INOMAX®

INOMAX (nitric oxide) for inhalation

INOMAX is approved by the FDA to treat term and near-term (greater than 34 weeks) infants with HRF caused by pulmonary hypertension.1

 

INOMAX is an inhaled gas that helps to relax or open up the blood vessels of the lungs in newborns.  This, in turn, helps the infant’s heart and lungs process more oxygen and deliver more oxygenated blood to the rest of the body.2

 

Treatment with INOMAX reduces the need for extracorporeal membrane oxygenation (ECMO), a form of surgery that requires the use of a heart-lung machine.1 To learn more about what the March of Dimes has to say about treating HRF with INOMAX, and its ability to prevent the use of ECMO for newborn infants click here.

 

How INOMAX works

The active substance in INOMAX, nitric oxide (NO), is a compound that is naturally produced by many cells in the human body. NO is known as a “signalling molecule” because it is able to penetrate cell membranes to deliver a signal to nearby muscles to relax.3

 

As the muscles relax, blood flow increases, helping the heart and lungs to process more oxygen and deliver more oxygenated blood to a baby’s body. 

 

The researchers who discovered the role of NO in the human body earned the Nobel Prize for Physiology or Medicine.3,4

 

What to expect if your infant is treated with INOMAX

During treatment, your baby will receive a mixture of INOMAX and oxygen while connected to a ventilator. As your baby’s condition improves, he or she will slowly be weaned from ventilatory support and INOMAX over time.

If INOMAX does not work, other treatments, such as extracorporeal membrane oxygenation (ECMO), may be considered.

 

Questions

For more information about INOMAX, ask your healthcare professional or see full Prescribing Information.  Additionally, questions can be directed to our Customer Service Department by calling 1-877-KNOW-INO (1-877-566-9466).

Important Treatment Information

 

INOMAX, 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.

 

The safety and effectiveness of INOMAX have been established in a patient population receiving other therapies for hypoxic respiratory failure, including vasodilators, intravenous fluids, bicarbonate therapy, and mechanical ventilation.

  • INOMAX should not be used in the treatment of neonates known to be dependent on right-to-left shunting of blood
  • 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 can cause methemoglobinemia regardless of their route of administration
  • Nitrogen dioxide (NO2) forms rapidly in gas mixtures containing nitric oxide and oxygen. NO2 formed in this way can cause airway inflammation and damage
  • INOMAX must be administered through a system that does not cause excessive generation of NO2 and that monitors for NO, NO2, and FiO2
  • Abrupt discontinuation of INOMAX therapy can lead to worsening of PaO2 and increasing pulmonary artery pressure (PAP). Deterioration in oxygenation and elevation in PAP can also occur in children with no apparent response to INOMAX

 

Please see full Prescribing Information.



References

  1. INOMAX [package insert]. Clinton, NJ: INO Therapeutics LLC; 2007.

  2. The Neonatal Inhaled Nitric Oxide Study Group. Inhaled nitric oxide in full-term and nearly full-term infants with hypoxic respiratory failure. New Engl J Med. 1997:336:597-604.

  3. Bryan NS, Bian K, Murad F. Discovery of the nitric oxide signaling pathway and targets for drug development. Front Biosci. 2009;14:1-18.

  4. The Nobel Prize Web Site. The Nobel Prize in Physiology or Medicine 1998: the nitric oxide as a signalling molecule in the cardiovascular system. http://nobelprize.org/nobel_prizes/medicine/laureates/1998/illpres/. Accessed May 11, 2009.