Drug Facts
Composition & Profile
Identifiers & Packaging
16 HOW SUPPLIED/STORAGE AND HANDLING Size D Portable aluminum cylinders containing 362 liters at STP of nitric oxide gas in 800 ppm concentration in nitrogen (delivered volume 350 liters) (NDC 82605-006-02) Size 88 Aluminum cylinders containing 2138 liters at STP of nitric oxide gas in 800 ppm concentration in nitrogen (delivered volume 2083 liters) (NDC 82605-006-01) Distributed by Airgas Therapeutics LLC Radnor, PA 19087 USA AirGas Therapeutics an Air Liquide company © 2023 Airgas ULSPI 01; Ulspira TM (nitric oxide for inhalation) 800 PPM Rx Only CAUTION: HIGH PRESSURE GAS. CAN CAUSE RAPID SUFFOCATION WITHOUT WARNING. Use equipment rated for cylinder pressure. Store and use with adequate ventilation. Secure cylinder in use and storage. Close valve after each use and when empty. USE IN ACCORDANCE WITH APPROPRIATE SDS. WARNING: Administration of this gas mixture may be hazardous or contraindicated. For use only by or under the supervision of a licensed practitioner who is experienced in the use and administration of gas mixtures, and is familiar with the indications, effects, dosages, methods, and frequency and duration of administration, and with the hazards, contraindications, and side effects and the precautions to be taken. FIRST AID: IF INHALED, remove person to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen. Get medical help. RETURN WITH 25 PSIG. TO BE REFILLED ONLY BY A PHARMACEUTICAL FACILITY AUTHORIZED BY AIRGAS THERAPEUTICS, LLC Manufactured Under Pharmaceutical Current Good Manufacturing Practices (cGmps). DO NOT REMOVE THIS PRODUCT LABEL Store at 25 C (77 F) with excursions permitted between 15 – 30 C (59 – 86 F). Volume 2138 Liters Airgas Therapeutics An Air Liquide company Manufactured by: AIRGAS THERAPEUTICS, LLC 6141 Easton Road Plumsteadville, PA 18949-0310 For Product Inquiry 1-833-ULSPIRA (857-7472) UN1956 COMPRESSED GAS, N.O.S. (NITRIC OXIDE, NITROGEN) 2.2 Net Weight: 2.5 kg LOT: EXP: NDC 82605-006-01 006-01; Ulspira TM (nitric oxide for inhalation) 800 PPM Rx Only CAUTION: HIGH PRESSURE GAS. CAN CAUSE RAPID SUFFOCATION WITHOUT WARNING. Use equipment rated for cylinder pressure. Store and use with adequate ventilation. Secure cylinder in use and storage. Close valve after each use and when empty. USE IN ACCORDANCE WITH APPROPRIATE SDS. WARNING: Administration of this gas mixture may be hazardous or contraindicated. For use only by or under the supervision of a licensed practitioner who is experienced in the use and administration of gas mixtures, and if familiar with the indications, effects, dosages, methods, and frequency and duration of administration, and with the hazards, contraindications and side effects and the precautions to be taken. FIRST AID: IF INHALED, remove person to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen. Get medical help. RETURN WITH 25 PSIG. TO BE REFILLED ONLY BY A PHARMACEUTICAL FACILITY AUTHORIZED BY AIRGAS THERAPEUTICS, LLC Manufactured Under Pharmaceutical Current Good Manufacturing Practices (cGMPs). DO NOT REMOVE THIS PRODUCT LABELS Store at 25 C (77 F) with excursions permitted between 15 - 30 C (59 – 86 F). Volume 362 Liters Airgas Therapeutics An Air Liquide company Manufactured by: AIRGAS THERAPEUTICS, LLC 6141 Easton Road Plumsteadville, PA 18949-0310 For Product Inquiry 1-833-ULSPIRA (857-7472) UN 1956 COMPRESSED GAS, N.O.S. (NITRIC OXIDE, NITROGEN) 2.2 Net Weight: 0.4 kg LOT: EXP: NDC 82605-006-02 006-02
