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NeoProfen

Generic Name: ibuprofen lysine
Dosage Form: injection

Indications and Usage for NeoProfen

NeoProfen 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.

NeoProfen Dosage and Administration

Dosage Forms and Strengths

10 mg/mL as a clear sterile preservative-free solution of the L-lysine salt of ibuprofen in a 2 mL single-use vial.

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Contraindications

NeoProfen is contraindicated in:

  • Preterm infants with proven or suspected infection that is untreated;
  • Preterm infants with congenital heart disease in whom patency of the PDA is necessary for satisfactory pulmonary or systemic blood flow (e.g., pulmonary atresia, severe tetralogy of Fallot, severe coarctation of the aorta);
  • Preterm infants who are bleeding, especially those with active intracranial hemorrhage or gastrointestinal bleeding;
  • Preterm infants with thrombocytopenia;
  • Preterm infants with coagulation defects;
  • Preterm infants with or who are suspected of having necrotizing enterocolitis;
  • Preterm infants with significant impairment of renal function.

Warnings and Precautions

Adverse Reactions

Drug Interactions

Drug interactions of NeoProfen in neonates have not been assessed.

Overdosage

The following signs and symptoms have occurred in individuals (not necessarily in premature infants) following an overdose of oral ibuprofen: breathing difficulties, coma, drowsiness, irregular heartbeat, kidney failure, low blood pressure, seizures, and vomiting. There are no specific measures to treat acute overdosage with NeoProfen. The patient should be followed for several days because gastrointestinal ulceration and hemorrhage may occur.

NeoProfen Description

NeoProfen ® is a clear sterile preservative-free solution of the L-lysine salt of (±)-ibuprofen which is the active ingredient. (±)-Ibuprofen is a nonsteroidal anti-inflammatory agent (NSAID). L-lysine is used to create a water-soluble drug product salt suitable for intravenous administration. Each mL of NeoProfen contains 17.1 mg of ibuprofen lysine (equivalent to 10 mg of (±)-ibuprofen) in Water for Injection, USP. The pH is adjusted to 7.0 with sodium hydroxide or hydrochloric acid.

The structural formula is:

NeoProfen is designated chemically as α-methyl-4-(2-methyl propyl) benzeneacetic acid lysine salt. Its molecular weight is 352.48. Its empirical formula is C 19H 32N 2O 4. It occurs as a white crystalline solid which is soluble in water and slightly soluble in ethanol.

NeoProfen - Clinical Pharmacology

Clinical Studies

In a double-blind, multicenter clinical study premature infants of birth weight between 500 and 1000 g, less than 30 weeks post-conceptional age, and with echocardiographic evidence of a PDA were randomized to placebo or NeoProfen. These infants were asymptomatic from their PDA at the time of enrollment. The primary efficacy parameter was the need for rescue therapy (indomethacin, open-label ibuprofen, or surgery) to treat a hemodynamically significant PDA by study day 14. An infant was rescued if there was clinical evidence of a hemodynamically significant PDA that was echocardiographically confirmed. A hemodynamically significant PDA was defined by three of the following five criteria ― bounding pulse, hyperdynamic precordium, pulmonary edema, increased cardiac silhouette, or systolic murmur ― or hemodynamically significant ductus as determined by a neonatologist.

One hundred and thirty-six premature infants received either placebo or NeoProfen (10 mg/kg on the first dose and 5 mg/kg at 24 and 48 hours). Mean birth age was 1.5 days (range: 4.6 – 73.0 hours), mean gestational age was 26 weeks (range: 23 – 30 weeks), and mean weight was 798 g (range: 530 – 1015 g). All infants had a documented PDA with evidence of ductal shunting. As shown in Table 2, 25% of infants on NeoProfen required rescue therapy versus 48% of infants on placebo (p=0.003 from logistic regression controlling for site).

