Ulspira Dosage

2.1 Dosage

Term and near-term neonates with hypoxic respiratory failure

The recommended dose of ULSPIRA 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 ULSPIRA therapy.

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

2.2 Administration

Nitric Oxide Delivery Systems

ULSPIRA 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 ULSPIRA with Inomax DSIR Plus and DSIR Plus MRI NODS.

Do not use ULSPIRA in the MRI 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 ULSPIRA and periodically throughout treatment [see Warnings and Precautions (5.2)].

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

Weaning and Discontinuation

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