- 16 HOW SUPPLIED/STORAGE AND HANDLING Size D Portable aluminum cylinders containing 362 liters at STP of nitric oxide gas in 800 ppm concentration in nitrogen (delivered volume 350 liters) (NDC 82605-006-02) Size 88 Aluminum cylinders containing 2138 liters at STP of nitric oxide gas in 800 ppm concentration in nitrogen (delivered volume 2083 liters) (NDC 82605-006-01) Distributed by Airgas Therapeutics LLC Radnor, PA 19087 USA AirGas Therapeutics an Air Liquide company © 2023 Airgas ULSPI 01
- Ulspira TM (nitric oxide for inhalation) 800 PPM Rx Only CAUTION: HIGH PRESSURE GAS. CAN CAUSE RAPID SUFFOCATION WITHOUT WARNING. Use equipment rated for cylinder pressure. Store and use with adequate ventilation. Secure cylinder in use and storage. Close valve after each use and when empty. USE IN ACCORDANCE WITH APPROPRIATE SDS. WARNING: Administration of this gas mixture may be hazardous or contraindicated. For use only by or under the supervision of a licensed practitioner who is experienced in the use and administration of gas mixtures, and is familiar with the indications, effects, dosages, methods, and frequency and duration of administration, and with the hazards, contraindications, and side effects and the precautions to be taken. FIRST AID: IF INHALED, remove person to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen. Get medical help. RETURN WITH 25 PSIG. TO BE REFILLED ONLY BY A PHARMACEUTICAL FACILITY AUTHORIZED BY AIRGAS THERAPEUTICS, LLC Manufactured Under Pharmaceutical Current Good Manufacturing Practices (cGmps). DO NOT REMOVE THIS PRODUCT LABEL Store at 25 C (77 F) with excursions permitted between 15 – 30 C (59 – 86 F). Volume 2138 Liters Airgas Therapeutics An Air Liquide company Manufactured by: AIRGAS THERAPEUTICS, LLC 6141 Easton Road Plumsteadville, PA 18949-0310 For Product Inquiry 1-833-ULSPIRA (857-7472) UN1956 COMPRESSED GAS, N.O.S. (NITRIC OXIDE, NITROGEN) 2.2 Net Weight: 2.5 kg LOT: EXP: NDC 82605-006-01 006-01
- Ulspira TM (nitric oxide for inhalation) 800 PPM Rx Only CAUTION: HIGH PRESSURE GAS. CAN CAUSE RAPID SUFFOCATION WITHOUT WARNING. Use equipment rated for cylinder pressure. Store and use with adequate ventilation. Secure cylinder in use and storage. Close valve after each use and when empty. USE IN ACCORDANCE WITH APPROPRIATE SDS. WARNING: Administration of this gas mixture may be hazardous or contraindicated. For use only by or under the supervision of a licensed practitioner who is experienced in the use and administration of gas mixtures, and if familiar with the indications, effects, dosages, methods, and frequency and duration of administration, and with the hazards, contraindications and side effects and the precautions to be taken. FIRST AID: IF INHALED, remove person to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen. Get medical help. RETURN WITH 25 PSIG. TO BE REFILLED ONLY BY A PHARMACEUTICAL FACILITY AUTHORIZED BY AIRGAS THERAPEUTICS, LLC Manufactured Under Pharmaceutical Current Good Manufacturing Practices (cGMPs). DO NOT REMOVE THIS PRODUCT LABELS Store at 25 C (77 F) with excursions permitted between 15 - 30 C (59 – 86 F). Volume 362 Liters Airgas Therapeutics An Air Liquide company Manufactured by: AIRGAS THERAPEUTICS, LLC 6141 Easton Road Plumsteadville, PA 18949-0310 For Product Inquiry 1-833-ULSPIRA (857-7472) UN 1956 COMPRESSED GAS, N.O.S. (NITRIC OXIDE, NITROGEN) 2.2 Net Weight: 0.4 kg LOT: EXP: NDC 82605-006-02 006-02
Overview
ULSPIRA (nitric oxide gas) is a drug administered by inhalation. Nitric oxide, the active substance in ULSPIRA, is a pulmonary vasodilator. ULSPIRA is a gaseous blend of nitric oxide and nitrogen (0.08% and 99.92%, respectively for 800 ppm). ULSPIRA 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: NO pic
Indications & Usage
ULSPIRA™ 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. ULSPIRA 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.
