Comprehensive medication guide to Nemluvio including estimated pricing, availability information, side effects, and how to find it in stock at your local pharmacy.
Estimated Insurance Pricing
Specialty tier on most commercial plans; prior authorization required. Eligible commercially insured patients may pay as little as $0 per dose with Galderma Copay Assistance Program (up to $15,000/year savings). Medicare Part D annual out-of-pocket cap is $2,100 in 2026.
Estimated Cash Pricing
$4,356–$6,144 retail per 30 mg pen (1–2 pens per month depending on dose and weight); no generic or biosimilar available. Galderma Patient Assistance Program can provide it at no cost to eligible uninsured patients.
Medfinder Findability Score
65/100
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Nemluvio (nemolizumab-ilto) is a prescription biologic medication manufactured by Galderma Laboratories. It is the brand name for nemolizumab, a humanized IgG2 monoclonal antibody that targets the interleukin-31 receptor alpha (IL-31RA). The FDA first approved Nemluvio on August 12, 2024 for prurigo nodularis (PN) in adults, then expanded approval in December 2024 to include moderate-to-severe atopic dermatitis (eczema) in adults and patients aged 12 and older.
The FDA considers Nemluvio a first-in-class medication — the first monoclonal antibody specifically approved to target the IL-31 receptor. It received Breakthrough Therapy Designation in 2019 and Priority Review in February 2024, reflecting the significant unmet medical need in prurigo nodularis.
Nemluvio is not a steroid and is not an immunosuppressant. It is a targeted biologic that precisely blocks a specific immune signaling pathway, leaving the rest of the immune system intact. It is supplied as a single-dose, prefilled dual-chamber pen for subcutaneous injection and is given once monthly after a loading dose.
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Nemluvio works by blocking the IL-31 receptor alpha (IL-31RA) on the surface of cells in the skin and nervous system. IL-31 is a naturally occurring cytokine that functions as the primary "itch cytokine" — it binds to receptors on sensory nerve fibers and triggers the brain's itch response. In prurigo nodularis and atopic dermatitis, IL-31 is overproduced, driving relentless, chronic itch and a cycle of scratching that worsens the skin.
By selectively binding to IL-31RA, Nemluvio prevents IL-31 from attaching to its receptor and initiating the itch signal. This targeted block has downstream effects: it reduces pruritus (itch), decreases skin inflammation, improves epidermal barrier function, and reduces the fibrosis (hardening) that characterizes prurigo nodularis nodules over time.
Because Nemluvio acts through subcutaneous injection and is absorbed into the bloodstream, it reaches skin tissue systemically. Its terminal elimination half-life is approximately 18.9 days, supporting a once-monthly dosing schedule that many patients find more convenient than the every-two-week schedule of Dupixent (dupilumab).
30 mg — Subcutaneous injection (prefilled dual-chamber pen)
Single-dose prefilled pen; lyophilized powder reconstituted with water for injection. Delivers 30 mg/0.49 mL after reconstitution.
Nemluvio is not in shortage as of 2026 — it is not listed on the FDA's drug shortage database, and Galderma reports stable supply through its specialty pharmacy network. However, patients routinely encounter difficulty finding or obtaining Nemluvio because it is exclusively distributed through specialty pharmacies, not retail chains like CVS or Walgreens.
The barriers to access are primarily administrative: prior authorization requirements from insurance companies, the need to enroll in the GPS (Galderma Patient Services) specialty pharmacy program, and the relatively new status of the drug (approved in late 2024) means some insurance formularies are still catching up. Nemluvio is a moderate-findability medication — not a shortage drug, but not easily picked up at your corner pharmacy either.
If you're having difficulty getting Nemluvio filled, medfinder can call specialty pharmacies on your behalf to identify which ones can fill your prescription, cutting down on frustrating phone calls and delays.
Nemluvio is not a controlled substance and has no DEA scheduling restrictions. Any licensed prescriber can technically write a prescription. However, in practice, Nemluvio is almost exclusively prescribed by specialists due to the complex diagnostic and documentation requirements for prior authorization.
