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【drug-news】FDA批准卡泊芬净可用于儿童
Caspofungin should be administered by slow intravenous (IV) infusion for approximately 1 hour. Precise dosing of caspofungin in children should be based on the patient's body surface area. For all indications, a single 70-mg/m2 loading dose should be administered on day 1, followed by 50 mg/m2 daily thereafter; the loading and maintenance doses should not exceed 70 mg, regardless of the patient's calculated dose.
When caspofungin is coadministered with inducers of drug clearance (eg, rifampin, efavirenz, nevirapine, phenytoin, dexamethasone, or carbamazepine) to pediatric patients, a dose of 70 mg/m2 daily (not to exceed 70 mg) should be considered.
Approval of pediatric indications for caspofungin was based primarily on data from 2 prospective clinical trials.
In 1 multicenter study, 82 children aged 2 to 17 years with persistent fever and neutropenia and suspected fungus infection were randomly assigned in a 2:1 ratio to receive empiric therapy with caspofungin (50 mg/m2 IV daily after a 70-mg/m2 loading dose on day 1) or 3 mg/kg IV daily of liposomal amphotericin B (AmBisome; Gilead Sciences, Inc, for Fujisawa Healthcare, Inc). A significant portion of each group (27%) were considered high-risk patients, if they had undergone allogenic stem cell transplantation or had relapsed acute leukemia.
Overall results showed that 46.4% of children receiving caspofungin vs 32.0% of those given liposomal amphotericin achieved a favorable response (46.4% vs 32.0%), defined as no documented breakthrough fungus infections up to 7 days after therapy, no discontinuation of the study drug because of toxicity or inefficacy, resolution of fever during the period of neutropenia, and successful treatment of any documented baseline fungus infection.
For high-risk patients, caspofungin was significantly more effective than liposomal amphotericin to achieve favorable response (60% vs 0%); corresponding response rates for low-risk patients were 41.5% and 44.4%, respectively. Serious adverse events were significantly less common in the caspofungin group (0.6% vs 11.5%).
The efficacy of caspofungin for documented pediatric fungus infections was demonstrated in an open-label, noncomparative study of children aged 3 months to 17 years, showing that the favorable response rate was 81% (30/37) for patients with candidemia and other Candida infections, 100% (1/1) for patients with esophageal candidiasis, and 50% (5/10) for patients with invasive aspergillosis as salvage therapy.
Across these and other safety and pharmacokinetic studies, the most commonly reported adverse events in caspofungin-treated pediatric patients were pyrexia (29.2%), decreased serum potassium (15.2%), diarrhea (14.0%), increased aspartate aminotransferase levels (11.1%), rash (11.7%), increased alanine aminotransferase levels (11.1%), hypotension (11.1%), and chills (11.1%). Infusion-related adverse events occurred in 21.6% of caspofungin-treated children vs 34.6% of patients receiving liposomal amphotericin.
The FDA notes that the safety and efficacy of caspofungin has not been adequately studied in prospective clinical trials of neonates and infants aged younger than 3 months, and available pharmacokinetic data are insufficient to establish safe dosing guidelines for neonatal candidiasis. Caspofungin has not been studied as initial therapy for invasive aspergillosis in children or for the treatment of pediatric patients with endocarditis, osteomyelitis, or meningitis resulting from Candida. 本人已认领该文编译，48小时后若未提交译文，请其他战友自由认领。 On July 29, the FDA approved pediatric indications for caspofungin acetate injection (Cancidas; Merck and Co, Inc), allowing its use in children aged 3 months to 17 years for the treatment of candidemia and other Candida infections (intra-abdominal abscesses, peritonitis, and pleural space infections), esophageal candidiasis, and invasive aspergillosis in patients refractory or intolerant of other therapies. It also may be used as empiric therapy for presumed fungus infection in patients with fever and neutropenia.
在7月19日,FDA批准注射用醋酸卡泊芬净（科赛斯）可用于3个月到17岁的小孩，治疗对其他抗霉菌药物治疗反应不佳的念珠菌血症和其他念珠菌引起的感染（阑尾周围脓肿， 腹膜炎，胸腔积液感染），食道念珠菌感染，侵袭性曲霉感染。也可以用于白细胞减少发热病人中怀疑可能有真菌感染的经验性用药。
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作者:admin@医学,生命科学 2011-02-23 05:14
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