The INOmax® (nitric oxide) gas, for inhalation,
cylinder benefits

100% tested and inspected 100% tested and inspected

Be confident in our drug purity*

  • INOmax drug is produced in our FDA-regulated Port Allen, Louisiana, pharmaceutical manufacturing facility1
  • 100% of INOmax cylinders are tested and inspected to ensure quality and purity meet specifications2
  • Testing, verification, and distribution specifications ensure you are delivering INOmax through your INOmax device2
*Purity requirement is ±5% of INOmax cylinder concentration.2

Innovative cylinder-delivery technology

Our next-generation INOmax EVOLVE™ DS delivery system uses 0.4-L INOmax mini-cylinders that weigh 1.43 lb.3

Ergonomic mini-cylinders5,6 Ergonomic mini-cylinders5,6

Used INOmax cylinders are returned to Mallinckrodt, where they are reprocessed and refilled5

greater than three-hundred thousand

cylinders produced in the last 3 years,*
with a maximum of >121,000 cylinders produced in 2021.6

*Data from 2020 to 2022.

The long-standing legacy
of INOmax

  • In 1992, nitric oxide was named Molecule of the Year11
  • In 1998, 3 scientists won the Nobel Prize in Physiology and Medicine for their discoveries concerning the role of nitric oxide as a signaling molecule12
  • Inhaled nitric oxide (iNO) was the first selective pulmonary vasodilator and was FDA-approved as INOmax in 199910,13
  • INOmax continues to be the market leader* of iNO delivery for HRF over 20 years later14
*Based on December 2022 market share data.

See how INOmax works

Watch this video to see INOmax’s mechanism of action

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Learn about the safety and efficacy of INOmax

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Learn about dosing, administration, and weaning required for INOmax

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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.

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. INOmax. Label. INO Therapeutics LLC. DailyMed; 2023. Updated April 12, 2023. Accessed May 11, 2023. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=762b51be-1893-4cd1-9511-e645fc420d3a 2. Data on File – Ref-06554. Mallinckrodt Pharmaceuticals. 3. INOmax EVOLVE™ DS Operation Manual. Hazelwood, MO: Mallinckrodt Pharmaceuticals; 2023. 4. Manual Handling in Occupational Tasks. Kodak’s Ergonomic Design for People at Work. 2003;(9780471418634):511-563. 5. Data on File – Ref-05971. Mallinckrodt Pharmaceuticals. 6. Data on File – Ref-06556. Mallinckrodt Pharmaceuticals. 7. Williams LJ, Shaffer TH, Greenspan JS. Inhaled nitric oxide therapy in the near-term or term neonate with hypoxic respiratory failure. Neonatal Netw. 2004;23(1):5-13. doi:10.1891/0730-0832.23.1.5 8. Lakshminrusimha S, Saugstad OD. The fetal circulation, pathophysiology of hypoxemic respiratory failure and pulmonary hypertension in neonates, and the role of oxygen therapy. J Perinatol. 2016;36(suppl 2):S3-S11. doi:10.1038/jp.2016.43 9. Lakshminrusimha S. The pulmonary circulation in neonatal respiratory failure. Clin Perinatol. 2012;39(3):655-683. doi:10.1016/j.clp.2012.06.006 10. INOmax. Package insert. Mallinckrodt Pharmaceuticals. 11. Koshland DE Jr. The molecule of the year. Science. 1992;258(5090):1861. doi:10.1126/science.1470903 12. SoRelle R. Nobel prize awarded to scientists for nitric oxide discoveries. Circulation. 1998;98(22):2365-2366. doi:10.1161/01.cir.98.22.2365 13. 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 14. Data on File – Ref-06557. 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.