NeoProfen®
(ibuprofen lysine)

• NeoProfen is a non-steroidal anti-inflammatory therapy available in clear glass single-use vials, each containing 10 mg/mL.

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Indication
NeoProfen® (ibuprofen lysine) Injection (10mg/mL) is indicated to close a clinically significant patent ductus arteriosus (PDA) in premature infants weighing between 500 and 1500 g, who are no more than 32 weeks gestational age when usual medical management (e.g., fluid restriction, diuretics, respiratory support, etc.) is ineffective. The clinical trial was conducted among infants with an asymptomatic PDA. However, the consequences beyond 8 weeks after treatment have not been evaluated; therefore, treatment should be reserved for infants with clear evidence of a clinically significant PDA.

Important Safety Information
NeoProfen has been shown to prolong bleeding time, to decrease urinary output, to alter usual signs of infection, and to cause adverse events classified as renal insufficiency.  NeoProfen should not be used in preterm infants with untreated infection, thrombocytopenia, coagulation defects, necrotizing colitis, renal insufficiency, who have congenital heart disease but require PDA patency, and who are bleeding.  There are no long-term evaluations of ibuprofen’s effects on neurodevelopmental outcome, growth and disease processes associated with prematurity.  The most frequent side effects associated with NeoProfen in the primary clinical trial supporting NDA approval include sepsis, anemia, total bleeding, intraventricular hemorrhage, apnea and non-necrotizing enterocolitis. 

For more information, please see Full Prescribing Information.

® Trademark of Lundbeck Inc., Deerfield, IL 60015, U.S.A.