Overview
11 DESCRIPTION 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]).
Mechanism of Action
12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Nitric oxide relaxes vascular smooth muscle by binding to the heme moiety of cytosolic guanylate cyclase, activating guanylate cyclase and increasing intracellular levels of cyclic guanosine 3',5'-monophosphate, which then leads to vasodilation. When inhaled, nitric oxide selectively dilates the pulmonary vasculature, and because of efficient scavenging by hemoglobin, has minimal effect on the systemic vasculature. Nitric oxide appears to increase the partial pressure of arterial oxygen (PaO2) by dilating pulmonary vessels in better ventilated areas of the lung, redistributing pulmonary blood flow away from lung regions with low ventilation/perfusion (V/Q) ratios toward regions with normal ratios. 12.
Indications
- 1 INDICATIONS AND 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...
Common Doses
- Refer to label
Dosage
2 DOSAGE AND 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).
Contraindications
- 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).
Side Effects
- 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.
Interactions
- 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. Nitric oxide donor compounds may increase the risk of developing methemoglobinemia (7).