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
Hypoxic Respiratory Failure (HRF) continues to be a concern in term and near-term infants.
HRF affects approximately 23,400 term and near-term
infants annually1,2
- HRF may have a negative impact on neonatal development3,4
- HRF morbidities include neurodevelopmental abnormalities, cognitive delays, and a high rate of chronic childhood diseases and learning disabilities3,4
HRF in neonates has several etiologies5-7
- Meconium aspiration syndrome (MAS)
- Persistent Pulmonary Hypertension of the Newborn (PPHN)
- Respiratory Distress Syndrome (RDS)
- Pneumonia
Nitric Oxide is an endogenous signaling molecule. INOMAX is the first and only exogenous inhaled drug approved for use in humans for the treatment of hypoxic respiratory failure in term and near-term infants.8
