Poractant Alfa

Endogenous pulmonary surfactant reduces surface tension at the air-liquid interface of the alveoli during ventilation and stabilizes the alveoli against collapse at resting transpulmonary pressures. A deficiency of pulmonary surfactant in preterm infants results in Respiratory Distress Syndrome (RDS) characterized by poor lung expansion, inadequate gas exchange, and a gradual collapse of the lungs (atelectasis).

• CUROSURF ® (poractant alfa) Intratracheal Suspension is indicated for the rescue treatment of Respiratory Distress Syndrome (RDS) in premature infants. CUROSURF reduces mortality and pneumothoraces associated with RDS.

• None. None.contraindicated

Before administering CUROSURF, assure proper placement and patency of endotracheal tube ( 2.1 ) Administer intratracheally either in ( 2.1 ): Two divided aliquots through a 5 French end-hole catheter; or A single bolus through secondary lumen of a dual lumen endotracheal tube without interrupting mechanical ventilation Initial recommended dose is 2.5 mL/kg birth weight ( 2.2 ) Up to two repeat doses of 1.25 mL/kg birth weight may be administered at approximately 12-hour intervals ( 2.2 ) Maximum total dose (initial plus repeat doses) is 5 mL/kg ( 2.2 ) See Full Prescribing Information for instructions on preparation and administration of the CUROSURF suspension ( 2.3 , 2.4 ) 2.1 Important Administration Instructions For intratracheal administration only. CUROSURF should be administered by, or under the supervision of clinicians experienced in intubation, ventilator management, and general care of premature infants. Before administering CUROSURF, assure proper placement and patency of the endotracheal tube. At the discretion of the clinician, the endotracheal tube may be suctioned before administering CUROSURF. Allow the infant to stabilize before proceeding with dosing. Administer CUROSURF either: Intratracheally by instillation in two divided aliquots through a 5 French end-hole catheter or Intratracheally in a single bolus through the secondary lumen of a dual lumen endotracheal tube without interrupting mechanical ventilation.

Acute Changes in Lung Compliance : Frequently assess need to modify oxygen and ventilatory support to respiratory changes ( 5.1 ) Administration-Related Adverse Reactions : Transient adverse effects include bradycardia, hypotension, endotracheal tube blockage, and oxygen desaturation. These events require stopping CUROSURF administration and taking appropriate measures to alleviate the condition ( 5.2 ) 5.1 Acute Changes in Oxygenation and Lung Compliance The administration of exogenous surfactants, including CUROSURF, can rapidly affect oxygenation and lung compliance. Therefore, infants receiving CUROSURF should receive frequent clinical and laboratory assessments so that oxygen and ventilatory support can be modified to respond to respiratory changes. CUROSURF should only be administered by those trained and experienced in the care, resuscitation, and stabilization of pre-term infants. 5.2 Administration-Related Adverse Reactions Transient adverse reactions associated with administration of CUROSURF include bradycardia, hypotension, endotracheal tube blockage, and oxygen desaturation. These events require stopping CUROSURF administration and taking appropriate measures to alleviate the condition. After the patient is stable, dosing may proceed with appropriate monitoring.

Common adverse reactions associated with the administration of CUROSURF include bradycardia, hypotension, endotracheal tube blockage, and oxygen desaturation. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Chiesi USA, Inc. at 1-888-661-9260 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. Adverse Reactions in Studies in Premature Infants with Respiratory Distress Syndrome The safety data described below reflect exposure to CUROSURF at a single dose of 2.5 mL/kg (200 mg/kg), in 78 infants of 700-2000 grams birth weight with RDS requiring mechanical ventilation and a FiO 2 ≥ 0.60 (Study 1) [see Clinical Studies ( 14.1 )]. A total of 144 infants were studied after RDS developed and before 15 hours of age; 78 infants received CUROSURF 2.5 mL/kg single dose (200 mg/kg), and 66 infants received control treatment (disconnection from the ventilator and manual ventilation for 2 minutes). Transient adverse reactions seen with the administration of CUROSURF included bradycardia, hypotension, endotracheal tube blockage, and oxygen desaturation. The rates of the most common serious complications associated with prematurity and RDS observed in Study 1 are shown in Table 1.

8.4 Pediatric Use The safety and effectiveness of CUROSURF for the rescue treatment, including the reduction of mortality and pneumothoraces, of Respiratory Distress Syndrome (RDS) have been established in premature infants and the information on this use is discussed throughout the labeling. The safety and effectiveness of CUROSURF in the treatment of full term infants or older pediatric patients with respiratory failure has not been established.

Metabolism

CUROSURF is administered directly to the lung, where biophysical effects occur at the alveolar surface. No human pharmacokinetic studies have been performed to characterize the absorption, biotransformation, or elimination of CUROSURF.

