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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.