NEODOSE

INDICATIONS

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
  • Amphotericin B deoxycholate is recommended.
  • Liposomal amphotericin B agent is an alternative.
  • 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 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

In a safety and pharmacokinetic study, doses of 1.5 mg/kg/day for 5 days in 8 neonates (6 out of 8 preterm) provided similar anidulafungin exposures compared to children and adults (100 mg/day). Despite sensitivity to amphotericin B, fungal peritonitis was not cleared in a full-term neonate until anidulafungin was added to liposomal amphotericin B; Candida albicans had been cultured from the peritoneum while the patient was receiving amphotericin B monotherapy. Doses for hematogenous Candida meningoencephalitis (HCME) are expected to be much higher than those used for other indications, based upon a translational study which used neonatal (6 out of 8 were preterm) pharmacokinetic data applied to an animal model of the disease

FDA APPROVED INDICATION

Treatment of candidemia, esophageal candidiasis, and intra-abdominal abscess and peritonitis due to Candida in patients older than 16 years.

CONTRAINDICATIONS

Contraindicated in patients with hypersensitivity to other echinocandins. Hepatitis, hepatic failure, and significant hepatic dysfunction have been reported. Anaphylactic reactions, including shock, have also been reported; discontinue use if reactions occur. Infusion-related reactions (eg, rash, urticaria, flushing, pruritus, bronchospasm, dyspnea, and hypotension) have been reported; to reduce occurrence, do not exceed an infusion rate of 1.1 mg/minute

ADVERSE EFFECTS

Adverse events reported were hypotension (1), adrenal insufficiency (1), abnormal X-ray of kidneys, ureter, and bladder (1), death (1), infection (1), pulmonary edema (1), and oliguria or uremia (2) in a safety study of 8 neonates.

ADMINISTRATION

Administer by IV Infusion (0.8 mg/mL) over 60 minutes; not to exceed 1.1 mg/minute.

MONITORING

For candidemia, monitor blood cultures daily or every other day until Candida is cleared . Monitor liver function tests. Also monitor for signs and symptoms of worsening hepatic function in patients who develop abnormal liver function tests during therapy.