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Perflutren Lipid Microsphere

Last Updated: October 12, 2012
Status: Resolved

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.

Available Products

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

Safety

  • 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.

Related Shortages

References

  1. Lantheus Medical Imaging (personal communications). April 19, June 27, July 6, August 22 and 29, September 26, and October 12, 2012.
  2. GE Healthcare (personal communications). April 25, 2012.
  3. Lantheus Medical Imaging. Definity (perflutren lipid microspheres) injectable suspension [product information]. North Billerica, MA: Lantheus Medical Imaging; October 2011.
  4. GE Healthcare. Optison (perflutren protein-type A microspheres injectable suspension , USP) [product information]. Princeton, NJ: GE Healthcare; May 2008.
  5. Center for Drug Evaluation and Research. Drugs@FDA. Food and Drug Administration, Department of Health and Human Services. Updated daily. Accessed February 21, 2012.
  6. Washburn DS, Hibberd M. Dear healthcare provider letter: Changes to Definity label. Lantheus Medical Imaging. Updated October 2011. Accessed February 21, 2012.
  7. Medical Information. Latex Content of Definity [written communication, February 22]. North Billerica, MA: Lantheus Medical Imaging; 2012.
  8. Medical Information. Availability and Latex Content of Optison [written communication, September 2]. Princeton, NJ: GE Healthcare; 2011.
  9. GE Healthcare. Optison: Instructions for use. Accessed February 22, 2012.

Updated

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.

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