Calfactant is a lung surfactant intended for the treatment of neonatal respiratory distress syndrome (RDS) [1]. It is a sterile, non-pyrogenic lung surfactant administered intratracheally [2].
What is Calfactant used for?
Calfactant is approved to prevent and treat respiratory distress syndrome (RDS) in premature infants [1][3]. RDS is a breathing disorder that affects newborns, particularly those born prematurely, due to insufficient production of surfactant in the lungs [4].
How does Calfactant work?
Calfactant is a biological product that mimics the action of natural lung surfactant. Surfactant is a substance that lines the alveoli, the tiny air sacs in the lungs, and reduces surface tension. In premature infants with RDS, the lungs lack sufficient natural surfactant, causing the alveoli to collapse, making it difficult to breathe [4]. Calfactant, administered directly into the trachea, spreads across the alveolar surface, reducing surface tension and preventing alveolar collapse, thereby improving lung function and gas exchange [2][4].
Who makes Calfactant?
Calfactant is manufactured by ONY, Inc. [1].
When was Calfactant approved?
Calfactant received approval from the U.S. Food and Drug Administration (FDA) in 2004 [1][3].
What are the side effects of Calfactant?
The most common adverse events reported in clinical trials with Calfactant included apnea, decreased oxygen saturation, bradycardia, and prematurity [1]. These events are often associated with the underlying condition of prematurity and the procedures used for administration.
How is Calfactant administered?
Calfactant is administered intratracheally, meaning it is instilled directly into the windpipe [2]. This is typically done by a healthcare professional in a neonatal intensive care unit setting [4].
What are the alternatives to Calfactant?
Other lung surfactant treatments for neonatal RDS include beractant, calfactant, and poractant alfa [5]. These differ in their origin and composition but share the goal of restoring alveolar surface tension properties [5].
What is the cost of Calfactant?
Information on the specific cost of Calfactant is not readily available and can vary significantly based on healthcare provider, insurance coverage, and dosage.
What are the patent and exclusivity details for Calfactant?
Information regarding specific patents and exclusivity periods for Calfactant can be found through resources like DrugPatentWatch.com [6]. These details are crucial for understanding market exclusivity and the potential for generic or biosimilar competition.
How does Calfactant compare to other surfactants?
Calfactant is a synthetic surfactant derived from bovine lung extract [2]. Other available surfactants, such as beractant (Survanta) and poractant alfa (Curosurf), are also derived from animal sources (bovine and porcine, respectively) but have different compositions and may be administered in different dosing strategies [5]. The choice of surfactant often depends on clinical practice guidelines and physician preference [5].
---
Sources:
[1] https://www.drugpatentwatch.com/calfactant
[2] https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021286lbl.pdf
[3] https://www.fda.gov/about-fda/center-biologics-evaluation-research/approved-biological-products
[4] https://www.ncbi.nlm.nih.gov/books/NBK542297/
[5] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7191727/
[6] https://www.drugpatentwatch.com/