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IL-31 Receptor Alpha (IL-31RA) Inhibitor Pregnancy: Available data in pregnant women exposed during clinical trials are insufficient to evaluate a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. In an enhanced pre- and postnatal development study in cynomolgus monkeys an increase in early postnatal death was observed at doses 36 times (prurigo nodularis) and 50 times (atopic dermatitis) the maximum recommended human dose; clinical significance unknown. Placental transfer of IgG increases through pregnancy, so nemolizumab may be present in infants exposed in utero.

Nemolizumab

Brand names: Nemluvio

Nemolizumab is a monoclonal antibody biologic given by subcutaneous injection for conditions driven by intense itch, including prurigo nodularis and moderate-to-severe atopic dermatitis.

Adult dose

Dose: Prurigo nodularis — adults weighing less than 90 kg: initial dose 60 mg (two 30 mg injections), followed by 30 mg. Adults weighing 90 kg or more: initial dose 60 mg (two 30 mg injections), followed by 60 mg.
Route: Subcutaneous injection (front upper thighs or abdomen, avoiding the 2-inch/5 cm area around the navel; upper arm only by a caregiver or healthcare professional)
Frequency: Loading dose at initiation, then every 4 weeks
Atopic dermatitis (adults and paediatric patients 12 years of age and older): initial dose 60 mg (two 30 mg injections), followed by 30 mg given every 4 weeks; after 16 weeks of treatment, for patients who achieve clear or almost clear skin, a dosage of 30 mg every 8 weeks is recommended. For atopic dermatitis, use with topical corticosteroids and/or topical calcineurin inhibitors, and discontinue the topical therapies when the disease has sufficiently improved. Complete all age-appropriate vaccinations as recommended by current immunisation guidelines PRIOR to treatment; avoid live vaccines during treatment. For the initial dose, administer each of the two injections at different injection sites; alternate the injection site with each injection; do not inject into skin that is tender, inflamed, swollen, damaged, bruised, scarred or has open wounds. Missed dose: administer as soon as possible, then resume the regular schedule. Must be reconstituted before administration (single-dose prefilled dual-chamber pen); allow to reach room temperature 30-45 minutes; after reconstitution each pen delivers 30 mg/0.49 mL; use within 4 hours and discard unused reconstituted pens thereafter. Paediatric: safety and effectiveness have NOT been established in prurigo nodularis in any paediatric patient, nor in atopic dermatitis below 12 years of age; in patients 12 years and older administer by or under the supervision of a trained adult or caregiver. No numeric per-kg paediatric dose is stated in the source — verify paediatric use against a children's formulary. Not from a UK SPC — UK product information may differ.

Dose independently re-sourced from US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — clinician-reviewed. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • Known hypersensitivity to nemolizumab or to any of the excipients

Side effects

  • Headache (including migraine)
  • Atopic dermatitis / eczema and eczema nummular (reported in prurigo nodularis trials)
  • Arthralgia
  • Urticaria
  • Myalgia
  • Hypersensitivity reactions, such as facial angioedema

Clinical monograph

How it works

It binds the interleukin-31 receptor alpha subunit, blocking IL-31 signalling — a key cytokine in the itch and neuroinflammatory pathways of these conditions.

Prescribing in practice

  • Assess for active infection before starting and avoid live vaccines during treatment, in keeping with biologic immunomodulators.
  • Peripheral oedema and, in atopic dermatitis, occasional early worsening of eczema or asthma-related symptoms have been reported.
  • Administer by subcutaneous injection and, in atopic dermatitis, it is generally used alongside topical therapy.

Monitoring

Monitoring is clinical, tracking reduction in itch and skin lesions and reviewing for infection, oedema or respiratory symptoms.

Counselling the patient

  • The main benefit is reduction of itch, which can improve sleep and skin healing over time.
  • Report signs of infection or any new swelling or breathing symptoms.
  • Continue any prescribed topical treatments and emollients alongside the injections.

Evidence & guidelines

Nemolizumab's efficacy in prurigo nodularis and atopic dermatitis was demonstrated in the OLYMPIA and ARCADIA phase 3 trial programmes.

Reference: OLYMPIA 1 & 2 trials (Yosipovitch et al. NEJM 2023); MHRA SPC Nemluvio 2024; Silverberg et al. NEJM 2023 (AD indication); BAD Prurigo Nodularis Guideline; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.