Nemluvio

NEMLUVIO is an interleukin-31 receptor antagonist indicated for:

Complete all age-appropriate vaccinations as recommended by current immunization guidelines prior to treatment with NEMLUVIO. (

• Adult Patients Weighing Less Than 90kg:
  The recommended subcutaneous dosage is an initial dose of 60 mg (two 30 mg injections), followed by 30 mg given every 4 weeks. (
  2.2

  Recommended Dosage for Prurigo Nodularis

  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.
  
  
  
  

  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.
  
  
  )
• Adult Patients Weighing 90kg or More:
  The recommended subcutaneous dosage is an initial dose of 60 mg (two 30 mg injections), followed by 60 mg given every 4 weeks. (
  2.2

  Recommended Dosage for Prurigo Nodularis

  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.
  
  
  
  

  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.
  
  
  )

• The recommended subcutaneous dosage is an initial dose of 60 mg (two 30 mg injections), followed by 30 mg given every 4 weeks. (
  2.3 Recommended Dosage for Atopic Dermatitis

  The recommended subcutaneous dosage of NEMLUVIO in adults and pediatric patients 12 years of age and older is an initial dose of 60 mg (two 30 mg injections), followed by 30 mg given every 4 weeks.
  
  
  
  After 16 weeks of treatment, for patients who achieve clear or almost clear skin, a subcutaneous dosage of 30 mg every 8 weeks is recommended.
  
  
  
  

  Concomitant Topical Therapies:
  
  

  Use NEMLUVIO with topical corticosteroids and/or topical calcineurin inhibitors. When the disease has sufficiently improved, discontinue use of topical therapies.
  ) 
• After 16 weeks of treatment, for patients who achieve clear or almost clear skin, a dosage of 30 mg every 8 weeks is recommended. (
  2.3 Recommended Dosage for Atopic Dermatitis

  The recommended subcutaneous dosage of NEMLUVIO in adults and pediatric patients 12 years of age and older is an initial dose of 60 mg (two 30 mg injections), followed by 30 mg given every 4 weeks.
  
  
  
  After 16 weeks of treatment, for patients who achieve clear or almost clear skin, a subcutaneous dosage of 30 mg every 8 weeks is recommended.
  
  
  
  

  Concomitant Topical Therapies:
  
  

  Use NEMLUVIO with topical corticosteroids and/or topical calcineurin inhibitors. When the disease has sufficiently improved, discontinue use of topical therapies.
  )
• Use NEMLUVIO with topical corticosteroids and/or topical calcineurin inhibitors. When the disease has sufficiently improved, discontinue use of topical therapies. (
  2.3 Recommended Dosage for Atopic Dermatitis

  The recommended subcutaneous dosage of NEMLUVIO in adults and pediatric patients 12 years of age and older is an initial dose of 60 mg (two 30 mg injections), followed by 30 mg given every 4 weeks.
  
  
  
  After 16 weeks of treatment, for patients who achieve clear or almost clear skin, a subcutaneous dosage of 30 mg every 8 weeks is recommended.
  
  
  
  

  Concomitant Topical Therapies:
  
  

  Use NEMLUVIO with topical corticosteroids and/or topical calcineurin inhibitors. When the disease has sufficiently improved, discontinue use of topical therapies.
  )
• Administer NEMLUVIO by subcutaneous injection. (
  2.5 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. In pediatric patients 12 years of age and older, administer NEMLUVIO by or under the supervision of a trained adult or caregiver.
  • For the initial dose, administer each of the two NEMLUVIO injections at different injection sites.
  • Administer NEMLUVIO subcutaneously into the front upper thighs or abdomen avoiding the 2-inch (5 cm) area around the navel. NEMLUVO may be subcutaneously injected into the upper arm, but this 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].
  )
• NEMLUVIO must be reconstituted prior to administration. (
  2.6 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, prefilled, 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. Refer to the Instructions for Use for complete preparation instructions with illustrations
    [ see Instructions for Use].
  • Following reconstitution, each prefilled 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 NEMLUVIO pens after 4 hours.
  • Discard any unused portions after administration.
  )

For injection: single-dose, prefilled, 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.

• Hypersensitivity:
  Hypersensitivity reactions have been reported with NEMLUVIO use. If a clinically significant hypersensitivity reaction occurs, immediately institute appropriate therapy and discontinue NEMLUVIO. (
  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:
  Avoid use of live vaccines during treatment with NEMLUVIO. (
  5.2 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.
  )