GENOSYL .98 mg/L
nitric oxide · GAS · VERO BIOTECH, INC.
GENOSYL is a gas containing nitric oxide at .98 mg/L, taken respiratory (inhalation). Manufactured by VERO BIOTECH, INC..
Key Facts
- Brand Name
- GENOSYL
- Generic Name
- nitric oxide
- NDC Code (Product)
72385-002- Manufacturer
- VERO BIOTECH, INC.
- Strength
- .98 mg/L
- Dosage Form
- GAS
- Route
- RESPIRATORY (INHALATION)
- Marketing Status
- Application #
- NDA202860
- Drug Class
- Vasodilator [EPC]
- Marketing Start
- 12/28/2022
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE GENOSYL ® 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. GENOSYL 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 ).
Dosage & Administration
2 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 ). 2.1 Dosage Term and near-term neonates with hypoxic respiratory failure The recommended dose of GENOSYL 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 GENOSYL therapy. Doses greater than 20 ppm are not recommended [see Warnings and Precautions (5.2) ]. 2.2 Administration Nitric Oxide Delivery System GENOSYL must be administered using a calibrated GENOSYL Delivery System. Only validated ventilator systems should be used in conjunction with GENOSYL [see Description (11) ]. Consult the GENOSYL Delivery System Operator's Manual or call 1-877-337-4118 or visit www.vero-biotech.com for needed information on training and technical support for users of GENOSYL with the GENOSYL Delivery System . Keep available a backup power supply to address power failures. The GENOSYL Delivery System consists of a primary system and a full…
Contraindications
4 CONTRAINDICATIONS GENOSYL is contraindicated in neonates dependent on right-to-left shunting of blood. Neonates dependent on right-to-left shunting of blood ( 4 ).
Drug Interactions
7 DRUG INTERACTIONS Nitric oxide donor compounds may increase the risk of developing methemoglobinemia ( 7 ). 7.1 Nitric Oxide Donor Agents Nitric oxide donor agents such as prilocaine, sodium nitroprusside and nitroglycerine may increase the risk of developing methemoglobinemia.
Adverse Reactions
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) ] The most common adverse reaction is hypotension ( 6 ). To report SUSPECTED ADVERSE REACTIONS, contact Vero Biotech at 1-877-337-4118 and http://www.vero-biotech.com/ or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 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 gas for inhalation, a result adequate to exclude nitric oxide mortality being more than 40% worse than pla…
Frequently Asked Questions
What is GENOSYL used for?
GENOSYL contains nitric oxide. It is a gas taken respiratory (inhalation). Consult your doctor for specific uses.
Is GENOSYL a controlled substance?
GENOSYL is not classified as a controlled substance by the DEA.
What is the generic name for GENOSYL?
The generic name for GENOSYL is nitric oxide. There are 4 other brand versions of nitric oxide.
What is the NDC code for GENOSYL .98 mg/L?
The NDC (National Drug Code) for GENOSYL .98 mg/L is 72385-002, listed by VERO BIOTECH, INC..