Version July 2025
Atopic dermatitis, moderate to severe: SUBQ: 60 mg followed by 30 mg every 4 weeks. In patients who achieve clear or almost clear skin after 16 weeks of therapy, a dose of 30 mg every 8 weeks is recommended.
Prurigo nodularis:
Weight <90 kg: SUBQ: 60 mg followed by 30 mg every 4 weeks.
Weight ≥90 kg: SUBQ: 60 mg followed by 60 mg every 4 weeks.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Mild to moderate impairment: No dosage adjustment needed.
Severe impairment: There are no dosage adjustments provided in the manufacturer's labeling; has not been studied.
Mild to moderate impairment: No dosage adjustment needed.
Severe impairment: There are no dosage adjustments provided in the manufacturer's labeling; has not been studied.
Refer to adult dosing.
(For additional information see "Nemolizumab: Pediatric drug information")
Atopic dermatitis:
Note: Complete all age-appropriate immunizations before initiating therapy; avoid administering live vaccines during therapy. Administer in combination with topical corticosteroids and/or topical calcineurin inhibitors.
Children ≥12 years and Adolescents: SUBQ: 60 mg (two 30 mg injections) once, then 30 mg every 4 weeks; after 16 weeks of therapy, may extend dosing interval to every 8 weeks in patients with good therapeutic response (eg, achieving clear or almost clear skin).
Children ≥12 years and Adolescents: SUBQ:
Mild to moderate impairment: No dosage adjustment needed.
Severe impairment: There are no dosage adjustments provided in the manufacturer's labeling; has not been studied.
Children ≥12 years and Adolescents: SUBQ:
Mild to moderate impairment: No dosage adjustment needed.
Severe impairment: There are no dosage adjustments provided in the manufacturer's labeling; has not been studied.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported for atopic dermatitis (AD) in adolescents and adults or prurigo nodularis (PN) in adults.
10%: Immunologic: Antibody development (AD, PN: 6% to 17%; neutralizing: 3% to 6%)
1% to 10%:
Dermatologic: Atopic dermatitis (PN: 4%), eczema (PN: 4%; eczema nummular [3%]), urticaria (AD: 1%)
Local: Injection-site reaction (AD: ≤1%)
Nervous system: Headache (AD, PN: 5% to 6%)
Neuromuscular & skeletal: Arthralgia (AD: 1%), myalgia (AD: 1%)
<1%: Infection: Herpes zoster infection (including ocular herpes zoster; AD)
Postmarketing (any indication): Hypersensitivity: Type I hypersensitivity reaction (including angioedema [facial: peri-ocular])
Hypersensitivity to nemolizumab or any component of the formulation.
Concerns related to adverse effects:
• Hypersensitivity reactions: Hypersensitivity (eg, facial angioedema) reactions have been reported. Discontinue nemolizumab and immediately institute appropriate therapy if hypersensitivity occurs.
Other warnings/precautions:
• Immunizations: Patients should be brought up to date with all immunizations before initiating therapy. Avoid live vaccines during therapy; there are no data available concerning secondary transmission of live vaccines in patients receiving therapy.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Auto-injector, Subcutaneous [preservative free]:
Nemluvio: Nemolizumab-ilto 30 mg (1 ea)
No
Auto-injector (Nemluvio Subcutaneous)
30 mg (per each): $5,088.00
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
SUBQ: For SUBQ use only; patients/caregivers may self-inject after proper training by a health care provider. Administer into the front upper thighs, abdomen (except for 2-inch area around the navel), or upper arm (if administered by a caregiver); rotate injection sites (≥1 inch apart). Pen should be held vertical to the injection site; once the injection has begun the pen should remain against the injection site for 15 seconds. Administer 60 mg dose (two 30 mg injections) at different injection sites. Do not administer into skin that is bruised, damaged, inflamed, swollen, scarred, tender, or that has open wounds. Do not administer if solution is cloudy or contains particulate. Also refer to the manufacturer’s instructions for use provided with each pen for detailed administration instructions.
Note: In pediatric patients ≥12 years, the medication must be administered under the direct supervision of or by a properly trained adult or caregiver.
SUBQ: Prefilled pen: Following reconstitution, administer SUBQ into the front upper thighs, abdomen (except for 2-inch area around the navel), or upper arm (if administered by a caregiver); rotate injection sites. If dose requires two injections, use 2 separate injection sites (≥1 inch apart). Do not administer into bruised, damaged, tender/inflamed, swollen, or scarred skin, or skin that has stretch marks or open wounds.
Place orange needle guard flat and firmly against skin. Press and hold the injection button and listen for click, hold injection button down for 15 seconds (ie, in the inspection window, the orange and gray rod stopped moving). Remove from skin; refer to manufacturer's labeling for additional information. Pens are for single use; discard immediately after use.
Atopic dermatitis, moderate to severe: Treatment of moderate to severe atopic dermatitis (in combination with topical corticosteroids and/or calcineurin inhibitors) in adults and pediatric patients ≥12 years of age whose disease is not adequately controlled with topical prescription therapies.
Prurigo nodularis: Treatment of prurigo nodularis in adults.
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.
CYP Substrates (Narrow Therapeutic Index/Sensitive with Inducers): Nemolizumab may decrease serum concentration of CYP Substrates (Narrow Therapeutic Index/Sensitive with Inducers). Risk C: Monitor
Efgartigimod Alfa: May decrease therapeutic effects of Fc Receptor-Binding Agents. Risk C: Monitor
Nipocalimab: May decrease therapeutic effects of Fc Receptor-Binding Agents. Risk C: Monitor
Rozanolixizumab: May decrease therapeutic effects of Fc Receptor-Binding Agents. Risk C: Monitor
Vaccines (Live): Nemolizumab may increase adverse/toxic effects of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Nemolizumab may decrease therapeutic effects of Vaccines (Live). Risk X: Avoid
Nemolizumab is a humanized monoclonal antibody (IgG2). Human IgG crosses the placenta. Fetal exposure is dependent upon the IgG subclass, maternal serum concentrations, placental integrity, newborn birth weight, and GA, generally increasing as pregnancy progresses. The lowest exposure would be expected during the period of organogenesis and the highest during the third trimester (Clements 2020; Palmeira 2012; Pentsuk 2009).
In utero exposure to nemolizumab may cause immunosuppression in the newborn; based on the half-life, this may persist for 3 months after birth.
It is not known if nemolizumab is present in breast milk.
Nemolizumab is a humanized monoclonal antibody (IgG2). Human IgG is present in breast milk; concentrations are dependent upon IgG subclass and postpartum age (Anderson 2021).
According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother.
Nemolizumab is a humanized IgG2 monoclonal antibody that inhibits IL-31 signaling by binding selectively to IL-31 RA, thus inhibiting the release of proinflammatory cytokines and chemokines. IL-31 is a naturally occurring cytokine that is involved in pruritus, inflammation, epidermal dysregulation, and fibrosis.
Distribution: Vd: ~7.67 L.
Metabolism: Degraded into small peptides by catabolic pathways.
Half-life elimination: ~18.9 days.
Time to peak: ~6 days after 60 mg dose.
Excretion: Clearance: 0.263 L/day.
Body weight: Exposure of nemolizumab decreases with increasing body weight. After a 30 mg dose every 4 weeks, the steady-state mean exposure in patients weighing >87 kg is expected to be 1.7-fold lower than patients weighing <62 kg.
