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CUROSURF is a brand name for Poractant Alfa, supplied as a suspension. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Curosurf® (poractant alfa) is indicated for: the treatment of Respiratory Distress Syndrome (RDS) in premature infants. To treat premature infants requiring mechanical ventilation with clinical signs of surfactant deficiency and/or RDS confirmed by x-ray. The first dose of Curosurf has to be administered as soon as…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations FOR INTRATRACHEAL ADMINISTRATION ONLY. 3 Administration using conventional administration methods). Before administering Curosurf assure proper placement and patency of the endotracheal tube. At the discretion of the clinician, the endotracheal tube may be suctioned before administering Curosurf.
The infant should be allowed to stabilize before proceeding with dosing. 3 Administration using LISA method). Curosurf should be administered by or under the supervision of clinicians experienced in intubation, ventilation management and general care of premature infants.
Marked improvements in oxygenation may occur within minutes of administration of Curosurf. Therefore, frequent and careful clinical observation and arterial or transcutaneous monitoring of systemic oxygenation are essential to avoid hyperoxia, which could cause an increased incidence of intracranial haemorrhage.
If oxygen saturation is in excess of 95 %, FiO2 should be promptly reduced until it reaches 90 - 95 % and, if necessary, peak ventilator inspiratory pressure reduced. Failure to reduce ventilatory inspiratory pressure rapidly can result in lung distension and fatal pulmonary air leaks.
Assisted ventilation should not be Serious Warnings and Precautions Curosurf is intended for Intratracheal use only (see DOSAGE AND ADMINISTRATION). Curosurf should only be administered by those trained and experienced in the care and resuscitation of preterm infants.
Prior to administering Curosurf, the infant’s general conditions should be stabilized (see INDICATIONS, WARNINGS AND PRECAUTIONS: General and Monitoring and Laboratory Tests sections below). The administration of exogenous surfactants, including Curosurf, can rapidly affect oxygenation and lung compliance; therefore, frequent clinical and laboratory assessments are needed to determine modifications to oxygen concentration and ventilator settings (see WARNINGS AND PRECAUTIONS: Monitoring and Laboratory Tests section below).
Administration of Curosurf may cause bradycardia, hypotension, endotracheal tube blockage, apnea, airway obstruction, and oxygen desaturation. Sto p administration and take appropriate measures to alleviate such conditions. Dosing may proceed after the patient is stable (see WARNINGS AND PRECAUTIONS).
01/CT/04/93). Adverse reactions generally seen with Curosurf are bradycardia and hypotension; other events reported were endotracheal tube blockage and oxygen desaturation (see DOSAGE AND ADMINISTRATION section on how to minimize these events).
Pulmonary haemorrhage has been reported both in clinical trials with Curosurf and in post-marketing adverse drug reaction (ADR) reports in infants who had received Curosurf. The Non-INvasive Surfactant APPlication (NINSAPP) study compared surfactant administration via LISA technique to conventional endotracheal intubation (referred to as “conventional administration”).
7%) patients, respectively. 8%] patients in the LISA and control groups, respectively). All these reactions were serious, either moderate or severe in intensity and resolved by the end of the study. 2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions.
The adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be comp ared to the rates in the clinical trials of another drug. Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use.
Use with conventional administration The six randomized, multicenter, controlled trials of Curosurf included four rescue studies and two prevention studies conducted in approximately 3,400 infants. 01/CT/04/93), patients were randomized if they were within specific gestational age limits (24 to 30 weeks and 25 to 31 weeks, respectively).
EURO I is the only study in which patients were randomised to receive either Curosurf or a “sham” treatment. In the “sham” treatment, patients were disconnected from the respirator for 2 minutes and manually ventilated using the same protocol as for patients treated with Curosurf except that no material was instilled into the airways.
Please see the SERIOUS WARNINGS AND PRECAUTIONS BOX at the beginning of Part I:
Health Professional Information. For management of a suspected drug overdose, contact your regional poison control centre. Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients Intratracheal Suspension 80 mg surfactant*/mL Suspension Sodium bicarbonate Sodium chloride Water for injection *Individual constituents of pig lung surfactant: phosphatidylchloline, dipalmitoylphosphatidylcholine, acidic phospholipids, surfactant proteins (SP-B & SP-C), Free fatty acids, triglycerides and cholesterol Curosurf® Product Monograph Page 11 of 32 General Curosurf should only be administered by those trained and experienced in the care, resuscitation, and stabilization of pre-term infants.
