Micafungin

Generic name
Micafungin
Brand name
ATC Code
J02AX05
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Micafungin

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

Interactions
PK
Renal impairment
References

Pharmacokinetics in children

In children, the AUC values were dose proportional for the
dose range of 0.5-4 mg/kg. Clearance was influenced by weight, with mean values of weight-adjusted clearance 1.35 times higher in young children (4 months to 5 years) and 1.14 times higher in pediatric patients aged 6 to 11 years. Older children (12-16 years) had the same mean clearance values as determined in adult patients. The mean weight-adjusted clearance in children younger than 4 months was approximately 2.6 times greater than that in
older children (12-16 years) and 2.3 times greater than that in adults. [SmPC]

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
    • Term neonate
      [1]
      • 4 - 10 mg/kg/day in 1 dose
      • Duration of treatment:

        At least 14 days. The antifungal treatment must be continued for at least one week after two successive negative blood cultures have been obtained and after the clinical symptoms and the symptoms of infection have disappeared.

    • 1 month up to 4 months
      [1]
      • 4 - 10 mg/kg/day in 1 dose
      • Duration of treatment:

        At least 14 days. The antifungal treatment must be continued for at least one week after two successive negative blood cultures have been obtained and after the clinical symptoms and the symptoms of infection have disappeared.

    • ≥ 4 months and < 40 kg
      [1]
      • 2 mg/kg/day in 1 dose. Max: 4 mg/kg/day.
      • Duration of treatment:

        At least 14 days. The antifungal treatment must be continued for at least one week after two successive negative blood cultures have been obtained and after the clinical symptoms and the symptoms of infection have disappeared.

      • If the cultures remain positive or the clinical condition does not improve, the dose may then be doubled to 4 mg/kg/day.

    • ≥ 4 months and ≥ 40 kg
      [1]
      • 100 mg/day in 1 dose. Max: 200 mg/day.
      • Duration of treatment:

        At least 14 days. The antifungal treatment must be continued for at least one week after two successive negative blood cultures have been obtained and after the clinical symptoms and the symptoms of infection have disappeared.

      • If the cultures remain positive or the clinical condition does not improve, the dose may then be doubled to 200 mg/day.
Prophylaxis of Candida infection
  • Intravenous
    • Term neonate
      [1]
      • 2 mg/kg/day in 1 dose
      • Duration of treatment:

        at least one further week after the neutrophils recover

    • 1 month up to 4 months
      [1]
      • 2 mg/kg/day in 1 dose
      • Duration of treatment:

        at least one further week after the neutrophils recover

    • ≥ 4 months and < 40 kg
      [1]
      • 1 mg/kg/day in 1 dose
      • Duration of treatment:

        at least one further week after the neutrophils recover

    • ≥ 4 months and ≥ 40 kg
      [1]
      • 50 mg/day in 1 dose
      • Duration of treatment:

        At least one further week after the neutrophils recover.
Prophylaxis during induction treatment ALL
  • Intravenous
    • 1 year up to 18 years
      [2]
      • 9 mg/kg/dose 2 times per WEEK. Max: 300 mg/dose.

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

Some side effects are more common in children, possibly caused by the underlying condition. Common (1-10%): tachycardia, hypertension, hypotension. Thrombocytopenia. Acute renal failure, elevated values of urea in blood. Hepatomegaly, hyperbilirubinemia. In children < 1 year, elevated values of ALAT, ASAT and AF, are seen about twice as often as in older children.
 

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

Only prescribe after consulting an infectiologist/microbiologist. Micafungin therapy is associated with significant hepatic function impairment (increase ALAT/ASAT or total bilirubin > 3 times the ULN in both healthy volunteers and in patients. More severe cases of hepatic dysfunction, hepatitis or liver failure have been reported in some patients, including some with fatal outcomes. Children aged < 1 year are possibly more susceptible to liver damage.
The hepatic function and renal function should be monitored carefully during treatment with micafungin.
 

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
J02AX06
J02AX04
J02AX01

References

  1. Astellas Pharma Europe B.V., SmPC Mycamine (EU/1/08/448/002 ) Rev 18; 23-03-2023, www.emea.europa.eu
  2. Princess Maxima Centre for Pediatric Oncology, Expert opinion informed by studies of Bury (pending formal review by Children's Formulary), 19 dec 2024
  3. Bury D., Micafungin twice-a-week for prophylaxis of invasive Aspergillus infections in children with acute lymphoblastic leukaemia: A controlled cohort study., Int J Antimicrob Agents, 2024, Jan;63(1), 107058.
  4. Bury D., Pharmacokinetic evaluation of twice-a-week micafungin for prophylaxis of invasive fungal disease in children with acute lymphoblastic leukaemia: a prospective observational cohort study., J Antimicrob Chemother., 2022, Feb 23;77(3), 699-703

Changes

Therapeutic Drug Monitoring


Overdose