[12 October 2012]
Products Affected - Description
Definity (perflutren lipid microsphere), Lantheus
Reason for the Shortage
- Lantheus states the shortage was due to manufacturing delays. Definity is manufactured for Lantheus by Ben Venue Laboratories.1
- Perflutren protein-type A microsphere is not affected by the shortage.2
- Ben Venue voluntarily suspended all manufacturing and distributing in mid-November, 2011 on a temporary basis. Product will become available in stages as production resumes.
Definity (perflutren lipid microsphere), Lantheus Medical Imaging1
2 mL vial (NDC 11994-0011-04)
Optison (perflutren protein-type A microsphere), GE Healthcare2
3 mL vial, package of 5 (NDC 00407-2707-03)
Estimated Resupply Dates
Lantheus has Definity 2 mL preservative-free vials available.1
Implications for Patient Care
- Perflutren lipid microsphere (Definity) is labeled for use in adult patients with suboptimal echocardiograms to opacify the left ventricle and improve delineation of the left ventricular endocardial borders.3
- Perflutren protein-type A microsphere (Optison) is another marketed ultrasound contrast agent with an identical labeled use.4
- Dosing recommendations vary for available perflutren products.3,4
Refer to specific product labeling prior to use.
- Perflutren protein-type A microsphere (Optison) contains human albumin.4 Products containing human albumin increase the risk for transmission of viral diseases and are contraindicated in patients with a hypersensitivity to blood products or albumin.
Alternative Agents & Management
- Lantheus is the sole manufacturer of perflutren lipid microsphere.
- Perflutren protein-type A microsphere (Optison) is an alternative ultrasound contrast agent for use in echocardiography.4 It differs slightly from perflutren lipid microsphere in specific labeling and some pharmaceutical properties.4
- The Table includes a comparison of the available perflutren products.
- Consult cardiology and radiology for specific recommendations about product interchangeability.
- Lantheus Medical Imaging (personal communications). April 19, June 27, July 6, August 22 and 29, September 26, and October 12, 2012.
- GE Healthcare (personal communications). April 25, 2012.
- Lantheus Medical Imaging. Definity (perflutren lipid microspheres) injectable suspension [product information]. North Billerica, MA: Lantheus Medical Imaging; October 2011.
- GE Healthcare. Optison (perflutren protein-type A microspheres injectable suspension , USP) [product information]. Princeton, NJ: GE Healthcare; May 2008.
- Center for Drug Evaluation and Research. Drugs@FDA. Food and Drug Administration, Department of Health and Human Services. Updated daily. Accessed February 21, 2012.
- Washburn DS, Hibberd M. Dear healthcare provider letter: Changes to Definity label. Lantheus Medical Imaging. Updated October 2011. Accessed February 21, 2012.
- Medical Information. Latex Content of Definity [written communication, February 22]. North Billerica, MA: Lantheus Medical Imaging; 2012.
- Medical Information. Availability and Latex Content of Optison [written communication, September 2]. Princeton, NJ: GE Healthcare; 2011.
- GE Healthcare. Optison: Instructions for use. Accessed February 22, 2012.
Updated October 12, 2012 by Leslie Jensen, Pharm.D., Drug Information Specialist. Created April 25, 2012, by M. Christina Beckwith, Pharm.D., Drug Information Specialist and Megan Dryer, Pharm.D., Drug Information Specialist. Copyright 2012, Drug Information Service, University of Utah, Salt Lake City, UT.
This information is provided through the support of Novation to ASHP solely as a service to its members, which shall not use this information for their further commercial use. The content was prepared by the Drug Information Center of University of Utah. Novation, ASHP, and the University of Utah make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, which respect to such information, and specifically disclaim all such warranties. Users of this information are advised that decisions regarding the use of drugs and drug therapies are complex medical decisions and that in using this information, each user must exercise his or her own independent professional judgment. Neither Novation, ASHP nor the University of Utah assumes any liability for persons administering or receiving drugs or other medical care in reliance upon this information, or otherwise in connection with this bulletin. Neither Novation, ASHP nor University of Utah endorses or recommends the use of any drug.
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