Propofol Importation Statement
As part of its efforts to resolve a critical shortage of propofol 1% injection products, FDA has authorized the importation of Fresenius Propoven 1% injection from the European Union, until such time that sources within the United States are capable of meeting local demand. Fresenius Propoven 1% (propofol 1%) contains the active ingredient propofol, in the same concentration (propofol 1%) as the propofol 1% injection products that are currently in short supply. Fresenius Propoven 1% is manufactured by Fresenius Kabi AG, the parent company of APP Pharmaceuticals in FDA-inspected facilities that are in compliance with FDA manufacturing standards. Beginning November 16, 2009, Fresenius Propoven 1% will be distributed in the US by APP Pharmaceuticals through an allocation process that will help manage imbalances in supply and alleviate the critical shortage of propofol products.
While Fresenius Propoven 1% is a clinically acceptable substitute to currently marketed US propofol 1% products, there are some key differences in the formulation and labeling between the two products as follows:
- Fresenius Propoven 1% contains medium and long-chain triglycerides as opposed to only the long-chain triglycerides found in the US propofol products. As with all propofol products, special care should be taken in patients with disorders of fat metabolism, patients receiving Total Parenteral Nutrition (TPN) and in patients with other conditions where lipid emulsions must be used with caution.
- As opposed to US propofol 1% products that contain a preservative, Fresenius Propoven 1% does not contain an anti-microbial retardant. Strict aseptic technique must always be maintained during handling. Each vial of Fresenius Propoven 1% is intended for single administration for an individual patient. Vials are not intended for multi-dose use. After being drawn up into a syringe, the syringe should be discarded after 6 hours. The unused portion of a vial should be discarded immediately following vial penetration. When used for intravenous infusion, all propofol product and infusion therapy systems should be discarded after 12 hours.
- Although the Fresenius Propoven 1% label indicates that it may be used for general anesthesia in pediatric patients down to one month of age, it is recommended that, in keeping with the US propofol labels, Fresenius Propoven 1% be used for maintenance of anesthesia in patients above the age of two months. Fresenius Propoven 1% may be used for induction of anesthesia in patients above the age of 3 years.
- Fresenius Propoven 1% should not be used for sedation in patients less than 16 years of age.
- Fresenius Propoven 1% is contraindicated in patients who are allergic to soy or peanut.
- The 36-month expiration date on the Fresenius Propoven 1% product as opposed to the 24-month expiration date on the US propofol products should have no impact on safety or effectiveness.
- The barcode used on the Fresenius Propoven 1% product is an international pharmaceutical manufacturing code that may not be appropriately registered by scanning systems in the US. Alternative methods of confirming appropriate drug administration to individual patients should be utilized.
- The Patient Information Leaflet contained in the Fresenius Propoven product contains patient contact information that may not apply to patients in the US. Inquiries regarding Fresenius Propoven product in the US should be directed to APP Medical Information at 1-800-551-7171 between the hours of 8 a.m. and 5 p.m. (CST), or by e mail at appmedicalinfo@APPpharma.com.
A Dear Healthcare Provider letter is being distributed with the product and will be posted on the FDA website; a copy of the letter is attached. Health care professionals should continue to report all adverse events seen to occur with the Fresenius Propoven 1% product to the FDA MedWatch system. FDA will monitor the propofol shortage and importation situation and will send out appropriate announcements regarding progress of the situation.
Updated information can be obtained at the following FDA website: http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm050792.htm