vaccine (T cell-dependent) and a meningococcal polysaccharide vaccine (T cell-independent) and immune responses were assessed 4 weeks later. Antibody responses to both non-live vaccines were not negatively impacted by the concomitant lebrikizumab treatment. No adverse interactions between the non-live vaccines and lebrikizumab were noted in the study. Therefore, patients receiving lebrikizumab may receive concurrent inactivated or non-live vaccinations. For information on live vaccines see section 4.4. Concomitant therapies Given that lebrikizumab is a monoclonal antibody, no pharmacokinetic interactions are expected.

HOS-100232 · has-pregnancy-information · PDF-Seite 5

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 (see section 5.3).

HOS-100230 · has-warning-information · PDF-Seite 4

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. Conjunctivitis Patients treated with lebrikizumab who develop conjunctivitis that does not resolve following standard treatment should undergo ophthalmological examination (see section 4.8). 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. Immune responses to non-live vaccines were assessed in a combined tetanus, diphtheria and acellular pertussis vaccine (TdaP) and a meningococcal polysaccharide vaccine (see section 4.5). Excipients This medicine contains 0.6 mg of polysorbate 20 (E 432) in each pre-filled syringe or pre-filled pen of 250 mg, which is equivalent to 0.3 mg/mL. Polysorbates may cause allergic reactions.