Itraconazole Starting Age Group
Itraconazole is not approved in the European Union for patients under 18 years of age, but clinical guidelines support its use in children at any age when indicated for serious fungal infections, with extensive pediatric safety and efficacy data available. 1
Regulatory Status and Age Restrictions
- European Union: Itraconazole is not approved for patients <18 years of age 1
- Clinical practice: Despite regulatory restrictions, itraconazole has been successfully used in infants, neonates, and children across all age groups when clinically indicated 1, 2
- The drug has been studied and used safely in infants as young as neonates for both superficial and systemic fungal infections 2
Guideline-Supported Pediatric Use by Indication
High-Risk Oncology and Transplant Patients
- Prophylaxis for invasive aspergillosis: Itraconazole is recommended (A-IIt) for children with acute leukemia, bone marrow failure syndromes, and allogeneic HSCT recipients, with therapeutic drug monitoring (TDM) required 1
- Age consideration: While not EU-approved for <18 years, extensive pediatric pharmacokinetic and safety data support its use 1
Chronic Granulomatous Disease
- Itraconazole prophylaxis is strongly recommended (A-II) for children with CGD, who have the highest lifetime incidence of invasive aspergillosis 1
- This represents an approved indication with robust clinical trial evidence 1
Pediatric Dosing by Age and Indication
Superficial Fungal Infections
- Infants and children ≥2 years: 5 mg/kg/day of oral suspension in two divided doses, with TDM 1
- Duration: Typically short-term (weeks) for superficial infections 2, 3
- Clinical studies demonstrate safety and efficacy at this dose for tinea capitis and other dermatophyte infections 3
Systemic Fungal Infections
- Infants (including neonates): 10 mg/kg/day for invasive fungal infections 2
- Children ≥2 years: 5 mg/kg/day for prophylaxis; 10 mg/kg/day (loading dose) for treatment 1
- Maximum dose should not exceed 400 mg/day in children 1
Specific Age-Related Pharmacokinetic Considerations
- Infants 6 months to 2 years: This age group achieves substantially lower plasma concentrations than older children and adults, requiring careful TDM 1
- Neonates and young infants: Successfully treated at 5 mg/kg/day for superficial infections and 10 mg/kg/day for systemic infections with good safety profiles 2
Critical Safety and Monitoring Requirements
Therapeutic Drug Monitoring
- Mandatory for all pediatric patients receiving itraconazole for prophylaxis or treatment of invasive fungal infections 1
- Target trough concentrations should be similar to adult targets (typically ≥0.5 mg/L for prophylaxis, higher for treatment) 1
- Younger children (especially <2 years) may require dose adjustments due to altered pharmacokinetics 1
Drug Interactions
- High risk with immunosuppressants: Special caution required when co-administering with cyclosporine, tacrolimus, or sirolimus in transplant recipients 1
- These interactions are particularly relevant in the pediatric transplant population where itraconazole is commonly used 1
Common Pitfalls to Avoid
- Do not withhold itraconazole in life-threatening fungal infections in children solely based on EU regulatory age restrictions when it is the most appropriate agent 1
- Do not use adult dosing in children—weight-based dosing (mg/kg) is essential, with maximum caps 1
- Do not skip TDM in the 6-month to 2-year age group, as they achieve unpredictably low levels and may require higher doses 1
- Do not use capsule formulation in young children—oral suspension is preferred for better absorption and dosing accuracy 3