beractant

Action and Spectrum

Actions and Spectrum 

Action: 

Surfactant Replacement: beractant is a natural surfactant replacement that contains phospholipids, neutral lipids, and specific proteins. When administered, it helps restore the inadequate or deficient endogenous surfactant in the lungs of premature infants.  

Reduction of Surface Tension: The drug acts at the air-liquid interface within the alveoli, reducing the surface tension. This action prevents the collapse of the alveoli during expiration, improving lung compliance and preventing atelectasis (collapsed lung tissue).  

Increased Lung Stability: By reducing surface tension, beractant helps stabilize the alveoli, preventing them from collapsing and sticking together. This improves gas exchange, maintains lung inflation, and reduces the work of breathing.  

Spectrum: 

The drug is specifically designed for the treatment of respiratory distress syndrome (RDS) in premature infants. RDS is a condition that affects the lungs of premature babies due to the insufficient production or immaturity of endogenous pulmonary surfactant. The drug is not typically used for other respiratory conditions or in older children or adults. 

Drug Interaction

Adverse Reaction

Frequency defined  

>10% 

Transient bradycardia (12%) 

1-10% 

O2 desaturation (10%) 

<1% 

Vasoconstriction 

Apnea 

Sepsis 

Hypertension/hypotension 

Endotracheal tube blockage 

Hypotension 

Hypercarbia 

Endotracheal tube reflux 

Black Box Warning

Black Box Warning:  

None  

Contraindication / Caution

Contraindication/Caution:  

Known hypersensitivity: The drug should not be used in individuals who have a known hypersensitivity or allergy to any of its components. Allergic reactions to beractant can include difficulty breathing, wheezing, rash, itching, swelling, or other symptoms of an allergic response. 

Bleeding disorders: The drug administration may increase the risk of bleeding in individuals with certain bleeding disorders. The surfactant administration procedure involves inserting a catheter into the trachea, which carries a small risk of bleeding. Therefore, caution should be exercised in individuals with known bleeding disorders or those at an increased risk of bleeding. 

Infection: The drug should not be administered to infants with suspected or confirmed bacterial infection. In such cases, the underlying infection should be treated before considering surfactant replacement therapy. 

Pneumothorax: The drug is not contraindicated in infants with pneumothorax, However, caution should be exercised during administration, as it may worsen the condition or necessitate additional interventions. 

Coagulation abnormalities: The drug administration may interfere with the clotting process, leading to coagulation abnormalities. Careful monitoring of coagulation parameters may be necessary, particularly in infants with pre-existing coagulation disorders or those at risk of bleeding. 

Pregnancy / Lactation

Pregnancy warnings:     

Pregnancy category: N/A 

Lactation: Excreted into human milk is unknown 

Pregnancy Categories:         

Category A: Studies that were well-controlled and met expectations revealed no risk to the fetus in either the first or second trimester. 

Category B: There were a lack of studies on pregnant women and no evidence of risk to the fetus in animal experiments.   

Category C: there was evidence of risk of adverse effects in animal reproduction studies, and no adequate evidence in human studies must take care of potential risks in pregnant women.    

Category D: adequate data with sufficient evidence of human fetal risk from various platforms, but despite the potential risk, and used only in emergency cases for potential benefits.   

Category X: Drugs listed in this category outweigh the risks over benefits. Hence these categories of drugs need to be avoided by pregnant women.    

Category N: There is no data available for the drug under this category

Pharmacology

Pharmacology:  

beractant is a pulmonary surfactant used to treat respiratory distress syndrome (RDS) in premature infants. 

It is a natural surfactant derived from bovine lung extract and is primarily composed of phospholipids, with the major phospholipid component being dipalmitoylphosphatidylcholine (DPPC).  

Pharmacodynamics:  

The drug primarily acts as a replacement for the deficient endogenous surfactant in the lungs of premature infants with RDS. Surfactant is a substance that lines the alveoli in the lungs and helps reduce surface tension, preventing the collapse of the alveoli during expiration. In RDS, the immature lungs of premature infants do not produce enough surfactant, leading to respiratory difficulties. beractant, which is derived from bovine lung extract, provides a source of exogenous surfactant that helps restore proper lung function.   

Pharmacokinetics: 

Absorption 

The drug is administered directly into the lungs via intratracheal instillation or endotracheal tube during a procedure called artificial surfactant replacement therapy. The medication is introduced into the alveolar spaces of the lungs, where it spreads across the lung surface. 

Distribution 

After administration, beractant spreads across the lung surface and forms a thin film that reduces surface tension, preventing the collapse of alveoli during expiration. The drug remains localized in the lungs and does not distribute extensively to other tissues or organs. 

Metabolism 

beractant is not metabolized within the body. It functions primarily as a physical barrier and improves lung compliance by reducing surface tension in the alveoli. It aids in the stabilization and expansion of alveoli, preventing their collapse during expiration. 

Excretion and elimination 

 Since beractant is not metabolized, it is not excreted through the typical metabolic pathways. Over time, the natural lung surfactant components present in beractant are cleared from the lungs by normal lung clearance mechanisms, such as lymphatic drainage and mucociliary transport. 

Adminstartion

Patient Information Leaflet