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The Food and Drug Administration has approved a new drug intended for the prevention of Aspergillus and Candida fungal infections in immunocompromised patients.
Posaconazole, which will be marketed as Noxafil by Schering-Plough, was approved on the basis of two randomized controlled trials that showed greater efficacy than fluconazole in preventing infections in patients aged 13–82 years.
In a study of patients with graft-versus-host disease who had undergone hematopoietic stem cell transplantation, 2% of patients experienced clinical failure due to proven or probable invasive fungal infection (IFI) after 7 days' treatment, versus 7% of patients on fluconazole; after 16 weeks' treatment, these figures were 5% for those on posaconazole and with 9% for those on fluconazole.
In a separate study of patients with hematologic malignancy or prolonged neutropenia, 2% of those on posaconazole had clinical failure due to proven/probable IFI after 7 days, versus 8% of those on fluconazole/itraconazole. After 100 days, these figures were 5% for the posaconazole group and 11% for the fluconazole/itraconazole group.
Reported side effects of posaconazole include nausea, vomiting, diarrhea, changes in QTc interval, and hepatic impairment.
Posaconazole should be given only with a full meal or liquid nutritional supplement, according to the FDA-approved label. No dose adjustment is required for those with mild to moderate renal impairment or for pediatric or geriatric patients.
Coadministration is contraindicated for ergot alkaloids, terfenadine, astemizole, cisapride, pimozide, halofantrine, and quinidine.
The drug works by blocking fungal cells' synthesis of the membrane component ergosterol.
Noxafil was approved in Europe by the European Medicines Agency in October 2005, based on complete or partial resolution of invasive aspergillosis in 42% of patients, compared with 26% of control patients.
The Food and Drug Administration has approved a new drug intended for the prevention of Aspergillus and Candida fungal infections in immunocompromised patients.
Posaconazole, which will be marketed as Noxafil by Schering-Plough, was approved on the basis of two randomized controlled trials that showed greater efficacy than fluconazole in preventing infections in patients aged 13–82 years.
In a study of patients with graft-versus-host disease who had undergone hematopoietic stem cell transplantation, 2% of patients experienced clinical failure due to proven or probable invasive fungal infection (IFI) after 7 days' treatment, versus 7% of patients on fluconazole; after 16 weeks' treatment, these figures were 5% for those on posaconazole and with 9% for those on fluconazole.
In a separate study of patients with hematologic malignancy or prolonged neutropenia, 2% of those on posaconazole had clinical failure due to proven/probable IFI after 7 days, versus 8% of those on fluconazole/itraconazole. After 100 days, these figures were 5% for the posaconazole group and 11% for the fluconazole/itraconazole group.
Reported side effects of posaconazole include nausea, vomiting, diarrhea, changes in QTc interval, and hepatic impairment.
Posaconazole should be given only with a full meal or liquid nutritional supplement, according to the FDA-approved label. No dose adjustment is required for those with mild to moderate renal impairment or for pediatric or geriatric patients.
Coadministration is contraindicated for ergot alkaloids, terfenadine, astemizole, cisapride, pimozide, halofantrine, and quinidine.
The drug works by blocking fungal cells' synthesis of the membrane component ergosterol.
Noxafil was approved in Europe by the European Medicines Agency in October 2005, based on complete or partial resolution of invasive aspergillosis in 42% of patients, compared with 26% of control patients.
The Food and Drug Administration has approved a new drug intended for the prevention of Aspergillus and Candida fungal infections in immunocompromised patients.
Posaconazole, which will be marketed as Noxafil by Schering-Plough, was approved on the basis of two randomized controlled trials that showed greater efficacy than fluconazole in preventing infections in patients aged 13–82 years.
In a study of patients with graft-versus-host disease who had undergone hematopoietic stem cell transplantation, 2% of patients experienced clinical failure due to proven or probable invasive fungal infection (IFI) after 7 days' treatment, versus 7% of patients on fluconazole; after 16 weeks' treatment, these figures were 5% for those on posaconazole and with 9% for those on fluconazole.
In a separate study of patients with hematologic malignancy or prolonged neutropenia, 2% of those on posaconazole had clinical failure due to proven/probable IFI after 7 days, versus 8% of those on fluconazole/itraconazole. After 100 days, these figures were 5% for the posaconazole group and 11% for the fluconazole/itraconazole group.
Reported side effects of posaconazole include nausea, vomiting, diarrhea, changes in QTc interval, and hepatic impairment.
Posaconazole should be given only with a full meal or liquid nutritional supplement, according to the FDA-approved label. No dose adjustment is required for those with mild to moderate renal impairment or for pediatric or geriatric patients.
Coadministration is contraindicated for ergot alkaloids, terfenadine, astemizole, cisapride, pimozide, halofantrine, and quinidine.
The drug works by blocking fungal cells' synthesis of the membrane component ergosterol.
Noxafil was approved in Europe by the European Medicines Agency in October 2005, based on complete or partial resolution of invasive aspergillosis in 42% of patients, compared with 26% of control patients.