General Information
Manufacturer: Galderma Laboratories,
Medical Name: Nemolizumab-ilto
Purpose: Nemluvio is 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.
Possible Side Effects
The most common side effects of Nemluvio vary slightly depending on whether it is used for prurigo nodularis or atopic dermatitis
| Side Effect | Likelihood (Nemluvio group) | Likelihood (Placebo group) |
|---|---|---|
| Headache | 5% (atopic dermatitis) to 6% (prurigo nodularis) | 3% to 4% |
| Atopic dermatitis | 4% (prurigo nodularis) | 0.5% |
| Eczema | 4% (prurigo nodularis) | 2% |
| Eczema nummular | 3% (prurigo nodularis) | 0% |
| Joint pain (Arthralgia) | 1% (atopic dermatitis) | 0.2% |
| Hives (Urticaria) | 1% (atopic dermatitis) | 0.3% |
| Muscle ache (Myalgia) | 1% (atopic dermatitis) | 0.2% |
| Injection site reactions | 1.2% | 0.9% |
Serious but Less Common Side Effects
- Breathing problems or wheezing
- Swelling of the face, lips, mouth, tongue, or throat
- Fainting, dizziness, or feeling lightheaded
- Fast pulse
- Swollen lymph nodes, joint pain, or fever in conjunction with a rash
Preconditions and Warnings
| Precondition | Description |
|---|---|
| Known hypersensitivity (allergy) to nemolizumab-ilto or any of its ingredients. | Hypersensitivity reactions can be severe and life-threatening, such as facial angioedema (swelling), difficulty breathing, or a severe rash. |
| Vaccinations | Patients should complete all age-appropriate vaccinations before starting Nemluvio treatment. The use of live vaccines is to be avoided during treatment with Nemluvio. |
| Pediatric Use | The safety and effectiveness of Nemluvio have not been established in pediatric patients younger than 12 years of age for atopic dermatitis, or in patients younger than 18 for prurigo nodularis. |
| Pregnancy and Breastfeeding | There is limited data on Nemluvio use in pregnant or breastfeeding women. It should be used during pregnancy only if the potential benefit justifies the potential risks to the fetus. Patients should discuss pregnancy planning or breastfeeding with their healthcare provider before using this drug. |
| Injection Site Conditions | Nemluvio should not be injected into skin that is tender, inflamed, swollen, damaged, or has bruises, scars, or open wounds. |
| Product Integrity | Do not use the medicine if the powder is not white, the diluent is cloudy or contains visible particles, or if the reconstituted solution has discoloration or particles. |