NOXAFIL (posaconazole) suspension
NOXAFIL (posaconazole) tablet, coated
 [Merck Sharp & Dohme Corp.]
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use NOXAFIL safely and effectively. See full prescribing information for NOXAFIL.
Noxafil® (posaconazole) delayed-release tablets, 100 mg and
Noxafil® (posaconazole) oral suspension 40 mg/mL
Initial U.S. Approval: 2006 (oral suspension)
RECENT MAJOR CHANGES

Indications and Usage (1) 11/2013
Dosage and Administration (2) 11/2013
Warnings and Precautions (5.1) 11/2013

默沙东（Merck & Co）11月26日宣布，Noxafil（posaconazole，泊沙康唑，100 mg）缓释片获FDA批准。Noxafil缓释片是一种新的配方，在治疗第一天的负荷剂量（loading dose）为300mg（即3片100mg缓释片），一天2次；从治疗的第二天开始，维持剂量（maintenance dose）为300mg（即3片100mg缓释片），一天1次。
同时，默沙东还销售Noxafil（40mg/mL）口服混悬液，剂量为每天给药3次。
Noxafil缓释片和口服混悬液，适应症为用于因免疫功能严重低下而具有高风险的侵袭性曲霉菌和念珠菌感染的13岁及以上患者，如患有移植物抗宿主病（GVHD）的造血干细胞移植（HSCT）受者，或那些因化疗导致长期的中性粒细胞减少（低白细胞计数）的恶性血液病患者。
Noxafil缓释片的获批，是基于一项药代动力学研究。该项研究是一项非对照、多中心临床研究，在已发生或预期将发生显著中性粒细胞减少（neutropenia）的急性髓性系白血病（AML）或骨髓增生异常综合症（MDS）患者、以及已接受造血干细胞移植（HSCT）同时正接受免疫抑制治疗以预防移植物抗宿主病（GVHD）的患者中开展中，评价了Noxafil缓释片的药代动力学、安全性和耐受性。
 
INDICATIONS AND USAGE
Noxafil is an azole antifungal agent indicated for:
Delayed-release tablets and oral suspension
•prophylaxis of invasive Aspergillus and Candida infections in patients, 13 years of age 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. (1.1)
 
Oral suspension
•treatment of oropharyngeal candidiasis (OPC), including OPC refractory (rOPC) to itraconazole and/or fluconazole. (1.2)

DOSAGE AND ADMINISTRATION

Indication
 
Dose and Duration of Therapy

Prophylaxis of invasive Aspergillus and Candida infections Delayed-Release Tablets:
Loading dose: 300 mg (three 100 mg delayed-release tablets) twice a day on the first day.
Maintenance dose: 300 mg (three 100 mg delayed-release tablets) once a day, starting on the second day. Duration of therapy is based on recovery from neutropenia or immunosuppression. (2.1)
Oral Suspension: 200 mg (5 mL) three times a day. Duration of therapy is based on recovery from neutropenia or immunosuppression. (2.2)
Oropharyngeal Candidiasis (OPC) Oral Suspension:
Loading dose: 100 mg (2.5 mL) twice a day on the first day.
Maintenance dose: 100 mg (2.5 mL) once a day for 13 days. (2.2)
OPC Refractory (rOPC) to Itraconazole and/or Fluconazole Oral Suspension: 400 mg (10 mL) twice a day. Duration of therapy is based on the severity of the patient's underlying disease and clinical response. (2.2)

DOSAGE FORMS AND STRENGTHS
 
• Noxafil delayed-release tablet 100 mg (3)
• Noxafil oral suspension 40 mg per mL (3)

CONTRAINDICATIONS
 
•Do not administer to persons with known hypersensitivity to posaconazole, any component of Noxafil, or other azole antifungal agents. (4.1)
•Do not coadminister Noxafil with the following drugs; Noxafil increases concentrations of: ◦ Sirolimus: can result in sirolimus toxicity (4.2, 7.1)
◦ CYP3A4 substrates (pimozide, quinidine): can result in QTc