What is INOmax?
INOmax is an inhalation gas containing the active principle nitrogen oxide diluted in nitrogen gas at a concentration of 400 parts per million (ppm).
What is INOmax used for?
INOmax is indicated to treat newborns suffering from hypoxic respiratory failure associated with evidence of pulmonary hypertension (pulmonary insufficiency accompanied by high blood pressure in the lungs). It is used together with artificial ventilation and other drugs in newborns of 34 weeks of gestation or more. INOmax is used to improve oxygenation and reduce the need for an extracorporeal membrane oxygenator (ECMO), a system used to oxygenate the blood outside the body by relying on a device similar to a heart-lung machine.
The medicine can only be obtained with a prescription.
How is INOmax used?
Treatment with INOmax must be supervised by a physician experienced in neonatal intensive care. The INOmax prescription should only be limited to neonatal units that have received adequate training in the use of nitric oxide delivery systems. INOmax must be dispensed according to the prescription of a neonatologist.
INOmax is used in artificially ventilated newborns for which the need for support for more than 24 hours is expected. INOmax should only be used after optimizing the respiratory support. INOmax is administered after being diluted with a mixture of oxygen / air delivered to the newborn via the ventilator. The maximum recommended concentration of INOmax is 20 ppm. Within 4 to 24 hours of starting therapy, the dose should be reduced to 5 ppm, as long as there is adequate arterial oxygenation. You can continue the treatment by maintaining this dose until you reach an improvement in oxygen levels, for a maximum of 96 hours. Therapy should not be stopped abruptly, but gradually. For more information, see the package leaflet.
How does INOmax work?
The active ingredient in INOmax, nitric oxide, is a chemical naturally occurring in the body, responsible for the relaxation of muscles in endothelial cells of blood vessels. If administered by inhalation, it allows the vessels in the lungs to dilate, reducing pulmonary hypertension and allowing the blood to reach the tissues more easily, thus improving oxygenation and elimination of waste carbon dioxide. It also favors the flow of blood into the areas of the lungs that contain most of the oxygen and helps to reduce lung inflammation.
What studies have been carried out on INOmax?
Given that nitric oxide is a well-known chemical, the manufacturing company used data from the published literature to support the use of INOmax.
INOmax has also been examined in two important studies conducted on 421 newborns of 34 weeks or more of gestation suffering from pulmonary hypertension. In the first study, 235 infants with respiratory failure received INOmax or placebo (a dummy treatment). The main measure of effectiveness was the percentage of newborns who died or had to be treated with ECMO during the first 120 days of hospitalization. In the second study, 186 newborns with respiratory failure were treated with INOmax or placebo. The main measure of effectiveness was the number of newborns requiring recourse to ECMO.
What benefit has INOmax shown during the studies?
INOmax was more effective than placebo: in the first study, 52 newborns (46%) out of 114 treated with INOmax died or needed ECMO compared to 77 infants (64%) out of 121 who were given placebo. This result is due not so much to a reduction in the mortality rate, when rather to the decrease in the use of ECMO. In the second study, 30 newborns (31%) of the group who were administered INOmax were treated with ECMO compared to 51 infants (57%) out of 89 who were given placebo.
What is the risk associated with INOmax?
The most common side effect with INOmax (seen in more than 1 patient in 10) is thrombocytopenia (decreased blood platelet levels). For the full list of all side effects reported with INOmax, see the Package Leaflet.
INOmax must not be used in babies who may be hypersensitive (allergic) to nitric oxide or any of the other ingredients (nitrogen). Furthermore, it must not be used in newborns who depend on the right to left blood shunt or significant left to right shunt (abnormal circulation of blood in the heart).
Why has INOmax been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that INOmax's benefits are greater than its risks for the treatment of 34-week-old newborns or those with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension. The Committee therefore recommended that the product be granted marketing authorization.
Other information on INOmax:
On 1 August 2001 the European Commission granted INO Therapeutics AB a marketing authorization valid for INOmax, valid throughout the European Union. The marketing authorization was renewed on 1 August 2006.
The full EPAR for INOmax can be found here.
Last update of this summary: 10-2007.
