Term and near-term neonates with hypoxic respiratory failure

The recommended dose of INOmax is 20 ppm. Maintain treatment up to 14 days or until the underlying oxygen desaturation has resolved and the neonate is ready to be weaned from INOmax therapy.

Doses greater than 20 ppm are not recommended [see Warnings and Precautions (5.2)].

Nitric Oxide Delivery Systems

INOmax must be administered using a calibrated, FDA-cleared Nitric Oxide Delivery System (NODS). There are various FDA-cleared NODS; refer to the NODS labeling to determine which NODS to use with this drug product and for needed information on training and technical support for users of this drug product with the NODS.

When utilizing a nitric oxide delivery system specifically cleared for use in the MRI suite (e.g., the INOmax DSIR® Plus MRI) only use INOmax MR conditional cylinders at 100 gauss or less [see How Supplied/Storage and Handling (16)].

Keep available a backup battery power supply and an independent reserve nitric oxide delivery system to address power and system failures.

Monitoring

Measure methemoglobin within 4-8 hours after initiation of treatment with INOmax and periodically throughout treatment [see Warnings and Precautions (5.2)].

Monitor for PaO2 and inspired NO2 during INOmax administration [see Warnings and Precautions (5.3)].

Weaning and Discontinuation

Avoid abrupt discontinuation of INOmax [see Warnings and Precautions (5.1)]. To wean INOmax, downtitrate in several steps, pausing several hours at each step to monitor for hypoxemia.