There have been no reports of overdosage following the administration of CUROSURF. In the event of accidental overdosage, and if there are clear clinical effects on the infant's respiration, ventilation, or oxygenation, aspirate as much of the suspension as possible and provide the infant with supportive treatment, with particular attention to fluid and electrolyte balance.

• Nov 18, 1999BLABLA020744Chiesi Usa Inc

1. 1Neonatal Hypoxia11917%
2. 2Off Label Use7811%
3. 3Pulmonary Haemorrhage7811%
4. 4Bradycardia Neonatal507.0%
5. 5Ill-defined Disorder496.9%
6. 6Drug Ineffective456.3%
7. 7Endotracheal Intubation Complication344.8%
8. 8Product Complaint344.8%
9. 9Pneumothorax334.6%
10. 10Infantile Apnoea304.2%
11. 11Neonatal Respiratory Failure283.9%
12. 12Pulmonary Haemorrhage Neonatal273.8%
13. 13Product Administration Error263.7%
14. 14Oxygen Saturation Decreased243.4%
15. 15Cyanosis Neonatal233.2%

The 10 most recently updated of 54 ClinicalTrials.gov registrations naming Poractant Alfa as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Surfactant Therapy Via Supraglottic Airway to Preterm Neonates With RDS in Vietnam
  Recruiting · Interventional · 440 enrolled · Karolinska Institutet
  NCT07098910updated 2026-05-27
• Surfactant Using a Supraglottic Airway Device in Late Preterm to Early Term Infants
  Enrolling by invitation · Interventional · 422 enrolled · Sharp HealthCare
  NCT07176117updated 2026-05-19
• Duration of Surfactant Administration and Impact on Stabilisation of Vital Parameters in Very Preterm Neonates: 1 Minutes Versus 5 Minutes
  Recruiting · Phase 4 · Interventional · 76 enrolled · Medical University of Graz
  NCT07261787updated 2026-05-14
• Calfactant vs Poractant Alfa Using a Less Invasive Technique in Preterm Infants With Respiratory Distress Syndrome
  Recruiting · Phase 4 · Interventional · 234 enrolled · Uludag University
  NCT07350018updated 2026-04-28
• The Budesonide in Babies (BiB) Trial
  Active not recruiting · Phase 3 · Interventional · 642 enrolled · NICHD Neonatal Research Network
  NCT04545866updated 2026-04-15
• LISA in the Delivery Room for Extremely Preterm Infants
  Completed · Interventional · 60 enrolled · University of Texas Southwestern Medical Center
  NCT04715373updated 2026-01-08
• Early Caffeine and LISA Compared to Caffeine and CPAP in Preterm Infants
  Completed · Interventional · 180 enrolled · Sharp HealthCare
  NCT04209946updated 2025-12-18
• EXTERNAL NEGATIVE PRESSURE DURING LISA
  Not yet recruiting · Interventional · 25 enrolled · Charles University, Czech Republic
  NCT07271368updated 2025-12-17
• Feasibility Study of Placement and Surfactant Administration Through a Preterm Size Laryngeal Mask Airway in Very Low Birth Weight Neonates With Respiratory Distress Syndrome
  Completed · Interventional · 45 enrolled · Karolinska Institutet
  NCT06606444updated 2025-08-19
• Prophylactic Minimally Invasive Surfactant Evaluation
  Recruiting · Phase 4 · Interventional · 200 enrolled · Endeavor Health
  NCT06007547updated 2025-08-07

Frequently asked questions

How does Poractant Alfa work?

Endogenous pulmonary surfactant reduces surface tension at the air-liquid interface of the alveoli during ventilation and stabilizes the alveoli against collapse at resting transpulmonary pressures. A deficiency of pulmonary surfactant in preterm infants results in Respiratory Distress Syndrome (RDS) characterized by poor lung expansion, inadequate gas exchange, and a gradual collapse of the lungs (atelectasis).

What is Poractant Alfa used for?

According to FDA labeling, Poractant Alfa carries indications including: CUROSURF ® (poractant alfa) Intratracheal Suspension is indicated for the rescue treatment of Respiratory Distress Syndrome (RDS) in premature infants. CUROSURF reduces mortality and pneumothoraces associated with RDS.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Poractant Alfa?

Poractant Alfa is classified as Surfactant, Surfactant Activity, Alveolar Surface Tension Reduction.

What are the brand names for Poractant Alfa?

Poractant Alfa is marketed under brand names including Curosurf.

What are the contraindications for Poractant Alfa?

Poractant Alfa labeling lists contraindications including: None. None.. Always consult the full prescribing information and a clinician.