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Inomax

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Inomax

INDICATIONS

Treatment of Hypoxic Respiratory Failure

INOmax® is a vasodilator, which, in conjunction with ventilatory support and other appropriate agents, is indicated for the treatment of term and near-term ( > 34 weeks) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension, where it improves oxygenation and reduces the need for extracorporeal membrane oxygenation.

Utilize additional therapies to maximize oxygen delivery with validated ventilation systems [see DOSAGE AND ADMINISTRATION]. In patients with collapsed alveoli, additional therapies might include surfactant and high-frequency oscillatory ventilation.

The safety and effectiveness of INOmax have been established in a population receiving other therapies for hypoxic respiratory failure, including vasodilators, intravenous fluids, bicarbonate therapy, and mechanical ventilation. Different dose regimens for nitric oxide were used in the clinical studies [see Clinical Studies].

Monitor for PaO2, methemoglobin, and inspired NO2 during INOmax administration.

DOSAGE AND ADMINISTRATION

To ensure safe and effective administration of INOmax to avoid adverse events associated with nitric oxide or NO2, administration of INOmax should only be performed by a health care professional who has completed and maintained training on the safe and effective use of a Nitric Oxide Delivery System provided by the manufacturer of the delivery system and the drug.

Dosage

Term and near-term neonates with hypoxic respiratory failure

The recommended dose of INOmax is 20 ppm. Treatment should be maintained up to 14 days or until the underlying oxygen desaturation has resolved and the neonate is ready to be weaned from INOmax therapy.

As the risk of methemoglobinemia and elevated NO2 levels increases significantly when INOmax is administered at doses > 20 ppm; doses above this level are not recommended.

Administration

Methemoglobin should be measured within 4-8 hours after initiation of treatment with INOmax and periodically throughout treatment [see WARNINGS AND PRECAUTIONS].

Nitric Oxide Delivery Systems

INOmax must be administered using the INOmax DSIR ®, INOmax® DS, or INOvent® Nitric Oxide Delivery Systems, which deliver operator-determined concentrations of nitric oxide in conjunction with a ventilator or breathing gas administration system after dilution with an oxygen/air mixture. A Nitric Oxide Delivery System includes a nitric oxide administration apparatus, a nitric oxide gas analyzer and a nitrogen dioxide gas analyzer. Failure to calibrate the Nitric Oxide Delivery System could result in under-or over-dosing of nitric oxide.

To address potential power failure, keep available a backup battery power supply. To address potential system failure, keep available an independent reserve nitric oxide delivery system. Failure to transition to a reserve nitric oxide delivery system can result in abrupt or prolonged discontinuation of nitric oxide [see WARNINGS AND PRECAUTIONS].

Training in Administration

The user of INOmax and Nitric Oxide Delivery Systems must complete a comprehensive training program for health care professionals provided by the delivery system and drug manufacturers.

Health professional staff that administers nitric oxide therapy have access to supplier-provided 24 hour/365 days per year technical support on the delivery and administration of INOmax at 1877-566-9466.

Weaning and Discontinuation

Abrupt discontinuation of INOmax may lead to increasing pulmonary artery pressure (PAP) and worsening oxygenation even in neonates with no apparent response to nitric oxide for inhalation. To wean INOmax, downtitrate in several steps, pausing several hours at each step to monitor for hypoxemia.

HOW SUPPLIED

Dosage Forms And Strengths

INOmax (nitric oxide) for inhalation is a gas available in 100 ppm and 800 ppm concentrations.

Storage And Handling

INOmax (nitric oxide) is available in the following sizes:

Size D Portable aluminum cylinders containing 353 liters at STP of nitric oxide gas in 800 ppm concentration in nitrogen (delivered volume 344 liters) (NDC 64693-002-01)
Size D Portable aluminum cylinders containing 353 liters at STP of nitric oxide gas in 100 ppm concentration in nitrogen (delivered volume 344 liters) (NDC 64693-001-01)
Size 88 Aluminum cylinders containing 1963 liters at STP of nitric oxide gas in 800 ppm concentration in nitrogen (delivered volume 1918 liters) (NDC 64693-002-02)
Size 88 Aluminum cylinders containing 1963 liters at STP of nitric oxide gas in 100 ppm concentration in nitrogen (delivered volume 1918 liters) (NDC 64693-001-02)

Store at 25°C (77°F) with excursions permitted between 15–30°C (59–86°F) [see USP Controlled Room Temperature].

All regulations concerning handling of pressure vessels must be followed. Protect the cylinders from shocks, falls, oxidizing and flammable materials, moisture, and sources of heat or ignition.

The cylinders should be appropriately transported to protect from risks of shocks and falls.

Occupational Exposure

The exposure limit set by the Occupational Safety and Health Administration (OSHA) for nitric oxide is 25 ppm, and for NO2 the limit is 5 ppm.

INO Therapeutics Perryville III Corporate Park 53 Frontage Road, Third Floor. P.O. Box 9001 Hampton, NJ 08827-9001. Revised: 3/2013

Last reviewed on RxList: 3/20/2013
This monograph has been modified to include the generic and brand name in many instances.

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