Nemluvio (Nemolizumab)

What Is Nemluvio and What Is It Used For?

Nemluvio (nemolizumab) is a biologic medicine that blocks interleukin-31 (IL-31), a protein that drives itch and skin inflammation. It is used to treat moderate-to-severe atopic dermatitis in adults and adolescents aged 12 years and older, and moderate-to-severe prurigo nodularis in adults, when systemic therapy is warranted.

Nemluvio contains the active substance nemolizumab, which belongs to a class of medicines known as monoclonal antibodies. Monoclonal antibodies are specialised proteins engineered to recognise and bind to specific targets in the body. In the case of nemolizumab, the target is the interleukin-31 receptor alpha (IL-31RA), which is the receptor through which IL-31 signals its effects on cells.

Interleukin-31 (IL-31) is a cytokine – a chemical messenger produced by certain immune cells, particularly T-helper type 2 (Th2) cells. Research has established that IL-31 plays a pivotal role in the pathogenesis of pruritus (itching) and skin inflammation seen in conditions such as atopic dermatitis (eczema) and prurigo nodularis. Patients with these conditions often have significantly elevated IL-31 levels compared to healthy individuals. IL-31 activates sensory nerve fibres and immune cells in the skin, triggering the intense itch cycle that characterises these diseases.

By binding to IL-31RA, nemolizumab prevents IL-31 from activating its receptor, thereby interrupting the signalling cascade that leads to itch and inflammation. This mechanism addresses a fundamental driver of disease rather than merely suppressing symptoms, which is why Nemluvio represents a significant advance in the treatment of itch-predominant dermatological conditions.

Atopic Dermatitis (Eczema)

Atopic dermatitis is a chronic, relapsing inflammatory skin disease characterised by intense itching, redness, dryness, and skin barrier dysfunction. It affects approximately 15–20% of children and 2–10% of adults worldwide, according to the World Health Organization (WHO). Moderate-to-severe forms significantly impair quality of life, affecting sleep, work productivity, and mental health. Nemluvio is approved for adults and adolescents aged 12 years and older with moderate-to-severe atopic dermatitis who are candidates for systemic therapy – meaning their disease is not adequately controlled by topical treatments alone.

In clinical trials (ARCADIA 1 and ARCADIA 2), nemolizumab demonstrated statistically significant and clinically meaningful improvements in itch severity (measured by the Peak Pruritus Numerical Rating Scale), skin clearance (measured by EASI and IGA scores), and patient-reported quality of life measures compared to placebo. Nemluvio can be used with or without topical corticosteroids or calcineurin inhibitors.

Prurigo Nodularis

Prurigo nodularis (also called chronic nodular prurigo) is a chronic skin condition characterised by firm, intensely itchy nodules (lumps) that develop as a result of persistent scratching. The condition creates a debilitating itch-scratch cycle that can be extremely difficult to break. It affects adults of all ages and can significantly impact daily functioning and quality of life. IL-31 has been identified as a key mediator of the itch in prurigo nodularis.

Nemluvio is approved for adults with moderate-to-severe prurigo nodularis who are candidates for systemic therapy. In the OLYMPIA clinical trial programme, nemolizumab significantly reduced itch intensity and the number of nodular lesions compared to placebo.

What Should You Know Before Taking Nemluvio?

Before starting Nemluvio, inform your doctor about all your medical conditions, particularly asthma or other respiratory diseases, allergies, current medications, and vaccination history. Do not use Nemluvio if you are allergic to nemolizumab or any of its excipients.

Contraindications

You should not use Nemluvio if you are allergic (hypersensitive) to nemolizumab or any of the other ingredients in this medicine. The excipients include sucrose, trometamol, trometamol hydrochloride, arginine hydrochloride, poloxamer 188, and water for injections. If you think you may be allergic or if you are unsure, consult your doctor, pharmacist, or nurse before using Nemluvio.

