Nemolizumab-ilto
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Parth Vikram Singh, MBBS[2]
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Overview
Nemolizumab-ilto is an interleukin-31 receptor alpha antagonist that is FDA approved for the treatment of adults with prurigo nodularis.. Common adverse reactions include *headache,
- dermatitis atopic,
- eczema, and
- eczema nummular..
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
- NEMLUVIO is an interleukin-31 receptor alpha antagonist indicated for the treatment of adults with prurigo nodularis.
- Complete all age-appropriate vaccinations as recommended by current immunization guidelines prior to initiating treatment with NEMLUVIO,
- Adult Patients Weighing Less Than 90kg: The recommended dosage is an initial dose of 60 mg (two 30 mg injections), followed by 30 mg given every 4 weeks (Q4W).
- Adult Patients Weighing 90kg or More: The recommended dosage is an initial dose of 60 mg (two 30 mg injections), followed by 60 mg given every 4 weeks (Q4W).
- Administer NEMLUVIO by subcutaneous injection.
- NEMLUVIO must be reconstituted prior to administration.
- For injection: single-dose pre-filled dual-chamber pen containing 30 mg of nemolizumab-ilto lyophilized powder and diluent, water for injection.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Nemolizumab-ilto in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Nemolizumab-ilto in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Nemolizumab-ilto FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Nemolizumab-ilto in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Nemolizumab-ilto in pediatric patients.
Contraindications
- Known hypersensitivity to nemolizumab-ilto or to any of the excipients in NEMLUVIO.
Warnings
Hypersensitivity
- Hypersensitivity reactions, such as facial angioedema, have been reported with use of NEMLUVIO.
- NEMLUVIO is contraindicated in patients with a known hypersensitivity to nemolizumab-ilto or to any of the excipients in NEMLUVIO.
- If a clinically significant hypersensitivity reaction occurs, immediately institute appropriate therapy and discontinue NEMLUVIO.
Vaccinations
- Complete all age-appropriate vaccinations as recommended by current immunization guidelines prior to treatment with NEMLUVIO.
- Avoid use of live vaccines in patients during treatment with NEMLUVIO.
- It is unknown if administration of live vaccines during NEMLUVIO treatment will impact the safety or effectiveness of these vaccines.
- No data are available on the response to non-live vaccines.
Adverse Reactions
Clinical Trials Experience
- Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
- A total of 508 adult subjects with prurigo nodularis were treated with NEMLUVIO in two placebo-controlled trials and an open label long-term extension trial. Of these, 375 subjects were exposed for at least 1 year in the development program for prurigo nodularis.
- Two randomized, double-blind, placebo-controlled, multicenter trials (OLYMPIA 1 and OLYMPIA 2) evaluated the safety of NEMLUVIO in adult subjects with prurigo nodularis. Subjects were treated for up to 24 weeks in OLYMPIA 1 and up to 16 weeks in OLYMPIA 2. In these 2 trials, 370 subjects were treated with subcutaneous injections of NEMLUVIO, and 186 subjects received placebo injections.
- Subjects weighing less than 90 kg in the NEMLUVIO group received NEMLUVIO 60 mg or placebo at Week 0, followed by 30 mg injections every 4 weeks. Subjects weighing 90 kg or more in the NEMLUVIO group received NEMLUVIO 60 mg or placebo at Week 0 and every 4 weeks.
- During the treatment period in NEMLUVIO trials (OLYMPIA 1 and OLYMPIA 2), the proportion of subjects who discontinued treatment because of adverse reactions was 4% in NEMLUVIO group versus 3% in the placebo group. Table 1 summarizes the adverse reactions that occurred at a rate of at least 1% in the NEMLUVIO group, and for which the rate exceeds the rate in the placebo group through Week 16.
Specific Adverse Reactions
- Hypersensitivity reactions
Type 1 hypersensitivity reactions (Ig-E mediated reactions), including one report of discrete facial (peri-ocular) angioedema, were reported in subjects treated with NEMLUVIO
Postmarketing Experience
There is limited information regarding Nemolizumab-ilto Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Nemolizumab-ilto Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Nemolizumab-ilto in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Nemolizumab-ilto in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Nemolizumab-ilto during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Nemolizumab-ilto in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Nemolizumab-ilto in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Nemolizumab-ilto in geriatric settings.
Gender
There is no FDA guidance on the use of Nemolizumab-ilto with respect to specific gender populations.
Race
There is no FDA guidance on the use of Nemolizumab-ilto with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Nemolizumab-ilto in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Nemolizumab-ilto in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Nemolizumab-ilto in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Nemolizumab-ilto in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Nemolizumab-ilto Administration in the drug label.
Monitoring
There is limited information regarding Nemolizumab-ilto Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Nemolizumab-ilto and IV administrations.
Overdosage
There is limited information regarding Nemolizumab-ilto overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Nemolizumab-ilto Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Nemolizumab-ilto Mechanism of Action in the drug label.
Structure
There is limited information regarding Nemolizumab-ilto Structure in the drug label.
Pharmacodynamics
There is limited information regarding Nemolizumab-ilto Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Nemolizumab-ilto Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Nemolizumab-ilto Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Nemolizumab-ilto Clinical Studies in the drug label.
How Supplied
There is limited information regarding Nemolizumab-ilto How Supplied in the drug label.
Storage
There is limited information regarding Nemolizumab-ilto Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Nemolizumab-ilto Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Nemolizumab-ilto interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Nemolizumab-ilto Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Nemolizumab-ilto Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.