Source: FDA, National Drug Code (US) Revision Year: 2020
Noxivent is a vasodilator 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.
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 [see Warnings and Precautions (5.2)].
The user of Noxivent and Nitric Oxide Delivery Systems must satisfactorily complete a comprehensive periodic training program for health care professionals provided by the delivery system and drug manufacturers. Health professional staff that administers nitric oxide therapy have access to supplier-provided 24 hour/365 days per year technical support on the delivery and administration of Noxivent at 1-833-669-8368.
Noxivent must be administered using a calibrated NOxBOXi. Only validated ventilator systems should be used in conjunction with Noxivent. Consult the Nitric Oxide Delivery System label or call 833-669-8368/visit praxair.com for a current list of validated systems. Keep available a backup battery power supply and an independent reserve nitric oxide delivery system to address power and system failures.
Measure methemoglobin within 4-8 hours after initiation of treatment with Noxivent and periodically throughout treatment [see Warnings and Precautions (5.2)].
Monitor for PaO2 and inspired NO2 during Noxivent administration [see Warnings and Precautions 5.3)].
Avoid abrupt discontinuation of Noxivent [see Warnings and Precautions (5.1)]. To wean Noxivent, downtitrate in several steps, pausing several hours at each step to monitor for hypoxemia.
Overdosage with Noxivent is manifest by elevations in methemoglobin and pulmonary toxicities associated with inspired NO2. Elevated NO2 may cause acute lung injury. Elevations in methemoglobin reduce the oxygen delivery capacity of the circulation. In clinical studies, NO2 levels >3 ppm or methemoglobin levels >7% were treated by reducing the dose of, or discontinuing, nitric oxide. Methemoglobinemia that does not resolve after reduction or discontinuation of therapy can be treated with intravenous vitamin C, intravenous methylene blue, or blood transfusion, based upon the clinical situation.
Store at 25°C (77°F) with excursions permitted between 15-30°C (59-86°F) [see USP Controlled Room Temperature].
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