Prior to starting treatment with Curosurf the infant’s general conditions should be stabilized. Correction of acidosis, hypotension, anaemia, hypoglycemia and hypothermia is also recommended. During administration of Curosurf, transient episodes of bradycardia, hypotension, endotracheal tube blockage, apnea, airway obstruction, and oxygen desaturation may occur.
These events require stopping Curosurf administration and taking appropriate measures to alleviate the condition. After the patient is stable, dosing may proceed with appropriate monitoring. Administration of Curosurf to preterm infants with severe hypotension has not been studied.
Infants born following prolonged rupture of membranes (> 3 weeks) may not demonstrate an optimal response. Surfactant administration can be expected to reduce the severity of RDS but will not eliminate entirely the mortality and morbidity associated with prematurity, as preterm babies may have other complications.
In cases of unsatisfactory response to treatment with Curosurf or rapid relapse, it is advisable to consider the possibility of other complications of immaturity such as patent ductus arteriosus or other lung diseases such as pneumonia before the administration of the next dose.
Curosurf is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
No specific contraindications have been identified. Curosurf® Product Monograph Page 6 of 32
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Curosurf® Product Monograph Page 7 of 32 abruptly stopped so as not to increase the risk of apnoea. Transient episodes of bradycardia, hypotension, endotracheal tube blockage, apnea, airway obstruction, and oxygen desaturation have occurred during the dosing procedure of Curosurf by endotracheal tube or thin tube (LISA technique).
These events require interrupting the administration of Curosurf and taking the appropriate measures to alleviate the condition. After stabilization, dosing may resume with appropriate monitoring. Infants whose ventilation becomes markedly impaired during or shortly after dosing may have mucous plugging of the endotracheal tube, particularly if pulmonary secretions were prominent prior to drug administration.
Suctioning of all infants prior to dosing ma y lessen the probability of mucous plugs obstructing the endotracheal tube. If endotracheal tube obstruction from such plugs is suspected, and suctioning is unsuccessful in removing the obstruction, the blocked endotracheal tube should be replaced immediat ely.
5 mL/kg (200 mg/kg) birth weight. This dose may be determined from the Curosurf dosing chart below. This dose is administered into each main bronchus via a feeding tube to ensure proper distribution (and not into the lower trachea). 25 mL/kg (100 mg/kg) birth weight each may be administere d, using the same technique described for the initial dose.
Repeat doses should be administered, at approximately 12-hour intervals, in infants who remain intubated and in whom RDS is considered responsible for their persisting or deteriorating respiratory status. The maximum recommended total dose (sum of the initial and up to two repeat doses) is 5 mL/kg (300 -400 mg/kg).
3 Administration Curosurf should be inspected visually for discoloration prior to administration. The color of Curosurf is white to creamy white. A slight color change, towards yellow, may occur on aging without denoting product degradation.
Before use, the vial should be slowly warmed to room temperature (by holding it in an incubator for about one hour or in a thermostated bath for about three minutes), and gently turned upside- down, in order to obtain a uniform suspension.
DO NOT SHAKE. See STORAGE, STABILITY AND DISPOSAL, and SPECIAL HANDLING INSTRUCTIONS. Use with conventional administration Curosurf is administered intratracheally by instillation through a 5 French […]
Most common (≥ 10% of patients in either treatment group) complications associated with prematurity by treatment in a randomised study (EURO I) in which Curosurf was compared to placebo (“sham”) treatment are reported in Table 3.
