Frequently asked Questions

Name: Nemluvio HCP
Creator: Nemluvio

Have questions about NEMLUVIO for AD?
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PRESCRIBING AND SYMPTOM RELIEF

Which patients are appropriate to be prescribed NEMLUVIO^®?

NEMLUVIO should be prescribed for the treatment of adults and pediatric patients 12 years of age and older with moderate-to-severe atopic dermatitis in combination with TCS/TCI when the disease is not adequately controlled with topical prescription therapies.¹

Why should I consider NEMLUVIO for my patients with AD?

NEMLUVIO provides lasting skin healing and fast itch relief, as soon as 48 hours,* for patients with AD and has a favorable safety profile. In addition to significantly reducing itch and improving skin healing, NEMLUVIO only requires dosing every 4 weeks.^1-3

When can patients expect itch relief with NEMLUVIO?

NEMLUVIO provides lasting skin healing and fast itch relief, as soon as 48 hours* after their first dose. Over the course of 1 year, 8 out of 10 patients in clinical trials taking NEMLUVIO experienced lasting itch relief.^2,3†

When can patients with AD expect their skin to heal?

In a clinical study, 44% of patients taking NEMLUVIO achieved significantly clearer skin (≥75% EASI improvement from baseline) by Week 16 and 7 out of 10 patients achieved clearance with over a year of treatment.^1,3‡

In clinical trials, how was “significant itch relief” defined?

In both ARCADIA 1 and ARCADIA 2, the PP-NRS scale, a patient-reported outcome designed to measure the worst itch over the previous 24-hour period, was used to evaluate itch relief. PP-NRS response is defined as a ≥4-point improvement from baseline, where 0 was no itch and 10 was worst itch imaginable.^1,4

How is the mechanism of action for NEMLUVIO different from other biologics that treat AD?

NEMLUVIO is the first and only neuroimmune-targeted treatment to block the IL-31 signaling that is a direct driver of itch, inflammation, skin barrier dysfunction, and fibrosis.^1,5

Why prescribe NEMLUVIO to treat AD instead of other approved treatments?

NEMLUVIO offers itch relief as soon as 48 hours.* In a clinical study, 8 of 10 patients taking NEMLUVIO + TCS/TCI experienced continued itch relief over a year.^† NEMLUVIO also has convenient Q4W dosing, has no boxed warning, requires no preliminary lab evaluations or ongoing lab testing, and has a favorable safety profile.^1-3

Safety Profile

Does NEMLUVIO have a boxed warning?

NEMLUVIO does not have a boxed warning.¹

Does NEMLUVIO require any lab tests before or during treatment?

NEMLUVIO requires no preliminary lab evaluations or ongoing lab monitoring.¹

What common adverse reactions occurred in clinical trials?

The most common adverse reactions (incidence ≥1% and greater than placebo) were headache (including migraine), arthralgia, urticaria, and myalgia. NEMLUVIO was well-tolerated in the ARCADIA LTE after over a year of treatment.^1,3

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Is NEMLUVIO an immunosuppressant?

NEMLUVIO is not an immunosuppressant. NEMLUVIO inhibits IL-31, a neuroimmune cytokine that drives itch, inflammation, skin barrier dysfunction, and fibrosis.^1,5

OTHER CONSIDERATIONS WHEN PRESCRIBING NEMLUVIO

Does NEMLUVIO require refrigeration?

It is recommended that NEMLUVIO be refrigerated. However, it can be stored at room temperature (≤77 °F) for up to 90 days within the labeled expiration period.¹

What vaccine schedule should be followed when administering NEMLUVIO?

Consider completing all age-appropriate vaccinations as recommended by current immunization guidelines prior to initiating treatment with NEMLUVIO. Avoid use of live vaccines in patients during treatment with NEMLUVIO. It is unknown if administration of live vaccines during NEMLUVIO treatment will impact the safety or effectiveness of these vaccines. No data are available on the response to non-live vaccines.¹

Are there any drug-to-drug interactions with NEMLUVIO?

The effects of nemolizumab on the pharmacokinetics of midazolam, warfarin, omeprazole, metoprolol, and caffeine were evaluated in a 12-week study. No clinically significant changes in the exposure of CYP450 substrates before and after multiple nemolizumab injections were observed and the concomitant use of nemolizumab-ilto is unlikely to influence the PK profiles of CYP substrates.¹

Is NEMLUVIO appropriate for geriatric use?

The safety and effectiveness observed in ARCADIA 1 and ARCADIA 2 were consistent between subjects younger and older than 65 years of age; however, clinical studies of NEMLUVIO in AD did not include a sufficient number of subjects 65 years of age or older to determine whether they respond differently than younger subjects.¹

Is NEMLUVIO appropriate for use in pregnant women?

There is a limited amount of data from the use of NEMLUVIO in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to fetal toxicity (see Prescribing Information section 8.1). NEMLUVIO should be used during pregnancy only if the potential benefit justifies the potential risks to the fetus.¹

Should my patients be worried about missing a dose?

