Nemluvio

Nemluvio (nemolizumab) is a prescription biologic medicine used to treat moderate-to-severe eczema (atopic dermatitis) in patients 12 years and older and prurigo nodularis in adults.

Nemluvio is an interleukin-31 receptor antagonist.

Nemluvio works by blocking IL-31, a signaling protein that plays a major role in itch and skin inflammation, in chronic itch conditions, including eczema and prurigo nodularis. By blocking IL-31, Nemluvio reduces itch, helping to break the itch-scratch cycle, which improves skin lesions, inflammation, and sleep.

Nemluvio is administered a subcutaneous injection once or twice monthly, depending on your treatment plan. Patients can self-inject using a pre-filled pen or may be given by a caregiver following training from a healthcare professional.

Nemluvio is used for the treatment of:

• Atopic dermatitis (moderate-to-severe) in adults and pediatric patients 12 years of age and older, when used in combination with topical corticosteroids and/or calcineurin inhibitors, and if the dermatitis is not adequately controlled with topical prescription therapies.
• Prurigo nodularis in adults

Nemluvio received FDA approval for the treatment of prurigo nodularis in adults on August 13, 2024. This approval was later expanded on December 15, 2024. The FDA approval was then extended to include moderate-to-severe atopic dermatitis in eligible adolescent and adult patients.

Nemluvio for prurigo nodularis results at 16 weeks

Itch improvement:

• 56% and 49% of Nemluvio-treated patients achieved at least a four-point reduction in itch intensity at Week 16 in the OLYMPIA 1 and OLYMPIA 2 trials compared to 16% in both placebo groups.
• Measured by the peak-pruritus numerical rating scale.

Skin nodule clearance:

• 26% and 38% of Nemluvio-treated patients reached clearance (IGA 0) or almost-clearance (IGA 1) of skin nodules at Week 16 in OLYMPIA 1 and 2, respectively, compared to 7% and 11% in the placebo group.
• Measured using investigator’s global assessment [IGA] score (range: 0-4).

Nemluvio for moderate-to-severe atopic dermatitis results at Week 16

Patients with clear or almost clear skin (Investigator’s Global Assessment (IGA 0/1):

• 36% Nemluvio patients vs 25% with placebo (ARCADIA 1 study)
• 38% Nemluvio patients vs 26% with placebo (ARCADIA 2 study)

Patients with ≥75% improvement in Eczema Area and Severity Index (EASI-75):

• 44% with Nemluvio patients vs 29% with placebo (ARCADIA 1 study)
• 42% with Nemluvio patients vs 30% with placebo (ARCADIA 2 study)

Phase III ARCADIA 1 and 2 trials studied adult patients with moderate to severe atopic dermatitis. Patients received subcutaneous Nemluvio every four weeks in combination with topical corticosteroids (TCS), with or without topical calcineurin inhibitors (TCI), versus placebo with the same topical therapies

Nemluvio is given as an injection under the skin (subcutaneous injection) using a single-dose pen. You will be told by your prescriber how much Nemluvio to inject and how often to inject it. If you are going to self-administer the pen or have a caregiver give you your injection, your healthcare provider will train you on how to prepare and inject Nemluvio properly.

Take the Nemluvio carton from the refrigerator 30-45 minutes before administration to allow it to reach room temperature.

Before reconstitution, look at the pen to check that the powder is white in one chamber and a clear diluent in the other chamber. You should not use the medicine if the powder is not white or if the diluent is cloudy or contains visible particles.

Before using Nemluvio, it must be reconstituted, which results in a clear and colorless to slightly yellow solution. Check the solution and do not use it if the reconstituted solution has discoloration or contains particles. The injection should be used within 4 hours after reconstitution. Discard any unused reconstituted pens after 4 hours or any unused portions after administration.

Nemluvio can be self-injected into the front upper thighs or abdomen, except for the 2 inches (5 cm) around the navel. You may have a caregiver or healthcare professional give you your injection in the upper arm. You should alternate the injection site with each injection. Do not inject into any skin that is inflamed, swollen, tender, damaged, or has bruises, scars, or open wounds.

Read the Instructions for Use for complete administration instructions with illustrations.

Your healthcare provider may prescribe other medicines to use with this injection. Use the other prescribed medicines exactly as your healthcare provider tells you to.

Do not use this injection if you are allergic to nemolizumab-ilto or to any of the inactive ingredients contained in this medicine.

Before taking Nemluvio, tell your doctor about all of your medical conditions.Tell your prescriber if you are scheduled to receive any vaccination, as you should not receive a live vaccine within 2 weeks before, during, or after Nemluvio treatment.

