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 profile.7
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.
- INOMAX safety was demonstrated in the CINRGI study and consistently replicated in other trials and post marketing surveillance
- 6-month follow-up data of patients in controlled studies who received INOMAX (n=278) or placebo (n=212) showed no evidence of an adverse event from treatment or the need for rehospitalization, special medical services, pulmonary disease, or neurologic sequelae7
- More than 294,000 patients treated with INOMAX since its approval in 1999*9
*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.
Please see Full Prescribing Information.
Read Full ISI.
References
7. INOMAX® [package insert]. Clinton, NJ: Ikaria Holdings; 2009.
9. Data on file. Clinton, NJ: Ikaria®; 2009.