Fresenius Kabi announced the availability of Propoven 2% (propofol 20mg/mL) Emulsion 100mL 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.
The Food and Drug Administration (FDA) recently issued an Emergency Use Authorization for the use of Propoven 2% Emulsion as a result of the continued shortage of propofol which is needed for ventilating COVID-19 patients. Propoven 2% Emulsion is an unapproved product that contains double the concentration of the FDA-approved Diprivan® Injectable Emulsion 10 mg/mL.
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.
Propoven 2% Emulsion will be distributed through direct shipments with additional product-related materials, including alert stickers on the vial, wall charts, and healthcare provider fact sheet and a patient and caregiver fact sheet.
“A higher concentration presentation of propofol could be helpful to providers managing COVID-19 patients who require mechanical ventilation,” said Seema Kumbhat, MD, senior vice president and regional medical director at Fresenius Kabi USA. “However, since US clinicians are not familiar with Fresenius Kabi Propoven 2%, we will be providing key information about the product’s differences from Diprivan 1% and making other product materials available to support the appropriate use of this product in the US.”
Medication errors, adverse events and quality issues with Propoven 2% Emulsion should be reported to FDA’s Medwatch and to the Company.
For more information visit fresenius-kabi.com.