Nemluvio
(nemolizumab-ilto)Dosage & Administration
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Nemluvio Prescribing Information
NEMLUVIO is indicated for the treatment of adults with prurigo nodularis.
Vaccination Prior to Treatment
Complete all age-appropriate vaccinations as recommended by current immunization guidelines prior to treatment with NEMLUVIO [see Warnings and Precautions ].
Recommended Dosage
Adult Patients Weighing Less Than 90 kg: The recommended subcutaneous dosage of NEMLUVIO for adult patients weighing less than 90 kg is an initial dose of 60 mg (two 30 mg injections), followed by 30 mg given every 4 weeks (Q4W).
Adult Patients Weighing 90 kg or More: The recommended subcutaneous dosage of NEMLUVIO for adult patients weighing 90 kg or more is an initial dose of 60 mg (two 30 mg injections), followed by 60 mg given every 4 weeks (Q4W).
Missed Dose
If a dose is missed, administer the dose as soon as possible. Thereafter, resume dosing at the regular scheduled time.
Important Administration Instructions
- NEMLUVIO is administered by subcutaneous injection.
- NEMLUVIO is intended for use under the guidance of a healthcare provider. Prior to the first injection, provide patients and/or caregivers with proper training on the preparation and administration of NEMLUVIO. Patients may self-inject NEMLUVIO after receiving training on subcutaneous injection techniques.
- For the initial dose, administer each of the two NEMLUVIO injections at different injection sites.
- Administer subcutaneous injection into the front upper thighs or abdomen except for the 2 inches (5 cm) around the navel. Injection in upper arm should only be performed by a caregiver or healthcare professional.
- Alternate the injection site with each injection. Do not inject NEMLUVIO into skin that is tender, inflamed, swollen, damaged or has bruises or scars or open wounds.
- Refer to the Instructions for Use for complete administration instructions with illustrations [see Instructions for Use].
Preparation for Use of NEMLUVIO
- Before injection, remove NEMLUVIO carton from the refrigerator and allow to reach room temperature (30-45 minutes).
- Inspect NEMLUVIO visually prior to reconstitution. NEMLUVIO is supplied in a single-dose pre-filled dual-chamber pen with white powder in one chamber and a clear diluent in the other chamber. Do not use if powder is not white, or if diluent is cloudy or contains visible particles.
- NEMLUVIO must be reconstituted prior to administration.
- Following reconstitution, each pre-filled pen delivers 30 mg/0.49 mL as a clear and colorless to slightly yellow solution. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if the reconstituted solution has discoloration or contains particles.
- Use NEMLUVIO pens within 4 hours after reconstitution. Discard unused reconstituted NEMOLUVIO pens after 4 hours.
- Discard any unused portions after administration
- Refer to the Instructions for Use for complete preparation instructions with illustrations [ see Instructions for Use.]
For injection: single-dose pre-filled dual-chamber pen containing 30 mg of nemolizumab-ilto as a white lyophilized powder in one chamber and diluent, water for injection, in the other chamber.
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 (see Clinical Considerations). 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.
Lactation
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.
Geriatric Use
Of the 370 subjects with prurigo nodularis exposed to NEMLUVIO in OLYMPIA 1 and OLYMPIA 2, 99 (26.8%) subjects were 65 years of age or older. The long-term safety of NEMLUVIO was assessed in 508 subjects, among which 133 (26.2%) were 65 years of age or older. Clinical trials of NEMLUVIO did not include sufficient number of subjects 65 years of age or older to determine whether they respond differently than younger adult subjects [ see Clinical Pharmacology (12.3)].
NEMLUVIO is contraindicated in patients who have known hypersensitivity to nemolizumab-ilto or to any of the excipients in NEMLUVIO [ see Warnings and Precautions (5.1)].
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 [ see Contraindications (4), Adverse Reactions (6.1)].
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.