Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Acute Changes in Oxygenation and Lung Compliance [ see Warnings and Precautions (5.1 )] Administration-Related Adverse Reactions [see Warnings and Precautions (5.2) ] Intraventricular Hemorrhage and Periventricular Leukomalacia [ see Warnings and Precautions (5.3) ] 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 safety of INFASURF is based on the pooled safety population from three, randomized, active-controlled clinical trials that evaluated INFASURF to reduce the risk of respiratory distress syndrome (RDS) and rescue treatment of RDS [ see Clinical Studies (14) ], which included 1,554 preterm neonates who received at least one dose of INFASURF.
The most common INFASURF administration-related adverse reactions were cyanosis (65%), airway obstruction (39%), bradycardia (34%), reflux of surfactant into the endotracheal tube (21%), requirement for manual ventilation (16%), and reintubation (3%).
6.2 Complications of RDS and Neurodevelopmental Outcomes Incidence of Common Complications of Prematurity The controlled trials of INFASURF included the incidence of common complications of prematurity and RDS as safety endpoints.
Tables 1 and 2 display the results in the INFASURF vs.
colfosceril palmitate trials and the INFASURF and beractant trials, respectively.
Trials 1, 2, and 3 were not designed to evaluate meaningful comparisons of the incidence of adverse reactions in the INFASURF and the colfosceril palmitate and beractant treatment groups.
Table 1 Common Complications of Prematurity and RDS in Controlled Trials of INFASURF vs colfosceril palmitate Complication INFASURF (N=1,001) % colfosceril palmitate (N=978) % Apnea 61 61 Patent ductus arteriosus 47 48 Intracranial hemorrhage 29 31 Severe intracranial hemorrhage a 12 10 IVH and PLV b 7 3 Sepsis 20 22 Pulmonary air leaks 12 22 Pulmonary interstitial emphysema 7 17 Pulmonary hemorrhage 7 7 Necrotizing enterocolitis 5 5 a Grade III and IV by the method of Papile.
b Patients with both intraventricular hemorrhage and periventricular leukomalacia.
Table 2 Common Complications of Prematurity and RDS Controlled Trials of INFASURF vs beractant Complication INFASURF (N=553) % beractant (N=566) % Apnea 76 76 Patent ductus arteriosus 45 48 Intracranial hemorrhage 36 36 Severe intracranial hemorrhage a 9 7 IVH and PVL b 5 5 Sepsis 28 27 Pulmonary air leaks 15 15 Pulmonary interstitial emphysema 10 10 Pulmonary hemorrhage 7 6 Necrotizing enterocolitis 17 18 a Grade III and IV by the method of Papile.
5 WARNINGS AND PRECAUTIONS 5.1 Acute Changes in Oxygenation and Lung Compliance The administration of exogenous surfactants, including INFASURF, can rapidly affect oxygenation and lung compliance.
Frequently monitor neonates who receive INFASURF so that oxygen and ventilatory support can be modified in response to changes in respiratory status.
INFASURF should only be administered by those trained and experienced in the care, resuscitation, and stabilization of preterm neonates with RDS who require intubation.
5.2 Administration-Related Adverse Reactions Administration-related adverse reactions associated with INFASURF use included cyanosis, bradycardia, airway obstruction, and reflux of INFASURF into the endotracheal tube.
These adverse reactions occurred more frequently in neonates who received repeat doses of INFASURF at 12-hour intervals than neonates that received colfosceril palmitate, the comparator, in randomized controlled trials (Trials 1 and 3) [ see Clinical Studies (14) ].
Like all medications, Infasurf can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: