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NEOPHYR is a brand name for Nitric Oxide. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Neophyr, in conjunction with ventilatory support and other appropriate active substances, is indicated: for the treatment of newborn infants ≥ 34 weeks gestation with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension, in order to improve oxygenation and to…
Verbatim from this product's MHRA label. Tap a section to expand.
Persistent Pulmonary Hypertension in the Newborn (PPHN) Prescription of nitric oxide should be supervised by a physician experienced in neonatal intensive care. Prescription should be limited to those neonatal units that have received adequate training in the use of a nitric oxide delivery system.
Neophyr should only be delivered according to a neonatologist’s prescription. Neophyr should be used in ventilated newborn infants expected to require support >24 hours. Neophyr should be used only after respiratory support has been optimised.
This includes optimising tidal volume/pressures and lung recruitment (surfactant, high frequency ventilation, and positive end expiratory pressure). Pulmonary hypertension associated with heart surgery Prescription of nitric oxide should be supervised by a physician experienced in cardiothoracic anaesthesia & intensive care.
Prescription should be limited to those cardio-thoracic units that have received adequate training in the use of a nitric oxide delivery system. Neophyr should only be delivered according to an anaesthetist’s or intensive care physician’s prescription.
Posology The posology will be determined in accordance with the medical condition of the patient. Due to the potential risk of NO2 formation, continuous monitoring of NO2 must be performed. Persistent Pulmonary Hypertension in the Newborn (PPH) Newborns > 34 weeks gestation: The maximum recommended dose of Neophyr is 20 ppm and this dose should not be exceeded.
Starting as soon as possible, and in the first 4-24 hours of therapy, the dosage must be reduced gradually to 5 ppm or less, titrating it to the needs of the individual patient, as long as the clinical parameters (oxygenation, arterial pulmonary pressure) are within the desired limits.
60). The treatment can be pursued up to 96 hours or until the oxygen de-saturation is resolved and the patient is ready for gradual withdrawal from Neophyr treatment. The duration of the treatment should be limited to be as short as possible.
The duration is variable, but typically, less than 4 days. If there is no response to the inhaled nitric oxide, consult section
Summary of safety profile Abrupt discontinuation of the administration of inhaled nitric oxide may cause rebound reaction; decrease in oxygenation and increase in central pressure and subsequent decrease in systemic blood pressure.
Rebound reaction is the most commonly adverse reaction in association with the clinical use of Neophyr. The rebound may be seen early as well as late during therapy. In one clinical study (NINOS), treatment groups were similar with respect to the incidence and severity of intracranial haemorrhage, Grade IV haemorrhage, periventricular leukomalacia, cerebral infarction, seizures requiring anticonvulsant therapy, pulmonary haemorrhage, or gastrointestinal haemorrhage.
Tabulated list of adverse reactions The adverse reactions listed are derived from CINGRI study, review of public domain scientific literature and post marketing safety surveillance (the table below shows adverse reactions that occurred in at least 5 % of patients receiving iNO in the CINRGI study).
Adverse reactions are listed according to MedDRA frequency convention: very common (≥ 1/10), common (≥ 1/100 to <1/10), uncommon (≥ 1/1,000 to <1/100), rare (≥ 1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
System organ class Very common Common Not known Blood and lymphatic system disorders Thrombocytopenia - - Metabolism and nutrition disorders Hypokalemia - - Nervous system disorders - Headache* Vascular diorders Hypotension - Pulmonary artery pressure increased** Hypotension** Respiratory, thoracic and mediastinal disorders Atelectasis - - Hepatobiliary disorders Hyperbilirubinemia Investigations Methaemo globin increased, Hypoxemia** * Post-Marketing Safety Surveillance (PMSS) data, symptom experienced by personnel associated to accidental environmental exposure **PMSS data, effects associated with acute withdrawal of the medicinal product, and dose errors associated with the delivery system.
4. Weaning Attempts to wean Neophyr should be made after the ventilator support is substantially decreased or after 96 hours of therapy. When the decision is made to discontinue inhaled nitric oxide therapy, the dose should be reduced to 1 ppm for 30 minutes to one hour.
If there is no change in oxygenation during administration of Neophyr at 1 ppm, the FiO2 should be increased by 10 %, the Neophyr is discontinued, and the neonates monitored closely for signs of hypoxaemia. If oxygenation falls >20 %, Neophyr therapy should be resumed at 5 ppm and discontinuation of Neophyr therapy should be reconsidered after 12 to 24 hours.
Infants who cannot be weaned off Neophyr by 4 days should undergo careful diagnostic work-up for other diseases. Pulmonary hypertension associated with heart surgery Neophyr should be used only after conservative support has been optimised.
