Rapid and Sustained Oxygenation |
INOMAX® is a vasodilator, which, in conjunction with ventilatory support and other appropriate agents, is indicated for the treatment of term and near-term (>34 weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension, where it improves oxygenation and reduces the need for extracorporeal membrane oxygenation.
INOMAX Important Safety Information (ISI)
INOMAX should not be used in the treatment of neonates known to be dependent on right-to-left shunting of blood
Efficacy
Adding INOMAX significantly improves PaO2 in as little as 30 minutes, proven in trial after trial5,7-9
Please see detailed study descriptions.
INOMAX sustained higher PaO2 levels over the entire trial measurement, up to 24 hours9
Effective Across Disease Severity
Adding INOMAX improves oxygenation, independent of baseline OI9
Please see detailed study descriptions.
Treat HRF earlier, before it progresses to more severe stages
Less Time on Ventilation9
Adding INOMAX shortens time on ventilation9
Please see detailed study descriptions.
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.
Reduced Need for a More Invasive Procedure — ECMO
Please see detailed study descriptions.
Significantly fewer neonates treated with INOMAX received ECMO.
Please see Full Prescribing Information.
References
5. The Neonatal Inhaled Nitric Oxide Study Group. Inhaled nitric oxide in full-term and nearly full-term infants with hypoxic respiratory failure. N Engl J Med. 1997;336:597-604.
7. INOMAX® [package insert]. Clinton, NJ: Ikaria Holdings; 2009.
8. Davidson D, Barefield ES, Kattwinkel J, et al. Inhaled nitric oxide for the early treatment of persistent pulmonary hypertension of the term newborn: a randomized, double-masked, placebo-controlled, dose-response, multicenter study. Pediatrics. 1998;101:325-334.
9. Data on file. Clinton, NJ: Ikaria®; 2009.
9. Data on file. Clinton, NJ: Ikaria®; 2009.
