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Nemluvio is a brand name for Nemolizumab. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 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…
Verbatim from this product's EMA label. Tap a section to expand.
Treatment with nemolizumab should be initiated and supervised by healthcare professionals experienced in the diagnosis and treatment of conditions for which nemolizumab is indicated. Posology Atopic dermatitis (AD) The recommended dose is: - An initial dose of 60 mg (two 30 mg injections), followed by 30 mg given every 4 weeks (Q4W) 3 - After 16 weeks of treatment, for patients who achieve clinical response, the recommended maintenance dose is 30 mg every 8 weeks (Q8W) Nemolizumab can be used with or without topical corticosteroids (TCS).
Topical calcineurin inhibitors (TCI) may be used, but should be reserved for problem areas only, such as the face, neck, intertriginous and genital areas. Any use of topical therapies should be tapered and subsequently discontinued when the disease has sufficiently improved.
Consideration should be given to discontinuing treatment in patients who have shown no response after 16 weeks of treatment for atopic dermatitis. Some patients with initial partial response may further improve with continued treatment beyond 16 weeks.
Once clinical response is achieved, the recommended maintenance dose of nemolizumab is 30 mg every 8 weeks. Prurigo nodularis (PN) The recommended dose 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 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). Continue treatment to maintain a therapeutic response. Consideration should be given to discontinuing treatment in patients who have shown no response on pruritus after 16 weeks of treatment for prurigo nodularis.
Missed dose If a dose is missed, it should be administered as soon as possible. Thereafter, dosing should be resumed at the regular scheduled time. 2). 2). Paediatric population Atopic dermatitis The safety and efficacy of nemolizumab in children less than 12 years of age and body weight < 30 kg have not yet been established.
No data are available. Prurigo nodularis The safety and efficacy of nemolizumab in children less than 18 years of age have not been established. No data are available. Method of administration Subcutaneous use. 4 The subcutaneous injection should be administered into the front upper thighs or abdomen avoiding the 5 cm area around the navel.
4). 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 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 Uncommon Atopic dermatitis* Eczema* Eczema nummular* Bullous pemphigoid§ 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 §From post-marketing reporting Description of selected adverse reactions Hypersensitivity 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.
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.
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. 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. 5). 5
1.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Injection into the upper arm should only be performed by a caregiver or healthcare professional. For subsequent doses, it is recommended to rotate the injection site with each dose. Nemolizumab should not be injected into skin that is tender, inflamed, swollen, damaged or has bruises, scars or open wounds.
Nemolizumab is intended for use under the guidance of a healthcare professional. A patient may self- inject nemolizumab or the patient’s caregiver may administer nemolizumab if their healthcare professional determines that this is appropriate.
Prior to first injection, patients and/or caregivers should be given proper training on the preparation and administration of nemolizumab according to the instructions for use at the end of the package leaflet.
4). 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.
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. 5%). These eczematous reactions were mild or moderate in severity.
5%) patients. Patients > 65 years of age had a higher rate of eczematous reactions. Eosinophilia 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. 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. Paediatric population Atopic dermatitis Adolescents (12 to 17 years of age) 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 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 product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.