Dosage & Administration
2.1 Dosage Term and near-term neonates with hypoxic respiratory failure The recommended dose of ULSPIRA 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 ULSPIRA therapy. Doses greater than 20 ppm are not recommended [see Warnings and Precautions (5.2)] . 2.2 Administration Nitric Oxide Delivery Systems ULSPIRA 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 ULSPIRA with Inomax DSIR Plus and DSIR Plus MRI NODS. Do not use ULSPIRA in the MRI 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 ULSPIRA and periodically throughout treatment [see Warnings and Precautions (5.2)]. Monitor for PaO2 and inspired NO2 during ULSPIRA administration [see Warnings and Precautions 5.3)] . Weaning and Discontinuation Avoid abrupt discontinuation of ULSPIRA [see Warnings and Precautions (5.1)]. To wean ULSPIRA, downtitrate in several steps, pausing several hours at each step to monitor for hypoxemia. 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).
Warnings & Precautions
5.1 Rebound Pulmonary Hypertension Syndrome following Abrupt Discontinuation Wean from ULSPIRA [see Dosage and Administration (2.2)]. Abrupt discontinuation of ULSPIRA may lead to worsening oxygenation and increasing pulmonary artery pressure, i.e., Rebound Pulmonary Hypertension Syndrome. Signs and symptoms of Rebound Pulmonary Hypertension Syndrome include hypoxemia, systemic hypotension, bradycardia, and decreased cardiac output. If Rebound Pulmonary Hypertension occurs, reinstate ULSPIRA therapy immediately. 5.2 Hypoxemia from Methemoglobinemia Nitric oxide combines with hemoglobin to form methemoglobin, which does not transport oxygen. Methemoglobin levels increase with the dose of ULSPIRA; it can take 8 hours or more before steady-state methemoglobin levels are attained. Monitor methemoglobin and adjust the dose of ULSPIRA to optimize oxygenation. If methemoglobin levels do not resolve with decrease in dose or discontinuation of ULSPIRA, additional therapy may be warranted to treat methemoglobinemia [see Overdosage (10)]. 5.3 Airway Injury from Nitrogen Dioxide Nitrogen dioxide (NO2) forms in gas mixtures containing NO and O2. Nitrogen dioxide may cause airway inflammation and damage to lung tissues. If there is an unexpected change in NO2 concentration, or if the NO2 concentration reaches 3 ppm when measured in the breathing circuit, then the delivery system should be assessed in accordance with the Nitric Oxide Delivery System O&M Manual troubleshooting section, and the NO2 analyzer should be recalibrated. The dose of ULSPIRA and/or FiO2 should be adjusted as appropriate. 5.4 Worsening Heart Failure Patients with left ventricular dysfunction treated with ULSPIRA may experience pulmonary edema, increased pulmonary capillary wedge pressure, worsening of left ventricular dysfunction, systemic hypotension, bradycardia and cardiac arrest. Discontinue ULSPIRA gas while providing symptomatic care. Rebound: Abrupt discontinuation of ULSPIRA may lead to worsening oxygenation and increasing pulmonary artery pressure (5.1). Methemoglobinemia: Methemoglobin increases with the dose of nitric oxide; following discontinuation or reduction of nitric oxide, methemoglobin levels return to baseline over a period of hours (5.2). Elevated NO 2 Levels: Monitor NO 2 levels (5.3). Heart Failure: In patients with pre-existing left ventricular dysfunction, ULSPIRA may increase pulmonary capillary wedge pressure leading to pulmonary edema (5.4).
Contraindications
ULSPIRA is contraindicated in neonates dependent on right-to-left shunting of blood. Neonates dependent on right-to-left shunting of blood (4).
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. The most common adverse reaction is hypotension. (6). To report SUSPECTED ADVERSE REACTIONS, contact Airgas Therapeutics at 1-833-ULSPIRA (857-7472) and http://www.ulspira.com/ or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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. Nitric oxide donor compounds may increase the risk of developing methemoglobinemia (7).
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