Understanding NEMLUVIO safety

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Favorable safety profile

Favorable safety profile

The most common side effect for adults using NEMLUVIO® prurigo nodularis (PN) was headache (only 6% vs 3% with placebo). Atopic dermatitis and eczema were also seen in more than 1% of adults using NEMLUVIO and were more common than placebo.1

Do not use NEMLUVIO if you are allergic to nemolizumab-ilto or to any ingredients in NEMLUVIO.1 Before using NEMLUVIO, tell your healthcare provider about all of your medical conditions, including if you:

  • Are scheduled to receive any vaccination1
  • Are pregnant or plan to become pregnant1
  • Are breastfeeding or plan to breastfeed1

A placebo is a harmless substance without medical effect used to help measure treatment success and side effects.3

What is a biologic?

What is a biologic?

NEMLUVIO is a biologic injection, which means it is a medicine made from living organisms that specifically addresses a cause of a certain disease—in this case, NEMLUVIO blocks a key driver of itch within the body.1,2

NEMLUVIO:

  • Is not a steroid or cream1
  • Is not an immunosuppressant1
  • Requires no preliminary lab evaluations or ongoing lab monitoring during treatment1

Immunosuppressants are a type of medicine that affects the immune system and can leave you at risk of infection. NEMLUVIO is not an immunosuppressant.5,6

Topical steroids can help reduce itch and inflammation of the skin. If used for longer than directed by a healthcare provider, steroids can cause side effects, including thinning of the skin.4,5

Just 1 dose 
every 4 weeks1

Learn how to use NEMLUVIO and 
how to properly store your doses.

NEMLUVIO DOSING 

Not an actual patient.

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. United States Food & Drug Administration. Glossary of terms. Published April 19, 2019. Accessed May 28, 2024. https://www.fda.gov/patients/clinical-trials-what-patients-need-know/glossary-terms 4. National Eczema Association. Risks of topical corticosteroids. Accessed May 28, 2024. https://nationaleczema.org/risks-of-topical-corticosteriods/ 5. Yale Medicine. Prurigo nodularis. Accessed May 29, 2024. https://www.yalemedicine.org/conditions/prurigo-nodularis-overview 6. National Cancer Institute at the National Institutes of Health. NCI Dictionary of Cancer Terms. Accessed May 30, 2024. https://www.cancer.gov/publications‌‌​/dictionaries‌‌​/cancer-terms

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.