Actor Portrayal

The efficacy and safety of INOmax® (nitric oxide) gas, for inhalation,
have a robust, extensively studied clinical profile

Pivotal studies

Improved oxygenation reduced need for extracorporeal membrane oxygenation (ECMO)1-3

The Neonatal Inhaled Nitric Oxide Study (NINOS)

NINOS was a double-blind, randomized, placebo-controlled, multicenter trial in 235 term or near-term neonates with hypoxic respiratory failure (HRF) unresponsive to conventional therapy. The primary objective of the study was to determine whether INOmax would reduce mortality and/or the need for ECMO.1,2

  • The neonates received either 100% oxygen with or without 20 ppm of INOmax for up to 14 days1,2
  • Neonates with a less than full response were evaluated for a response to 80 ppm of INOmax* or control gas1,2
*As per INOmax PI, the recommended dose is 20 ppm; doses greater than 20 ppm are not recommended.1

Summary of clinical results from the NINOS study1,2

Placebo (n=121) INOmax (n=114) P value
ECMO or Deatha 77 (64%) 52 (46%) 0.006
ECMO 66 (55%) 44 (39%) 0.014
Death 20 (17%) 16 (14%) 0.60
aDeath or need for ECMO was the study’s primary endpoint.

The INOmax group also had significantly greater increases in PaO2 and greater decreases in the oxygenation index (OI) and the alveolar-arterial oxygen gradient than the control group (P<0.001 for all parameters).1,2

Clinical Inhaled Nitric Oxide Research Group Initiative (CINRGI)

CINRGI was a double-blind, randomized, placebo-controlled, multicenter trial of 186 term and near-term neonates with pulmonary hypertension and hypoxic respiratory failure. The primary objective of the study was to determine whether INOmax would reduce the receipt of ECMO in these patients.1,3

Neonates received either 20 ppm of INOmax or nitrogen gas; neonates who exhibited a PaO2>60 mm Hg and a pH <7.55 were weaned to 5 ppm INOmax or nitrogen gas.1,3

Summary of clinical results from the CINRGI study1

Placebo (n=89) INOmax (n=97) P value
ECMOa 51 (57%) 30 (31%) <0.001
Death 5 (6%) 3 (3%) 0.48
aECMO was the primary endpoint of this study.

The INOmax group had significantly improved oxygenation as measured by PaO2, OI, and alveolar-arterial gradient (P<0.001 for all parameters).1

INOmax adverse reactions

In the NINOS study

  • Treatment groups were similar with respect to the incidence and severity of intracranial hemorrhage, Grade IV hemorrhage, periventricular leukomalacia, cerebral infarction, seizures requiring anticonvulsant therapy, pulmonary hemorrhage, or gastrointestinal hemorrhage1,2
  • No infant had study drug discontinued for toxicity1,2

In the CINRGI study

  • The most common adverse reaction was hypotension (14% vs 11%; >2% higher incidence on INOmax than on placebo)1
  • 2/97 patients (2%) were withdrawn from study drug due to methemoglobin levels >4%1

Other adverse reactions of INOmax include hypoxemia due to methemoglobinemia and worsening of heart failure in patients with left ventricular dysfunction.1

Duration of hospitalization in the pivotal trials was similar in INOmax and placebo-treated groups.1

  • In patients with at least 6 months of follow-up, there was no evidence of an adverse effect of treatment on the need for rehospitalization, special medical services, pulmonary disease, or neurological sequelae1

To learn more about the clinical profile of INOmax and about studies that have assessed the effect of INOmax on HRF, please contact a representative.

Contact a representative

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. Package insert. Mallinckrodt Pharmaceuticals. 2. Neonatal Inhaled Nitric Oxide Study Group. Inhaled nitric oxide in full-term and nearly full-term infants with hypoxic respiratory failure. N Engl J Med. 1997;336(9):597-604. doi:10.1056/NEJM199702273360901 3. Clark RH, Kueser TJ, Walker MW, et al. Low-dose nitric oxide therapy for persistent pulmonary hypertension of the newborn. Clinical Inhaled Nitric Oxide Research Group. N Engl J Med. 2000;342(7):469-474. doi:10.1056/NEJM200002173420704

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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.