GENOSYL- nitric oxide gas

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

NITRIC OXIDE (UNII: 31C4KY9ESH) (NITRIC OXIDE - UNII:31C4KY9ESH)

MAH:

VERO BIOTECH, INC.

administration_route:

RESPIRATORY (INHALATION)

prescription_type:

PRESCRIPTION DRUG

therapeutic_indication:

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 contraindicated in neonates dependent on right-to-left shunting of blood. The safety and efficacy of nitric oxide for inhalation has been demonstrated in term and near-term neonates with hypoxic respiratory failure associated with evidence of pulmonary hypertension [see Clinical Studies (14.1)] . Additional studies conducted in premature neonates for the prevention of bronchopulmonary dysplasia have not demonstrated substantial evidence of efficacy [see Clinical Studies (14.3)] . No information about its effectiveness in other age populations is available. Nitric oxide is not indicated for use in the adult population. Vero Biotech Inc. 387 Technology Circle N

leaflet_short:

GENOSYL Delivery System cassettes produce at least 216 liters of 800 ppm nitric oxide gas (at standard temperature and pressure, STP) (NDC 72385-002-01). Store at 20°C to 25°C (68°F to 77°F) with excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature]. The GENOSYL Delivery System must be used with antioxidant cartridges not older than 12 months from the manufacturing date. 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 5ppm.

authorization_status:

New Drug Application

SPC

GENOSYL- NITRIC OXIDE GAS
VERO BIOTECH, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
GENOSYL SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR GENOSYL. GENOSYL
(NITRIC OXIDE), FOR
INHALATION USE
INITIAL U.S. APPROVAL: 1999
INDICATIONS AND USAGE
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 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).
DOSAGE FORMS AND STRENGTHS
GENOSYL (nitric oxide) is a gas, available at concentrations up to 800
ppm. (3)
CONTRAINDICATIONS
Neonates dependent on right-to-left shunting of blood (4).
WARNINGS AND PRECAUTIONS
Rebound Pulmonary Hypertension: Abrupt discontinuation of GENOSYL 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 Levels: Monitor NO levels (5.3).
Heart Failure: In patients with pre-existing left ventricular
dysfunction, GENOSYL may increase pulmonary
capillary wedge pressure leading to pulmonary edema (5.4).
ADVERSE REACTIONS
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.
DRUG INTERACTIONS
Nitric oxide donor compounds may increase the risk of developing
methemoglo