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
Cytochrome P450 Substrates
- The formation of CYP450 enzymes can be altered by increased levels of certain cytokines (e.g., IL-1, IL-6, IL-10, TNFα, IFN) during chronic inflammation. Treatment with NEMLUVIO may modulate serum levels of some cytokines and influence the formation of CYP450 enzymes.
- Therefore, upon initiation or discontinuation of NEMLUVIO in patients who are receiving concomitant drugs which are CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for effect (e.g., for warfarin) or drug concentration (e.g., for cyclosporine) and consider dosage modification of the CYP450 substrate.
Use in Specific Populations
Pregnancy
Risk Summary
- Available data on NEMLUVIO use in pregnant women exposed during clinical trials are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes.
- Transport of human IgG antibody across the placenta increases as pregnancy progresses and peaks during the third trimester; therefore, NEMLUVIO may be transferred from the mother to the developing fetus.
- In an enhanced pre- and postnatal development study in cynomolgus monkeys, when nemolizumab-ilto was administered subcutaneously during organogenesis to parturition, an increase in early postnatal death was observed at a dose 36 times the maximum recommended human dose (MRHD) (see Data). The clinical significance of this nonclinical finding is unknown.
- The background risk of major birth defects and miscarriage for the indicated populations are unknown.
- All pregnancies have a background risk of birth defects, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Clinical Considerations
- Fetal/Neonatal Adverse Reactions.
- Because nemolizumab-ilto may interfere with immune response to infections, risks and benefits should be considered prior to administering live vaccines to infants exposed to NEMLUVIO in utero.
- There are no data regarding infant serum levels of nemolizumab-ilto at birth and the duration of persistence of nemolizumab-ilto in infant serum after birth. Although a specific timeframe to delay live virus immunizations in infants exposed in utero is unknown, a minimum of 3 months after birth should be considered because of the half-life of the product.
Data
- Animal Data.
- In an enhanced pre- and postnatal development study, subcutaneous doses up to 25 mg/kg of nemolizumab-ilto were administered to pregnant cynomolgus monkeys once every two weeks during organogenesis to parturition.
- No maternal or embryofetal toxicities were observed at doses up to 25 mg/kg (36 times the MRHD, based on AUC comparison). Early postnatal death occurred in the offspring of one control monkey and 3 monkeys at 25 mg/kg (36 times the MRHD, based on AUC comparison).
- The clinical significance of this nonclinical finding is unknown. Nemolizumab-ilto was administered subcutaneously to the offspring at doses up to 25 mg/kg (122 times the MRHD, based on AUC comparison), once every 2 weeks for 6 months, starting from postnatal day 35. No adverse effects were noted in the remaining offspring.
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
Risk Summary
- There are no data on the presence of nemolizumab-ilto in human milk, the effects on the breastfed infant, or the effects on milk production. *Nemolizumab-ilto was detected in breast milk of monkeys (see Data). *Endogenous maternal IgG and monoclonal antibodies are transferred in human milk.
- The effects of local gastrointestinal exposure and limited systemic exposure in the breastfed infant to nemolizumab-ilto are unknown.
- 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.
Data
- Nemolizumab-ilto was detected in breast milk of monkeys in the enhanced pre- and postnatal development study following subcutaneous doses up to 25 mg/kg once every two weeks during organogenesis to parturition.
- The mean nemolizumab-ilto concentrations in milk were approximately 0.3 – 0.5% of the maternal plasma levels from lactation day 7 to 63.
- The concentration of nemolizumab-ilto in animal milk does not necessarily predict the concentration of drug in human milk.
Pediatric Use
The safety and effectiveness of NEMLUVIO have not been established in pediatric patients.
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.