Overview:
The Beractant drug helps in the normal functioning of the lungs. It is an exogenous natural pulmonary surfactant or an agent that works on the lung surface. Beractant is a modified bovine pulmonary surfactant that contains the lung extracts such as phospholipids, fatty acids, neutral lipids, and bovine surfactant proteins to which DPPC (dipalmitoylphosphatidylcholine), tripalmitin, and palmitic acid are added. It functions similarly to the fluid that is naturally present in the lungs, which helps in the maintenance of effective breathing. It is used in the treatment of respiratory distress syndrome in premature babies whose lungs are not fully developed.
Beractant is manufactured by an American biopharmaceutical company, Abbvie, and the generic form of this drug is manufactured by Tekzima. The food and drug administration of the United States (FDA) approved Beractant for marketing in the year 1991. It was approved for the treatment of respiratory distress syndrome and the prevention of hyaline membrane disease (respiratory distress syndrome) in premature babies.
How Does Beractant Work?
In preparation for birth, the fetal lung produces endogenous lung surfactant to lower the surface tension on the alveolar surfaces and to prevent alveolar collapse against resting transpulmonary pressures. However, the developmental deficiency of surfactant due to the presence of respiratory distress syndrome results in the collapse of the alveoli. This causes rapid breathing, increased heart rate, hypoxia, and death in some cases. Beractant, a natural form of surfactant containing phospholipids, neutral lipids, fatty acids, and surfactant-associated proteins, replenishes the lung surfactant and restores the activity of surfactant by lowering surface tension on alveolar surfaces and preventing alveolar collapse by stabilizing it against collapse at resting transpulmonary pressures. It compensates for surfactant deficiency in premature babies and restores pulmonary compliance, and shows marked improvement in lung pressure-volume measurements and oxygenation.
What Are the Uses of Beractant?
- Beractant is used in the rescue (treatment) of respiratory distress syndrome in premature babies in whom respiratory distress syndrome has been confirmed by a radiograph and in those who require mechanical ventilation.
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Beractant is used in the prevention of hyaline membrane disease (respiratory distress syndrome) in premature babies with birth weights of fewer than 1250 grams or in those with evidence of surfactant deficiency.
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The treatment with Beractant lowers the incidence of rhonchi, wheezing, and tachypnea at follow-up during 24 months.
What Is the Dosage of Beractant?
Beractant intratracheal suspension is supplied in single-use glass vials that contain 4 mL or 8 mL of Beractant. The dosage of Beractant is expressed in terms of phospholipids. Each milliliter (mL) of Beractant contains 25 milligrams (mg) of phospholipids, including 11 to 15.5 mg of DPPC and of fewer than 1 mg of surfactant proteins.
Dosage for Preventing Respiratory Distress Syndrome in Premature Neonates
Beractant is used as an intratracheal suspension. It is administered as 100 mg per kg (kilogram), which is 4 mL per kg of birth weight in four divided doses. It should be given within 15 minutes after birth. Repeated doses are administered if the neonate has radiographically confirmed respiratory distress syndrome.
Dosage for Treatment of Respiratory Distress Syndrome in Premature Neonates
100 mg per kg of Beractant, which is 4 mL per kg of birth weight, and is given in four divided doses. It should be given within 8 hours after birth. Repeated doses are administered if the neonate remains intubated.
What Are the Drug Warnings?
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It should be used under the supervision of clinicians who are experienced in intubation, ventilatory support, and general care of premature neonates.
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Beractant therapy can affect oxygenation and lung compliance. Arterial or transcutaneous measurement of systemic oxygen and carbon dioxide should be performed to avoid hyperoxia.
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Bradycardia may occur. Beractant should be discontinued if bradycardia occurs, and appropriate treatment should be started to alleviate bradycardia and resume Beractant therapy.
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Infectious Complications: Post-treatment nosocomial sepsis may occur in Beractant therapy.
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Respiratory Effects: Rales and breath sounds may occur in this therapy.
For Patients
What Is Respiratory Distress Syndrome?
Respiratory distress syndrome is a condition in which adequate surfactant is not present in the lungs. It is a common disorder in newborn babies born six weeks or more before the due date. Surfactant is a natural liquid produced in the lungs at about 26 weeks of pregnancy. As the fetus develops, more surfactant is produced. Respiratory distress syndrome usually develops within 24 hours after birth. Surfactant lowers the surface tension on the alveolar surfaces and prevents alveolar collapse against resting transpulmonary pressures. However, the developmental deficiency of surfactant results in the collapse of the alveoli. This causes rapid breathing, increased heart rate, hypoxia, and death in some cases.