If a dose is missed, administer the dose as soon as possible. Thereafter, resume dosing at the regular scheduled time.¹

ACCESS AND PATIENT SUPPORT

Is there support available for my patients so they have access to NEMLUVIO?

GPS (Galderma Patient Services) for NEMLUVIO™ helps patients navigate insurance coverage and provides financial assistance to ensure eligible patients can start treatment as soon as possible.

How much does NEMLUVIO cost?

The cost of NEMLUVIO depends on the insurance coverage of individual patients. Commercially insured patients may be able to reduce or eliminate co-pay responsibility, paying as little as $0.

For patients who may have lost insurance or are changing jobs, is there gap insurance coverage?

GPS for NEMLUVIO includes the Bridge Program to prevent a gap in treatment for eligible patients who have a temporary loss of insurance coverage.

How can I get my patients started on NEMLUVIO if their insurance coverage is delayed?

Quick Start is available to provide the first dose of NEMLUVIO free of charge for eligible patients whose treatment is impacted by an insurance company’s prior authorization process.

What other options are available if my patient doesn't have health insurance?

GPS 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.

At which Specialty Pharmacies is NEMLUVIO available?

To view the full list of Specialty Pharmacies where NEMLUVIO is available, click the download link below.

SPECIALTY PHARMACY LIST

What resources are available to help educate patients on how to use NEMLUVIO?

Injection training resources and videos are available. In addition, GPS for NEMLUVIO offers Nurse Navigator support to help patients manage their NEMLUVIO experience with confidence and ease.

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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).^1,2

Observed cases of ≥4-point improvement in the Pruritus VAS component of SCORAD in ARCADIA LTE interim analysis.²

EASI-75 data for patients reaching 56 weeks during interim analysis of ARCADIA LTE.³

EASI=Eczema Area and Severity Index; IL-31=interleukin 31; LTE=long-term extension; PP-NRS=Peak Pruritus Numerical Rating Scale; Q4W=every 4 weeks; SCORAD=Scoring Atopic Dermatitis; TCI=topical calcineurin inhibitor; TCS=topical corticosteroid; VAS=visual analog scale.

References: 1. NEMLUVIO (nemolizumab-ilto) injection 30 mg Prescribing Information. Dallas, TX: Galderma Laboratories, L.P. 2. Galderma Laboratories, L.P.; data on file. 3. Galderma Laboratories, L.P.; data on file. Clinical Study Report RD.06.SIR.118163 [ARCADIA LTE]; October 2023. 4. Kwatra SG, Yosipovitch G, Legat FJ, et al. Phase 3 trial of nemolizumab in patients with prurigo nodularis. N Engl J Med. 2023;389(17):1579-1589. doi:10.1056/NEJMoa2301333 5. 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

IMPORTANT SAFETY INFORMATION

INDICATIONS: NEMLUVIO^® (nemolizumab-ilto) is an interleukin-31 receptor alpha antagonist indicated for:

the treatment of adults and pediatric patients 12 years of age and older with moderate-to-severe atopic dermatitis in combination with topical corticosteroids and/or calcineurin inhibitors when the disease is not adequately controlled with topical prescription therapies.
the treatment of adults with prurigo nodularis.

CONTRAINDICATION: NEMLUVIO is contraindicated in patients with known hypersensitivity to nemolizumab-ilto or to any of the excipients in NEMLUVIO.

WARNINGS AND PRECAUTIONS:
Hypersensitivity reactions have been reported with NEMLUVIO use. If clinically significant hypersensitivity reaction occurs, immediately institute appropriate therapy, and discontinue NEMLUVIO. Avoid use of live vaccines during treatment with NEMLUVIO.

ADVERSE REACTIONS:
Most common adverse reactions (incidence ≥1%) are:

Atopic Dermatitis: headache (including migraine), arthralgia, urticaria, and myalgia.
Prurigo Nodularis: headache, dermatitis atopic, eczema, and eczema nummular.

USE IN SPECIFIC POPULATIONS:
Pregnancy: There are no adequate and well-controlled studies on NEMLUVIO in pregnant women. The limited available information on NEMLUVIO use during pregnancy is not sufficient to inform a drug- associated risk of major birth defects or miscarriage in humans. Human IgG antibodies are known to cross the placental barrier; therefore, NEMLUVIO may be transmitted from the mother to the developing fetus.

Lactation: There are no data on the presence or transfer of NEMLUVIO in human milk, the effects on the breastfed infant, or the effects on milk production. Human IgG is known to be present in human milk. The effects of local gastrointestinal and limited systemic exposure to NEMLUVIO on the breastfed infant are unknown. NEMLUVIO has not been administered to nursing/lactating women. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for NEMLUVIO and any potential adverse effects on the breastfed child from NEMLUVIO or from the underlying maternal condition.

Pediatric Use: The safety and effectiveness of NEMLUVIO have not been established in pediatric patients younger than 12 years of age for the treatment of moderate-to-severe atopic dermatitis or pediatric patients younger than 18 years of age for the treatment of prurigo nodularis.

Please see full Prescribing Information, including Patient Information.