Posaconazole (Noxafil)
The Pharmacy and Therapeutics Committee voted to add posaconazole to the inpatient formulary with Antimicrobial Restrictions, effective April 27, 2007. In order to make this medication available as a formulary agent for the general medical staff and to ensure appropriate usage, the Pharmacy and Therapeutics Committee has approved the following requirements for posaconazole use:
- Any use will require review and approval by the Infectious Disease (ID) Service or the Hematology/Oncology Service. The ordering physician is responsible for contacting the ID or Hem/Onc service. The drug will be started with a 24-hour stop date unless approval for continued use is obtained; therefore, the approval must be received within 24 hours of the original order.
- If use is approved, the ID or Hem/Onc service will relay this information to the ordering physician as well as to the pharmacy for continued administration of posaconazole. If posaconazole is thought to be inappropriate, the ID or Hem/Onc service will provide alternative recommendations and communicate these recommendations to the physician originating the posaconazole order.
New Formulations of Posaconazole
Until recently, posaconazole was only available as an oral suspension with poor absorption that hindered its use.1 Recently, two new formulations of posaconazole have been approved by the FDA. Delayed release tablets became available in late 2013 and an intravenous injection form became available in early 2014. The tablets offer a significant advantage in oral bioavailability over the oral solution and the IV formulation provides a treatment option in those unable to take oral agents. All formulations of posaconazole are currently on formulary and are restricted to use by hematology/oncology and infectious disease services.
The different formulations of posaconazole have been reviewed and a guideline for their role in therapy is below:
Poscaonazole delayed release tablets
- Option for first line prophylaxis therapy in AML patients refractory to chemotherapy treatment
- Second line therapy in patients intolerant of voriconazole requiring anti-mold prophylaxis (e.g., AML, myelodysplastic syndrome, GVHD and on steroids)
- Treatment of mucormycosis and other susceptible infections where voriconazole is ineffective or not tolerated
Posaconazole injection
- Option for above indications when oral route of administration is not possible or ineffective (i.e. severe gastrointestinal GVHD, short gut, etc.)
Table 1: Comparison of posaconazole formulations2
| Posaconazole Suspension | Posaconazole Tablets | Posaconazole Injection | |
|---|---|---|---|
| Labeled Indications | -Prophylaxis of Aspergillus and Candida infections -Treatment of oropharyngeal candidiasis (=13 years old) |
-Prophylaxis of invasive Aspergillus and Candida infections (=13 years old) | -Prophylaxis of invasive Aspergillus and Candida infections and Candida infections (=18 years old) |
| Dose (prophylaxis) | 200 mg three times daily | 300 mg BID x 1 day then 300 mg daily |
300 mg BID x 1 day then 300 mg daily |
| Administration | Administer before meal or with carbonated beverage | Administer with food | Infuse over 90 minutes via central venous line (peripheral line may lead to infusion site reaction) |
- Krishna G, Ma L, Martinho M, O'Mara E. Single-dose phase I study to evaluate the pharmacokinetics of posaconazole in new tablet and capsule formulations relative to oral suspension. Antimicrob Agents Chemother. 2012 Aug;56(8):4196-201.
- Noxafil (posaconazole) [package insert]. Whitehouse Station, NJ: Merck & CO., INC.; 2014