Warnings and Precautions

Talk to your doctor, pharmacist, or nurse before using Nemluvio if any of the following apply to you:

• Respiratory conditions: If you have asthma, chronic obstructive pulmonary disease (COPD), or chronic bronchitis, talk to your doctor before using Nemluvio. Worsening of asthma has been reported as a common side effect during treatment. If your respiratory condition worsens after starting Nemluvio, contact your doctor immediately. Your doctor may need to adjust your asthma treatment or discontinue Nemluvio.
• Allergic reactions: Nemluvio can cause allergic reactions (hypersensitivity reactions), which can sometimes be serious. These reactions may occur shortly after administration or may be delayed. Signs include breathing difficulties, swelling of the face, mouth, or tongue, fainting, dizziness, hives, itching, or skin rash. If you notice signs of an allergic reaction, stop using Nemluvio and seek medical attention immediately.
• Vaccination status: It is recommended that you are up to date with all recommended vaccinations before starting Nemluvio. You should avoid receiving live vaccines while using Nemluvio. Discuss your current vaccination schedule with your doctor.

Use in Children and Adolescents

Atopic dermatitis: Nemluvio is approved for use in adolescents aged 12 years and older who weigh at least 30 kg. It has not been studied in children under 12 years of age or in adolescents weighing less than 30 kg with atopic dermatitis.

Prurigo nodularis: Nemluvio should not be given to children or adolescents under 18 years of age for prurigo nodularis, as it has not been studied in this age group for this condition.

Pregnancy and Breastfeeding

The effects of Nemluvio during pregnancy are not known. As a precaution, it is preferable to avoid using Nemluvio during pregnancy unless your doctor advises that the benefits outweigh the potential risks. If you are pregnant, think you might be pregnant, or are planning to become pregnant, consult your doctor before using this medicine.

It is not known whether nemolizumab passes into breast milk. As a large protein molecule (monoclonal antibody), nemolizumab may be present in breast milk, particularly during the first few days after birth. If you are breastfeeding or planning to breastfeed, discuss the benefits and risks with your doctor so that you can decide together whether to use Nemluvio.

Driving and Operating Machinery

Nemluvio is unlikely to affect your ability to drive or use machines. However, if you experience any side effects such as dizziness after injection, wait until these symptoms resolve before driving.

Other Medicines and Nemluvio

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines. Also inform your doctor if you have recently been vaccinated or plan to receive any vaccinations. While nemolizumab is not expected to interact with most conventional medicines (as it is cleared by intracellular catabolism rather than hepatic enzymes), it is always important to provide a complete medication history to your healthcare team.

How Does Nemluvio Interact with Other Drugs?

Nemluvio (nemolizumab) has a low potential for drug-drug interactions because it is a monoclonal antibody that is eliminated through intracellular catabolism, not through liver enzymes. However, live vaccines should be avoided during treatment, and patients on concomitant asthma medications should be monitored carefully.

Unlike small-molecule drugs that are metabolised by liver enzymes such as the cytochrome P450 (CYP) system, monoclonal antibodies like nemolizumab are large protein molecules that are cleared from the body through intracellular degradation (catabolism). This means that nemolizumab does not directly compete with or inhibit drug-metabolising enzymes, resulting in a low likelihood of pharmacokinetic drug-drug interactions.

However, there are several important considerations when using Nemluvio alongside other medicines:

What Is the Correct Dosage of Nemluvio?

Nemluvio is administered as a subcutaneous injection. For atopic dermatitis, the starting dose is 60 mg (two 30 mg injections) followed by 30 mg every 4 weeks. For prurigo nodularis, dosing depends on body weight. Treatment should be initiated and supervised by a physician experienced in these conditions.

Always use Nemluvio exactly as your doctor or pharmacist has told you. Do not change your dose without consulting your doctor first. Nemluvio is a powder that must be reconstituted (mixed with solvent) before injection. The pre-filled pen contains both the powder and the solvent in separate chambers.

Adults and Adolescents with Atopic Dermatitis (aged 12 years and older)

Adults with Prurigo Nodularis

After 16 weeks of treatment for prurigo nodularis, your doctor will evaluate how well the medicine is working and decide whether continued treatment is appropriate.

How to Administer Nemluvio

Nemluvio is given as a subcutaneous injection (an injection under the skin) using the pre-filled pen. Before injecting, the powder must be reconstituted by following the instructions provided with the pen. Key steps include:

1. Allow the pen to reach room temperature for 30–45 minutes before use
2. Activate the pen by twisting the activation knob to the right until it stops, which transfers the solvent to the powder chamber
3. Wait for the grey rod to stop moving, then shake the pen up and down for 30 seconds
4. Wait approximately 5 minutes for the powder to dissolve completely
5. Check that the solution is clear, colourless to slightly yellow, and free of particles
6. Inject into the front of the upper thigh or the abdomen (avoiding 5 cm around the navel). A caregiver may also inject into the upper arm

You and your doctor or nurse will decide whether you can self-inject. Do not attempt self-injection until you have received proper training. Rotate injection sites with each administration. Do not inject into skin that is tender, inflamed, damaged, bruised, scarred, or has open wounds.

