Anidulafungine

Generic name
Anidulafungine
Brand name
ATC Code
J02AX06

Anidulafungine

Dosages
Side effects in children
Warnings & precautions in children
Contra-indications in children

Interactions
PK
Renal impairment
References

Pharmacokinetics in children

Body weight adjusted CL (l / h / kg) and volume of distribution at steady state (l / kg) were similar in all age groups. (SmPC Ecalta)

Age Vd (L/kg) Cl (L/kg/hour) T1/2 (hour)
Neonates (Cohen) 1,7  0.02  -
1 month-2 years (Cohen) 0,9  0,015 -
> 2 years 0,434-0,537 (SmPC)  0,0159 - 0,0175 (Benjamin) 40-50 (SmPC)

SmPC: Immunocomrpomised patients

 

dose recommendation of formulary compared to licensed use (on-label versus off-label)

No information is present at this moment.

Available formulations

No information is present at this moment.

Dosages

Invasive candidiasis
  • Intravenous
    • 1 month up to 18 years
      [3]
      • Initial dose: 3 mg/kg/day in 1 dose once only. Max: 200 mg/day.
      • Maintenance dose: 1.5 mg/kg/day in 1 dose. Max: 100 mg/day.
      • Continue treatment for at least 14 days after last positive test.

Renal impaiment in children > 3 months

GFR ≥10 ml/min/1.73m2: Dose adjustment not required.

GFR <10 ml/min/1.73m2: A general recommendation on dose adjustment cannot be provided.

The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here

Side effects in children

Hepatic and bile side effects appear to be more common in children than in adults.

The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here

Contra-indications

No information available on specific contra indications in children.

The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here

Warnings & precautions in children

Treatment of neonates (<1 month) is not recommended. When treating neonates, attention should be paid to the range of disseminated candidiasis, including the central nervous system (CNS); non-clinical infection models indicate that higher doses of anidulafungin are required to obtain adequate CNS permeation
leading to higher doses of polysorbate 80, an excipient of the formulation. High
doses of polysorbates have been associated with potentially life-threatening toxicities in neonates. (SmPC Ecalta)

Interactions

The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here

ANTIMYCOTICS FOR SYSTEMIC USE

This pages provides a list of drugs from the same ATC class for comparison. This does not necessarily mean that these drugs are interchangeable.

Antibiotics
J02AA01
Triazole and tetrazole derivatives
J02AC01
J02AC02
J02AC03
Other antimycotics for systemic use
J02AX04
J02AX01
J02AX05

References

  1. Benjamin DK Jr, et al, Safety and pharmacokinetics of intravenous anidulafungin in children with neutropenia at high risk for invasive fungal infections, Antimicrob Agents Chemother, 2006, 50(2), 632-8
  2. Cohen-Wolkowiez M, et al, Safety and pharmacokinetics of multiple-dose anidulafungin in infants and neonates., Clin Pharmacol Ther, 2011, 89(5), 702-7
  3. Pfizer Europe MA EEIG, SmPc Ecalta (EU/1/07/416) 27-05-2020, www.geneesmiddeleninformatiebank.nl

Changes

Therapeutic Drug Monitoring


Overdose