Improve Oxygenation Earlier

Efficacy

Rapid and Sustained Oxygenation

Adding INOMAX significantly improves PaO₂ in as little as 30 minutes, proven in trial after trial⁹

Please see detailed study descriptions.

Effective Across Disease Severity

Adding INOMAX improves oxygenation, independent of baseline OI⁹

Please see detailed study descriptions.

INOMAX should be administered with monitoring of PaO₂, methemoglobin, and NO₂.

Decrease the Probability of Developing Severe HRF

Fewer infants progressed to an OI>40 with INOMAX¹³

Blood levels of methemoglobin or NO₂ in the ventilatory circuit were not elevated in patients treated with INOMAX. The incidence of other neonatal complications such as bleeding and/or coagulation disorders, hypotension, or infections was not different between groups.¹³

Improve OI Over Time

In patients with moderate HRF (10<30), adding INOMAX significantly improved OI over 48 hours¹³

"Early use of iNO in newborns with moderate respiratory failure improves oxygenation and decreases the probability of developing severe hypoxemic respiratory failure."¹³

Less Median Time on Ventilation

Adding INOMAX shortens time on mechanical ventilation⁹

Please see detailed study descriptions.

• The median time on mechanical ventilation was 11 days in the ventilation + INOMAX group vs 14 days in the ventilation alone group⁹

The safety and effectiveness of INOMAX have been established in a patient population receiving other therapies for hypoxic respiratory failure, including vasodilators, intravenous fluids, bicarbonate therapy, and mechanical ventilation. 

Less Median Time on Oxygen

Adding INOMAX shortens time on oxygen therapy¹⁰

Please see detailed study descriptions.

• In a retrospective analysis from the CINRGI phase III study, the median time on oxygen therapy was 17 days in the ventilation + INOMAX group vs 34 days in the ventilation alone group*¹⁰

• In a separate randomized, controlled, open-label study of early vs late INOMAX treatment in 56 term and near-term infants with moderate HRF, the median time on oxygen therapy in the early INOMAX group was 11.5 days vs 18 days in the control group (P<0.03)^†13

*Time on oxygen therapy shown in a Kaplan-Meier analysis of retrospective data from the CINRGI phase III study. Median oxygen time is defined as the day at which 50% of patients went off oxygen therapy. Patients who died or received extracorporeal membrane oxygenation are censored. Total length of hospital stay was not different between study groups. CINRGI was not sufficiently powered to show significance in this endpoint.

^†Results from an independent, prospective, randomized, controlled, open-label trial of early vs late INOMAX treatment in 56 term and near-term infants with moderate HRF (10<30) in two centers in Santiago, Chile. Unlike in the United States, extracorporeal membrane oxygenation was not available in Chile during the study period. Therefore, the results of this study should be interpreted with caution.

Please see Full Prescribing Information.

References

9. Golombek SG, Young JN. Efficacy of inhaled nitric oxide for hypoxic respiratory failure in term and late preterm infants by baseline severity of illness: a pooled analysis of three clinical trials. Clin Ther. 2010;32(5):939-948.

13. González A, Fabres J, D’Apremont l, et al. Randomized controlled trial of early compared with delayed use of inhaled nitric oxide in newborns with a moderate respiratory failure and pulmonary hypertension. J Perinatol. 2010;30(6):420-424.

10. Data on file. Hampton, NJ: Ikaria^®; 2010.