Ivermectin dosing for children under 2 years

Area of Science:

• Pharmacokinetics and Pharmacodynamics
• Pediatric Pharmacology
• Dermatology

Background:

• Ivermectin is an effective scabies treatment but lacks a licensed dosage for children under 15 kg.
• There is a need for a safe and effective ivermectin dosing strategy in young children.

Purpose of the Study:

• To identify an ivermectin dosing strategy for children aged under 2 years.
• To achieve therapeutic drug exposure levels comparable to older children.

Main Methods:

• A population pharmacokinetic (PopPK) model incorporating CYP3A4 enzyme maturation was utilized.
• Simulations were performed for three age subgroups under 2 years.
• Doses were adjusted to achieve a target plasma area under the concentration-time curve (AUC0-∞) and rounded to feasible tablet fractions.

Main Results:

• For infants aged 3-7 months, 0.75 mg (1/4 tablet) yielded a median AUC0-∞ of 835 μg/L h.
• For infants aged 8-12 months, 1.5 mg (1/2 tablet) yielded a median AUC0-∞ of 848 μg/L h.
• For children aged 13-24 months, 3 mg (1 tablet) yielded a median AUC0-∞ of 1033 μg/L h. All doses achieved target exposures.

Conclusions:

• A pediatric ivermectin dosing strategy for children aged 3 months to 2 years was successfully developed.
• The proposed regimen is based on a CYP3A4 maturation-based PopPK model.
• This strategy requires evaluation in a clinical trial for safe and effective scabies treatment in young children.