China
Africa
Explore chapters and articles related to this topic
Anti-Infective Agents
Published in Radhwan Nidal Al-Zidan, Drugs in Pregnancy, 2020
Risk Summary: It is better to be avoided during the 1st Trimester because the pregnancy experience in humans is limited, and the reproduction studies in animals have shown the risk of teratogenicity associated with the use of Micafungin.
Echinocandins for prevention and treatment of invasive fungal infections
Published in Mahmoud A. Ghannoum, John R. Perfect, Antifungal Therapy, 2019
Melissa D. Johnson, John Mohr, Ahmad Mourad
Micafungin was also investigated as a single agent or in combination antifungal therapy in some recent studies [127,136,158]. The first study describes 225 evaluable adults and children who received micafungin for proven or probable invasive aspergillosis refractory or intolerant to initial antifungal therapy [127]. Eighty-five percent of these patients added micafungin to a failing antifungal regimen. Complete/partial responses were experienced by 35.6% (8% complete, 27.6% partial) of patients at the end of antifungal therapy, while 53.5% of patients experienced progression of infection. This study showed no advantage of a combination antifungal therapy compared to micafungin alone as either primary (29.4% vs. 50%) or salvage (34.5% vs. 40.9%) therapy; however, the overall number of patients included in these groups was small, so it was underpowered to detect such differences. In a second, multicenter, open-label study, 98 adult and pediatric HSCT recipients with invasive aspergillosis received micafungin as a single agent (8%) or in combination with other antifungals (92%) as primary (15%) or salvage (85%) therapy [136]. Most of the patients (83%) had invasive pulmonary aspergillosis. Amphotericin B or its lipid formulations were most commonly used in conjunction with micafungin. Treatment success was experienced by 26% of patients, who had either complete (5%) or partial (20%) responses. Success rates were similar among those receiving micafungin as primary therapy (22%) and as salvage therapy (24%). Success was 24% among those receiving micafungin in combination with other antifungals, and 38% among the eight patients receiving micafungin alone. Thus, micafungin demonstrated some success in treating invasive aspergillosis in this very challenging patient population. Another randomized trial evaluating the use of micafungin as salvage therapy in patients with invasive aspergillosis, who were intolerant or refractory to other systemic antifungals, showed 25% of patients on 300 mg/day of micafungin monotherapy and 60% of patients in the control arm achieved treatment success. However, the study was concluded early due to the common use of combination antifungals for salvage therapy at the time, and no clear conclusion could be made about the use of micafungin monotherapy for salvage therapy [158].
An overview of micafungin as a treatment option for invasive candidiasis in pediatric patients younger than 4 months old
Published in Expert Opinion on Pharmacotherapy, 2022
Matteo Bassetti, Daniele Roberto Giacobbe, Antonio Vena, Susanna Esposito
Micafungin (sodium salt) is administered intravenously. A dosage of 4–10 mg/kg/day is recommended in pediatric patients younger than 4 months old to achieve therapeutic plasma concentrations (the highest dose is suggested to maximize antifungal effect in the case of Candida meningitis or meningoencephalitis) [22,23]. Notably, the dosage of 4–10 mg/kg/day is higher than that of 1–4 mg/kg/day recommended in pediatric patients ≥4 months old [22,24]. This reflects the increased clearance of micafungin in infants younger than 4 months old in comparison to older pediatric patients, possibly due to lower levels of plasma proteins [25,26]. In turn, a higher fraction of free micafungin is more rapidly eliminated in pediatric patients younger than 4 months old than in older pediatric patients, with a lack of substantial differences in hepatobiliary clearance [25,26]. Of note, this could also imply the achievement of a higher concentration of free micafungin in pediatric patients younger than 4 months old than in older pediatric patients and adults independent of weight-adjusted dosage [27]. However, dosages of 10 mg/kg and also up to 15 mg/kg/die were generally well-tolerated in available studies [27,28].
Micafungin injection for the treatment of invasive candidiasis in pediatric patients under 4 months of age
Published in Expert Review of Anti-infective Therapy, 2022
Nahed Abdel-Haq, Stephanie M. Smith, Basim I. Asmar
The dose of Micafungin for infants under 4 months of age ranges from 7 to 15 mg/kg/day to achieve therapeutic plasma levels. This is compared to the 1–4 mg/kg/dose in infants older than 4 months [68]. Micafungin displays linear pharmacokinetics with minimal systemic accumulation after repeated administration. A steady state is reached within 4 days of once daily dosing. The pharmacokinetics are similar for adults and adolescents. However, faster clearance and a shorter half-life are observed in young children and premature neonates [60,69]. The higher doses required are due to the increased clearance of Micafungin in infants <4 months compared to older children and adults [57]. Simulation studies have suggested that to achieve AUC values of 166.5 mg.h/L which are associated with maximal antifungal effect in an experimental model of Candida meningitis doses of 10 mg/kg are required [70]. There are a handful of studies that evaluate different dosing regimens for neonates and infants <4 months that have found doses up to 15 mg/kg/day safe in this patient population [71]. Some theories as to why micafungin clearance differs between these patient populations, is that it could be due to the low level of plasma proteins in younger infants and neonates [72]. Binding is about 8 times lower in neonates than adults, this leads to a higher amount of free Micafungin to be eliminated by the neonate [72]. A summary of PK data in infants younger than 4 months of age that were enrolled in clinical outcome studies is shown in Table 3.
Pharmacological prophylaxis of infection in pediatric acute myeloid leukemia patients
Published in Expert Opinion on Pharmacotherapy, 2020
Nira Arad-Cohen, Jacob M Rowe, Yael Shachor-Meyouhas
The randomized multi-institutional study conducted in 2004 in the University of Minnesota, comparing prophylaxis with fluconazole and micafungin in 882 patients undergoing HSCT (mainly adults), demonstrated that the overall success rate in the intent-to-treat population was higher for patients in the micafungin arm, but with no significant difference in the breakthrough infection or mortality. Adverse events were comparable but fewer cases of drug discontinuation occurred in the micafungin arm. A subgroup analysis of 84 pediatric patients did not provide different results [72]. A small study reported findings in 21 children with high risk for IFI, who received micafungin twice weekly. None of them had IFI, the drug was well tolerated and its plasma level was suggested to be effective in 9 out of 11 children [73]. In the recommendation by the German Society for Hematology and Medical Oncology, published in 2018 [74], micafungin received a low score. A recent study evaluated micafungin prophylaxis among 150 patients, including 55 children (18 had AML). Ten percent had breakthrough IFI, with more events occurring in children (15%, i.e. 8 cases, 3 of them were proven, 2 probable and 3 possible). With regard to safety, 6.7% had an adverse event considered related to the drug and 3.3% had a serious adverse event [75]. While multiple trials evaluating micafungin have not demonstrated its superiority over fluconazole or other azole therapy, it may serve as an alternative for patients who cannot tolerate azoles but must receive prophylaxis or treatment. A twice weekly regimen can help while oral formulation is not available [76].