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Noxafil
儿科标签批准日期
2021/5/31 0:00:00
特定指示/秒
Prophylaxis of invasive Aspergillus and Candida infections in pediatric patients 2 years of age and older (who weigh 40 kg or less) who are at high risk of developing these infections due to being severely immunocompromised
标签更改摘要
- Safety and effectiveness of Noxafil injection, Noxafil delayed-release tablets, Noxafil PowderMix for delayed-release oral suspension and Noxafil oral suspension for the prophylaxis of invasive Aspergillus and Candida infections have been established in pediatric patients aged 2 and older who are at high risk of developing these infections due to being severely immunocompromised, such as HSCT recipients with GVHD or those with hematologic malignancies with prolonged neutropenia from chemotherapy.
- The safety and effectiveness of Noxafil oral suspension have been established for the treatment of oropharyngeal candidiasis (OPC), including OPC refractory (rOPC) to itraconazole and/or fluconazole in pediatric patients aged 13 years and older.
- Use of Noxafil in these age groups is supported by evidence from adequate and well-controlled studies of Noxafil in adult and pediatric patients and additional pharmacokinetic and safety data in pediatric patients 2 years of age and older.
- Safety and effectiveness of Noxafil have not been established in pediatric patients younger than 2 years.
- Noxafil PowderMix for delayed-release oral suspension is not recommended for use in patients who weigh greater than 40 kg because the recommended dosage cannot be achieved with this formulation.
- Noxafil PowderMix for delayed-release oral suspension is contraindicated in patients with HFI.
- Because a diagnosis of HFI may not yet be established in pediatric patients, obtain a careful history of HFI symptoms with sorbitol/fructose/sucrose exposure prior to administration of Noxafil PowderMix for delayed-release oral suspension.
- Information on dosing, adverse reactions, PK parameters and clinical trials.
- Postmarketing study.