Products Affected - Description

Ibuprofen lysine injection

Reason for the Shortage

Lundbeck had Neoprofen injection on nationwide shortage due to manufacturing issues.¹

Available Products

NeoProfen injection, Lundbeck Inc.
10 mg/mL ibuprofen equivalent, 2 mL vial (NDC 67386-0122-52)

Estimated Resupply Dates

Implications for Patient Care

• Neoprofen is labeled for closing hemodynamically significant patent ductus arteriosus (PDA) in premature infants who weigh between 500-1500 g and are no more than 32 weeks gestational age, when medical management is ineffective.²
• Unlike indomethacin injection, ibuprofen lysine injection has no effect on the incidence of intraventricular hemorrhage when given as prophylaxis in very low birth weight neonates.^3.4

Safety

There are different formulations of intravenous ibuprofen. Ibuprofen lysine (Neoprofen) is the only product labeled for use in premature infants. Use caution when selecting an intravenous ibuprofen product.

Alternative Agents & Management

• Ibuprofen lysine injection and indomethacin injection are both labeled for use in treatment of clinically significant PDA.^2,5
• Indomethacin for injection is labeled for closing hemodynamically significant PDA in premature infants who weigh between 500-1750 g, when medical management is ineffective after 48 hours and there is clinical evidence of respiratory distress, continuous heart murmur, hyperactive precordium, cardiomegaly, or pulmonary plethora (by chest radiography).⁵ Although not labeled uses, indomethacin for injection has also been used prophylactically to reduce the occurrence of intraventricular hemorrhage in very low birth weight neonates.^3.4

1. Lundbeck Inc (formerly Ovation Pharmaceuticals) (personal communications). July 30, August 31 and November 19, 2010; January 26, February 16, March 8 and 22, April 19, May 13, June 16, July 27, September 2, and October 18, 2011; February 7, March 12, May 24, August 16, October 10 and 30, and November 20, 2012.
2. Neoprofen (ibuprofen lysine injection) product information. Deerfield, IL: Lundbeck Inc; 2010.
3. Sekar, KC and Corff, KE. Treatment of patent ductus arteriosus: indomethacin or ibuprofen? J Perinatol 2008;28:S60-s62.
4. McCrea HJ, Ment RM. The diagnosis, management, and postnatal prevention of intraventricular hemorrhage in the preterm neonate. Clin Perinatol. 2008 Dec;35(4):777-92.
5. Indocin I.V. [product information]. Deerfield, IL: Lundbeck Inc.; 2010.
6. Bedford Laboratories (personal communications). July 28, 2010.

Updated

Updated November 20, 2012 by Leslie Jensen, Pharm.D., Drug Information Specialist. Created November 24, 2009 by Jane Chandramouli, Pharm.D. Drug Information Specialist. Copyright 2012, Drug Information Service, University of Utah, Salt Lake City, UT.