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In term and near-term neonates with hypoxic respiratory failure (HRF) associated with pulmonary hypertension

Every Moment Counts

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INOmax reduces the need for ECMO

Extracorporeal membrane oxygenation (ECMO) is a rescue therapy for neonates with HRF.1-3 INOmax® (nitric oxide) gas, for inhalation, reduces the need for ECMO in term and near-term neonates with HRF.4

See the data

Possible complications of ECMO3,5-9

ECMO can result in serious short- and long-term complications, such as:

  • Mechanical complications
    • Thrombosis
    • Equipment failure
  • Patient complications
    • Neurologic
    • Hemorrhagic
    • Cardiopulmonary
    • Renal
    • Metabolic
    • Infection

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It only takes a moment for something to go wrong

Since inhaled nitric oxide (iNO) has a half-life of less than 6 seconds, an abrupt disruption of iNO treatment may lead to life-threatening rebound effects, such as rebound pulmonary hypertension. Signs and symptoms include4,10-12:

  • Hypoxemia
  • Systemic hypotension
  • Bradycardia
  • Decreased cardiac output

It is important to avoid abrupt discontinuation of iNO due to the possible rebound effects. To wean, down-titrate in several steps, pausing several hours at each step to monitor for hypoxemia.4

Our team is prepared for the unexpected

If you need product outside of a routinely scheduled order, we can arrange an emergency delivery.*

  • Regional Service Centers across the country facilitate an emergency equipment response

*Emergency deliveries are most often made within 4 to 6 hours, but may take up to 24 hours, depending on hospital location and/or circumstances.

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Your healthcare teams never rest, and neither does our support team

Emergencies can occur at any time, day or night. The INOmax Total Care team is committed to 24/7/365 US-based service, and our RT-based Product Support or Clinical Specialist Team is available to assist with your device-related questions or when a need arises.

“We are very satisfied with INOmax Total Care’s support team. They have always met our needs quickly, whether it has been the need for disposables, off-hours tech support, or additional tanks.”13

Watch this video to see how the INOmax Total Care offering supports critical care needs in the NICU

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The INOmax Total Care offering

The INOmax Total Care offering remains the market leader* for delivery systems, service, support, and INOmax® (nitric oxide) gas, for inhalation, for term and near-term neonates with hypoxic respiratory failure associated with pulmonary hypertension.4,14

*Based on December 2022 market share data.

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.

References: 1. Patel B, Chatterjee S, Davignon S, Herlihy JP. Extracorporeal membrane oxygenation as rescue therapy for severe hypoxemic respiratory failure. J Thorac Dis. 2019;11(suppl 14):S1688-S1697. doi:10.21037/jtd.2019.05.73 2. Conway RG, Tran D, Griffith BP, Wu ZJ. Extracorporeal membrane oxygenation (ECMO) for long-term support: recent advances. In: Firstenberg MS, ed. Advances in Extra-corporeal Perfusion Therapies. 2019:chap 14. Accessed November 10, 2022. https://www.intechopen.com/chapters/60888 3. Pandya S, Baser O, Wan GJ, et al. The burden of hypoxic respiratory failure in preterm and term/near-term infants in the United States 2011-2015. J Health Econ Outcomes Res. 2019;6(3):130-141. doi:10.36469/9682 4. INOmax. Package insert. Mallinckrodt Pharmaceuticals. 5. IJsselstijn H, Hunfeld M, Schiller RM, et al. Improving long-term outcomes after extracorporeal membrane oxygenation: from observational follow-up programs toward risk stratification. Front Pediatr. 2018;6:177. doi:10.3389/fped.2018.00177 6. Zwischenberger JB, Nguyen TT, Upp JR Jr, et al. Complications of neonatal extracorporeal membrane oxygenation. Collective experience from the Extracorporeal Life Support Organization. J Thorac Cardiovasc Surg. 1994;107(3):838-849. 7. Ramachandrappa A, Rosenberg ES, Wagoner S, Jain L. Morbidity and mortality in late preterm infants with severe hypoxic respiratory failure on extra-corporeal membrane oxygenation. J Pediatr. 2011;159(2):192-8.e3. doi:10.1016/j.jpeds.2011.02.015 8. Van Ommen CH, Neunert CE, Chitlur MB. Neonatal ECMO. Front Med (Lausanne). 2018;5:289. Published 2018 Oct 25. doi:10.3389/fmed.2018.00289 9. Mahmood B, Newton D, Pallotto EK. Current trends in neonatal ECMO. Semin Perinatol. 2018;42(2):80-88. 10. Liu X, Miller MJ, Joshi MS, Sadowska-Krowicka H, Clark DA, Lancaster JR Jr. Diffusion-limited reaction of free nitric oxide with erythrocytes. J Biol Chem. 1998;273(30):18709-18713. doi:10.1074/jbc.273.30.18709 11. Witek J, Lakhkar AD. Nitric oxide. In: StatPearls. StatPearls Publishing; 2022. https://www.ncbi.nlm.nih.gov/books/NBK554485/ 12. Cueto E, López-Herce J, Sánchez A, Carrillo A. Life-threatening effects of discontinuing inhaled nitric oxide in children. Acta Paediatr. 1997;86(12):1337-1339. doi:10.1111/j.1651-2227.1997.tb14909.x 13. Data on File – Ref-06559. Mallinckrodt Pharmaceuticals. 14. Data on File – Ref-06557. Mallinckrodt Pharmaceuticals. 15. INOmax DSIR® Plus Operation Manual. Hampton, NJ: INO Therapeutics LLC; 2014. 16. INOmax DSIR® Plus MRI Operation Manual. Hampton, NJ: INO Therapeutics LLC; 2015. 17. INOmax EVOLVE™ DS Operation Manual. Madison, WI: Mallinckrodt Pharmaceuticals; 2023. 18. Data on File – Ref-05507. Mallinckrodt Pharmaceuticals. 19. Ichinose F, Roberts JD Jr, Zapol WM. Inhaled nitric oxide: a selective pulmonary vasodilator: current uses and therapeutic potential. Circulation. 2004;109(25):3106-3111. doi:10.1161/01.CIR.0000134595.80170.62 20. Environmental assessment and/or FONSI: NDA 20845. Center for Drug Evaluation and Research. Published February 21, 1997.

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© 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.