Pronunciation: Nem LOO vee oh
Generic name: nemolizumab-ilto
Dosage form: subcutaneous injection pen (30 mg)
Drug class: Interleukin inhibitors

Medically reviewed by Melisa Puckey, BPharm. Last updated on Dec 19, 2024.

What is Nemluvio?

Nemluvio (nemolizumab) is used to treat eczema (atopic dermatitis) and prurigo nodularis, to help improve itch, skin lesions, inflammations, and sleep. Nemluvio is given once or twice monthly as an injection under the skin (subcutaneous) using a pre-filled pen. Nemluvio works by blocking a protein called IL-31 that is involved in causing itch and inflammation in atopic dermatitis and prurigo nodularis. Blocking IL-31 helps improve symptoms quickly.

Nemluvio FDA approval was received for the treatment of prurigo nodularis in adults on August 13, 2004, for the company Galderma. The FDA approval was then extended to cover atopic dermatitis in certain patients. 

Nemluvio mechansim of action is by inhibiting the IL-31 signaling protein (cytokine), which is involved in the itch, inflammation, and nodule formation in prurigo nodularis. By inhibiting IL-31 cytokine signaling, Nemluvio helps improve the symptoms of prurigo nodularis. Nemluvio is from a class of medicines called interleukin-31 receptor antagonist.

Who can use Nemluvio?

Nemluvio is indicated for the treatment 

• prurigo nodularis in adults
• atopic dermatitis that is 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 if the dermatitis is not adequately controlled with topical prescription therapies.

What is prurigo nodularis?

Prurigo nodularis is a long-term skin condition that has symptoms of severely itchy red or pink bumps that can later become larger nodules. These itchy areas usually occur on the outer side of your arms and legs, and also the shoulders, chest and buttocks. The cause of prurigo nodularis is unknown, although it is thought that it may be related to changes in the immune system, nerves, and inflammation. Patients with PN have elevated levels of Interleukin 31, a messenger protein (cytokine) that causes severe itching and dermatitis. Nemluvio blocks IL-31, which helps improve prurigo nodularis.

What is atopic dermatitis?

Atopic dermatitis, sometimes called eczema, is a common skin condition that has symptoms of itching, inflammation, dry skin, and lesions. Atopic dermatitis is a chronic condition that is long-lasting with periods of flares and improvements. Atopic dermatitis lesions have elevated levels of IL-31, which is involved in inflammation. Nemluvio blocks IL-31 to help improve atopic dermatitis.

How well does Nemluvio work?

Nemluvio for prurigo nodularis

Nemluvio reduced itch in 41% of patients after 4 weeks of treatment when used for prurigo nodularis, and by week 16, it showed significant and clinically meaningful improvements in both itch and skin nodules. 

How well Nemluvio works for prurigo nodularis was measured in clinical trials (OLYMPIA 1 and OLYMPIA 2).

For itch improvement,  56% of Nemluvio-treated patients in OLYMPIA 1 and 49% in OLYMPIA 2 achieved at least a four-point reduction in itch intensity at Week 16 compared to 16% in both placebo groups.

For skin nodule clearance, 26% of Nemluvio-treated patients in OLYMPIA 1 and 38% in OLYMPIA 2 reached clearance of skin nodules at Week 16 compared to 7% and 11% in the placebo groups; and

For sleep improvement, 50% of Nemluvio-treated patients in OLYMPIA 1 and 52% in OLYMPIA 2 achieved at least a four-point reduction in sleep disturbance at Week 16 compared to 12% and 21% in the placebo groups.

Nemluvio Side Effects

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 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.

Related/similar drugs

Warnings

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 this medicine

Before taking Nemluvio, tell your doctor about all of your medical conditions before starting this medicine.
Tell your prescriber if you are scheduled to receive any vaccination, as you should not have a live vaccine right before Nemluvio treatment or during the 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.

How should I use this medicine?

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.

Nemluvio Dosing Information

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.

What happens if I miss a dose?

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

What happens if I overdose?

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.

Nemluvio Enrollment form and copay support

The Nemluvio enrollment form for the GPS (Galderma Patient Services) is available on 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.

What other drugs will affect this medicine?

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.

Storage

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).

Ingredients

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.

Company

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

Nemluvio Biosimilars

Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.

Reference products

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for Nemluvio.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer