NEODOSE

INDICATION

• Neonatal Candidiasis Including CNS Infection:
  • Invasive candidiasis and candidemia, or very low-birth weight infants with asymptomatic candiduria.
    • Amphotericin B deoxycholate is recommended.
    Fluconazole IV or oral is an alternative for those who have not been receiving prophylaxis with fluconazole.
    • Lipid formulation amphotericin B agent is an alternative; however, use with caution, especially in the presence of urinary tract involvement.
    • Echinocandins (caspofungin, anidulafungin, or micafungin) should be limited to salvage therapy or scenarios of resistance or toxicity to amphotericin B deoxycholate or fluconazole.
  • Central nervous system infections:
    • Central nervous system infections Amphotericin B deoxycholate is recommended.
    • Salvage therapy with flucytosine may be added in those patients who have not responded to initial therapy.
    • Fluconazole may be used as step-down therapy for fluconazole-susceptible isolates in those patients who respond to initial therapy
  • Neonatal intensive care unit (with greater than 10% rate of invasive candidiasis):
    • Prophylaxis with IV or oral fluconazole for 6 weeks is recommended for neonates with birth weights of less than 1000 g
    • Prophylaxis with oral nystatin is an alternative in neonates with birth weights of less than 1500 g when fluconazole is unavailable or fluconazole resistance is present

FDA APPROVED INDICATION :

• Acute disseminated candidiasis without meningoencephalitis and/or ocular dissemination in pediatric patients younger than 4 months.
• Candida peritonitis or abscesses without meningoencephalitis and/or ocular dissemination in pediatric patients younger than 4 months.
• Candidemia in pediatric patients younger than 4 months without meningoencephalitis and/or ocular dissemination.

Contraindications/Precautions :

• Hematologic : Acute intravascular hemolysis and hemolytic anemia have been reported.
• Hepatic: Hepatic abnormalities (eg, liver function test (LFT) abnormalities, significant hepatic impairment, hepatitis, hepatic failure) have occurred. Evaluate risk vs benefit of continued treatment if abnormal liver function tests develop.
• Immunologic:
  • Immunologic: Hypersensitivity reactions (eg, anaphylaxis, shock) have been reported. Discontinue use if hypersensitivity occurs and institute appropriate treatment
  • Infusion reactions have been reported including rash, pruritus, facial swelling, and vasodilatation; slow the infusion rate if reaction occurs .
• Renal: Hemoglobinuria and renal dysfunction (eg, BUN or creatinine elevations, significant renal impairment, acute renal failure) have been reported

Limitation :

• Safety and effectiveness of micafungin have not been established for the treatment of candidemia with meningoencephalitis and/or ocular dissemination in pediatric patients younger than 4 months of age as a higher dose may be needed.
• Micafungin has not been adequately studied in patients with endocarditis, osteomyelitis and meningoencephalitis due to Candida.
• Efficacy of micafungin against infections caused by fungi other than Candida has not been established.

ADVERSE EFFECTS

Most common adverse events (2% to 3%) reported in pediatric clinical trials were hypokalemia, increases in AST, ALT, bilirubin, or alkaline phosphatase levels, abnormal liver function tests, and hypertension. More severe hepatic dysfunction, hepatitis, and hepatic failure have also been reported. Pediatric patients (especially less than 1 year of age) appear to be at higher risk than adults for developing liver injury. Neutropenia, thrombocytopenia, and hypomagnesemia also occurred in less than 2% of patients. Other common adverse events include nausea, vomiting, diarrhea, and rash.

ADMINISTRATION

Administer by intermittent IV infusion over 1 hour at a concentration between 0.5 to 1.5 mg/mL. The recommended concentration is 1 mg/mL. Existing IV line should be flushed with NS prior to administration. Concentrations higher than 1.5 mg/mL (up to 4 mg/mL) should be administered through a central line

MONITORING

Assess IV site for signs of irritation. Periodic measurement of serum potassium, calcium, BUN, hepatic transaminases, and creatinine (isolated renal dysfunction reported in adults). For candidemia, monitor blood cultures daily or every other day until Candida is cleared.