Source: European Medicines Agency (EU) Revision Year: 2025 Publisher: Galderma International, La Defense 4, Tour Europlaza, 20 Avenue Andre Prothin, 92927 Paris La Defense Cedex, France
Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1.
In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
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).
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.
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. No data are available on the response to non-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).
The safety and efficacy of concurrent use of nemolizumab with non-live vaccines has not been studied (see section 4.4).
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.
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.
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.
Animal studies showed no impairment of fertility (see section 5.3).
Nemluvio has no or negligible influence on the ability to drive and use machines.
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%) and eczema nummular (3.5%) were reported in prurigo nodularis.
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 Organ Class | Frequency | Adverse reactions |
|---|---|---|
| Infections and infestations | Common | Superficial fungal infections#* |
| Blood and lymphatic system disorders | Uncommon | Eosinophilia† |
| Immune system disorders | Common | Type I hypersensitivity (incl. urticaria† and angioedema*) |
| Nervous system disorders | Common | Headache* (incl. tension headache) |
| Respiratory, thoracic and mediastinal disorders | Common | Worsening of asthma* (incl. asthma, wheezing, peak expiratory flow rate decreased) |
| Skin and subcutaneous tissue disorders | Common | Atopic dermatitis*, Eczema*, Eczema nummular* |
| General disorders and administration site conditions | Common | Injection site reactions (incl. erythema, pruritus, haematoma†, pain†, irritation†, bruising*, and injection 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 fungal foot infection
Type 1 hypersensitivity reactions (Ig-E mediated reactions), including mild urticaria and mild facial (peri-ocular) angioedema, were commonly observed in subjects treated with nemolizumab during the clinical studies. These reactions did not lead to treatment discontinuation (see section 4.4).
In patients with prurigo nodularis, headache was more frequently reported in patients treated with nemolizumab (7.0%) compared to patients treated with placebo. Headache was more frequently observed in female patients in both groups. In the nemolizumab group, headache was mostly mild or moderate in severity and did not lead to discontinuation of treatment.
In the PN patients with pre-existing asthma (n=51), 8 (15.7%) patients experienced a worsening of asthma (WOA) after initiation of nemolizumab, 5 of whom had a body weight >90 kg and received 60 mg nemolizumab every 4 weeks. In the population of PN patients with pre-existing asthma, WOA was 3 times more frequent in patients with a body weight >90 kg who received 60 mg nemolizumab every 4 weeks than in patients with a body weight <90 kg who received 30 mg nemolizumab every 4 weeks.
The majority of WOA events occurred within the first two months of treatment initiation and all were reported as mild or moderate in severity. Most patients experienced a single event of WOA during treatment and the event resolved with standard of care asthma medications (inhalers) without the use of systemic steroids. None led to permanent discontinuation of treatment. The incidence of WOA did not increase with longer term exposure to nemolizumab (up to Week 52) in the PN open-label long- term extension study.
In patients with prurigo nodularis, eczematous reactions such as atopic dermatitis, eczema nummular or eczema were more frequently reported in nemolizumab-treated patients compared to patients treated with placebo: Atopic dermatitis (4.6%), eczema (3.8%) and eczema nummular (3.5%). These eczematous reactions were mild or moderate in severity. Atopic dermatitis led to nemolizumab discontinuation in 2 (0.5%) patients. Patients >65 years of age had a higher rate of eczematous reactions.
Proportion of patients with clinically significant elevated eosinophils (>700 cells/mcL) was 10,2% in the AD population (in the initial period) and 5,5% in the PN population. Severe eosinophilia (>5000 cells/mcL) was not observed in AD nemolizumab-treated patients in the initial treatment period. Adverse reactions of eosinophilia were reported in 0.2% of AD patients treated with nemolizumab during the initial treatment period up to Week 16. All events in AD subjects were mild in intensity and not associated with clinical symptoms. No TEAE of eosinophilia led to discontinuation of treatment. Apart from one case of eosinophilic colitis in an AD subject with other atopic comorbidities, there were no other reports of eosinophilic disorders.
The safety of nemolizumab was assessed in 176 paediatric subjects 12 to 17 years of age with moderate-to-severe atopic dermatitis enrolled in the ARCADIA 1 and ARCADIA 2 studies. The safety profile of nemolizumab in these subjects through Week 16 was similar to the safety profile seen in adults with atopic dermatitis.
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.