Frequently asked questions

Name: Nemluvio
Creator: Nemluvio

About NEMLUVIO

Who is NEMLUVIO^® for?

NEMLUVIO is intended for adults and adolescents (age 12 or older) with moderate-to-severe eczema (atopic dermatitis) that is not well controlled by current treatment.¹

What is a biologic?

A biologic is a medicine that is made from living organisms that specifically addresses a cause of a certain disease, such as eczema, or atopic dermatitis. In this case, NEMLUVIO blocks a key driver of itch and inflammation within the body. It’s common for biologics to be given as a subcutaneous injection under the skin.^1,2

How is NEMLUVIO different from other treatments I’ve tried before?

NEMLUVIO is the first and only self-injectable for eczema that you can use approximately once a month from the start. NEMLUVIO is not a steroid, cream, immunosuppressant, or daily medication. It is designed to directly block a key driver of itch and inflammation so skin can heal and clear.¹

How does NEMLUVIO help block signals for itch and inflammation?

Interleukin-31, or IL-31, is a key protein responsible for triggering itch, inflammation, and rashes in eczema. NEMLUVIO is the first and only approved treatment designed to directly block IL-31 signaling inside the body. By relieving the urge to scratch, NEMLUVIO allows skin to heal.^1,3

See how NEMLUVIO blocks IL-31 signaling for itch.

How NEMLUVIO Works

When can I expect to see results with NEMLUVIO?

NEMLUVIO was proven in clinical trials to help heal the rashes of eczema, leading to clearer skin. By Week 16, 44% of those using NEMLUVIO + topicals* had an improvement of at least 75% or more in the severity of their eczema and extent of their skin affected by it (vs 29% with placebo + topicals).^1†

Additionally, 36% achieved clear or almost clear skin (vs 25% with placebo + topicals) by Week 16.^1‡

View the before and after photos 16 weeks after using NEMLUVIO.

NEMLUVIO Results

How soon could NEMLUVIO start working to stop itch?

Itch relief with NEMLUVIO was seen in clinical trials as soon as 48 hours.^§ Adults and adolescents using NEMLUVIO continued to feel relief from itch over 1 year with treatment.⁴

NEMLUVIO Results

How do I get started with NEMLUVIO?

The first step is talking with your dermatologist about whether NEMLUVIO could be right for you. Be sure to sign up for updates so you can receive more information about starting NEMLUVIO and managing eczema (atopic dermatitis).

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Using NEMLUVIO

What are the most common side effects of NEMLUVIO?

The most common side effects for adults and adolescents using NEMLUVIO + topicals were headache, joint pain, muscle ache, and hives. Headache was the most common at 5% (vs 4% with placebo + topicals), with each of the other side effects occurring at 1% (vs 0% with placebo + topicals).¹

Learn more about NEMLUVIO safety.

NEMLUVIO SAFETY

How do I USE NEMLUVIO?

NEMLUVIO is given as a subcutaneous (under the skin) injection. It comes in a pre-filled self-injector pen to help make injections safe and simple.¹

Learn more about injections and get support.

Injection Support

How do I store NEMLUVIO?

NEMLUVIO may be stored at room temperature up to 77 °F (25 °C) for up to 90 days, making it easy to take on the go. Be sure to mark the date after NEMLUVIO is removed from the refrigerator. NEMLUVIO may be stored in the refrigerator at 36 °F to 46 °F (2 °C to 8 °C) until the expiration date.¹

Support and resources

What if I don’t have insurance coverage for NEMLUVIO?

GPS (Galderma Patient Services) for NEMLUVIO™ includes a Patient Assistance Program that provides access support for eligible patients who are uninsured for NEMLUVIO or underinsured and meet the program requirements.

Discover GPS for NEMLUVIO

What kind of financial assistance is available?

GPS for NEMLUVIO offers Co-Pay Assistance to help with out-of-pocket expenses and other programs to help reduce the financial burden of treatment for patients with commercial insurance who otherwise meet program criteria.

Learn more and see if you are eligible.

Discover GPS for NEMLUVIO

How do I contact my nurse navigator?

Nurse Navigator support is available to all patients being treated with NEMLUVIO. Our nurses can help educate you on other things like provide tips on how to care for your skin. Our nurses cannot give you any medical advice. Patients seeking medical advice should consult their prescriber.

Get in touch with a Nurse Navigator by calling 1-855-NEMLUVIO, 8:00 AM - 8:00 PM ET, Monday-Friday.

How do I enroll in GPS (GALDERMA PATIENT SERVICES) For NEMLUVIO™?

You are eligible to enroll for GPS for NEMLUVIO as soon as you get started with NEMLUVIO. With your permission, your dermatologist will enroll you in GPS for NEMLUVIO when they complete the NEMLUVIO enrollment form. You can also enroll at galdermaPS.com through our patient web application.

It's best to enroll when you receive your prescription, so you can take advantage of the many services that help ensure a more successful start to treatment. You may also enroll in services directly online or by calling 1‑855‑NEMLUVIO1‑855‑NEMLUVIO.

See what services could help you get started.

Discover GPS for NEMLUVIO

How do I fill my prescription?

Your dermatologist will work closely with an in-network Specialty Pharmacy specially contracted to distribute NEMLUVIO to set up your prescription and refills. This Specialty Pharmacy will ship your treatment directly to your home address.

If you have questions about filling your prescription, contact GPS for NEMLUVIO at  1-855-NEMLUVIO.

About eczema

What is eczema?

