INOmax - INOmax Prescribing and Safety Information

INOmax Prescribing and Safety Information | Safety and Efficacy | Key Trial Data | INO Mechanism of Action
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Click here to view the INOmax package insert.

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Indication
INOmax (nitric oxide) for inhalation, 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.

Important information about INOmax

•	INOmax should not be used in the treatment of neonates known to be dependent upon right-to-left shunting of blood.⁴
•	Methemoglobinemia is a dose-dependent side effect of inhaled nitric oxide therapy. Therefore, methemoglobin levels should be monitored during INOmax administration. Caution should be used when administering INOmax with other drugs that may cause methemoglobinemia regardless of their route of administration.⁴
•	Nitrogen dioxide (NO₂) forms rapidly in gas mixtures containing nitric oxide and oxygen. NO₂ formed in this way may cause airway inflammation and damage.⁴
•	INOmax must be administered through a system which does not cause excessive generation of NO₂ and that monitors for NO, NO₂, and FiO₂.⁴
•	Abrupt discontinuation of INOmax may lead to worsening of PaO₂ and increasing pulmonary artery pressure (PAP). Deterioration in oxygenation and elevation in PAP may also occur in patients with no apparent response to INOmax.⁴

Adverse events from the CINRGI study with an incidence of at least 5% in patients receiving INOmax, and that were more common in INOmax patients compared with placebo patients.⁴

•	6-month follow-up data of patients in controlled studies who received INOmax (n=278) or placebo (n=212) found no evidence of an adverse event of treatment on the need for rehospitalization, special medical services, pulmonary disease, or neurologic sequelae.⁴

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For complete INOmax prescribing information, CLICK HERE

Information intended for the United States. For information outside the US CLICK HERE