A Decade of Proven Safety |
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
Safety
INOMAX Has a Well-Established Safety Profile8
10
Reflects adverse events reported in the CINRGI study with an incidence of ≥5% in patients receiving INOMAX, and which were more common compared with placebo controls.
- 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 hemorrhage8
- 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 on the need for rehospitalization, special medical services, pulmonary disease, or neurological sequelae8
*Data reflect the cumulative number of exposed patients across periodically updated safety reports, and do not include patients in blinded clinical trials.
INOMAX IS SAFE AND WELL TOLERATED.
References
8. INOMAX® [package insert]. Hampton, NJ: Ikaria Holdings; 2010.
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.
10. Data on file. Hampton, NJ: Ikaria®; 2010.