Missed Dose

If you forget to inject a dose of Nemluvio, administer it as soon as possible and then continue with your original dosing schedule. Do not take a double dose to compensate for a missed injection.

Overdose

Stopping Nemluvio

Do not stop using Nemluvio without first talking to your doctor. Discontinuing treatment may lead to a return of symptoms. Your doctor will advise you on whether and when to stop treatment based on your clinical response.

What Are the Side Effects of Nemluvio?

Common side effects of Nemluvio include skin fungal infections, headache, eczema flares, injection site reactions, and worsening of asthma in patients with pre-existing asthma. Allergic reactions (hypersensitivity) can also occur. Most side effects are mild to moderate in severity.

Like all medicines, Nemluvio can cause side effects, although not everybody gets them. Most side effects are manageable and tend to be mild to moderate. However, some side effects can be serious and require immediate medical attention.

If you notice any of these side effects or experience any other symptoms not listed here, contact your doctor or pharmacist. Reporting suspected side effects helps ensure continuous monitoring of the medicine's benefit-risk profile.

Skin Fungal Infections

Fungal skin infections are among the most frequently reported side effects of Nemluvio. These include conditions such as tinea corporis (ringworm), tinea pedis (athlete's foot), onychomycosis (nail fungus), and tinea cruris (jock itch). While these infections are generally mild and treatable with antifungal medications, it is important to tell your doctor if you develop any new skin symptoms during treatment. Good skin hygiene and keeping the skin dry in fold areas can help reduce the risk.

Worsening of Asthma

If you have asthma or another chronic respiratory condition, your doctor will monitor you carefully during Nemluvio treatment. IL-31 may play a role in airway inflammation, and blocking it may theoretically affect respiratory immune responses. In clinical trials, worsening of asthma was reported as a common side effect in patients with pre-existing asthma. Do not reduce or stop your asthma medications without consulting your doctor, and seek immediate medical attention if you experience sudden worsening of breathing.

Eczema and Nummular Eczema

Some patients may experience eczema flares or develop nummular (discoid) eczema during treatment. Nummular eczema presents as round or oval patches of inflamed, itchy, and sometimes blistering skin. This is a recognised side effect and differs from the underlying atopic dermatitis. If you notice new or worsening eczema patches, particularly with an unusual pattern, inform your doctor.

How Should You Store Nemluvio?

Store Nemluvio in the refrigerator at 2°C to 8°C. Do not freeze. Keep in the original packaging to protect from light. If needed, it may be stored at room temperature (up to 25°C) for a single period of up to 90 days.

Keep Nemluvio out of the sight and reach of children. Do not use this medicine after the expiry date stated on the label and carton after "EXP." The expiry date refers to the last day of the stated month.

Refrigerator Storage (Recommended)

Store Nemluvio in the refrigerator between 2°C and 8°C. Do not freeze the pre-filled pen. Keep the pen in its original carton to protect it from light. If the pen has been frozen, do not use it – discard it and use a new one.

Room Temperature Storage (When Necessary)

If needed, Nemluvio may be stored at room temperature (up to 25°C) for a single period of up to 90 days. Once removed from the refrigerator, write the date of removal on the carton in the space provided. Do not return the pen to the refrigerator after room temperature storage. Use the medicine before whichever comes first: the expiry date or 90 days after removal from the refrigerator.

After Reconstitution

Once the powder has been dissolved (reconstituted), the medicine must be used within 4 hours. If not used within this time, the pen must be discarded. Store at room temperature (up to 25°C) during this period.

Do not use Nemluvio if the powder does not appear white before reconstitution, or if the reconstituted solution is cloudy or contains visible particles. Do not dispose of medicines via household waste or wastewater. Ask your pharmacist how to dispose of medicines no longer in use, as these measures help protect the environment.

What Does Nemluvio Contain?