What Causes Respiratory Distress Syndrome in Neonates?
Preterm delivery causes respiratory distress syndrome. Surfactant is produced in the lungs at about 26 weeks of pregnancy. As the fetus develops, more surfactant is produced. Respiratory Distress Syndrome occurs if babies are born six weeks or more before the due date. Around half of all babies delivered between 28 and 32 weeks of pregnancy develop respiratory distress syndrome.
What Happens in Respiratory Distress Syndrome?
Most neonates present symptoms within minutes after birth. It may include: bluish discoloration of the skin and mucous membrane, brief cessation of breathing (apnea), reduced urine output, rapid breathing, nasal flaring, shallow breathing, shortness of breath, presence of breath sounds, and unusual breathing movements like drawing back of the chest muscles while breathing.
Learn More About Beractant
Facts to Know Before Starting Beractant:
When and Why Switch to Beractant?
Surfactants are the mainstay treatment for respiratory distress syndrome. Natural surfactants like Beractant are more effective compared to synthetic surfactants. Steroids such as glucocorticoids are currently used in the management of respiratory distress syndrome. If a preterm delivery is anticipated, it is administered to the mother before birth and to the neonate soon after birth.
How Effective Is Beractamt?
Beractant effectively replenishes lung surfactant and restores the activity of surfactant by lowering surface tension on alveolar surfaces and preventing alveolar collapse by stabilizing it against collapse at resting transpulmonary pressures. It lowers surface tension to less than eight dynes per centimeter as measured by the pulsating bubble surfactometer and Wilhelmy surface balance.
Things to Know Before Starting Beractant
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Beractant is given in a hospital setting by a healthcare professional.
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It is given directly into the baby's lungs through a breathing tube.
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The baby is kept under constant supervision during Beractant treatment.
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The doctor's instructions during Beractant treatment should be carefully followed.
Starting Beractant:
How is Beractant given?
It is administered in a neonatal intensive care unit (NICU) or in a similar hospital setting. Beractant is administered directly into the baby's lungs via a breathing tube within minutes or hours after the birth of the baby. The breathing tube remains connected to a ventilator to provide oxygen support. The baby's breathing, blood pressure, oxygen levels, and other vital signs are monitored closely during treatment with Beractant. This helps in determining the duration of Beractant therapy.
Do's and Don'ts While Under Beractant:
For an effective treatment outcome, the instructions provided by the baby's caregivers should be carefully followed. The doctor's instructions on any restrictions in feeding, medications, or activity after Beractant treatment should be followed. Since this drug is administered in a hospital setting by a healthcare professional, it is unlikely to miss a dose. An overdose is unlikely to occur in a hospital setting, and a Beractant overdose does not produce any life-threatening symptoms.
Things to Do After Beractant Treatment:
The instructions provided by the baby's caregivers should be carefully followed, and the doctor's instructions on any restrictions in activity after Beractant treatment should be followed.
Diet Modifications:
The doctor's instructions on any restrictions in feeding should be followed.
Look Out for the Side Effects:
The baby's caregivers should be informed about the common and rare side effects of Beractant so that the symptoms can be easily recognized. If side effects are present, they should be informed to the doctor. Beractant may cause breathing difficulties and some other side effects that are not listed here.
The common side effects include the following
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Pale skin.
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Slow heartbeat.
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Cessation of breathing.
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Reduced urine output.
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Blood in the urine.
Respiratory Effects:
It causes respiratory side effects such as lung consolidation, deterioration after weaning, bleeding from the endotracheal tube, respiratory decompensation, subglottic stenosis, paralyzed diaphragm, and respiratory failure.
Cardiovascular Effects:
It causes cardiovascular side effects such as cardiac failure, hypotension, tachycardia, hypertension, ventricular tachycardia, aortic thrombosis, cardio-respiratory arrest, persistent fetal circulation, increased apical pulse, air embolism, total anomalous pulmonary venous return.
Gastrointestinal Effects:
It causes gastrointestinal effects like hemorrhage, abdominal distension, volvulus, bowel infarction, intestinal perforations, hepatic failure, and stress ulcers.
