Education for parents

Why is my baby having trouble breathing?

Sometimes babies can’t breathe on their own

After a baby is born, a condition called hypoxic respiratory failure (HRF) can occur in 2% of live births.1 This is a severe respiratory illness that can progress and require a more invasive intervention if there is a lack of response to treatment.1,2

HRF can occur in 2% of live births HRF can occur in 2% of live births
FDA approved in 1999 FDA approved in 1999

We know situations like these can be scary

  • INOmax® (nitric oxide) gas, for inhalation, is a prescription inhaled drug to treat HRF caused by increased blood pressure in the lungs. It helps to increase oxygen levels in the blood in newborns3
  • It was approved by the FDA in 19993

What are the possible side effects of INOmax? INOmax may cause the following serious side effects3:

  • Worsening oxygen levels in the blood if the medicine is suddenly stopped
  • Pulmonary edema (too much fluid in the lungs) in patients with existing heart failure
  • Reduced ability for blood to carry oxygen
  • Decrease in blood pressure
  • Injury to lungs

These are not all the possible side effects of INOmax. For more information on these and other side effects associated with INOmax, talk to your healthcare provider, visit our website at www.inomax.com, or call 877-566-9466.

Learn more about HRF and iNO treatment

If you have additional questions about INOmax or HRF, please ask your healthcare professional.

INDICATION

What is INOmax?
INOmax (also known as inhaled nitric oxide) is a prescription inhaled drug that is approved by the U.S. Food and Drug Administration (FDA) for treating Hypoxic Respiratory Failure (HRF) in newborns greater than 34 weeks gestational age (age measured from the beginning of the mother’s last menstrual period). HRF means that your newborn isn’t getting enough oxygen into his or her blood. Newborns with this form of breathing failure are unable to breathe on their own and have high pressure in the blood vessels of their lungs. High pressure in the blood vessels of the lungs is known as pulmonary hypertension.

Your baby should remain under the supervision of a healthcare provider during treatment with nitric oxide.

IMPORTANT SAFETY INFORMATION

Who should not use INOmax?
Normally blood will flow from the left side to right side of the heart. INOmax must not be used in newborns that solely depend on blood that flows from the right side to the left side of the heart. INOmax is not approved for use in adults.

What are the possible side effects of INOmax?
INOmax may cause the following serious side effects:

  • Worsening oxygen levels in the blood if the medicine is suddenly stopped
  • Reduced ability for blood to carry oxygen
  • Injury to lungs
  • Pulmonary edema (too much fluid in the lungs) in patients with existing heart failure
  • Decrease in blood pressure

These are not all the possible side effects of INOmax. For more information on these and other side effects associated with INOmax, talk to your healthcare provider, visit our website at www.inomax.com, or call 877-566-9466.

You may report negative side effects to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

This information does not take the place of talking with your doctor about your baby’s medical condition or treatment.

Please see package insert.

References: 1. 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 2. Mathew B, Lakshminrusimha S. Persistent pulmonary hypertension in the newborn. Children (Basel). 2017;4(8):63. doi:10.3390/children4080063 3. INOmax. Package insert. Mallinckrodt Pharmaceuticals.

Mallinckrodt, the “M” brand mark and the Mallinckrodt Pharmaceuticals logo are trademarks of a Mallinckrodt company. Other brands are trademarks of a Mallinckrodt company or their respective owners.

This website may identify third-party organizations and provide links to third-party websites or other third-party information (third-party content). The third-party content is meant for informational purposes only, is not endorsed by or under the control of Mallinckrodt, and is not meant to replace a physician’s medical advice. Mallinckrodt has no responsibility or liability for and makes no representations or warranties whatsoever about any third-party content. All trademarks, service marks, and logos appearing on this website are the property of their respective owners. Any rights not expressly granted herein are reserved.

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

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

By viewing this site you agree to our Terms of Use. The product information provided in this site is intended only for residents of the United States. The product discussed herein may have different product labeling in different countries.

INDICATION

What is INOmax?
INOmax (also known as inhaled nitric oxide) is a prescription inhaled drug that is approved by the U.S. Food and Drug Administration (FDA) for treating Hypoxic Respiratory Failure (HRF) in newborns greater than 34 weeks gestational age (age measured from the beginning of the mother’s last menstrual period). HRF means that your newborn isn’t getting enough oxygen into his or her blood. Newborns with this form of breathing failure are unable to breathe on their own and have high pressure in the blood vessels of their lungs. High pressure in the blood vessels of the lungs is known as pulmonary hypertension.

Your baby should remain under the supervision of a healthcare provider during treatment with nitric oxide.

INDICATION

What is INOmax?
INOmax (also known as inhaled nitric oxide) is a prescription inhaled drug that is approved by the U.S. Food and Drug Administration (FDA) for treating Hypoxic Respiratory Failure (HRF) in newborns greater than 34 weeks gestational age (age measured from the beginning of the mother’s last menstrual period). HRF means that your newborn isn’t getting enough oxygen into his or her blood. Newborns with this form of breathing failure are unable to breathe on their own and have high pressure in the blood vessels of their lungs. High pressure in the blood vessels of the lungs is known as pulmonary hypertension.

Your baby should remain under the supervision of a healthcare provider during treatment with nitric oxide.

IMPORTANT SAFETY INFORMATION

Who should not use INOmax?
Normally blood will flow from the left side to right side of the heart. INOmax must not be used in newborns that solely depend on blood that flows from the right side to the left side of the heart. INOmax is not approved for use in adults.

What are the possible side effects of INOmax?
INOmax may cause the following serious side effects:

  • Worsening oxygen levels in the blood if the medicine is suddenly stopped
  • Reduced ability for blood to carry oxygen
  • Injury to lungs
  • Pulmonary edema (too much fluid in the lungs) in patients with existing heart failure
  • Decrease in blood pressure

These are not all the possible side effects of INOmax. For more information on these and other side effects associated with INOmax, talk to your healthcare provider, visit our website at www.inomax.com, or call 877-566-9466.

You may report negative side effects to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

This information does not take the place of talking with your doctor about your baby’s medical condition or treatment.

Please see package insert.