Curosurf® Product Monograph Page 15 of 32 Table 3 EURO I TRIAL:
MOST COMMON COMPLICATIONS ASSOCIATED WITH PREMATURITY (≥ 10% of patients for each treatment group)* Percentage and Number (n/N) of Patients a Curosurf (200 mg/kg) Sham b Number of infants randomized Patients with at least one complicationa Acquired Pneumonia Acquired Septicemia Bronchopulmonary Dysplasia c Intracranial Haemorrhage d Patent Ductus Arteriosus Pneumothorax Pulmonary Interstitial Emphysema 78 89% (69/78) 17% (13/78) 14% (11/77) 19% (15/78) 51% (40/78) 60% (47/78) 21% (16/78) 21% (16/78) 66 91% (60/66) 21% (14/66) 18% (12/66) 22% (15/66) 64% (42/66) 48% (32/66) 36% (24/66) 38% (25/66) * At the time of the trial, adverse event reporting conventions allowed for collection of quantitative data related only to prematurity-related complications.
Adverse events other than those listed above may have occurred in ≥10% of patients. a Not all complications were assessed (as present or not present) for each patient; therefore, denominators reflect the total number of patients assessed for a specific complication b “Sham” treated patients received manual ventilation only with no surfactant instilled.
c Grades III - IV. d Grades I - IV. 01/CT/04/93, EURO I, EURO III, EURO IV, EURO VI) combined. The rates of these complications in the controlled trials for infants who received rescue or prevention treatment with Curosurf and were randomized, are in Table 4 (pooled data from six trials).
9% (21/237) * At the time of the trial(s), adverse event reporting conventions allowed for collection of quantitative data related only to prematurity-related complications. Adverse events other than those listed above may have occurred in ≥10% of patients.
NA Not assessed a Not all complications were assessed (as present or not present) for each patient; therefore, denominators reflect the total number of patients assessed for a specific complication. b […]
25 mL/kg (100 mg/kg), administration of more than three total doses, dosing more frequently than every 12 hours, or initiating therapy with Curosurf starting more than 15 hours after diagnosing RDS. , high-frequency ventilation. The administration of Curosurf to preterm infants with severe hypotension has not been studied.
The most common complication reported in the Curosurf group in clinical trials was patent ductus arteriosus, which was reported at a higher rate than in the sham group. This is not an unexpected finding, since the direction of blood flow through the ductus arteriosus is controlled largely by the degree of pulmonary vascular resistance in infants with RDS.
In most infants with RDS, pulmonary vascular resistance decreases as recovery from RDS begins, leading to the clinical appearance of pulmonary congestion from increased left -to-right blood flow. , “rescue” group). Apnoea and sepsis neonatal may occur as a consequence of the immaturity of the in fants.
Curosurf® Product Monograph Page 12 of 32 Preterm newborns have relatively high incidences of cerebral haemorrhages, cerebral ischemia, periventricular leukomalacia and haemodynamic anomalies such as patent ductus arteriosus and persistence of fetal circulation despite the provision of intensive care.
g. septicaemia). Preterm newborns also commonly develop haematological and electrolyte disorders which may be worsened by severe illness and mechanical ventilation. To complete the picture of complications of prematurity, the following disorders directly related to illness severity and use of mechanical ventilation, necessary for reoxygenation, may occur: pneumothorax, interstitial pulmonary emphysema and pulmonary haemorrhage.
Finally, the prolonged use of high concentrations of oxygen and mechanical ventilation are associated with the development of bronchopulmonary dysplasia and retinopathy of prematurity. Carcinogenesis and Mutagenesis Carcinogenicity studies have not been performed with Curosurf, or other surfactants.
Mutagenicity studies of Curosurf have not indicated an increase in mutagenic potential. Immune In antigenicity studies in animals, Curosurf did not provoke an acute anaphylactic reaction after repeat sensitization by the intratracheal route and did not induce the formation of specific antibodies after sensitization by the subcutaneous route.
, disconnection from respirator and manual ventilation for 2 minutes). Infants treated with surfactant should be carefully monitored with respect to signs of i nfection. At the earliest signs of infection, the infant should immediately be given appropriate antibiotic therapy.
Monitoring and Laboratory Tests After administration of exogenous surfactants, including Curosurf, pulmonary compliance (chest expansion) and oxygenation can improve rapidly, thus requiring prompt adjustment of ventilator settings.
Infants receiving Curosurf should receive frequent clinical and laboratory assessments so that oxygen and ventilator support can be modified to respond to respir atory changes. The improvement of alveolar gas exchange can result in a rapid increase of arterial […]