SAFETY

NEMLUVIO offers a favorable safety profile1

TREATMENT-EMERGENT ADVERSE REACTIONS1

Occurring in ≥1% of the NEMLUVIO group and greater than placebo*

 

ADVERSE REACTION

NEMLUVIO
N=370
n (%)

PLACEBO
N=186 
n (%)

Atopic dermatitis

16 (4%)

1 (0.5%)

Eczema

14 (4%)

3 (2%)

Headache†

23 (6%)

6 (3%)

Nummular eczema

11 (3%)

0

The safety profile of NEMLUVIO remained consistent over 3 years in the OLYMPIA long-term extension (LTE) study, with most events occurring within the first year and no increase in frequency over time.2

In the OLYMPIA 1 and OLYMPIA 2 trials through treatment period.1

Includes headache and tension headache.1

No increased incidence compared to placebo3:

  • Arthralgia
  • Conjunctivitis
  • Injection site reactions

No lab tests with
NEMLUVIO1:

  • No required preliminary laboratory evaluations or ongoing lab monitoring
  • Not an immunosuppressant
  • No boxed warning

Fast Itch Relief4

See how NEMLUVIO significantly improved itch in both pivotal and long-term studies2,4

VIEW THE DATA 

Q4W Dosing From the Start1

NEMLUVIO offers the convenience of less frequent dosing compared to the other biologic for PN1,5

LEARN MORE 

IMPORTANT SAFETY INFORMATION

INDICATIONS: NEMLUVIO® (nemolizumab-ilto) is an interleukin-31 receptor alpha antagonist indicated for:

  • the treatment of adults and pediatric patients 12 years of age and older with moderate-to-severe atopic dermatitis in combination with topical corticosteroids and/or calcineurin inhibitors when the disease is not adequately controlled with topical prescription therapies.
  • the treatment of adults with prurigo nodularis.

CONTRAINDICATION: NEMLUVIO is contraindicated in patients with known hypersensitivity to nemolizumab-ilto or to any of the excipients in NEMLUVIO.

WARNINGS AND PRECAUTIONS:
Hypersensitivity reactions have been reported with NEMLUVIO use. If clinically significant hypersensitivity reaction occurs, immediately institute appropriate therapy, and discontinue NEMLUVIO. Avoid use of live vaccines during treatment with NEMLUVIO.

ADVERSE REACTIONS:
Most common adverse reactions (incidence ≥1%) are:

  • Atopic Dermatitis: headache (including migraine), arthralgia, urticaria, and myalgia. 
  • Prurigo Nodularis: headache, dermatitis atopic, eczema, and eczema nummular. 

USE IN SPECIFIC POPULATIONS:
Pregnancy: There are no adequate and well-controlled studies on NEMLUVIO in pregnant women. The limited available information on NEMLUVIO use during pregnancy is not sufficient to inform a drug-associated risk of major birth defects or miscarriage in humans. Human IgG antibodies are known to cross the placental barrier; therefore, NEMLUVIO may be transmitted from the mother to the developing fetus.

Lactation: There are no data on the presence or transfer of NEMLUVIO in human milk, the effects on the breastfed infant, or the effects on milk production. Human IgG is known to be present in human milk. The effects of local gastrointestinal and limited systemic exposure to NEMLUVIO on the breastfed infant are unknown. NEMLUVIO has not been administered to nursing/lactating women. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for NEMLUVIO and any potential adverse effects on the breastfed child from NEMLUVIO or from the underlying maternal condition.

Pediatric Use: The safety and effectiveness of NEMLUVIO have not been established in pediatric patients younger than 12 years of age for the treatment of moderate-to-severe atopic dermatitis or pediatric patients younger than 18 years of age for the treatment of prurigo nodularis.

Please see full Prescribing Information, including Patient Information.