Hematologic Effects:
It causes hematologic effects like thrombocytopenia, coagulopathy, and disseminated intravascular coagulation.
Real Effects:
It causes renal effects like renal failure and hematuria.
Central Nervous System:
Beractant causes seizures as a side effect.
Endocrine Effects:
It causes metabolic side effects like adrenal hemorrhage and hyperphosphatemia.
Musculoskeletal Effects:
It causes musculoskeletal effects like an inguinal hernia.
Systemic effects:
Beractant causes side effects like fever and deterioration.
It causes less serious side effects are:
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Noisy breathing.
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Feeding or bowel problems.
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Bleeding around the endotracheal tube.
Staying on Beractant:
Tips to Stay on Track:
Since the Beractant drug is administered in a hospital setting by a healthcare professional, it is unlikely to miss a dose.
Things to remember,
1) The baby will receive Beractant in a neonatal intensive care unit, and the baby will remain under constant supervision during Beractant therapy.
2) The doctor's instructions on any restrictions in feeding, medications, or activity after Beractant treatment should be carefully followed.
3) The baby's parents or guardians should be aware of the risk of side effects such as slow heartbeat and reduced oxygen saturation.
For Doctors
Indications:
Beractant is indicated in the treatment of respiratory distress syndrome in premature babies in whom respiratory distress syndrome has been confirmed by a radiograph and in those who require mechanical ventilation. Beractant is used in the prevention of hyaline membrane disease (respiratory distress syndrome) in premature babies with birth weights of fewer than 1250 grams or in those with evidence of surfactant deficiency.
Mechanism of Action:
In preparation for birth, the fetal lung produces endogenous lung surfactant to lower the surface tension on the alveolar surfaces and to prevent alveolar collapse against resting transpulmonary pressures. However, the developmental deficiency of surfactant due to the presence of respiratory distress syndrome results in the collapse of the alveoli. This causes rapid breathing, increased heart rate, hypoxia, and death in some cases. Beractant, a natural form of surfactant containing phospholipids, neutral lipids, fatty acids, and surfactant-associated proteins, replenishes the lung surfactant and restores the activity of surfactant by lowering surface tension on alveolar surfaces and preventing alveolar collapse by stabilizing it against collapse at resting transpulmonary pressures. It compensates for surfactant deficiency in premature babies and restores pulmonary compliance, and shows marked improvement in lung pressure-volume measurements and oxygenation.
Pharmacodynamics:
In vitro studies showed that Beractant lowers the surface tension to less than eight dynes per centimeter as measured by the Wilhelmy surface balance and the pulsating bubble surfactometer. It restores pulmonary compliance in surfactant-deficient lungs. A single dose of Beractant improves lung pressure-volume measurements, lung compliance, and oxygenation.
Absorption:
Beractant is directly administered to the lungs, where it exerts effects at the alveolar surface. It shows marked improvements in oxygenation within minutes of administration. Following Beractant administration, improvements in arterial-alveolar oxygen ratio and mean airway pressure were sustained for 48 to 72 hours.
Distribution:
No information is available regarding the distribution of Beractant.
Metabolism:
Animal studies showed that alveolar clearance is rapid for radio-labeled lipid components of Beractant. The lipids enter the endogenous surfactant pathways of reutilization and recycling in the lungs. The effects of this drug on endogenous surfactant metabolism are not known.
Elimination:
No information is available regarding the route of elimination, half-life, and clearance of Beractant.
Warnings and Precautions:
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Beractant should be used under the supervision of clinicians who are experienced in intubation, ventilatory support, and general care of premature neonates.
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Beractant therapy can affect oxygenation and lung compliance. Arterial or transcutaneous measurement of systemic oxygen and carbon dioxide should be performed to avoid hyperoxia.
-
Bradycardia may occur. Beractant should be discontinued if bradycardia occurs, and appropriate treatment should be started to alleviate bradycardia and resume Beractant therapy.
-
Infectious Complications: Post-treatment nosocomial sepsis may occur in Beractant therapy.
-
Respiratory Effects: Rales and breath sounds may occur in this therapy.
Indications and Uses:
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Beractant is used in the rescue (treatment) of respiratory distress syndrome in premature babies in whom respiratory distress syndrome has been confirmed by a radiograph and in those who require mechanical ventilation.
