Nemluvio Application Scope

Nemluvio is a prescription biologic medication that blocks interleukin-31 to reduce itching and inflammation in conditions like prurigo nodularis and moderate-to-severe atopic dermatitis.

nemluvio

Characteristics

Ingredients: Nemolizumab-ilto

Properties:
- Nemluvio is an interleukin-31 receptor alpha antagonist.
- It is not classified as an immunosuppressant.
Packaging Specification: Available as a single-dose prefilled dual-chamber pen delivering 30 mg/0.49 mL after reconstitution.

Storage:
- Refrigeration:
  - Store at 36°F to 46°F (2°C to 8°C) in the original carton to protect from light.
  - Do not freeze.
- Room Temperature:
  - Alternatively, may be stored at room temperature (up to 77°F or 25°C) for up to 90 days.
  - Discard if not used within this period or by the expiration date, whichever comes first.
Expiry Date: Refer to the expiration date printed on the carton.
Executive Standard: Approved by the U.S. Food and Drug Administration (FDA).
Approval Number: US License No. 2289.
Date of Revision: August 2024.
Manufacturer: Galderma Laboratories, L.P., Dallas, TX 75201.

Guidelines for the Use of Nemluvio

Dosage and Administration:
- Prurigo Nodularis (Adults):
  - Patients <90 kg: Initial dose of 60 mg (two 30 mg injections), followed by 30 mg every 4 weeks.
  - Patients ≥90 kg: Initial dose of 60 mg (two 30 mg injections), followed by 60 mg every 4 weeks.
- Atopic Dermatitis (Adults and Pediatric Patients ≥12 years):
  - Initial dose of 60 mg (two 30 mg injections), followed by 30 mg every 4 weeks.
  - After 16 weeks, for patients achieving clear or almost clear skin, a maintenance dose of 30 mg every 8 weeks is recommended.
- Administration:
  - Administered via subcutaneous injection.
  - Injection sites include the front upper thighs or abdomen (avoiding the 2 inches around the navel).
  - The upper arm may be used if administered by a caregiver or healthcare professional.
  - Alternate injection sites with each dose.

Adverse Reactions:
- Common (≥1%):
  - Atopic Dermatitis: Headache (including migraine), arthralgia, urticaria, and myalgia.
  - Prurigo Nodularis: Headache, atopic dermatitis, eczema, and nummular eczema.
- Serious:
  - Hypersensitivity reactions, including facial angioedema.
Contraindications: Known hypersensitivity to nemolizumab-ilto or any excipients in Nemluvio.
Precautions:
- Vaccinations:
  - Complete all age-appropriate vaccinations prior to initiating treatment.
  - Avoid use of live vaccines during treatment.
- Pregnancy and Lactation:
  - Limited data available; use only if the potential benefit justifies the potential risk.
- Pediatric Use:
  - Safety and effectiveness not established in patients under 12 years for atopic dermatitis or under 18 years for prurigo nodularis.

Nemluvio Interactions

Drug Interactions:
- No clinically significant changes observed in the exposure of CYP450 substrates (e.g., midazolam, warfarin, omeprazole, metoprolol, caffeine) before and after multiple nemolizumab injections.
- Concomitant use is unlikely to influence the pharmacokinetic profiles of CYP substrates.

Note:

If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
It is only for internal discussion among medical staff and does not serve as a basis for medication. For specific medication guidelines, please consult the attending physician.