Nemluvio · 4.6 Fertility, pregnancy and lactation · 1

HOS-100602 · has-adverse-reaction-information · PDF-Seite 5

Summary of the safety profile 5 The most common adverse reactions in atopic dermatitis and prurigo nodularis are type I hypersensitivity (1.1%; includes urticaria 1.0% and angioedema 0.1%) and injection site reactions (1.2%) (see section 4.4). Additional adverse reactions such as headache (7.0%), atopic dermatitis (4.6%), eczema (3.8%), eczema nummular (3.5%), superficial fungal infections (3.0%) and worsening of asthma (2.2%) were reported in prurigo nodularis. Tabulated list of adverse reactions Table 1 includes all adverse reactions observed in clinical studies 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, adverse reactions are presented in order of decreasing seriousness. Table 1: List of adverse reactions MedDRA System Frequency Adverse reactions Organ Class Infections and Common Superficial fungal infections*# infestations Blood and Uncommon Eosinophilia† lymphatic system disorders Immune system Common Type I hypersensitivity (incl. urticaria† and disorders angioedema*) Nervous system Common Headache* (incl. tension headache) disorders Respiratory, Common Worsening of asthma* (incl. asthma, wheezing, peak thoracic and expiratory flow rate decreased) mediastinal disorders Skin and Common Atopic dermatitis* subcutaneous Eczema* tissue disorders Eczema nummular* Uncommon Bullous pemphigoid§ General disorders Common Injection site reactions (incl. erythema, pruritus, and administration haematoma†, pain†, irritation†, bruising*, and injection site conditions site oedema†) † Occurred in atopic dermatitis studies *Occurred in prurigo nodularis studies # Superficial fungal infections include: body tinea, tinea pedis, onychomycosis, fungal infection, tinea versicolor, tinea cruris, fungal skin infection and fu

Auszug; vollständigen Abschnitt im Original lesen.

HOS-100598 · has-contraindication-information · PDF-Seite 4

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

HOS-100597 · has-indication-information · PDF-Seite 2

Atopic dermatitis (AD) Nemluvio is indicated for the treatment of moderate-to-severe atopic dermatitis in patients aged 12 years and older who are candidates for systemic therapy. Prurigo nodularis (PN) Nemluvio is indicated for the treatment of adults with moderate-to-severe prurigo nodularis who are candidates for systemic therapy.

HOS-100600 · has-interaction-information · PDF-Seite 5

Live vaccines The safety and efficacy of concurrent use of nemolizumab with live attenuated vaccines has not been studied. Live vaccines should not be given concurrently with nemolizumab (see section 4.4). Non-live vaccines Immune responses to non-live vaccines were assessed in a study in which adults and adolescent patients with atopic dermatitis were treated with an initial nemolizumab dose of 60 mg (two 30 mg injections) followed by 30 mg given once every 4 weeks (Q4W) for 16 weeks. After 12 weeks of nemolizumab 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 nemolizumab treatment. No adverse interactions between the non-live vaccines and nemolizumab were noted in the study. Therefore, patients receiving nemolizumab may receive concurrent inactivated or non-live vaccinations (see section 4.4). Interactions with cytochrome P450 The effects of nemolizumab on the pharmacokinetics of midazolam (CYP3A4/5 substrate), warfarin (CYP2C9 substrate), omeprazole (CYP2C19 substrate), metoprolol (CYP2D6 substrate), and caffeine (CYP1A2 substrate) were evaluated in a study in subjects with moderate to severe AD. No clinically significant changes in the exposure of CYP450 substrates were observed compared to prior to nemolizumab treatment. No dose adjustment is necessary.

HOS-100601 · has-pregnancy-information · PDF-Seite 5

Pregnancy There is a limited amount of data on the use of nemolizumab 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 nemolizumab during pregnancy. Breast-feeding No data are present on the excretion of nemolizumab in human milk. In humans, excretion of IgG antibodies in milk occurs during the first few days after birth, which is decreasing to low concentrations soon afterwards. Consequently, transfer of IgG antibodies to the newborns through milk, may happen during the first few days. In this short period, a risk to the breastfed child cannot be excluded. Afterwards, nemolizumab could be used during breast-feeding if clinically needed. Fertility Animal studies showed no impairment of fertility (see section 5.3).

HOS-100599 · 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 Cases of type 1 hypersensitivity, including angioedema, have been reported. If a systemic hypersensitivity reaction (immediate or delayed) occurs, administration of nemolizumab should be discontinued immediately and appropriate therapy initiated (see section 4.8). Worsening of asthma (including PEF decrease) In the population of PN subjects with pre-existing asthma, a mild to moderate worsening of asthma (WOA) has been reported after initiation of nemolizumab. This was observed more frequently in patients weighing > 90 kg who received 60 mg nemolizumab every 4 weeks compared to patients weighing < 90 kg who received 30 mg nemolizumab every 4 weeks (see section 4.8). Patients with an exacerbation of asthma requiring hospitalization in the preceding 12 months, patients with uncontrolled asthma during the preceding 3 months and patients with a current medical history of COPD and/or chronic bronchitis were excluded from clinical studies. No information on the efficacy or safety of nemolizumab in those patients is available. Vaccinations It is recommended that patients complete all age-appropriate vaccinations in agreement with current immunisation guidelines prior to initiating treatment. Concurrent use of live vaccines in patients treated with nemolizumab should be avoided. It is unknown if administration of live vaccines during treatment will impact the safety or efficacy of these vaccines. Immune responses to the non-live combined tetanus, diphtheria and acellular pertussis vaccine (TdaP) and a meningococcal polysaccharide vaccine were assessed (see section 4.5). 4