Neophyr should be administered under close monitoring of hemodynamics and oxygenation. Newborn infants, infants and toddlers, children and adolescents, ages 0-17 years The starting dose of inhaled nitric oxide is 10 ppm(parts per million) of inhaled gas.
The dose may be increased up to 20 ppm if the lower dose has not provided sufficient clinical effects. The lowest effective dose should be administered and the dose should be weaned down to 5 ppm provided that the pulmonary artery pressure and systemic arterial oxygenation remain adequate at this lower dose.
Clinical data supporting the suggested dose in the age range 12-17 years is limited. Adults The starting dose of inhaled nitric oxide is 20 ppm (parts per million) of inhaled gas. The dose may be increased up to 40 ppm if the lower dose has not provided sufficient clinical effect.
The lowest effective dose should be administered and the dose should be weaned down to 5 ppm provided that the pulmonary artery pressure and systemic arterial oxygenation remain adequate at this lower dose. The effects of inhaled nitric oxide are rapid, decrease in pulmonary artery pressure and improved oxygenation is seen within 5-20 minutes.
Newborns with known dependency to right-left blood shunt or newborns with significant left-right shunt. - Patients with congenital or acquired deficiency of methaemoglobin reductase (MetHb reductase) or glucose 6 phosphate dehydrogenase (G6PD).
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Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Rapid rebound reactions such as intensified pulmonary vasoconstriction after sudden withdrawal of inhaled nitric oxide therapy has been described, precipitating cardiovascular collapse. Description of selected adverse reactions Inhaled nitric oxide therapy may cause an increase in methaemoglobin.
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard.
In case of insufficient response the dose may be titrated after a minimum of 10 minutes. Consideration should be given to discontinuation of treatment if no beneficial physiological effects are apparent after a 30-minute trial of therapy.
Treatment may be initiated at any time point in the perioperative course to lower pulmonary pressure. In clinical studies treatment was often initiated before separation from Cardio Pulmonary Bypass. Inhaled NO has been given for time periods up to 7 days in the perioperative setting, but common treatment times are 24 -48 hours.
Weaning Attempts to wean Neophyr should be commenced as soon as the hemodynamics have stabilised in conjunction to weaning from ventilator and inotropic support. The withdrawal of inhaled nitric oxide therapy should be performed in a stepwise manner.
The dose should be incrementally reduced to 1 ppm for 30 minutes with close observation of systemic and central pressure, and then turned off. Weaning should be attempted at least every 12 hours when the patient is stable on a low dose of Neophyr.
Too rapid weaning from inhaled nitric oxide therapy carries the risk of a re-bound increase in pulmonary artery pressure with subsequent circulatory instability.
Additional information on special populations:
No relevant information for dosage adjustment recommendation on special populations, such as renal/hepatic impairment or geriatric, has been found. Therefore caution is recommended in these populations. The safety and efficacy of inhaled nitric oxide in premature infants less than 34 weeks of gestation has not yet been established, no recommendation or posology can be made.
Method of administration For inhalation use. Modalities of administration of Neophyr can modify the toxicity profile of the drug. Administration recommendations have to be followed. Nitric oxide is normally administered by inhalation in patients via mechanical ventilation after it has been diluted with a mix of oxygen/air using a nitric oxide administration device that has been approved for clinical use as per the European Community standards (CE marked).
Direct endotracheal administration without dilution is contra-indicated due to the risk of local lesion of the mucous membrane when it comes into contact with the gas. NO must correctly mix with other gases in the ventilator circuit.
It is advisable to ensure the least amount of contact time possible between the nitric oxide and the oxygen in the inspiratory circuit in order to limit the risk of the formation of toxic oxidation derivatives in the inhaled gas. The administration system should supply a constant concentration of inhaled Neophyr, notwithstanding the ventilation equipment and ventilation modality utilised.
In order to avoid errors in the dosage, the concentration of Neophyr inhaled must be continually regulated in the inhalation branch of the circuit close to the patient, and near the tip of the endotracheal tube. The concentration of nitrogen dioxide (NO2) and FiO2 must also be regulated in the same place using a calibrated and EC-approved monitoring apparatus.
The concentration of NO2 in the inhaled mix must be as low as possible. If the concentration of NO2 exceeds 1 ppm, the dose of Neophyr and/or FiO2 must be reduced, having ruled out any possible malfunction in the administration system.
05: the fraction of inhaled oxygen must not vary more than 5% ). If an unexpected change in the concentration of Neophyr is produced, refer to the instruction for use of the administration device. The pressure of the Neophyr gas cylinder must be monitored in order to allow the gas cylinder to be changed without interruptions or changes to the treatment.
There must also be a reserve supply of gas cylinders to allow changes at the […]