Posaconazole

Paul A. Pham, Pharm.D., John G. Bartlett, M.D., Shmuel Shoham, M.D.
Posaconazole is a topic covered in the Johns Hopkins ABX Guide.

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INDICATIONS

FDA

  • Prophylaxis of invasive aspergillus and disseminated candidiasis in severely immunocompromised hosts, such as hemapoietic stem cell transplant recipients with graft vs. host (GVH) disease or those with hematologic malignancies with prolonged neutropenia from chemotherapy [IV & PO].
  • Treatment of oropharyngeal candidiasis, including itraconazole and/or fluconazole refractory cases [PO only].

NON-FDA APPROVED USES

  • Caution:
    • Initial therapy for invasive fungal infections using oral posaconazole formulations is generally not recommended unless the infection is of low enough intensity to allow for the prolonged time needed to achieve optimal drug exposure; 7-10 days for the oral solution and approximately 6 days for the delayed release tablets.
    • At this time treatment data for humans with the IV formulation is not available
    • Penetration of posaconazole into the CNS may be suboptimal for treatment of invasive fungal infections at those sites
  • Posaconazole may be useful as treatment of invasive fungal infections in patients who are intolerant to, or whose infections are refractory to standard therapy. Specific examples:
    • Aspergillosis
    • Histoplasmosis
    • Coccidioidomycosis
    • Candidiasis
    • Infections due to hyaline fungi (e.g. Fusarium spp., Scedosporium spp., Acremonium spp., Scopulariopsis spp., Purpureocillium spp.)
    • Chromoblastomycosis (a chronic subcutaneous infection caused by dematiaceous fungi
    • Maintenance therapy for zygomycosis in patients whose infection has been controlled with standard therapy (e.g. liposomal amphotericin B +/- surgery)
  • Posaconazole may be effective in combination with surgery for eumycotic mycetoma (localized fungal infections that may involve cutaneous and subcutaneous tissue, fascia and bone)
  • Based on in-vitro data and limited clinical experience, posaconazole may be effective for infections due to certain dematiaceous fungi (Alternaria spp., Acrophialophora spp., Bipolaris spp., Chaetomium spp., Cladophialophora spp., Exophiala spp., Exserohilum spp., Fonsecaea spp., Hortaea werneckii, Neoscytalidium dimidiatum, Ochroconis gallopava, Phaeoacremonium spp., Rhinocladiella mackenziei, Veronaea botryosa)

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INDICATIONS

FDA

  • Prophylaxis of invasive aspergillus and disseminated candidiasis in severely immunocompromised hosts, such as hemapoietic stem cell transplant recipients with graft vs. host (GVH) disease or those with hematologic malignancies with prolonged neutropenia from chemotherapy [IV & PO].
  • Treatment of oropharyngeal candidiasis, including itraconazole and/or fluconazole refractory cases [PO only].

NON-FDA APPROVED USES

  • Caution:
    • Initial therapy for invasive fungal infections using oral posaconazole formulations is generally not recommended unless the infection is of low enough intensity to allow for the prolonged time needed to achieve optimal drug exposure; 7-10 days for the oral solution and approximately 6 days for the delayed release tablets.
    • At this time treatment data for humans with the IV formulation is not available
    • Penetration of posaconazole into the CNS may be suboptimal for treatment of invasive fungal infections at those sites
  • Posaconazole may be useful as treatment of invasive fungal infections in patients who are intolerant to, or whose infections are refractory to standard therapy. Specific examples:
    • Aspergillosis
    • Histoplasmosis
    • Coccidioidomycosis
    • Candidiasis
    • Infections due to hyaline fungi (e.g. Fusarium spp., Scedosporium spp., Acremonium spp., Scopulariopsis spp., Purpureocillium spp.)
    • Chromoblastomycosis (a chronic subcutaneous infection caused by dematiaceous fungi
    • Maintenance therapy for zygomycosis in patients whose infection has been controlled with standard therapy (e.g. liposomal amphotericin B +/- surgery)
  • Posaconazole may be effective in combination with surgery for eumycotic mycetoma (localized fungal infections that may involve cutaneous and subcutaneous tissue, fascia and bone)
  • Based on in-vitro data and limited clinical experience, posaconazole may be effective for infections due to certain dematiaceous fungi (Alternaria spp., Acrophialophora spp., Bipolaris spp., Chaetomium spp., Cladophialophora spp., Exophiala spp., Exserohilum spp., Fonsecaea spp., Hortaea werneckii, Neoscytalidium dimidiatum, Ochroconis gallopava, Phaeoacremonium spp., Rhinocladiella mackenziei, Veronaea botryosa)

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Last updated: September 24, 2014