VORICONAZOLE- voriconazole injection, powder, lyophilized, for solution
XGen Pharmaceuticals DJB, Inc.
Voriconazole for injection is indicated in adults and pediatric patients (aged 12 to 14 years weighing greater than or equal to 50 kg and those aged 15 years and older regardless of body weight) for the treatment of invasive apergillosis (IA). In clinical trials, the majority of isolates recovered were Aspergillus fumigatus. There was a small number of cases of culture-proven disease due to species of Aspergillus other than A. fumigatus [see Clinical Studies (14.1), and Microbiology (12.4)] .
Voriconazole for injection is indicated in adult and pediatric patients (aged 12 to 14 years weighing greater than or equal to 50 kg and those aged 15 years and older regardless of body weight) for the treatment of candidemia in non-neutropenic patients and the following Candida infections: disseminated infections in skin and infections in abdomen, kidney, bladder wall, and wounds [see Clinical Studies (14.2) and Microbiology (12.4)].
Voriconazole for injection is indicated for the treatment of serious fungal infections caused by Scedosporium apiospermum (asexual form of Pseudallescheria boydii ) and Fusarium spp. including Fusarium solani , in adult and pediatric patients (aged 12 to 14 years weighing greater than or equal to 50 kg and those aged 15 years and older regardless of body weight) intolerant of, or refractory to, other therapy [see Clinical Studies (14.3) and Microbiology (12.4)].
Specimens for fungal culture and other relevant laboratory studies (including histopathology) should be obtained prior to therapy to isolate and identify causative organism(s). Therapy may be instituted before the results of the cultures and other laboratory studies are known. However, once these results become available, antifungal therapy should be adjusted accordingly.
Additional pediatric use information is approved for PF PRISM C.V.’s VFEND (voriconazole) for injection. However, due to PF PRISM C.V.’s marketing exclusivity rights, this drug product is not labeled with that information.
Voriconazole for injection requires reconstitution to 10 mg/mL and subsequent dilution to 5 mg/mL or less prior to administration as an infusion, at a maximum rate of 3 mg/kg per hour over 1 to 3 hours.
Administer diluted Voriconazole for injection by intravenous administration over 1 to 3 hours. Do not administer as an IV bolus injection.
Blood products and concentrated electrolytes
Voriconazole for injection must not be infused concomitantly with any blood product or short-term infusion of concentrated electrolytes, even if the two infusions are running in separate intravenous lines (or cannulas). Electrolyte disturbances such as hypokalemia, hypomagnesemia and hypocalcemia should be corrected prior to initiation of and during Voriconazole for injection therapy [see Warnings and Precautions (5.10)].
Intravenous solutions containing (non-concentrated) electrolytes
Voriconazole for injection can be infused at the same time as other intravenous solutions containing (non-concentrated) electrolytes, but must be infused through a separate line.
Total parenteral nutrition (TPN)
Voriconazole for injection can be infused at the same time as total parenteral nutrition, but must be infused in a separate line. If infused through a multiple-lumen catheter, TPN needs to be administered using a different port from the one used for Voriconazole for injection.
Invasive aspergillosis and serious fungal infections due to
Fusarium spp. and
See Table 1. Therapy must be initiated with the specified loading dose regimen of intravenous Voriconazole for injection on Day 1 followed by the recommended maintenance dose (RMD) regimen. Intravenous treatment should be continued for at least 7 days. Once the patient has clinically improved and can tolerate medication given by mouth, the oral tablet form or oral suspension form of voriconazole may be utilized. The recommended oral maintenance dose of 200 mg achieves a voriconazole exposure similar to 3 mg/kg intravenously; a 300 mg oral dose achieves an exposure similar to 4 mg/kg intravenously. Switching between the intravenous and oral formulations is appropriate because of the high bioavailability of the oral formulation in adults [see Clinical Pharmacology (12)].
Candidemia in non-neutropenic patients and other deep tissue Candida infections See Table 1. Patients should be treated for at least 14 days following resolution of symptoms or following last positive culture, whichever is longer.
|Infection||Loading dose||Maintenance Dose a|
|Intravenous infusion||Intravenous infusion|
|Invasive Aspergillosis *||6 mg/kg every 12 hours for the first 24 hours||4 mg/kg every 12 hours|
|Candidemia in nonneutropenic patients and other deep tissue Candida infections||6 mg/kg every 12 hours for the first 24 hours||3-4 mg/kg every 12 hours †|
|Scedosporiosis and Fusariosis||6 mg/kg every 12 hours for the first 24 hours||4 mg/kg every 12 hours|
a Increase dose when Voriconazole for injection is co-administered with phenytoin or efavirenz (
7); Decrease dose in patients with hepatic impairment (
d In a clinical study of IA, the median duration of intravenous Voriconazole for injection therapy was 10 days (range 2 to 85 days) ( 14.1)
e In clinical trials, patients with candidemia received 3 mg/kg intravenous infusion every 12 hours as primary therapy, while patients with other deep tissue Candida infections received 4 mg/kg every 12 hours as salvage therapy. Appropriate dose should be based on the severity and nature of the infection.
Method for Adjusting the Dosing Regimen in Adults
If patient is unable to tolerate 4 mg/kg intravenously every 12 hours, reduce the intravenous maintenance dose to 3 mg/kg every 12 hours.
All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.