Frequently asked Questions

Name: Nemluvio HCP
Creator: Nemluvio

Have questions about NEMLUVIO for PN?
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PRESCRIBING AND SYMPTOM RELIEF

Which patients are appropriate to be prescribed NEMLUVIO^®?

NEMLUVIO should be prescribed for the treatment of prurigo nodularis (PN) in adults.¹

Why should I consider NEMLUVIO for my patients with PN?

NEMLUVIO has been proven to provide fast and lasting relief for patients with PN, with a favorable safety profile. In addition to significantly reducing itch and significantly improving skin healing over the course of a year for most patients, NEMLUVIO has been demonstrated to help improve sleep in PN patients and only requires dosing once every 4 weeks.^1-3

When can patients expect itch relief with NEMLUVIO?

While some patients may experience itch relief as soon as 48 hours after their first dose,* nearly half of patients in clinical trials (49%) experienced significant relief^† by Week 16.^1,2‡

ITCH RELIEF DATA

When can patients expect their PN nodules to heal?

In a clinical study, most patients taking NEMLUVIO (55%) saw their PN nodules healed by Week 16.^3§

REVIEW SKIN HEALING RESULTS

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?

Most common adverse reactions (incidence ≥1%) are atopic dermatitis, eczema, headache, and nummular eczema.¹

Is NEMLUVIO an immunosuppressant?

NEMLUVIO is not an immunosuppressant. NEMLUVIO inhibits IL-31, a neuroimmune cytokine that drives itch, inflammation, skin dysregulation, and fibrosis.^1,4

Were asthma events observed in the pivotal clinical trials or the long-term extension (LTE) study of NEMLUVIO?

There are no restrictions on use in patients with asthma. 14.6% of patients in OLYMPIA 1 and 2 had well-controlled asthma as a co-morbidity. In Phase 3 trials, there was no increased incidence of new onset or worsening of asthma compared to placebo.^3,5,6

Did patients have atopic dermatitis, eczema, and nummular eczema before the clinical trials?

In the pivotal trials, a medical history of atopy occurred in 25.6% and atopic dermatitis was reported in 5.9% of patients. Most of the atopic dermatitis events were mild in severity and were managed with topical treatments without discontinuation of NEMLUVIO.^3,5

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 formation of CYP450 enzymes can be altered by increased levels of certain cytokines (eg, IL-1, IL-6, IL-10, TNFɑ, IFN) during chronic inflammation. Treatment with NEMLUVIO may modulate serum levels of some cytokines and influence the formation of CYP450 enzymes.

Therefore, upon initiation or discontinuation of NEMLUVIO in patients who are receiving concomitant drugs which are CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for effect (eg, for warfarin) or drug concentration (eg, for cyclosporine) and consider dosage modification of the CYP450 substrate.¹

Is NEMLUVIO appropriate for geriatric use?

The safety and effectiveness observed in OLYMPIA 1 and OLYMPIA 2 were consistent between subjects younger and older than 65 years of age; however, clinical studies of NEMLUVIO in PN 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

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.

VIEW ADMINISTRATION & DOSING

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Data from Phase 3 clinical study (OLYMPIA 2) post hoc descriptive analysis of daily PP-NRS improvement was achieved at 48 hours (15% vs 3% with placebo, P≤0.005).^1,2

PP-NRS response defined as a ≥4-point improvement from baseline.¹

Data shown from OLYMPIA 2; in OLYMPIA 1, 56% of patients achieved significant itch relief vs 16% for placebo.¹

Data based on interim analysis from OLYMPIA LTE.²

IFN=interferon; IgE=immunoglobulin E; IL-31=interleukin 31; LTE=long term extension; PN=prurigo nodularis; PP-NRS=Peak Pruritus Numerical Rating Scale; TNFɑ=tumor necrosis factor alpha.

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.SRE.203065 [OLYMPIA 2]; September 2023. 4. 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 5. Galderma Laboratories, L.P.; data on file. Clinical Study Report RD.06.SRE.202685 [OLYMPIA 1]; September 2023. 6. Galderma Laboratories, L.P.; data on file. Clinical Study Report RD.06.SIR.202699 [OLYMPIA LTE]; October 2023.

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.