Pregnancy

Tell your doctor if you are pregnant or plan to become pregnant, as it is not known whether this medicine will harm your unborn baby.

Breastfeeding

Tell your prescriber if you are breastfeeding or plan to breastfeed, as it is not known whether this medicine passes into your breast milk and if it can harm your baby.

Prurigo nodularis Nemluvio side effects

The most common Nemluvio side effects are:

• headache (6%)
• atopic dermatitis (4%)
• eczema (4%)
• nummular eczema, which is a type of eczema that presents as scattered circular patches (3%)

These are the side effects that occurred in 1% or more of patients being treated for prurigo nodularis in clinical trials.

Atopic dermatitis Nemluvio side effects

The most common Nemluvio side effects are:

• headache (5%)
• joint pain (1%)
• muscle pain (1%)
• hives (1%)

These are the side effects that occurred in 1% or more of patients being treated in clinical trials for atopic dermatitis.

Serious Nemluvio side effects

This medicine may cause allergic reactions (hypersensitivity). You should stop using Nemluvio and tell your healthcare provider or get emergency help right away if you get any of the following hypersensitivity symptoms:

• breathing problems or wheezing
• swelling of the face, lips, mouth, tongue, or throat
• fainting, dizziness, feeling lightheaded
• fast pulse
• swollen lymph nodes
• joint pain
• fever
• skin rash (red or rough skin)
• nausea or vomiting
• general ill feeling
• cramps in your stomach area.

Prurigo nodularis Nemluvio dosing information

Adult Patients Weighing Less Than 90kg:

• The recommended initial dose is 60 mg (two 30 mg injections), followed by a maintenance dose of 30 mg given every 4 weeks.

Adult Patients Weighing 90kg or More:

• The recommended initial dose is 60 mg (two 30 mg injections), followed by a maintenance dose of 60 mg given every 4 weeks.

Atopic dermatitis Nemluvio dosing information

Adults and pediatric patients 12 years:

• Recommended initial dose of 60 mg (two 30 mg injections) followed by a maintenance dose of 30 mg given every 4 weeks.
• After 16 weeks of treatment, for patients who achieve clear or almost clear skin, a subcutaneous dosage of 30 mg every 8 weeks is recommended.

Concomitant Topical Therapies:

Nemluvio is used with topical corticosteroids and/or topical calcineurin inhibitors. When the disease has sufficiently improved, discontinue the use of topical therapies.

General dosing information

• Nemluvio must be reconstituted before administration.
• Complete all age-appropriate vaccinations as recommended by current immunization guidelines before Nemluvio treatment.
• Nemluvio is available as a single-dose prefilled dual chamber pen containing 30 mg of nemolizumab-ilto lyophilized powder and diluent, water for injection.

If you miss a dose, inject the missed dose as soon as possible, then continue with your next dose at your regular scheduled time.

If you inject too much Nemluvio, call your healthcare provider or the Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away.

The Nemluvio enrollment form for the GPS (Galderma Patient Services) is available on the Nemluvio website. The Galderma Patient Service helps you with co-pay support if you have commercial insurance that covers Nemluvio, and also with the patient assistance program. They can also provide guidance, support one-on-one education, and refill reminders.

Other drugs may interact with this medicine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Medications that are Cytochrome P450 (CYP450) Substrates Upon starting or discontinuing Nemluvio, consider monitoring for effect (e.g., for warfarin) or drug concentration (e.g., for cyclosporine) and consider dosage modification of the CYP450 substrate.

Refrigerator storage

• Store in a refrigerator at 36°F to 46°F (2°C to 8°C) in the original carton to protect from light until the expiration date.
• Do not freeze.
• Do NOT expose to heat or direct sunlight.

Room temperature storage

• Store at room temperature [up to 77°F (25°C)] for up to 90 days.
• In the space provided on the inner partition for the pen, write the date the prefilled pen is first removed from the refrigerator.
• Do not use the pen beyond the expiration date or 90 days after the date it was first removed from the refrigerator (whichever is earlier).

Dual chamber single-dose, prefilled pen

Chamber one: contains activae ingrediet nemolizumab-ilto. Inactive ingredients arginine hydrochloride (9.5 mg), poloxamer 188 (0.15 mg), sucrose (25.8 mg), trometamol (0.10 mg), and tris hydrochloride for pH adjustment.

Chamber two: contains the diluent, water for injection.

Following reconstitution each prefilled pen delivers 30 mg/0.49 mL of nemolizumab-ilto with a pH of 6.7 to 7.3.

Manufactured by: Galderma Laboratories, L.P., Dallas, TX 75201