Noxivent Dosage

The recommended dose is 20 ppm, maintained for up to 14 days or until the underlying oxygen desaturation has resolved (2.1).

Doses greater than 20 ppm are not recommended (2.1, 5.2)

Administration:

• Avoid abrupt discontinuation (2.2, 5.1).

Term and near-term neonates with hypoxic respiratory failure

The recommended dose of Noxivent™ 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 Noxivent™ therapy.

Doses greater than 20 ppm are not recommended.

Nitric Oxide Delivery Systems

Noxivent™ 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. Do not use Noxivent with Inomax DSIR Plus and DSIP MRI NODS.

Do not use Noxivent in the MPI suite.

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 Noxivent™ and periodically throughout treatment.

Monitor for PaO2 and inspired NO2 during Noxivent™ administration.

Weaning and Discontinuation

Avoid abrupt discontinuation of Noxivent™. To wean Noxivent™, downtitrate in several steps, pausing several hours at each step to monitor for hypoxemia.