Noxivent 102
Noxivent 102 Prescribing Information
Noxivent™ is indicated to improve oxygenation and reduce the need for extracorporeal membrane oxygenation in term and near-term (>34 weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension in conjunction with ventilatory support and other appropriate agents.
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.
Measure methemoglobin within 4-8 hours after initiation of treatment with Noxivent™ and periodically throughout treatment [see
Nitric oxide combines with hemoglobin to form methemoglobin, which does not transport oxygen. Methemoglobin levels increase with the dose of Noxivent™; it can take 8 hours or more before steady-state methemoglobin levels are attained. Monitor methemoglobin and adjust the dose of Noxivent™ to optimize oxygenation.
If methemoglobin levels do not resolve with decrease in dose or discontinuation of Noxivent™, additional therapy may be warranted to treat methemoglobinemia [see Overdosage (10)].
Monitor for PaO2 and inspired NO2 during Noxivent™ administration [see
Nitrogen dioxide (NO2) forms in gas mixtures containing NO and O2. Nitrogen dioxide may cause airway inflammation and damage to lung tissues.
If there is an unexpected change in NO2concentration, or if the NO2concentration reaches 3 ppm when measured in the breathing circuit, then the delivery system should be assessed in accordance with the Nitric Oxide Delivery System O&M Manual troubleshooting section, and the NO2analyzer should be recalibrated. The dose of Noxivent™ and/or FiO2should be adjusted as appropriate.
Avoid abrupt discontinuation of Noxivent™ [see
Wean from Noxivent™ [see Dosage and Administration (2.2)]. Abrupt discontinuation of Noxivent™ may lead to worsening oxygenation and increasing pulmonary artery pressure, i.e., Rebound Pulmonary Hypertension Syndrome. Signs and symptoms of Rebound Pulmonary Hypertension Syndrome include hypoxemia, systemic hypotension, bradycardia, and decreased cardiac output. If Rebound Pulmonary Hypertension occurs, reinstate Noxivent™ therapy immediately.
Noxivent™ (nitric oxide) gas is available in 100 ppm and 800 ppm concentrations.
Nitric oxide is not indicated for use in the adult population.
Noxivent™ is contraindicated in neonates dependent on right-to-left shunting of blood.
Patients with left ventricular dysfunction treated with Noxivent™ may experience pulmonary edema, increased pulmonary capillary wedge pressure, worsening of left ventricular dysfunction, systemic hypotension, bradycardia and cardiac arrest. Discontinue Noxivent™ while providing symptomatic care.