Frequently asked questions

About NEMLUVIO

Using NEMLUVIO

Support and resources

About prurigo nodularis

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NEMLUVIO was evaluated in 2 Phase 3 clinical trials and a long-term study. Results shown are from the second clinical trial, OLYMPIA 2.3

PP-NRS response defined as a ≥4-point improvement from baseline. Data from Phase 3 clinical study (OLYMPIA 2) post hoc descriptive analysis of daily PP-NRS improvement; consistent results seen in OLYMPIA 1. Significant improvement was achieved at 48 hours (15% vs 3% with placebo, P≤0.005).1,2

Significant itch relief was defined as an itch improvement of at least 4 points on the PP-NRS, where 0 was no itch and 10 was worst itch imaginable.1

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

IGA=Investigator's Global Assessment; PP-NRS=Peak Pruritus Numerical Rating Scale.

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. Galderma Laboratories, L.P.; data on file. 4. Ludmann P. Prurigo nodularis. American Academy of Dermatology Association. Updated September 14, 2021. Accessed June 8, 2024. https://www.aad.org/public/diseases/a-z/prurigo-nodularis-overview 5. Williams KA, Roh YS, Brown I, et al. Pathophysiology, diagnosis, and pharmacological treatment of prurigo nodularis. Expert Rev Clin Pharmacol. 2021;14(1):67-77. doi:10.1080/17512433.2021.1852080 6. Rodriguez D, Kwatra SG, Dias-Barbosa C, et al. Patient perspectives on living with severe prurigo nodularis. JAMA Dermatol. 2023;159(11):1205-1212. doi:10.1001/jamadermatol.2023.3251

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.