Drug information of Beractant

Replaces deficient or ineffective endogenous lung surfactant in neonates with respiratory distress syndrome (RDS) or in neonates at risk of developing RDS. Surfactant prevents the alveoli from collapsing during expiration by lowering surface tension between air and alveolar surfaces

Onset of Action
Improved oxygenation: Within minutes

Respiratory distress syndrome: Prevention of respiratory distress syndrome (RDS) in premature neonates with birth weight <1,250 g or with evidence of surfactant deficiency (administer within 15 minutes of birth); treatment of RDS in neonates with x-ray confirmation of RDS and requiring mechanical ventilation (administer within 8 hours of birth

Usual Pediatric Dose for Respiratory Distress Syndrome
Less than 48 hours of life

Prevention of RDS in infants less than 1250 g birth weight: 100 mg/kg birth weight intratracheally, preferably within 15 minutes of birth

Treatment (rescue) of RDS: 100 mg/kg birth weight intratracheally, preferably by 8 hours of age

Maintenance dose: Doses of 100 mg/kg birth weight can be repeated every 6 hours

Maximum dose: Total of 4 doses within 48 hours of life

48
 hours of life or older: Data not available

There are no contraindications listed in the manufacturer's labeling

>10%
Cardiovascular: Bradycardia (transient
1%
to 10%: Respiratory: Oxygen desaturation
<1%
postmarketing, and/or case reports: Apnea, emphysema (pulmonary interstitial), hypercapnia, hypertension, hypotension, increased susceptibility to infection (post-treatment nosocomial sepsis), low blood CO2, obstruction of endotracheal tube, pallor, pneumothorax (including pneumopericardium), vasoconstriction

Bradycardia-Causing Agents, Ceritinib, Fexinidazole [INT], Ivabradine, Lacosamide, Midodrine,
Ruxolitinib, Siponimod, Terlipressin, Tofacitinib

Follow your doctor's instructions about any restrictions in feeding, medications, or activity after your baby has been treated with beractant

Safety and efficacy have not been established in patients older than 48 hours of life

There is an increased risk of post-treatment nosocomial sepsis in treated neonates this increased risk was not associated with increased mortality

Transient episodes of bradycardia and decreased oxygen saturation may occur. Discontinue dosing procedure and initiate measures to alleviate the condition; may reinstitute after the patient is stable. Rales and moist breath sounds may occur; endotracheal suctioning or other remedial action is necessary if clear-cut signs of airway obstruction are present

Your baby will receive this medication in a neonatal intensive care unit (NICU) or similar hospital setting

Beractant is given directly into the baby's lungs through a breathing tube that is also connected to a ventilator (a machine that moves air in and out of the lungs to help your baby breathe easier and get enough oxygen

Your baby will remain under constant supervision during treatment with beractant

Follow your doctor's instructions about any restrictions on feeding or other medications after your child has been treated with beractant

Beractant is given as soon as possible after the baby's birth, usually within minutes or hours

Your baby's breathing, blood pressure, oxygen levels, and other vital signs will be watched closely during treatment with beractant. This will help your doctor determine how long to continue treatment with beractant. Your child may also need blood tests

Since beractant is given as needed by a healthcare professional, it is not likely that your baby will miss a dose

This drug significantly reduces the incidence of mortality due to RDS and air leak complications

Marked improvements in oxygenation may occur within minutes of administration; monitor frequently and carefully the systemic oxygenation to avoid hyperoxia

Stop the dosing procedure if the infant experiences bradycardia or oxygen desaturation; initiate appropriate measures to alleviate the condition, and resume treatment after the infant has stabilized

Rales and moist breath sounds can occur transiently after administration

If clear-cut signs of airway obstruction are present, endotracheal suctioning or other remedial action may be necessary

Each vial of this drug is for single use only; used vials with residual drug should be discarded

Storage requirements: Refrigerated (2C to 8C

Leave this drug at room temperature for 20 minutes, or warm in the hand for 8 minutes before administration; artificial warming methods should not be used

Discard each vial if not used within 8 hours of rewarming to room temperature; vials should not be returned to the refrigerator once warmed

Inspect visually for discoloration prior to administration; some settling may occur during storage, which can be redispersed by gently inverting the vial several times, without shaking

There is no data regarding the use of this drug during pregnancy
Animal studies in rats showed no observable adverse effects in their offspring at the
maximum feasible dose volume of this drug