nitric oxide gas (Rx)

Brand and Other Names:INOmax, Genosyl

Dosing & Uses

AdultPediatric

Orphan Designations

Acute respiratory distress syndrome in adults

Cystic fibrosis

Pulmonary arterial hypertension

Sickle cell crisis: For acute treatment of sickle cell vaso-occlusive crisis (pain crises)

Diagnosis of sarcoidosis

Idiopathic pulmonary fibrosis

Nontuberculosis mycobacterial infections

Sponsors

  • INO Therapeutics, Inc; Perryville III Corporate Park, 53 Frontage RD, 3rd Floor; Hampton, NJ 08827
  • GeNo, LLC; 2941 Oxbow Circle; Cocoa, Florida 32926
  • Advanced Inhalation Therapies Ltd; 2 Ilan Ramon Street; Ness Ziona, Israel

Dosage Forms & Strengths

inhalation gas

  • 100ppm
  • 800ppm

Hypoxic Respiratory Failure

Indicated in term and near-term neonates with hypoxic respiratory failure associated with evidence of pulmonary hypertension

Additional studies conducted in premature neonates for the prevention of bronchopulmonary dysplasia have not demonstrated substantial evidence of efficacy

Term and near-term neonates (>34 weeks gestation): 20 ppm, inhaled for up to 14 days

Decrease dose gradually at end of treatment, do not discontinue abruptly

Chronic Lung Disease Prevention (Orphan)

Orphan designation to reduce the risk of chronic lung disease in premature neonates

Orphan indication sponsor

  • INO Therapeutics, Inc; Perryville III Corporate Park, 53 Frontage RD, 3rd Floor; Hampton, NJ 08827

Cystic Fibrosis (Orphan)

Orphan designation for treatment of cystic fibrosis

Orphan sponsor

  • Novoteris, LLC; 7245 Garden Grove Blvd. Suite C; Garden Grove, CA 92841
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Adverse Effects

>10%

Hypotension (13%)

Withdrawal (12%)

1-10%

Atelectasis (9%)

Hematuria (8%)

Hyperglycemia (8%)

Sepsis (7%)

Infection (6%)

Cellulitis (5%)

Stridor (5%)

Frequency Not Defined

Intracranial hemorrhage, due to platelet aggregation inhibition

Seizure

Gastrointestinal hemorrhage due to platelet aggregation inhibition

Methemoglobinemia

Hematuria due to platelet aggregation inhibition

Acute lung injury, atelectasis, hypoxemia, pulmonary edema, pulmonary hemorrhage, pulmonary toxicity due to nitrogen dioxide formation

Postmarketing Reports

Accidental exposure to nitric oxide for inhalation in hospital staff has been associated with chest discomfort, dizziness, dry throat, dyspnea, and headache

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Warnings

Contraindications

Hypersensitivity

Neonates dependent on right-to-left shunting of blood

Cautions

Methemoglobinemia and NO2 levels are dose dependent; the most common adverse reaction is hypotension

Closely monitor PaO2 and methemoglobin levels; measure methemoglobin levels within 4-8 hr after initiation of treatment and then periodically throughout treatment

Monitor NO2 levels continuously with a suitable nitric oxide delivery system

If methemoglobin levels are elevated and do not resolve with decreased dose or discontinuation, additional therapy may be warranted (eg, IV vitamin C, IV methylene blue, blood transfusion); hypoxemia from methemoglobinemia may occur

Wean gradually to avoid rebound pulmonary hypertension syndrome; symptoms include worsening oxygenation, increased pulmonary artery pressure (PAP), systemic hypotension, and decreased cardiac output; reinstate nitric oxide immediately

Nitrogen dioxide (NO2) forms in gas mixtures containing NO and O2 and may cause airway inflammation and damage to lung tissues; if NO2 exceeds 0.5 ppm, decrease the dose of nitric oxide

If there is unexpected change in NO2 concentration, or if NO2 concentration reaches 3 ppm when measured in breathing circuit, assess delivery system; may need to adjust dose as appropriate

Patients with left ventricular dysfunction may experience pulmonary edema when treated with nitric oxide, increased pulmonary capillary wedge pressure, worsening of left ventricular dysfunction, systemic hypotension, bradycardia, and cardiac arrest

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Pregnancy & Lactation

Pregnancy Category: C

Lactation: not known if excreted in breast milk

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

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Pharmacology

Mechanism of Action

Relaxes vascular smooth muscle, resulting in pulmonary vasodilation

Combines with oxyhemoglobin to produce methemoglobin & nitrate

Excretion

Nitrate excreted quickly, renal

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Administration

Ventilator Administration

Validated ventilatory systems

  • Must be adminstered using a calibrated and validated nitric oxide delivery system by trained personnel for the particular brand (eg, INOmax, Genosyl)
  • Keep available a back up battery power supply and an independent reserve nitric oxide delivery system to address power and system failures
  • INOmax
    • Consult the delivery system label or call 877-566-9466 or visit inomax.com for a current list of validated systems
  • Genosyl
    • Consult the Delivery system operator’s manual or call 1-877-337-4118 or visit www.vero-biotech.com

Monitoring

  • Measure methemoglobin within 4-8 hr after initiating and periodically throughout treatment
  • Monitor for PaO2 and inspired NO2 during administration

Weaning and discontinuation

  • Avoid abrupt discontinuation; wean gradually
  • To wean, downtitrate in several steps, pausing several hours at each step to monitor for hypoxemia
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Images

No images available for this drug.
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Patient Handout

A Patient Handout is not currently available for this monograph.
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Formulary

FormularyPatient Discounts

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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.