Frequently asked Questions
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PRESCRIBING AND SYMPTOM RELIEF
NEMLUVIO should be prescribed for the treatment of prurigo nodularis (PN) in adults.1
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
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*‡
In a clinical study, most patients taking NEMLUVIO (55%) saw their PN nodules healed by Week 16.2§
Safety Profile
NEMLUVIO does not have a boxed warning.1
NEMLUVIO requires no preliminary lab evaluations or ongoing lab monitoring.1
Most common adverse reactions (incidence ≥1%) are atopic dermatitis, eczema, headache, and nummular eczema.1
NEMLUVIO is not an immunosuppressant. NEMLUVIO inhibits IL-31, a neuroimmune cytokine that drives itch, inflammation, skin barrier dysfunction, and fibrosis.1
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
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.3,4
OTHER CONSIDERATIONS WHEN PRESCRIBING NEMLUVIO
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
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
The formation of CYP450 enzymes can be altered by increased levels of certain cytokines (eg, IL-1, IL-6, IL-10, TNFα, 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
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
There is 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 risk to the fetus.1
ACCESS AND PATIENT SUPPORT
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.
Galderma Patient Services (GPS) for NEMLUVIO helps patients navigate insurance coverage and provides financial assistance to ensure eligible patients can start treatment as soon as possible.
GPS for NEMLUVIO includes Bridge to prevent a gap in treatment for eligible patients who have a temporary loss of insurance coverage.
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.
To view the full list of Specialty Pharmacies where NEMLUVIO is available, click the download link below.
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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Data from post-hoc descriptive analysis of daily PP-NRS improvement for OLYMPIA 2; consistent results seen in OLYMPIA 1.2
PP-NRS response defined as ≥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 Long-Term Extension.2
IgE=immunoglobulin E; IL-31=interleukin-31; PN=prurigo nodularis.
References: 1. NEMLUVIO (nemolizumab-ilto) injection 30 mg Prescribing Information. Dallas, TX: Galderma Laboratories, L.P.; August 2024. 2. Galderma Laboratories, L.P.; data on file. 3. Galderma Laboratories, L.P.; data on file. Clinical Study Report RD.06.SRE.203065; September 2023. 4. Galderma Laboratories, L.P.; data on file. Clinical Study Report RD.06.SRE.202685; September 2023. 5. Galderma Laboratories, L.P.; data on file. Clinical Study Report RD.06.SIR.202699; October 2023.