INDICATION & IMPORTANT SAFETY INFORMATION
GENOSYL® 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.
- GENOSYL is contraindicated in the treatment of neonates dependent on right-to-left shunting of blood.
- Abrupt discontinuation of GENOSYL (nitric oxide) gas, for inhalation may lead to worsening oxygenation and increasing pulmonary artery pressure.
- Methemoglobin, NO2, and PaO2 should be monitored during nitric oxide administration.
- In patients with pre-existing left ventricular dysfunction, GENOSYL may increase pulmonary capillary wedge pressure leading to pulmonary edema.
- The most common adverse reaction is hypotension.
- Nitric oxide donor compounds may have an additive effect with GENOSYL on the risk of developing methemoglobinemia.
- Only validated ventilator systems or nasal cannulas should be used in conjunction with GENOSYL.
- See package insert for additional Important Safety Information.