-
Beractant is used in the prevention of hyaline membrane disease (respiratory distress syndrome) in premature babies with birth weights of fewer than 1250 grams or in those with evidence of surfactant deficiency.
Dosage Strength and Forms:
Beractant is used as an intratracheal suspension. Beractant intratracheal suspension is supplied in single-use glass vials that contain 4 mL or 8 mL of Beractant. The dosage of Beractant is expressed in terms of phospholipids. Each milliliter (mL) of Beractant contains 25 milligrams (mg) of phospholipids, including 11 to 15.5 mg of DPPC and of fewer than 1 mg of surfactant proteins.
Dosage:
Dosage for Preventing Respiratory Distress Syndrome in Premature Neonates
Beractant is used as an intratracheal suspension. It is administered as 100 mg per kg (kilogram), which is 4 mL per kg of birth weight in four divided doses. It should be given within 15 minutes after birth. Repeated doses are administered if the neonate has radiographically confirmed respiratory distress syndrome.
Dosage for Treatment of Respiratory Distress Syndrome in Premature Neonates
100 mg per kg of Beractant, which is 4 mL per kg of birth weight, is given in four divided doses. It should be given within 8 hours after birth. Repeated doses are administered if the neonate remains intubated.
A maximum of four doses should be given within the first 48 hours of birth. Safety and efficacy for single doses of more than 100 mg per kg birth weight have not been established, nor for dosing beyond 48 hours of life.
Considerations for Administration:
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Beractant should be administered only by intratracheal installation. The drug should be warmed at room temperature for 20 minutes or in hand for 8 minutes before administration. Beractant should not be warmed artificially.
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Beractant should not be administered more frequently than every 6 hours.
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The clinical status and systemic oxygenation should be monitored to avoid hyperoxia.
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Following completion of Beractant therapy, ventilator management and clinical care should be continued. Airways should not be suctioned for 1 hour after dosing.
Contraindication:
There are no known contraindications for this drug.
Adverse Effects:
The common adverse effects of Beractant include oxygen desaturation, transient bradycardia, endotracheal tube reflux, endotracheal tube blockage, hypertension, hypotension, pallor, vasoconstriction, apnea, hypercarbia, and hypocarbia.
Results from Clinical Trials:
Clinical studies showed a marked improvement in oxygenation within minutes of administration of Beractant. It significantly reduces the incidence of respiratory distress syndrome, mortality due to respiratory distress syndrome, and air leak complications. The multiple-dose controlled clinical trials showed that Beractant was associated with major adverse effects like transient bradycardia and oxygen desaturation. Some cases were also associated with adverse effects like pallor, vasoconstriction, endotracheal tube reflux, endotracheal tube blockage, hypertension, hypotension, apnea, hypercarbia, and hypocarbia. The controlled clinical trials showed that Beractant had no effects on laboratory tests such as serum sodium, potassium, bilirubin, creatinine, and white blood cell count.
Drug Interactions:
No known drug interactions have been reported.
Other Specifications:
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It should be used under the supervision of clinicians who are experienced in intubation, ventilatory support, and general care of premature neonates.
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Beractant therapy can affect oxygenation and lung compliance. Arterial or transcutaneous measurement of systemic oxygen and carbon dioxide should be performed to avoid hyperoxia.
-
Bradycardia may occur. Beractant should be discontinued if bradycardia occurs, and appropriate treatment should be started to alleviate bradycardia and resume Beractant therapy.
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Cardiovascular Effects: Transient bradycardia has been reported with Beractant treatment. Beractant should be discontinued if bradycardia occurs, and appropriate therapy should be started to alleviate this condition; following stabilization, Beractant therapy should be resumed.
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Infectious Complications: Post-treatment nosocomial sepsis may occur in Beractant therapy.
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Respiratory Effects: Rales and breath sounds may occur in this therapy.
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The safety and efficacy of Beractant in conjunction with other investigational therapies for respiratory distress syndrome, such as high-frequency ventilation and extracorporeal membrane oxygenation, has not been established.
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Pregnancy and Lactation: This drug is not intended for use in adults.
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Pediatric Use: Safety and efficacy have not been established for use in neonates less than 600 grams or more than 1750 grams birth weight.
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Renal Dose Adjustments: No information is available regarding renal dose adjustments.
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Hepatic Dose Adjustments: No information is available regarding hepatic dose adjustments.
