Information about using INOmax® (nitric oxide) gas, for inhalation

Recommended dosing, administration, and weaning instructions

Dosing1

  • For term and near-term neonates with hypoxic respiratory failure, the recommended dosing is 20 ppm
  • Doses greater than 20 ppm are not recommended
  • Maintain treatment for up to 14 days or until underlying oxygen desaturation has resolved and the neonate is ready to be weaned from INOmax therapy

Administration1

  • INOmax 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
  • When using the INOmax DSIR® Plus MRI (specifically cleared for use in the MRI suite), only use INOmax MR Conditional cylinders at 100 gauss or less
  • Keep available a backup battery power supply and an independent reserve nitric oxide delivery system
  • Measure methemoglobin within 4 to 8 hours after initiation of treatment with INOmax and periodically throughout treatment. Monitor for PaO2 and inspired NO2 during INOmax administration

Weaning1

  • 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
    • To wean INOmax, down titrate in several steps, pausing several hours at each step to monitor for hypoxemia
    • If desaturation occurs, reinstate INOmax immediately

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Device profile

INDICATION

INOmax 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.

IMPORTANT SAFETY INFORMATION

  • INOmax® (nitric oxide) gas, for inhalation, is contraindicated in the treatment of neonates dependent on right-to-left shunting of blood.
  • Abrupt discontinuation of INOmax may lead to increasing pulmonary artery pressure and worsening oxygenation.
  • 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.
  • In patients with pre-existing left ventricular dysfunction, INOmax may increase pulmonary capillary wedge pressure leading to pulmonary edema.
  • Monitor for PaO2, inspired NO2, and methemoglobin during INOmax administration.
  • INOmax must be administered using a calibrated FDA-cleared Nitric Oxide Delivery System.

Please see Full Prescribing Information.

Reference: 1. INOmax. Package insert. Mallinckrodt Pharmaceuticals.

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© 2023 Mallinckrodt. All rights reserved. US-2201223 11/23

© 2023 Mallinckrodt. All rights reserved. US-2300142 11/23

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INDICATION

INOmax 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.

INDICATION

INOmax 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.

IMPORTANT SAFETY INFORMATION

  • INOmax® (nitric oxide) gas, for inhalation, is contraindicated in the treatment of neonates dependent on right-to-left shunting of blood.
  • Abrupt discontinuation of INOmax may lead to increasing pulmonary artery pressure and worsening oxygenation.
  • 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.
  • In patients with pre-existing left ventricular dysfunction, INOmax may increase pulmonary capillary wedge pressure leading to pulmonary edema.
  • Monitor for PaO2, inspired NO2, and methemoglobin during INOmax administration.
  • INOmax must be administered using a calibrated FDA-cleared Nitric Oxide Delivery System.

Please see Full Prescribing Information.