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FDA Approves Antifungal Agent Noxafil (Posaconazole) for IV Use

New formulation expected to be available in mid-April

The FDA has approved Noxafil (posaconazole, Merck) injection (18 mg/mL), a new formulation of Noxafil for intravenous (IV) use. The antifungal agent is also marketed as delayed-release tablets (100 mg) and as an oral suspension (40 mg/mL).

The injection, delayed-release tablets, and oral suspension are indicated for prophylaxis of invasive Aspergillus and Candida infections in patients who are at high risk of developing these infections because of 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 from chemotherapy.

Noxafil injection is indicated in patients 18 years of age and older, whereas the delayed-release tablets and oral suspension are approved for patients 13 years of age and older.

Noxafil (posaconazole) should not be administered to persons allergic to posaconazole or other azole antifungal medications. 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, require dosage adjustments and frequent monitoring of their blood levels 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 the drug has been shown to prolong the QT interval. In addition, cases of potentially fatal irregular heart rhythm (torsades de pointes) have been reported in patients taking Noxafil.

Noxafil injection is administered with a loading dose of 300 mg (one 300-mg vial) twice a day on the first day of treatment, followed by 300 mg (one 300-mg vial) once a day thereafter. Once combined with a mixture of intravenous solution (150 mL of 5% dextrose in water or sodium chloride 0.9%), Noxafil injection should be immediately administered through an in-line filter. Clinicians should administer Noxafil through a central venous line by slow IV infusion over approximately 90 minutes. If not used immediately, the solution can be stored for up to 24 hours, refrigerated at 2 to 8 degrees C (36 to 46 degrees F).

Co-administration of drugs that can decrease the plasma concentration of posaconazole should generally be avoided unless the benefit outweighs the risk. If such drugs are necessary, patients should be monitored closely for breakthrough fungal infections.

In clinical trials, the adverse reactions reported for Noxafil IV injection were generally similar in type to those reported in trials of Noxafil oral suspension. The most frequently reported adverse reactions with an onset during the posaconazole IV phase of dosing 300 mg once-daily therapy were diarrhea (32%), hypokalemia (22%), fever (21%), and nausea (19%).

Noxafil (posaconazole) injection is expected to be available at wholesalers in mid-April.

Source: Merck; March 16, 2014.

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