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nitric oxide gas (Rx)Brand and Other Names:INOmax

 
 
 

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

Sponsor

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

Dosage Forms & Strengths

inhalation gas

  • 100ppm
  • 800ppm
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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 wk 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

Dependent on neonates 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

Instructions

Must be adminstered using a calibrated INOmax DS-IR nitric oxide delivery system by trained personnel

Only validated ventilator systems should be used in conjunction with INOmax; consult the delivery system label or call 877-566-9466/visit inomax.com for a current list of validated systems

Keep available a back up battery power supply and an independent reserve nitric oxide delivery system to address power and system failures

Monitoring

Measure methemoglobin within 4-8 hr after initiating and periodically throughout treatment

Monitor for PaO2 and inspired NO2 during administration

Weaning & 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

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Formulary

FormularyPatient Discounts

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Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
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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.
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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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