WARNINGS
Do not take NEMLUVIO if you are allergic to nemolizumab-ilto or to any ingredients in NEMLUVIO. See the end of this Patient Information leaflet for a complete list of ingredients in NEMLUVIO.
What should I avoid while taking NEMLUVIO?
You should avoid receiving live vaccines while taking NEMLUVIO.
USES
What is NEMLUVIO?
NEMLUVIO is a prescription medicine used:
to treat adults with prurigo nodularis.
to treat adults and children 12 years of age and older with moderate-to-severe eczema (atopic dermatitis) that is not well controlled with prescription therapies used on the skin (topical). NEMLUVIO can be used with certain prescription topical medicines.
It is not known if NEMLUVIO is safe and effective in children with prurigo nodularis under 18 years of age.
It is not known if NEMLUVIO is safe and effective in children with atopic dermatitis under 12 years of age.
HOW TO USE
How should I take NEMLUVIO?
See the detailed Instructions for Use that comes with NEMLUVIO for information on how to prepare and inject NEMLUVIO and how to properly store and throw away (dispose of) used NEMLUVIO prefilled pens.
Use NEMLUVIO exactly as prescribed by your healthcare provider.
Use NEMLUVIO with prescription topical therapies. When your eczema has sufficiently improved, your healthcare provider may discontinue topical therapies.
Your healthcare provider will tell you how much NEMLUVIO to inject and how often to inject it.
NEMLUVIO comes as a single-dose prefilled pen with a needle guard.
NEMLUVIO is given as an injection under the skin (subcutaneous injection).
If your healthcare provider decides that you or a caregiver can give the injections of NEMLUVIO, you or your caregiver should receive training on the right way to prepare and inject NEMLUVIO. Do not try to inject
NEMLUVIO until you have been shown the right way by your healthcare provider.
If you miss a dose, inject the missed dose as soon as possible, then continue with your next dose at your regular scheduled time.
If you inject too much NEMLUVIO, call your healthcare provider or the Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away.
Your healthcare provider may prescribe other medicines to use with NEMLUVIO. Use the other prescribed medicines exactly as your healthcare provider tells you to.
What are the possible side effects of NEMLUVIO?
NEMLUVIO may cause serious side effects, including:
• allergic reactions (hypersensitivity). NEMLUVIO can cause allergic reactions that can sometimes be serious.
Stop using NEMLUVIO and tell your healthcare provider or get emergency help right away if you get any of the following symptoms:
o breathing problems or wheezing
o swelling of the face, lips, mouth, tongue, or throat
o fainting, dizziness, feeling lightheaded
o fast pulse o swollen lymph nodes o joint pain
o fever o skin rash (red or rough skin) o nausea or vomiting
o general ill feeling
o cramps in your stomach area
The most common side effects of NEMLUVIO in people treated for prurigo nodularis include:
• headache
• skin rashes: atopic dermatitis (a type of eczema), eczema, and eczema nummular (scattered circular patches)
The most common side effects of NEMLUVIO in people treated for atopic dermatitis include:
• headache
• joint pain
• hives (itchy red rash or wheals)
• muscle aches
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 FDA at 1-800-FDA-1088.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use NEMLUVIO for a condition for which it was not prescribed. Do not give NEMLUVIO to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about NEMLUVIO that is written for healthcare professionals.
What are the ingredients in NEMLUVIO?
Active ingredient: nemolizumab-ilto
Inactive ingredients: arginine hydrochloride, poloxamer 188, sucrose, trometamol, and tris hydrochloride.
OVERDOSE
If you inject too much NEMLUVIO, call your healthcare provider or the Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away.
MISSED DOSE
If you miss a dose, inject the missed dose as soon as possible, then continue with your next dose at your regular scheduled time.
STORAGE
How should I store NEMLUVIO?
• Store NEMLUVIO in the refrigerator between 36-degrees F to 46-degrees F (2-degrees C to 8-degrees C) until the expiration date.
• Store NEMLUVIO in the original carton to protect from light.
• NEMLUVIO can be stored at room temperature up to 77-degrees F (25-degrees C) for a single period up to 90 days.
• Throw away (dispose of) NEMLUVIO after the expiration date and any NEMLUVIO that has been left at room
temperature for longer than 90 days.
• After the NEMLUVIO lyophilized powder and water for injection are mixed (reconstituted), NEMLUVIO must be
used within 4 hours or thrown away (discarded).
• Do not heat or put NEMLUVIO pen into direct sunlight.
• Do not freeze the NEMLUVIO pen.
• If the NEMLUVIO pen was heated or frozen, throw it away (dispose of it).
Keep NEMLUVIO and all medicines out of the reach of children.
NOTES
Medication Guide: revision date 06/2025
Prescribing Information: revision date 06/2025
Please call your healthcare provider for more information.
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.
