INOMAX Important Safety Information

INOMAX^® is a vasodilator, which, in conjunction with ventilatory support and other appropriate agents, is indicated for the treatment of term and near-term (>34 weeks) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension, where it improves oxygenation and reduces the need for extracorporeal membrane oxygenation.

Utilize additional therapies to maximize oxygen delivery with validated ventilation systems.

• INOMAX is contraindicated in the treatment of neonates known to be dependent on right-to-left shunting of blood.
• Abrupt discontinuation of INOMAX may lead to increasing pulmonary artery pressure and worsening oxygenation even in neonates with no apparent response to nitric oxide for inhalation.
• Methemoglobinemia and NO₂ levels are dose dependent. Nitric oxide donor compounds may have an additive effect with INOMAX on the risk of developing methemoglobinemia. Nitrogen dioxide may cause airway inflammation and damage to lung tissues.
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• In patients with pre-existing left ventricular dysfunction, INOMAX may increase pulmonary capillary wedge pressure leading to pulmonary edema.
• Monitor for PaO₂, methemoglobin, and inspired NO₂ during INOMAX administration.
• Use only with an INOmax DS_IR^®, INOmax^® DS, or INOvent^® operated by trained personnel.
• Please see Full Prescribing Information.