Inomax (Ino Therapeutics, 800 Ppm, 4880 Ppm): Uses, Side Effects and Dosage

What INOmax is used for:

INOmax is used to treat newborns (born at 34 weeks of gestation or later) with hypoxic respiratory failure. This is a serious condition where the lungs can’t get enough oxygen into the blood. It can be caused by other medical conditions such as high blood pressure in the lungs, when fecal material blocks the lungs, and infection. INOmax is used in combination with artificial ventilation and other therapies to:

• help improve blood oxygen levels; and
• reduce the need for extracorporeal membrane oxygenation (ECMO; a technique to oxygenate the blood outside the body using a device similar to a heart-lung machine).

How INOmax works:

INOmax can improve the flow of blood through the lungs by relaxing the cells into the blood vessels and allowing the blood vessels to widen. This may help to increase the amount of oxygen that reaches your newborn’s blood.

The ingredients in INOmax are:

Medicinal ingredient: nitric oxide.

Non-medicinal ingredient: nitrogen.

INOmax comes in the following dosage form:

Gas for inhalation: 800 parts per million (ppm) and 4880 ppm of nitric oxide per cylinder.

Your newborn must not take INOmax if they:

• have a rare heart defect or condition that causes deoxygenated blood to bypass the lungs and directly mix with oxygenated blood.

To help avoid side effects and ensure proper use, talk to your newborn’s healthcare professional before your newborn takes INOmax. Talk about any health conditions or problems they may have, including if they:

• have a congenital diaphragmatic hernia (a serious birth defect where the diaphragm muscle doesn’t fully form). This defect creates a hole that lets organs, such as the stomach, intestines and liver, move into the chest. This crowds the lungs and heart, and can cause underdeveloped lungs, and breathing or heart problems after birth.
• have heart problems that cause an abnormal pattern of blood flow or poor blood circulation.
• have pulmonary veno-occlusive disease (a rare and serious type of high blood pressure in the lungs). This condition is caused by a buildup of abnormal fibrous tissue in the small blood vessels of the lungs.

Other warnings you should know about:

Testing and monitoring: Before your newborn’s healthcare professional gives INOmax, other types of therapy may be given to try to improve your newborn’s condition. If these other therapies do not improve their condition, INOmax may be given. Before they do so, they may:

• insert a long, thin tube (catheter) through the large vein of your newborn that supplies blood to the lungs; or
• perform an echocardiogram (an ultrasound test).

These measures will help to monitor your newborn’s heart function, structure and blood flow.

INOmax will be administered by a trained healthcare professional. During treatment with INOmax, your newborn’s healthcare professional will examine them for any side effects. This includes if your newborn has:

• a decrease in their blood’s ability to carry oxygen.
• an increase in the amount of inhaled nitrogen dioxide as it may cause airway inflammation or damage.

Given your newborn’s condition and the unknown long-term effects of INOmax, the healthcare professional caring for your newborn will also monitor their health after treatment. They will monitor for:

• a worsened condition if treatment with INOmax is stopped too quickly. High blood pressure in the lungs and low blood oxygen levels have been known to occur if treatment with INOmax is stopped too quickly.
• normal signs of development as your newborn grows such as growth, hearing, and physical, lung and learning development.

Tell your newborn’s healthcare professional about all the medicines they take, including any drugs, vitamins, minerals, natural supplements, or alternative medicines.

The following may interact with INOmax:

• Medicines that are nitric oxide donors (e.g., nitroprusside, nitroglycerin, prilocaine)
• Medicines that can affect the blood’s ability to carry oxygen

How to take INOmax:

INOmax is a medical gas that is inhaled directly into the lungs. It will be given:

• by a trained healthcare professional;
• through a system designed for delivering nitric oxide. This system delivers the correct amount of INOmax to your newborn’s lungs by diluting INOmax with an oxygen/air mixture immediately before delivery. This system is also fitted with devices that will constantly monitor the amount of nitric oxide and nitrogen dioxide being delivered to your newborn’s lungs;
• at the lowest effective dose possible. This is to decrease the risk of side effects.
• in a place with the proper equipment available to your newborn for intensive care.

INOmax may be given in combination with other therapies such as a breathing machine (ventilator).

INOmax should not be stopped too quickly as it may worsen your newborn’s condition. Your newborn’s healthcare professional should gradually lower the dose to avoid side effects.

Usual dose:

Your newborn’s healthcare professional will decide on the dose and for how long INOmax will be given. Usually, the treatment lasts for 4 days or less.

Overdose:

Signs of an overdose with INOmax may include:

• bluish skin
• shortness of breath
• lack of energy
• headache

Possible side effects from using INOmax:

These are not all the possible side effects your newborn may have when taking INOmax. Your newborn’s healthcare professional will examine your newborn closely for all side effects, including the side effects below:

• When nitric oxide is inhaled it may cause the red blood cells to have less capacity to carry oxygen. It can also be harmful to your baby’s lungs (i.e., cause airway inflammation or damage).
• In some babies with heart failure, inhaled nitric oxide may cause a worsening of the blood circulation in the heart and lungs.
• If treatment with nitric oxide gas is stopped too quickly, it may cause a worsened condition (i.e., high blood pressure in the lungs and low blood oxygen levels).
• Other side effects of inhaled nitric oxide may include low blood pressure, blood in urine, high blood sugar, blood poisoning, infection, and skin infection.
• Nitric oxide gas may, in some cases, cause blood not to clot as well and cause bleeding in the brain or lungs.

If your newborn has a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with their daily activities (even after your newborn leaves the hospital), tell their healthcare professional.

Reporting side effects

Storage:

INOmax will be stored at 25°C by hospital staff, with excursions permitted between 15°C - 30°C.

If you want more information about INOmax:

• Talk to your newborn’s healthcare professional.
• Find the full product monograph that is prepared for healthcare professionals and includes the Patient Medication Information by visiting the Health Canada Drug Product Database website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the website http://www.mallinckrodt.ca/our-products/ino-max; or by calling 1-877-KNOW-INO (1-877-566-9466).

Date of Authorization: 2026-10-15

Mallinckrodt the “M” brand mark, the Mallinckrodt Pharmaceutical logo and other brands are trademarks of a Keenova Therapeutics plc company. ©2026 Keenova.