NEMLUVIO

Posology Atopic dermatitis (AD) The recommended dosage of Nemluvio is: - An initial dose of 60 mg (two 30 mg injections), followed by 30 mg given every 4 weeks (Q4W) - After 16 weeks of treatment, for patients who achieve clinical response, the recommended maintenance dose of Nemluvio is 30 mg every 8 weeks (Q8W).

Concomitant Topical Therapies:

Use Nemluvio with topical corticosteroids and/or topical calcineurin inhibitors. When the disease has sufficiently improved, discontinue use of topical therapies. Consideration should be given to discontinuing treatment with Nemluvio in patients who have shown no response after 16 weeks of treatment.

Prurigo nodularis (PN) The recommended dose of Nemluvio for patients weighing < 90 kg is an initial dose of 60 mg (two 30 mg injections), followed by 30 mg given every 4 weeks (Q4W). The recommended dose of Nemluvio for patients weighing ≥ 90 kg is an initial dose of 60 mg dose (two 30 mg injections), followed by 60 mg given every 4 weeks (Q4W).

Consideration should be given to discontinuing treatment in patients who have shown no response after 16 weeks of treatment for prurigo nodularis. Missed dose If a dose is missed, administer the dose as soon as possible. Thereafter, resume dosing at the regular scheduled time.

2). 2). 2). 2). Paediatric population The safety and efficacy of Nemluvio in children with moderate-to-severe atopic dermatitis younger than 12 years old have not yet been established. The safety and efficacy of Nemluvio has not been established in patients below the age of 18 years with prurigo nodularis.

Method of administration Subcutaneous use. Administer subcutaneous injection into the front upper thighs or abdomen avoiding the 5 cm area around the navel. Injection into the upper arm should only be performed by a caregiver or healthcare professional.

For the initial dose, administer each of the two Nemluvio injections at different injection sites. For subsequent doses, it is recommended to rotate the injection site with each dose. Nemluvio should not be injected into skin that is tender, inflamed, swollen, damaged or has bruises, scars or open wounds.

Nemluvio is intended for use under the guidance of a healthcare professional. A patient may self-inject Nemluvio or the patient’s caregiver may administer Nemluvio if their healthcare professional determines that this is appropriate.

Prior to first injection, patients and/or caregivers should be given proper instructions for preparation and administration of Nemluvio according to the instructions for use at the end of the package leaflet.

Summary of the safety profile The most common adverse reaction in patients with atopic dermatitis is urticaria. The most common adverse reactions in patients with prurigo nodularis are headache, dermatitis atopic, eczema and eczema nummular.

4). Tabulated list of adverse reactions The Nemluvio safety data presented in Table 1 were evaluated in a pool of three randomized, placebo-controlled trials in subjects with atopic dermatitis (1192 patients receiving Nemluvio and 640 patients receiving placebo), and two randomized, placebo-controlled trials in subjects with prurigo nodularis (370 patients receiving Nemluvio and 186 patients receiving placebo).

Listed in Table 1 are adverse reactions observed in 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, adverse reactions are presented in order of decreasing seriousness.

Table 1:

List of adverse reactions MedDRA System Organ Class Frequency Adverse reactions Nervous system disorders Common Headache (incl. tension headache)* Common Urticaria† Dermatitis atopic*, Eczema*, Eczema nummular* Skin and subcutaneous tissue disorders Uncommon Angioedema* Bullous pemphigoid# Uncommon Injection site reactions (includes erythema, pruritus, pain†, irritation†, bruising*) General disorders and administration site conditions Rare Injection site oedema† †Occurred in atopic dermatitis studies *Occurred in prurigo nodularis studies # From post-marketing reporting In atopic dermatitis, the safety profile of Nemluvio through Week 52 in the open- label trial (ARCADIA LTE) was generally consistent with the safety profile observed at Week 16.

In prurigo nodularis, the safety profile of Nemluvio through Week 52 in the open- label trial (OLYMPIA LTE) was generally consistent with the safety profile observed at Week 16 and at Week 24. Description of selected adverse reactions Hypersensitivity Type 1 hypersensitivity reactions (Ig-E mediated reactions) were reported in patients treated with Nemluvio in atopic dermatitis and prurigo nodularis.

3%) that did not lead to discontinuation of treatment. There were no reports of anaphylactic shock or serum-sickness. 5%). 6%). There were no severe injection site reactions. For both indications, none of the reactions led to discontinuation of treatment.

6%). Headache was more frequently observed in female patients in both groups. In the Nemluvio group, headache was mostly mild or moderate in severity and did not lead to discontinuation of treatment. 5% subjects versus 0% subjects respectively).

These eczematous reactions were mild or moderate in severity. 5%) patients. No event of eczema nummular or eczema led to study discontinuation. Immunogenicity As with all therapeutic proteins, there is a potential for immunogenicity with Nemluvio.

The observed incidence of anti-drug antibodies is highly dependent on the sensitivity and specificity of the assay. Differences in assay methods preclude meaningful comparisons of the incidence of anti-drug antibodies in the trials described below with the incidence of anti-drug antibodies in other trials, including those of nemolizumab.

Anti-Drug-Antibodies (ADA) responses were not generally associated with impact on nemolizumab exposure, safety, or efficacy. 5% of subjects. 5% of subjects. Paediatric population Atopic dermatitis Adolescents (12 to 17 years of age) The safety of Nemluvio was assessed in 176 subjects 12 to 17 years of age with moderate-to-severe atopic dermatitis enrolled in the ARCADIA 1 and ARCADIA 2 trials.

The safety profile of Nemluvio in these subjects through Week 16 was similar to the safety profile seen in adults with atopic dermatitis. The safety profile of Nemluvio in adolescent subjects followed through Week 48 was similar to the safety profile observed at Week 16.

The long-term safety profile of Nemluvio in subjects 12 to 17 years of age was consistent with that seen in adults with atopic dermatitis (ARCADIA LTE). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal […]

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 Nemluvio should be discontinued and appropriate therapy initiated.

Vaccinations Consider completing all age-appropriate vaccinations as recommended by current immunization guidelines prior to initiating treatment with Nemluvio. Avoid use of live vaccines in patients treated with Nemluvio. It is unknown if administration of live vaccines during Nemluvio treatment will impact the safety or efficacy of these vaccines.

No data are available on the response to non-live vaccines. Uncontrolled asthma Patients with uncontrolled asthma were excluded from the trials and no data with Nemluvio are available in this population.

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