默沙东宣布，FDA 已批准Noxafil（泊沙康唑）的新制剂，即静脉注射液（18mg/ml）。该抗真菌剂有口服混悬液（40mg/ml）和延释片（100mg）剂型以同一品牌名Noxafil销售。Noxafil注射液、延释片和口服混悬剂的适应症均为侵袭性曲霉菌和念珠菌感染的预防。Noxafil注射液适用于18岁及以上人群。
静脉给药制剂对于那些因为各种原因不能接受口服制剂的患者尤为重要。此外，开始使用注射液的患者在病情减轻后可以转用口服制剂。Noxafil注射液预计将在4月中旬应市。
Merck's NOXAFIL injection gets FDA approval for intravenous use
Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration has approved NOXAFIL®(posaconazole) injection (18 mg/ mL), a new formulation of NOXAFIL for intravenous (IV) use. Merck's antifungal agent is also marketed as NOXAFIL (100 mg) delayed-release tablets and NOXAFIL (40 mg/mL) oral suspension. NOXAFIL injection, delayed-release tablets and oral suspension are indicated for prophylaxis of invasive Aspergillusand Candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant (HSCT) recipients with graft-versus-host disease (GVHD) or those with hematologic malignancies with prolonged neutropenia (low white blood cell counts) fromchemotherapy. NOXAFIL injection is indicated in patients 18 years of age and older. NOXAFIL delayed-release tablets and oral suspension are indicated in patients 13 years of age and older. With this approval, Merck now provides an IV formulation and two oral formulations of NOXAFIL for prophylaxis against invasive Aspergillus and Candidainfections in high-risk patients.
NOXAFIL should not be administered to persons allergic to posaconazole or other azole antifungal medicines. The administration of NOXAFIL with sirolimus, pimozide, quinidine,atorvastatin, lovastatin, simvastatin and ergot alkaloids must be avoided. When administered with NOXAFIL, some drugs such as cyclosporine and tacrolimus required dosage adjustments and frequent monitoring of their levels in the blood as serious side effects in the kidney (nephrotoxicity) or brain (leukoencephalopathy) including deaths have been reported in patients with increased cyclosporine or tacrolimus blood levels. NOXAFIL should be administered with caution to patients who may develop an irregular heart rhythm as NOXAFIL has been shown to prolong the QT interval and cases of potentially fatal irregular heart rhythm (torsades de pointes) have been reported in patients taking NOXAFIL (posaconazole). (See Selected Safety Information below.)
"Merck is pleased to add NOXAFIL injection to the NOXAFIL family of products. The availability of a NOXAFIL formulation for intravenous administration is particularly imp0rtant for those patients who may benefit from or require intravenous therapy, or who, for a variety of reasons, might not be able to take an oral formulation. In addition, patients have the possibility to start on NOXAFIL injection and transition to oral NOXAFIL," said Dr. Nicholas Kartsonis, executive director, Infectious Disease, Merck Research Laboratories.
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