Genosyl (Inhalation)

Nitric oxide is used along with a breathing machine (ventilator) and other agents to treat newborn (term and near-term) babies who have respiratory failure due to pulmonary hypertension.

Nitric oxide is a gas that is inhaled through the nose or mouth. It helps by relaxing the smooth muscles to widen the blood vessels in the lungs.

This medicine should only be given by or under the direct supervision of a doctor.

It is very important that your baby's doctor checks your baby closely while receiving this medicine. This will help the doctor see if the medicine is working properly and decide if your baby should continue to receive it. Blood tests may be needed to check for unwanted effects.

Your baby's doctor also needs to monitor your baby's breathing, oxygen levels, and other vital signs while receiving this medicine.

Stopping this medicine suddenly may increase your baby's risk of having rebound pulmonary hypertension syndrome. Symptoms include: bluish lips or skin, slow heartbeat, lightheadedness, dizziness, fainting, or decreased cardiac output.

This medicine may cause a rare, but serious blood problem called methemoglobinemia. Your baby's doctor will measure how much methemoglobin is in your baby's blood while receiving this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medicine, you and your doctor must consider the risks of taking the medicine along with the benefits it may provide. For this medicine, keep the following points in mind:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know if you have other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

So far, studies have not shown any specific problems in children that would limit the use of inhaled nitric oxide in newborn babies with respiratory failure.

Geriatric

Inhaled nitric oxide is not recommended for older patients.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Carefully weigh the potential benefits against the potential risks before using this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines might be used together even if an interaction could happen. In these situations, your doctor may want to adjust the dose, or other precautions might be necessary. It's especially important for your healthcare professional to know if you are taking any of the medicines listed below while receiving this medicine. The following interactions are highlighted based on their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may choose not to treat you with this medication or adjust some of your other medicines.

• Riociguat

Using this medicine with any of the following medicines may increase the risk of certain side effects, but using both drugs may be the best option for you. If both medicines are prescribed together, your doctor may adjust the dose or frequency of use for one or both medicines.

• Prilocaine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken around the time of eating food or certain types of food due to possible interactions. Using alcohol or tobacco with specific medicines may also lead to interactions. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical issues may impact the use of this medicine. Be sure to inform your doctor if you have any other medical problems, especially:

• Heart failure or
• Lung or breathing problems—Use with caution. May increase the risk for more serious side effects.

• Heart problem (e.g., babies dependent on right-to-left shunt)—Should not be given to patients with this condition.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may happen, if they do occur, they may need medical attention.

Check with your doctor or nurse right away if any of the following side effects occur:

More common

• Blurred vision
• confusion
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• sweating
• unusual tiredness or weakness

Incidence not known

• Bluish lips or skin
• chest discomfort
• difficult or labored breathing
• dizziness
• tightness in the chest
• trouble breathing

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

• Bluish-colored lips, fingernails, or palms
• dark urine
• fever
• headache
• pale skin
• rapid heart rate
• sore throat
• unusual bleeding or bruising

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known

• Dry throat

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Genosyl
• Inomax
• Noxivent

Available Dosage Forms:

• Gas

Therapeutic Class: Stimulant, Respiratory

A nurse or other trained health professional will give your baby this medicine in a hospital. This medicine is inhaled into your baby's lungs through the mouth or nose.

This medicine must be given using the nitric oxide delivery system (eg, Genosyl®, INOmax DS®, INOmax® DS, INOvent®) together with a ventilator (breathing gas administration system).

This medicine is usually given for up to 14 days or until your baby is ready to be weaned from nitric oxide treatment.