INOmax Inhalational gas
INOmax Inhalational gas is a brand of medicine containing the active ingredient nitric oxide.
Find out more about active ingredients.
Consumer medicine information (CMI) leaflet
Developed by the pharmaceutical company responsible for this medicine in Australia, according to TGA regulations.
Nitric oxide gas for inhalation
Consumer Medicine Information
What is in this leaflet?
This leaflet answers some common questions about INOmax®. It does not contain all the available information. It does not take the place of talking to your specialist, doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed up the risks of using INOmax® against the benefits it is expected to have for your baby.
If you have any questions about using this medicine, ask your doctor or pharmacist.
Keep this leaflet. You may need to read it again.
What dosage form does INOmax® come in?
INOmax® is a medicinal product that is in the form of a gas and is packaged in gas cylinders in a concentration of 800 parts per million (ppm).
What does INOMAX® contain?
Medicinal ingredient is:
Non-medicinal ingredients are:
Nitrogen is the only inactive ingredient. Nitrogen is a major component of the air we breathe.
What is INOmax® used for?
Babies who have been born near or at term and who have been diagnosed with a condition called hypoxic respiratory failure may be given INOmax®.
A baby with hypoxic respiratory failure has less blood flow through the lungs, and low amounts of oxygen in the blood. Some medical conditions, such as pulmonary hypertension (high blood pressure in the lung), meconium aspiration (faecal material that blocks the lungs) and infection, may cause hypoxic respiratory failure.
Before your baby’s doctor prescribes INOmax®, other types of therapy may be given to try to improve your baby’s condition. If these other therapies do not improve your baby’s condition, INOmax® may be given.
INOmax® is a ‘PRESCRIPTION ONLY MEDICINE’. It is to be given only to the person for whom it has been prescribed.
How INOmax® works
INOmax® can improve the flow of blood through the lungs by relaxing the cells in the blood vessels and allowing the blood vessels to widen. This may help to increase the amount of oxygen that reaches your baby’s blood.
When INOmax® should not be used
INOmax® is not to be given to babies who have an abnormal circulation within the heart.
Some babies may have hypoxic respiratory failure, but may not be helped by INOmax®. If the hypoxic respiratory failure is caused by a condition known as congenital diaphragmatic hernia (when the bowel moves into the lung area), INOmax® has not been shown to be effective.
INOmax® should not be used in pre-mature babies born before 34 weeks from conception.
INOmax® is not indicated for use in the adult population. Passive exposure to INOmax® during pregnancy and breast-feeding should be avoided.
How to use INOmax®
Because side effects increase with higher doses of inhaled nitric oxide therapy, your baby will be given a low dose of INOmax®. Since INOmax® is a gas; the dose is measured in parts per million, or ppm. If for example the INOmax® dose is 20 ppm, there are 20 parts of nitric oxide in 1 million parts of the inhaled gas mixture.
Your baby’s doctor will decide the correct dose of INOmax® and will administer INOmax® to your baby’s lungs through a system designed for delivering nitric oxide. This system delivers the correct amount of INOmax® to your baby’s lungs by diluting INOmax® with an oxygen/air mixture immediately before delivery.
For your baby’s safety, the delivery systems intended for administration of INOmax® are fitted with devices that constantly measure the amount of nitric oxide, nitrogen dioxide, and oxygen being delivered to your baby’s lungs. In addition, your baby’s blood will be tested throughout the treatment period to make sure there is no interference with the ability of the blood to carry oxygen.
Your baby’s doctor will decide how long your baby should be treated with INOmax®. Usually a baby is on INOmax® therapy for 4 days or less.
INOmax® treatment should be stopped gradually, so that the circulation in your baby’s lungs is able to adjust to oxygen/air without INOmax®. So when your baby’s treatment with INOmax® is almost finished, a gradual reduction in the amount of INOmax® being administered to your baby will be supervised by your baby’s doctor.
Abnormally low amounts of oxygen in the blood and slow heart beat; low blood pressure and reduced amounts of blood being pumped out by the heart have been known to occur if treatment with INOmax® is stopped suddenly without first lowering the dose.
If you take too much (overdose)
As INOmax® will be given to your baby under the supervision of your doctor it is unlikely that your baby will receive too much.
Before your baby is given INOmax®
Other things to be aware of before your baby is treated with INOmax® include:
Interactions with other medicines:
The doctor will decide when to treat your baby with INOmax® and with other medicines, and will carefully supervise the treatment. INOmax® could be given with some medicines called “nitric oxide donors” or medicines that themselves can affect the blood’s ability to carry oxygen.
Patients with abnormal heart function:
In patients whose hearts are less efficient than normal at pumping blood around the body, nitric oxide can increase the chance of serious side effects occurring, such as the build up of fluid in the lungs, worsening of abnormal heart function, low blood pressure, abnormally slow heart beat, and stopping of the heart. For these patients, the doctor will weigh up the risks of using INOmax® against the benefits it is expected to provide.
Like all medicines, nitric oxide can have side effects. Your baby’s doctor will examine your baby closely for all side effects. If you notice any side effects not mentioned in this leaflet, even after your baby leaves the hospital, please inform your baby’s doctor.
Short-term side effects
When nitric oxide is inhaled it may cause the red blood cells to have less capacity to carry oxygen. It can also be harmful in other ways to your baby’s lungs. The doctor should be monitoring the blood for these and other effects.
If your baby has these side effects, the long-term clinical outcomes are unknown.
When your baby is receiving INOmax® therapy the INOmax® cannot be stopped too quickly. The dose of INOmax® will be gradually reduced because oxygen levels in your child’s blood may get worse when INOmax® is stopped too quickly.
Other side effects of inhaled nitric oxide may include: infections, blood in the urine, high blood sugar, noisy breath sounds, low blood platelets, low blood pressure, low blood potassium, airless or collapsed lungs and high amounts of bile pigment (bilirubin).
Nitric oxide gas may in some cases cause blood not to clot as well as usual and cause bleeding in the brain or lungs.
Long-term side effects
Studies of inhaled nitric oxide in newborn babies have not followed the babies’ condition for more than 2 years, so long-term side effect information is not definitely known. There are possibly long-term side effects that could affect the development of the lungs, brain and walking ability.
If your baby receives INOmax® therapy, it is recommended that you have your baby checked by a doctor periodically and monitored for normal developmental signs, including: growth, hearing, physical development, lung development, and learning development.
Controlling side effects
Your baby’s doctor will give the lowest INOmax® dose possible to try to avoid any side effects. Your baby’s doctor will check for any side effects of the INOmax® therapy and will decrease the INOmax® dose or stop the INOmax® therapy completely if necessary.
This is not a complete list of side effects. For any unexpected effects while your baby is taking INOmax® contact your doctor.
Each cylinder of INOmax® contains the active ingredient Nitric oxide 800 ppm.
INOmax® also contains:
Nitrogen, Grade 5
INOmax® is supplied as
- a size MD 15 cylinder
- a size 88 cylinder
INOmax® does not contain:
Store at 25°C, avoid temperature dropping to below 5°C.
Keep INOmax® out of the reach of children.
Note the expiry date on the pack. Do not use after this expiry date.
Ikaria Australia Pty Ltd
695 Burke Road
This leaflet was prepared on 28 January 2014.
Australian Register Number: AUST R 128136
INOmax® is a registered trademark of INO Therapeutics.
CMI provided by MIMS Australia, August 2014