Table 2. Summary of Efficacy Results, n (%)
NeoProfen

N=68
Placebo

N=68
Required rescue through study day 14
Total 17 (25) 33 (48)
By age at treatment
    Birth to < 24 hours 3/14 (21) 8/16 (50)
    24-48 hours 9/32 (28) 16/37 (43)
    > 48 hours 5/22 (23) 9/15 (60)
 
Echocardiographically proven PDA prior to rescue 17 (100) 32 (97)
Reasons for Rescue
Hemodynamically significant PDA per neonatologist 14 (82) 25 (76)
Bounding pulse 6 (35) 12 (36)
Systolic murmur 6 (35) 15 (45)
Pulmonary Edema 3 (18) 5 (15)
Hyperdynamic precordium 2 (12) 3 (9)
Increased cardiac silhouette 1 (6) 5 (15)

Of the infants requiring rescue within the first 14 days after the first dose of study drug, no statistically significant difference was observed between the NeoProfen and placebo groups for mean age at start of first rescue treatment (8.7 days, range 4-15 days, for the NeoProfen group and 6.9 days, range 2-15 days, for the placebo group).

The groups were similar in the number of deaths by day 14, the number of patients on a ventilator or requiring oxygenation at day 1, 4 and 14, the number of patients requiring surgical ligation of their PDA (12%), the number of cases of Pulmonary Hemorrhage and Pulmonary Hypertension by day 14, and Bronchopulmonary Dysplasia at day 28. In addition, no significant differences were noted in the incidences of Stage 2 and 3 Necrotizing Enterocolitis, Grades 3 and 4 Intraventricular Hemorrhage, Periventricular Leukomalacia and Retinopathy of Prematurity between groups as determined at 36±1 weeks adjusted gestational age.

Two supportive studies also determined that ibuprofen, either prophylactically (n=433, weight range: 400 – 2165 g) or as treatment (n=210, weight range: 400 – 2370 g), was superior to placebo (or no treatment) in preventing the need for rescue therapy for a symptomatic PDA.

How Supplied/Storage and Handling

How Supplied

NeoProfen (ibuprofen lysine) Injection is dispensed in clear glass single-use vials, each containing 2 mL of sterile solution (NDC 55292-122- 52). The solution is not buffered and contains no preservatives. Each milliliter contains 17.1 mg/mL (±)-ibuprofen L-lysine [equivalent to 10 mg/mL (±)-ibuprofen] dissolved in Water for Injection, USP. NeoProfen is supplied in a carton containing 3 single-use vials.

Storage and Handling

Store at 20 – 25°C (68 – 77°F); excursions permitted 15 – 30°C (59 – 86°F) [see USP Controlled Room Temperature]. Protect from light. Store vials in carton until contents have been used.

Patient Counseling Information

PRINCIPAL DISPLAY PANEL


NDC
55292-122-52

3 x 2 mL Single Use Vials

NeoProfen ®
(ibuprofen lysine) injection

10 mg/mL

Sterile Solution for IV Use Only

RECORDATI RARE DISEASES GROUP

Rx only

Each mL contains:
Ibuprofen 10 mg (as ibuprofen lysine) in Water for Injection, USP.

Dilute to an appropriate volume with dextrose or saline. Please refer to the Package Insert for full prescribing information.

Store at 20-25ºC (68-77ºF); excursions permitted 15-30ºC (59-86ºF). Store vials in carton until use.

Manufactured by: AAIPharma Services
Charleston, SC 29405, U.S.A.

For: Recordati Rare Diseases Inc.
Lebanon, NJ 08833, U.S.A.

® Trademark of Recordati Rare Diseases Inc.
PC-4478B

Lot:

Exp.:

 

NeoProfen 
ibuprofen lysine solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:55292-122
Route of Administration INTRAVENOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IBUPROFEN LYSINE (IBUPROFEN) IBUPROFEN 10 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER  
Packaging
# Item Code Package Description
1 NDC:55292-122-52 3 VIAL in 1 CARTON
1 2 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021903 04/13/2006
Labeler - RECORDATI RARE DISEASES, INC. (181699406)
Establishment
Name Address ID/FEI Operations
AAIPharma Services Corp. 832394733 manufacture(55292-122)
Revised: 01/2016
 
RECORDATI RARE DISEASES, INC.
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