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INOMAX® (nitric oxide) for inhalation

A therapy of great possibilities

From the moment it was discovered, nitric oxide has inspired countless researchers and clinicians to realize the benefits of this vasodilator. At Ikaria, we too are inspired by this Nobel Prize-winning discovery and are dedicated to realizing its full potential. When administered as an inhaled drug, nitric oxide is the only drug that selectively dilates the pulmonary vasculature.1

 

A therapy of great value

As the first and only endogenous signalling molecule in gas form approved for use in humans, INOMAX is used to treat newborns suffering from hypoxic respiratory failure (HRF), and is making a major impact on the critical care environment.2 In HRF, blood vessels in the lungs constrict, making it difficult to oxygenate blood. INOMAX relaxes pulmonary blood vessels, improves oxygenation, and treats HRF in this delicate newborn population.

 

A therapy of great breadth

The value of INOMAX goes beyond its science to include a comprehensive suite of service and technologies that stand behind it—INOtherapy®.

 

Delivery systems

Delivering the full benefit of INOtherapy requires state-of-the-art medication management technology. When INOMAX is on board at your institution, you can rest assured that all drug-delivery technology, equipment, and disposables are included. Accurate dosing, patient monitoring, and individualized record keeping are all part of the INOtherapy experience. And, because we know critical care, you’ll also find that INOvent®, INOmax DS, and INOmax DSIR™ technologies are compatible with many ventilation methods and respiratory strategies.

 

INOMAX delivery systems are compatible with more than 50 models of3-6:

 

Additionally, the technology:

 

INOtherapy is a comprehensive offering
INOtherapy includes the drug, delivery system, distribution, emergency supply, technical assistance, clinical assistance, and quality maintenance.

 

People

Behind INOMAX is an extensive interdisciplinary team of clinical and logistical professionals who are on-call 24/7/365.

 

Our goal is to ensure that INOMAX is on hand when a patient is in need, that caregivers are knowledgeable about administering and optimizing therapy, and that there is someone to talk to if reimbursement questions arise.

 

Whether we’re scheduling an emergency delivery of medication, flying in equipment from one of our seven regional centers, or providing middle-of-the-night technical assistance, we do what it takes to ensure that clinicians and their patients are able to benefit from this vital therapy.

 

For customer support, and contact information, please click here.

 

For more information on INOMAX and its delivery systems, please visit www.INOMAX.com.

Important Safety Information

 

INOMAX is a vasodilator, which, in conjunction with ventilatory support and other appropriate agents, is indicated for the treatment of term and near-term (>34 weeks gestation) 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 inhaled nitric oxide have been established in a 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) rapidly forms 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
  • In patients with pre-existing left ventricular dysfunction, inhaled nitric oxide may increase pulmonary capillary wedge pressure leading to pulmonary edema

 

Please see full Prescribing Information.

 

Warning

 

The INOvent, INOmax DS, and INOmax DSIR Delivery Systems must only be used in accordance with the indications, usage, contraindications, warnings, and precautions described in the nitric oxide drug package inserts and labeling.

 

References

  1. INOMAX [package insert]. Clinton, NJ: INO Therapeutics LLC; 2011.
  2. Bryan NS, Bian K, Murad F. Discovery of the nitric oxide signaling pathway and targets for drug development. Front Biosci. 2009;14:1-18.
  3. Data on file. Clinton, NJ: Ikaria, Inc; 2009.
  4. Datex-Ohmeda, Inc. INOvent Delivery System Operational and Maintenance Manual.  Madison, WI: Datex-Ohmeda, Inc; 2000. Publication 1605-0014-000. 
  5. INO Therapeutics.  INOmax DS Operation Manual. Clinton, NJ: INO Therapeutics LLC; 2002. Part No. 20003 Rev-02. 
  6. INO Therapeutics. INOblender Operation and Maintenance Manual. Clinton, NJ: INO Therapeutics LLC; 2001. Part No. 20004 Rev-01. 

 

INOblender, INOMAX, INOtherapy, and INOvent are registered trademarks of INO Therapeutics LLC.

DSIR is a trademark of Ikaria, Inc.


Important Safety Information

INOMAX is a vasodilator, which, in conjunction with ventilatory support and other appropriate agents, is indicated for the treatment of term and near-term (>34 weeks gestation) 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 inhaled nitric oxide have been established in a population receiving other therapies for hypoxic respiratory failure, including vasodilators, intravenous fluids, bicarbonate therapy, and mechanical ventilation.