INOMAX has a well-established safety profile
INOMAX has been used for over 14 years on over 600,000 patients worldwide*8
INOMAX Important Safety Information
INOMAX is indicated to improve oxygenation and reduce the need for extracorporeal membrane oxygenation in term and near-term (>34 weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension in conjunction with ventilatory support and other appropriate agents.
- INOMAX is contraindicated in the treatment of neonates dependent on right-to-left shunting of blood.
- Abrupt discontinuation of INOMAX may lead to increasing pulmonary artery pressure and worsening oxygenation.
- Methemoglobinemia and NO2 levels are dose dependent. Nitric oxide donor compounds may have an additive effect with INOMAX on the risk of developing methemoglobinemia. Nitrogen dioxide may cause airway inflammation and damage to lung tissues.
- In patients with pre-existing left ventricular dysfunction, INOMAX may increase pulmonary capillary wedge pressure leading to pulmonary edema.
- Monitor for PaO2, inspired NO2, and methemoglobin during INOMAX administration.
- INOMAX must be administered using a calibrated INOmax DSIR® Nitric Oxide Delivery System operated by trained personnel. Only validated ventilator systems should be used in conjunction with INOMAX.
Additional safety profile data
In the NINOS study, treatment groups were similar with respect to the incidence and severity of intracranial hemorrhage, grade IV hemorrhage, periventricular leukomalacia, cerebral infarction, seizures requiring anticonvulsant therapy, pulmonary hemorrhage, or gastrointestinal hemorrhage.4
From all controlled studies, at least 6 months of follow-up is available for 278 patients who received INOMAX and 212 patients who received placebo. Among these patients, there was no evidence of an adverse effect of treatment or the need for rehospitalization, special medical services, pulmonary disease, or neurological sequelae.4
In CINRGI, the only adverse reaction (>2% higher incidence on INOMAX than on placebo) was hypotension (14% vs. 11%).
Based upon post-marketing experience, accidental exposure to nitric oxide for inhalation in hospital staff has been associated with chest discomfort, dizziness, dry throat, dyspnea, and headache.
Please see Full Prescribing Information.
*Data reflect the cumulative number of exposed patients across periodically updated safety reports and do not include patients in blinded clinical trials.