Dermatologists — primary prescribers for both prurigo nodularis and atopic dermatitis
Allergists and Immunologists — may prescribe for atopic dermatitis patients with concurrent allergic conditions
Nurse Practitioners (NP) and Physician Assistants (PA) — in dermatology or allergy practices with prescriptive authority
Telehealth dermatology options exist for established patients, particularly those seeking Nemluvio prescription renewals for atopic dermatitis. First-time prurigo nodularis diagnoses typically require in-person examination of the skin nodules. Telehealth platforms including dedicated dermatology services can connect patients with licensed prescribers remotely.
No. Nemluvio (nemolizumab-ilto) is not a controlled substance and has no DEA schedule. It does not require a special DEA prescription form, and there are no restrictions on the number of refills based on controlled substance scheduling.
While Nemluvio does not have DEA restrictions, it is a prescription-only medication that requires a valid prescription from a licensed healthcare provider. Because it is a specialty biologic, all prescriptions must be channeled through the GPS for Nemluvio enrollment process and dispensed by specialty pharmacies — but this is a logistical requirement, not a controlled substance requirement.
Nemluvio has a favorable safety profile with no FDA boxed warnings. Common side effects (occurring in ≥1% of clinical trial patients):
Headache
Atopic dermatitis or eczema flares (in PN patients)
Nummular eczema (round, coin-shaped patches of itchy rash)
Injection site reactions (redness, swelling, discomfort at injection site)
Muscle and joint pain (myalgia, arthralgia)
Hypersensitivity reactions (including facial angioedema) — rare but potentially serious. Stop Nemluvio and seek emergency care if you experience swelling of the face, lips, tongue, or throat, difficulty breathing, or severe hives.
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Dupixent (dupilumab)
IL-4/IL-13 receptor antagonist; FDA-approved for both prurigo nodularis and atopic dermatitis (ages 6 months+). Given every 2 weeks. Most established biologic for these conditions.
Adbry (tralokinumab)
IL-13 antagonist; FDA-approved for moderate-to-severe atopic dermatitis in patients 12+. Not approved for prurigo nodularis. Given every 2 weeks initially, may reduce to monthly.
Ebglyss (lebrikizumab)
IL-13 antagonist; FDA-approved for moderate-to-severe atopic dermatitis in adults 18+. Not approved for prurigo nodularis. Monthly maintenance dosing.
Rinvoq (upadacitinib)
Oral JAK1 inhibitor; FDA-approved for moderate-to-severe atopic dermatitis in adults and patients 12+. Once-daily pill. Carries boxed warnings for serious infections, malignancy, and cardiovascular events.
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Live vaccines (all types)
majorNemluvio may reduce the efficacy of live vaccines. Complete all recommended live vaccinations before starting treatment. Do not administer live vaccines during Nemluvio therapy.
Warfarin (Coumadin)
moderateNemluvio may affect CYP450 enzyme activity. Monitor INR when initiating or discontinuing Nemluvio in patients taking warfarin. Dose adjustment may be needed.
Cyclosporine
moderateCYP450 substrate with narrow therapeutic index. Monitor blood concentrations when initiating or discontinuing Nemluvio in patients on cyclosporine.
Nemluvio represents a significant advance in the treatment of prurigo nodularis and atopic dermatitis. As the first IL-31 receptor antagonist approved by the FDA, it fills a critical gap for patients who haven't found adequate relief with topical therapies or other biologics. Its monthly dosing schedule and favorable safety profile (no boxed warnings) make it a compelling option for appropriate patients.
The primary barrier to Nemluvio is access — not supply. Prior authorization requirements, specialty pharmacy enrollment, and insurance formulary gaps can delay treatment. Patients who understand the GPS for Nemluvio support programs (Quick Start, Copay Assistance, Bridge, and Patient Assistance) are far better positioned to navigate these barriers. For those without insurance, the Patient Assistance Program may provide medication at no cost.
If you're struggling to find Nemluvio at a pharmacy or navigate specialty pharmacy access, medfinder can help. We call pharmacies near you to identify which ones can fill your prescription, and we text you the results — so you can focus on your health rather than spending hours on hold.
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