Noxivent (Nitric Oxide) – Inhalation

What Is Noxivent?

Noxivent is an inhaled medication used to treat infants with respiratory failure caused by pulmonary hypertension—a condition that occurs when blood vessels in the lungs don't open wide enough. This reduces how much oxygen is delivered to the brain and other organs.

Noxivent belongs to a group of drugs called vasodilators. It works by helping to expand blood vessels in the lungs and improves oxygen delivery throughout the body.

What Is Noxivent Used For?

Noxivent is an inhaled medication used to treat respiratory failure in babies with persistent pulmonary hypertension of the newborn (PPHN). This severe condition can cause a baby not to get enough oxygen after birth.

PPHM affects approximately 2 out of every 1,000 live births and is one of the most common critical illnesses affecting babies in the neonatal intensive care unit (NICU). PPHM occurs when blood vessels in the lungs don't expand wide enough after birth. This reduces blood flow to the lungs and decreases oxygen delivery to the brain and other parts of the body.

Signs of PPHM include:

• Rapid breathing
• Retractions (the skin under and in between the ribs pulls in with each breath)
• Grunting
• Blue color of the lips, skin, or nails (cyanosis)
• Low oxygen levels in the blood
  

Healthcare providers may administer Noxivent, mechanical ventilation (a breathing machine), and other therapies to treat PPHM.

How to Take Noxivent

Noxivent is an inhaled gas administered by healthcare providers in the NICU. A special machine attaches to a ventilator (breathing machine) and pumps the Noxivent gas through the ventilator tubes and into the baby's lungs.

Noxivent is typically administered for up to 14 days or until oxygen levels improve.

Storage

Your baby's healthcare provider will administer and store this medication.

Off-Label Uses

Healthcare providers may prescribe medicines for conditions not approved by the Food and Drug Administration (FDA). This is called off-label use. Healthcare providers may prescribe Noxivent off-label to treat:

• Congenital diaphragmatic hernia (a hole in the diaphragm)
• Bronchopulmonary dysplasia (chronic lung disease primarily affecting premature newborns requiring oxygen therapy)
  

What Are the Side Effects of Noxivent?

This is not a complete list of side effects, and others may occur. A healthcare provider can advise you on side effects. If you experience other effects, contact your pharmacist or healthcare provider. You may report side effects to the FDA at fda.gov/medwatch or 800-FDA-1088.

Common Side Effects

A common side effect of Noxivent is low blood pressure (hypotension).

Severe Side Effects

Healthcare providers in the NICU will monitor your baby continuously for any reactions to Noxivent.

Severe side effects of Noxivent may include but are not be limited to:

• Methemoglobinemia  (a condition that makes some red blood cells unable to transport oxygen)
• Lung tissue damage and airway inflammation

Long-Term Side Effects

Abruptly stopping Noxivent can lead to rebound pulmonary hypertension syndrome, causing oxygen levels and pulmonary hypertension to worsen. Your child's healthcare provider will slowly decrease Noxivent to avoid this reaction.

Dosage: How Much Noxivent Should I Take?

Your baby's healthcare provider will determine and administer (give) the proper dosage of Noxivent to your baby.

Modifications

The following modifications (changes) should be kept in mind when using Noxivent:

Adults: Noxivent is not normally used to treat adults. However, it can be prescribed off-label by a healthcare provider who has completed a special training program.

Pregnancy: Not enough is known about the safety and effectiveness of Noxivent in pregnant people and their unborn fetuses. Noxivent is not normally used to treat adults.

Breastfeeding: When a nursing person takes a medicine, it can get into the breast milk. This means the nursing baby may be exposed to those medicines. This exposure can have negative effects on the baby. However, not enough is known about the safety of Noxivent in human breast milk and nursing babies.

Talk with your and/or your child's healthcare provider to discuss your questions or concerns.

Adults over 65: Noxivent is not normally used to treat adults. However, it can be prescribed off-label by a healthcare provider who has completed a comprehensive training program.

Children: Noxivent is approved to treat babies born to term and near term (greater than 34 weeks' gestation) with respiratory failure (trouble breathing) caused by pulmonary hypertension (high blood pressure in the lungs). Further studies were done to see if Noxivent could prevent bronchopulmonary dysplasia (a chronic lung disease) in premature babies.

However, it was found to be ineffective (it didn't work). Insufficient information is available on treating premature babies with conditions other than pulmonary hypertension with Noxivent.

Missed Dose

Healthcare providers in the neonatal intensive care unit (NICU) will administer (give) Noxivent continuously to your baby.

Overdose: What Happens If I Take Too Much Noxivent?

The symptoms of a suspected Noxivent overdose include:

• Methemoglobinemia
• Lung tissue damage and airway inflammation

Your baby's healthcare provider will monitor for any reactions and decrease the dose or discontinue Noxivent if appropriate.

Precautions

What Are Reasons I Shouldn’t Take Noxivent?

Babies with the following conditions should not receive Noxivent:

• Certain congenital heart diseases
• Severe left ventricular dysfunction (a type of heart failure)
• Severe congenital (present at birth) methemoglobinemia
  

What Other Medications Interact With Noxivent?

Use caution when taking Noxivent with the following medications:

• Prilocaine or other numbing medicines
• Sodium nitroprusside
• Nitroglycerine
• Medicines that lower blood pressure

What Medications Are Similar?

Noxivent is a vasodilator that works by expanding blood vessels in the lungs. Another medicine that works similarly to treat babies with respiratory failure caused by pulmonary hypertension is Revatio (sildenafil).

Oral or intravenous (IV) Revatio may be considered if there is suboptimal (not the best) or no response to Noxivent or if Noxivent is unavailable.

How Can I Stay Healthy While Taking Noxivent

If your baby is receiving Noxivent, it means they're in the NICU, which can be a stressful, overwhelming, and exhausting situation for any parent. Consider some of these tips to help you get through this emotional time:

• Review the NICU's visitations guidelines: Be sure to know how many people can visit at one time, the rules on vaccination status of visitors, and if there are age-based restrictions, such as for young siblings.
• Participate in rounds: Each day, your baby's healthcare providers will discuss your baby's condition and care plan. Find out when rounds take place—times when the medical team visits patients to review their status and plan of care—and attend if possible. This is a great time to hear about your baby's health and for you to bring up your questions or concerns.
• Help with your baby's care: With healthcare providers taking care of your baby around the clock, it's easy to feel like your role as a parent has been diminished. Let your baby's healthcare team know you'd like to be involved as much as possible. Depending on your baby's condition, you may be able to change diapers, feed, and bathe them.
• Consider joining a parent support group: Ask what resources are available at the hospital and in the community. Talking with other parents in a similar situation can help you feel less alone.
• Don't forget to take care of yourself: It may seem impossible, but getting a good night's sleep and eating a nutritious diet are essential for managing the stress associated with having a child in the NICU. Ask for help when you need it. If you feel guilty—or have other feelings—for taking some time for yourself, consider reaching out to a mental healthcare provider or other options like self-compassion meditation practices.