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Anti-IL-31 receptor monoclonal antibody 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; the clinical significance is 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 subcutaneous monoclonal antibody used for conditions driven by type 2 inflammation and 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 dosing at the regular scheduled time. Must be reconstituted before administration (single-dose prefilled dual-chamber pen); allow the carton to reach room temperature for 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 is a humanised monoclonal antibody against the interleukin-31 receptor alpha subunit, blocking IL-31 signalling, a key cytokine in the sensation of itch and in associated inflammation.

Prescribing in practice

  • Live vaccines should be avoided during treatment, and patients should be assessed for active infection before initiation.
  • Reactions reported with treatment include headache, peripheral oedema and hypersensitivity, which should be reviewed if they occur.
  • Administered by subcutaneous injection, frequently alongside topical corticosteroids in atopic dermatitis.

Monitoring

Monitor itch and lesion response together with adverse effects such as hypersensitivity reactions and oedema.

Counselling the patient

  • This treatment targets the itch pathway and is given by injection under the skin.
  • Tell your healthcare team before having vaccinations, particularly live vaccines.
  • Continue your emollients and any prescribed topical treatments alongside it.

Evidence & guidelines

Nemolizumab demonstrated efficacy for prurigo nodularis and atopic dermatitis in phase 3 trials (the OLYMPIA and ARCADIA programmes); follow current prescribing references for approved indications.

Reference: NICE TA1056; SmPC; 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.