The Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to allow for the use of Propoven 2% (propofol 20mg/mL) Emulsion 100mL (Fresenius Kabi) to maintain sedation via continuous infusion in patients ≥16 years old who require mechanical ventilation in an intensive care unit (ICU) setting during the coronavirus disease 2019 (COVID-19) pandemic.
Propoven 2% Emulsion is an unapproved product that contains double the concentration of the FDA-approved product Diprivan® Injection Emulsion 10mg/mL and therefore carries a risk of unintentional overdose. Under the EUA, Propoven 2% Emulsion:
- Will be used only to maintain sedation via continuous infusion in patients greater than 16 years old who require mechanical ventilation.
- Will be administered only by a licensed healthcare provider in an ICU setting.
- Will NOT be administered to pregnant women, unless there are no FDA-approved products available to maintain sedation for these patients should they require mechanical ventilation in an ICU setting.
- Will be used only in accordance with the dosing regimens as detailed in the authorized Fact Sheets.
The FDA authorized the EUA for Propoven 2% Emulsion as a result of a continued shortage of propofol, a critical supportive medication needed for ventilating COVID-19 patients. The decision was based on the Agency’s assessment of available evidence that showed the drug is expected to be effective for this purpose.
In addition, Hikma Pharmaceuticals has announced the availability of Propofol Injectable Emulsion 20mL, 50mL, and 100mL vials in the US following approval of its supplemental Abbreviated New Drug Application. The Company is launching limited quantities of the product with plans to scale up manufacturing as quickly as possible.