Also known as atopic dermatitis, eczema is a chronic skin disease that causes dry, itchy skin from below the surface. Eczema affects the skin’s ability to heal and can lead to redness, discoloration, flaky or scaly patches of skin, or painful rashes.⁵

Eczema causes an urge to scratch that is nearly impossible to ignore. This contributes to a vicious cycle of itch, inflammation, and discomfort. It can also affect important parts of everyday life like school, relationships, and sleep. That’s why relieving the urge to scratch is such an important part of managing eczema.^5,6

Learn more about eczema and the itch-scratch cycle.

WHAT IS ECZEMA?

How do I talk to my dermatologist about my eczema?

Is the intense, persistent itch of eczema almost impossible to ignore? Does managing eczema take up energy and mind space? Do your symptoms disrupt important parts of life like focus at school or work, relationships, social activities, self-esteem, and sleep?

This discussion guide can help foster a more informed conversation with a dermatologist about how eczema impacts your life. Download the guide for your next appointment and ask if NEMLUVIO could be an option for you.

DOWNLOAD THE GUIDE

SIGN UP FOR HELPFUL INFORMATION ON
NEMLUVIO AND TREATING ECZEMA

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Response defined as EASI-75 (improvement of at least 75%).¹

Topicals used in the ARCADIA studies included topical corticosteroids and topical calcineurin inhibitors.¹

Clear or almost clear skin was defined as a 1 or below on the IGA scale, where 0 was clear and 4 was severe, with a 2-point or more improvement from baseline.¹

PP-NRS response defined as a ≥4-point improvement from baseline. Data from Phase 3 clinical study (ARCADIA 1) post hoc descriptive analysis of daily PP-NRS improvement; consistent results seen in ARCADIA 2. Significant improvement was achieved at 48 hours (9% with NEMLUVIO + TCS/TCI vs 3% with placebo + TCS/TCI, P≤0.001).^1,4

EASI=Eczema Area and Severity Index; IGA=Investigator's Global Assessment; PP-NRS=Peak Pruritus Numerical Rating Scale; TCS=topical corticosteroid; TCI=topical calcineurin inhibitor.

References: 1. NEMLUVIO (nemolizumab-ilto) injection 30 mg Prescribing Information. Dallas, TX: Galderma Laboratories, L.P. 2. Morrow T, Felcone LH. Defining the difference: what makes biologics unique. Biotechnol Healthc. 2004;1(4):24-29. 3. Nemmer JM, Kuchner M, Datsi A, et al. Interleukin-31 signaling bridges the gap between immune cells, the nervous system and epithelial tissues. Front Med (Lausanne). 2021;8:639097. doi:10.3389/fmed.2021.639097 4. Galderma Laboratories, L.P.; data on file. 5. National Eczema Association. Atopic dermatitis. Accessed October 11, 2024. https://nationaleczema.org/eczema/types-of-eczema/atopic-dermatitis/ 6. Silverberg JI, Mohawk JA, Ciruli J, et al. Burden of disease and unmet needs in atopic dermatitis: results from a patient survey. Dermatitis. 2023;34(2):135-144. doi:10.1089/derm.2022.29015.jsi

Important Safety Information

Indications: NEMLUVIO^® (nemolizumab-ilto) is a prescription medicine used:

to treat adults and children 12 years of age and older with moderate-to-severe eczema (atopic dermatitis or AD) in combination with prescription therapies used on the skin (topical) when the eczema is not well controlled by topical therapies alone. It is not known if NEMLUVIO is safe and effective in children with atopic dermatitis under 12 years of age.
to treat adults with prurigo nodularis. It is not known if NEMLUVIO is safe and effective in children with prurigo nodularis under 18 years of age.

Do not take NEMLUVIO if you are allergic to nemolizumab-ilto or to any ingredients in NEMLUVIO. Before taking NEMLUVIO, tell your healthcare provider about all of your medical conditions, including if you:

are scheduled to receive any vaccination. You should not receive a live vaccine right before or during treatment with NEMLUVIO.
are pregnant or plan to become pregnant. It is not known whether NEMLUVIO will harm your unborn baby.
are breastfeeding or plan to breastfeed. It is not known whether NEMLUVIO passes into your breast milk and if it can harm your baby.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

NEMLUVIO may cause serious side effects, including: allergic reactions (hypersensitivity). Stop using NEMLUVIO and tell your healthcare provider or get emergency help right away if you get any of the following 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

The most common side effects of NEMLUVIO include:

Eczema: headache, joint pain, hives (itchy red rash or wheals), and muscle aches
Prurigo Nodularis: headache and skin rashes: atopic dermatitis (a type of eczema), eczema, and eczema nummular (scattered circular patches)

These are not all of the possible side effects of NEMLUVIO.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Please see full Prescribing Information, including Patient Information.

Frequently asked questions

About NEMLUVIO

Who is NEMLUVIO® for?

What is a biologic?

How is NEMLUVIO different from other treatments I’ve tried before?

How does NEMLUVIO help block signals for itch and inflammation?

When can I expect to see results with NEMLUVIO?

How soon could NEMLUVIO start working to stop itch?

How do I get started with NEMLUVIO?

Using NEMLUVIO

What are the most common side effects of NEMLUVIO?

How do I USE NEMLUVIO?

How do I store NEMLUVIO?

Support and resources

What if I don’t have insurance coverage for NEMLUVIO?

What kind of financial assistance is available?

How do I contact my nurse navigator?

How do I enroll in GPS (GALDERMA PATIENT SERVICES) For NEMLUVIO™?

How do I fill my prescription?

About eczema

What is eczema?

How do I talk to my dermatologist about my eczema?

SIGN UP FOR HELPFUL INFORMATION ONNEMLUVIO AND TREATING ECZEMA

Who is NEMLUVIO^® for?

SIGN UP FOR HELPFUL INFORMATION ON
NEMLUVIO AND TREATING ECZEMA