Each Nemluvio pre-filled pen contains 30 mg of nemolizumab as a white powder, along with solvent (water for injections) for reconstitution. The pen is a single-use, dual-chamber device containing both the powder and the solvent.

Active Ingredient

The active substance is nemolizumab. Each single-use pre-filled pen contains 30 mg nemolizumab. Nemolizumab is a humanised IgG2 monoclonal antibody produced in Chinese hamster ovary (CHO) cells using recombinant DNA technology.

Inactive Ingredients (Excipients)

Powder: Sucrose, trometamol (tromethamine), trometamol hydrochloride (for pH adjustment), arginine hydrochloride, poloxamer 188.

Solvent: Water for injections.

These excipients serve as stabilisers and buffering agents to maintain the stability and correct pH of the medicine during storage and reconstitution.

Pen Appearance and Packaging

Nemluvio powder and solvent for solution for injection comes in a single-use, dual-chamber pre-filled pen. The pen contains a glass cartridge with a white powder and a clear, colourless solvent. The solvent is not visible in the inspection window before reconstitution. After reconstitution, the solution should appear clear and colourless to slightly yellow.

Nemluvio is available as a 30 mg pre-filled pen in packs of 1 pen, or multipacks of 2 or 3 cartons each containing 1 pen. Not all pack sizes may be available in your country.

Marketing Authorisation Holder

Galderma International, La Defense 4, Tour Europlaza, 20 Avenue Andre Prothin, 92927 Paris La Defense Cedex, France.

How Does Nemluvio Work in the Body?

Nemluvio works by blocking interleukin-31 (IL-31), a cytokine that plays a central role in triggering itch and skin inflammation in atopic dermatitis and prurigo nodularis. By binding to the IL-31 receptor alpha (IL-31RA), nemolizumab prevents IL-31 from activating sensory nerves and immune cells, breaking the itch-inflammation cycle.

The mechanism of action of nemolizumab is fundamentally different from other biologics used in dermatology. While medicines like dupilumab target the IL-4/IL-13 pathway (which drives type 2 inflammation broadly), nemolizumab specifically targets IL-31, which is considered the "itch cytokine." This targeted approach makes Nemluvio particularly effective at controlling pruritus, which is often the most distressing symptom for patients with atopic dermatitis and prurigo nodularis.

The Role of IL-31 in Itch and Inflammation

IL-31 is produced primarily by activated CD4+ T-helper type 2 (Th2) cells, but also by mast cells, macrophages, and dendritic cells. Once released, IL-31 binds to a heterodimeric receptor complex composed of IL-31 receptor alpha (IL-31RA) and oncostatin M receptor beta (OSMRβ). This receptor complex is expressed on sensory dorsal root ganglion neurons, keratinocytes, and various immune cells.

When IL-31 activates its receptor on sensory neurons, it directly triggers itch signals that are transmitted to the brain. Simultaneously, IL-31 signalling in keratinocytes and immune cells promotes inflammation, impairs skin barrier function, and recruits additional immune cells to the skin. This creates a self-reinforcing cycle where inflammation causes itch, scratching damages the skin, and the resulting inflammation produces more IL-31, perpetuating the disease.

How Nemolizumab Breaks the Cycle

Nemolizumab binds specifically to IL-31RA with high affinity, preventing IL-31 from interacting with its receptor. This blockade interrupts the itch signalling at the neural level and reduces the inflammatory cascade in the skin. In clinical trials, patients treated with nemolizumab experienced rapid and significant improvements in itch scores, often within the first 1–2 weeks of treatment, which is consistent with direct inhibition of the neuro-immune itch pathway.

Pharmacokinetic Profile

Following subcutaneous administration, nemolizumab has a bioavailability of approximately 85%. Peak serum concentrations are typically reached within 3 to 14 days after injection. The elimination half-life is approximately 2 to 4 weeks, which supports the once-every-4-weeks dosing regimen. Steady-state concentrations are generally achieved by approximately 16 weeks of treatment.

As a monoclonal antibody, nemolizumab is eliminated through intracellular catabolism (protein degradation within cells), similar to endogenous immunoglobulins. It is not metabolised by liver enzymes, which contributes to its low drug-drug interaction potential. Body weight can influence nemolizumab pharmacokinetics, which is why the dosing regimen for prurigo nodularis is weight-based (different doses for patients weighing less than or at least 90 kg).

Frequently Asked Questions About Nemluvio