Noxivent 102

FDA Drug Information • Also known as: Noxivent 102

Brand Names: Noxivent 102
Drug Class: Vasodilator [EPC]
Route: RESPIRATORY (INHALATION)
Dosage Form: GAS
Product Type: HUMAN PRESCRIPTION DRUG

Description

11. DESCRIPTION Noxivent™ (nitric oxide gas) is a drug administered by inhalation. Nitric oxide, the active substance in Noxivent™, is a pulmonary vasodilator. Noxivent™ is a gaseous blend of nitric oxide and nitrogen (0.08% and 99.92%, respectively for 800 ppm; 0.01% and 99.99%, respectively for 100 ppm). Noxivent™ is supplied in aluminum cylinders as a compressed gas under high pressure (2000 pounds per square inch gauge [psig]). The structural formula of nitric oxide (NO) is shown below: formula

What Is Noxivent 102 Used For?

INDICATIONS AND USAGE Noxivent™ is a vasodilator indicated to improve oxygenation and reduce the need for extracorporeal membrane oxygenation in term and near-term (>34 weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension in conjunction with ventilatory support and other appropriate agents. 1. INDICATIONS AND USAGE Noxivent™ is indicated to improve oxygenation and reduce the need for extracorporeal membrane oxygenation in term and near-term (>34 weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension in conjunction with ventilatory support and other appropriate agents.

Dosage and Administration

DOSAGE AND ADMINISTRATION The recommended dose is 20 ppm, maintained for up to 14 days or until the underlying oxygen desaturation has resolved ( 2.1 ). Doses greater than 20 ppm are not recommended ( 2.1 , 5.2 ) Administration:

Avoid abrupt discontinuation ( 2.2 , 5.1 ). 2. DOSAGE AND ADMINISTRATION 2.1 Dosage Term and near-term neonates with hypoxic respiratory failure The recommended dose of Noxivent™ is 20 ppm. Maintain treatment up to 14 days or until the underlying oxygen desaturation has resolved and the neonate is ready to be weaned from Noxivent™ therapy. Doses greater than 20 ppm are not recommended [see Warnings and Precautions (5.2) ]. 2.2 Administration Nitric Oxide Delivery Systems Noxivent™ must be administered using a calibrated FDA-cleared Nitric Oxide Delivery System (NODS). There are various FDA-cleared NODS; refer to the NODS labeling to determine which NODS to use with this drug product and for needed information on training and technical support for users of this drug product with the NODS. Do not use Noxivent with Inomax DSIR Plus and DSIP MRI NODS. Do not use Noxivent in the MPI suite. Keep available a backup battery power supply and an independent reserve nitric oxide delivery system to address power and system failures. Monitoring Measure methemoglobin within 4-8 hours after initiation of treatment with Noxivent™ and periodically throughout treatment [see Warnings and Precautions (5.2 )]. Monitor for PaO 2 and inspired NO 2 during Noxivent™ administration [see Warnings and Precautions 5.3 )]. Weaning and Discontinuatio n Avoid abrupt discontinuation of Noxivent™ [see Warnings and Precautions (5.1 )]. To wean Noxivent™, downtitrate in several steps, pausing several hours at each step to monitor for hypoxemia.

Side Effects (Adverse Reactions)

ADVERSE REACTIONS The most common adverse reaction is hypotension. ( 6 ). To report SUSPECTED ADVERSE REACTIONS, contact Linde, Inc. at 1-800-772-9247 and www.linde.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6. ADVERSE REACTIONS The following adverse reactions are discussed elsewhere in the label; Hypoxemia [see Warnings and Precautions (5.2 )] Worsening Heart Failure [see Warnings and Precautions (5.4 )] 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The adverse reaction information from the clinical studies does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates. Controlled studies have included 325 patients on nitric oxide doses of 5 to 80 ppm and 251 patients on placebo. Total mortality in the pooled trials was 11% on placebo and 9% on nitric oxide, a result adequate to exclude nitric oxide mortality being more than 40% worse than placebo. In both the NINOS and CINRGI studies, the duration of hospitalization was similar in nitric oxide and placebo-treated groups. From all controlled studies, at least 6 months of follow-up is available for 278 patients who received nitric oxide and 212 patients who received placebo. Among these patients, there was no evidence of an adverse effect of treatment on the need for rehospitalization, special medical services, pulmonary disease, or neurological sequelae. In the NINOS study, treatment groups were similar with respect to the incidence and severity of intracranial hemorrhage, Grade IV hemorrhage, periventricular leukomalacia, cerebral infarction, seizures requiring anticonvulsant therapy, pulmonary hemorrhage, or gastrointestinal hemorrhage. In CINRGI, the only adverse reaction (>2% higher incidence on nitric oxide than on placebo) was hypotension (14% vs. 11%). 6.2 Post-Marketing Experience Post marketing reports of accidental exposure to nitric oxide for inhalation in hospital staff has been associated with chest discomfort, dizziness, dry throat, dyspnea, and headache.

Drug Interactions

DRUG INTERACTIONS Nitric oxide donor compounds may increase the risk of developing methemoglobinemia ( 7 ). Revised: 08/2023 7. DRUG INTERACTIONS 7.1 Nitric Oxide Donor Agents Nitric oxide donor agents such as prilocaine, sodium nitroprusside and nitroglycerine may increase the risk of developing methemoglobinemia.

Contraindications

CONTRAINDICATIONS Neonates dependent on right-to-left shunting of blood ( 4 ). 4. CONTRAINDICATIONS Noxivent™ is contraindicated in neonates dependent on right-to-left shunting of blood.

Overdosage

10. OVERDOSAGE Overdosage with Noxivent™ is manifest by elevations in methemoglobin and pulmonary toxicities associated with inspired NO 2 . Elevated NO 2 may cause acute lung injury. Elevations in methemoglobin reduce the oxygen delivery capacity of the circulation. In clinical studies, NO 2 levels >3 ppm or methemoglobin levels >7% were treated by reducing the dose of, or discontinuing, nitric oxide. Methemoglobinemia that does not resolve after reduction or discontinuation of therapy can be treated with intravenous vitamin C, intravenous methylene blue, or blood transfusion, based upon the clinical situation.

How Supplied

16. HOW SUPPLIED/STORAGE AND HANDLING Noxivent™ (nitric oxide) is available in the following sizes: Size AD Portable aluminum cylinders containing 362 liters at STP of nitric oxide gas in 800 ppm concentration in nitrogen (delivered volume 323 liters) (NDC 59579-102-02) Size AQ Aluminum cylinders containing 2154 liters at STP of nitric oxide gas in 800 ppm concentration in nitrogen (delivered volume 2082 liters) (NDC 59579-102-01) 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. Use of Noxivent cylinders in the MRI suite may create a projectile hazard. Occupational Exposure The exposure limit set by the Occupational Safety and Health Administration (OSHA) for nitric oxide is 25 ppm, and for NO 2 the limit is 5 ppm. Distributed by Linde Gas & Equipment Inc. 10 Riverview Drive Danbury, CT 06810-6268 © 2023 Linde Inc MDI-7003 (Rev. 03)

About This Information

This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.

What are side effects?

Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.

What are drug interactions?

Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.