Alveofact

Alveofact is indicated for prevention and treatment of Respiratory Distress Syndrome (RDS) (hyaline membrane disease) in premature infants. Prevention:  In premature infants less than 1250 g birthweight, or with evidence of surfactant deficiency, give Alveofact ... Read more Alveofact is indicated for prevention and treatment of Respiratory Distress Syndrome (RDS) (hyaline membrane disease) in premature infants. Prevention:  In premature infants less than 1250 g birthweight, or with evidence of surfactant deficiency, give Alveofact as soon as possible, preferably within 15 minutes of birth. Rescue:  To treat infants with RDS confirmed by X-ray and requiring mechanical ventilation, give Alveofact as soon as possible, preferably by 8 hours of age. Results from clinical studies suggest that little benefit is likely to be gained from giving Alveofact to infants who have completed a prenatal course of corticosteroids, unless they develop RDS within the first 6-8 hours of life. The results of outborn compared to inborn infants were not analysed separately in the clinical trials. Outborn infants were distributed equally between the treatment groups and were not considered likely to bias the estimation of treatment effect. Therefore, there does not appear to be any evidence to suggest that outborn infants  respond less well to treatment with Alveofact.

Endogenous pulmonary surfactant lowers surface tension on alveolar surfaces during respiration and stabilizes the alveoli against collapse at resting transpulmonary pressures. Deficiency of pulmonary surfactant causes Respiratory Distress Syndrome (RDS) in premature infants. Phospholipid replenishes surfactant and restores surface activity to the lungs of these infants. In vitro, Phospholipid reproducibly lowers minimum surface tension to less than 8 dynes/cm on the pulsating bubble surfactometer and Wilhelmy Surface Balance. In vivo, single Phospholipid doses improve lung pressure-volume measurements,  lung compliance, and oxygenation in premature rabbit and sheep.

For Intratracheal Administration Only. Survanta should be administered by or under the supervision of clinicians experienced in intubation, ventilator management and general care of premature infants. Marked improvements in oxygenation may occur within minutes of administration of Survanta. Therefore, frequent and careful clinical observation and monitoring of systemic oxygenation are essential to avoid hyperoxia. Each dose of Survanta is 100 mg of phospholipid/kg birth weight (4 mL/kg). The Survanta Dosage Chart shows the total dosage for a range of birth weights. Four doses of Survanta can be administered in the first 48 hours of life. Doses should be given no more frequently than every 6 hours.

Respiratory : lung consolidation, blood from the endotracheal tube, deterioration after weaning, respiratory decompensation, subglottic stenosis, paralyzed diaphragm, respiratory failure.

Cardiovascular : hypotension, hypertension, tachycardia, ventricular tachycardia, aortic thrombosis, cardiac failure, cardio-respiratory arrest, increased apical pulse, persistent foetal circulation, air embolism, total anomalous pulmonary venous return.

Gastrointestinal : abdominal distension, haemorrhage, intestinal perforations, volvulus, bowel infarct, loading intolerance, hepatic failure, stress ulcer.

Renal : renal failure, haematuria.

Haematologic : coagulopathy, thrombocytopenia, disseminated intravascular coagulation

Central Nervous System : seizures.

Endocrine/Metabolic : adrenal haemorrhage, inappropriate ADH secretion, hyperphosphataemia.

Musculoskeletal : inguinal hernia.

Systemic : fever, deterioration.

Alveofact are intended for intratracheal use only. Alveofact can rapidly affect oxygenation and lung compliance. Therefore, its use should be restricted to a highly supervised clinical setting with immediate availability of clinicians experienced with intubation, ventilator management and general care of premature infants. Infants receiving Alveofact should be frequently monitored with arterial or transcutaneous measurement of systemic oxygen and carbon dioxide. During the dosing procedure, transient episodes of bradycardia and decreased oxygen saturation have been reported.  If these occur, stop the dosing procedure and initiate appropriate measures to alleviate the condition. After stabilization, resume the dosing procedure. General: Rales and moist breath sounds can occur transiently after administration. Endotracheal suctioning or other remedial action is not necessary unless clear-cut signs of airway obstruction are present. Increased probability of post-treatment nosocomial sepsis in Alveofact-treated infants was observed in the controlled clinical trials (See Table). The increased risk for sepsis among Alveofact-treated infants was not associated with increased mortality among these infants. The causative organisms were similar in treated and control infants. There was no significant difference between groups in the rate of post-treatment infections other than sepsis. Use of Alveofact in infants less than 600 g birth weight or greater than 1750 g birth weight has not been evaluated in controlled trials. There is no controlled experience with use of Alveofact in conjunction with experimental therapies for RDS (eg. high-frequency ventilation or extracorporeal membrane oxygenation). No information is available on the effects of doses other than 100 mg Alveofacts / kg, more than four doses, dosing more frequently than every 6 hours, or administration after 48 hours of age.

Overdosage with Alveofact has not been reported. Based on animal data, overdosage might result in acute airway obstruction. Treatment should be symptomatic and supportive. Rales and moist breath sounds can transiently occur after Alveofact is given, and do not indicate overdosage. Endotracheal suctioning or other remedial action is not required unless clear-cut signs of airway obstruction are present.

Store unopened vials at refrigeration temperature (2-8°C). Protect from light. Store vials in carton until ready for use. Vials are for single use only.  Upon opening, discard unused drug.