INOMAX Is Proven Safe and Effective in the Treatment of Term and Near-Term Infants With Hypoxic Respiratory Failure2-4 |
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 must not be used in the treatment of neonates known to be dependent on right-to-left shunting of blood
Clinical Profile
Clinical trials have proven that INOMAX is both effective and well tolerated.3
INOMAX safety was demonstrated in the CINRGI study and consistently replicated in other trials and postmarketing surveillance.
Over 450,000 patients treated with INOMAX since its approval in 1999.*2
*Data reflect the cumulative number of exposed patients across periodically updated safety reports, and do not include patients in blinded clinical trials.
References
2. Data on file. Hampton, NJ: Ikaria®; 2012.
3. INOMAX® [package insert]. Hampton, NJ: Ikaria, Inc.; 2011.
4. 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(3 pt 1):325-334.
3. INOMAX® [package insert]. Hampton, NJ: Ikaria, Inc.; 2011.
2. Data on file. Hampton, NJ: Ikaria®; 2012.