HOW SUPPLIED

Review guidelines for storage, preparation, dosing, and administration of CUROSURF

CUROSURF 1.5 mL vial and 3 mL vial

CUROSURF intratracheal suspension is a white to creamy white suspension available in sterile, rubber-stoppered, clear glass vials (1 vial per carton) containing1:

  • Green — 1.5 mL [120 mg poractant alfa (surfactant extract)] of suspension
  • Blue — 3.0 mL [240 mg poractant alfa (surfactant extract)] of suspension

Download the complete User Guide that walks through the storage, dosing, and administration procedures found in the Full Prescribing Information.

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Storing CUROSURF1

Ready-to-use CUROSURF comes in 2 vial sizes (green = 1.5 mL; blue = 3.0 mL)
  • Each carton contains 1 sterile, rubber-stoppered, clear glass vial
  • Protect from light
  • Vials are for single use only
  • Vials with unused surfactant should be discarded after initial entry
Refrigerate CUROSURF vials at 36–46°F (+2 to +8°C)
  • Unopened, unused vials can be returned to the refrigerator within 24 hours
  • Do not warm to room temperature and return to the refrigerator more than once

Dosing instructions1

Initial recommended dose = 2.5 mL/kg birth weight.

  • Administered as 1 or 2 aliquots, depending upon the instillation procedure

Repeat doses

  • Up to 2 repeat doses of 1.25 mL/kg birth weight each may be administered at approximately 12-hour intervals in infants in whom respiratory distress syndrome (RDS) is considered responsible for their persisting or deteriorating respiratory status

Maximum recommended total dosage (sum of the initial and up to 2 repeat doses) is 5 mL/kg birth weight.

Please download User Guide for dosing instructions.

CUROSURF dosing chart

WEIGHT (grams) INITIAL DOSE REPEAT DOSE WEIGHT (grams) INITIAL DOSE REPEAT DOSE
EACH DOSE in mL (mg) EACH DOSE in mL (mg)
600–650 1.60 (128) 0.80 (64) 1301–1350 3.30 (264) 1.65 (132)
651–700 1.70 (136) 0.85 (68) 1351–1400 3.50 (280) 1.75 (140)
701–750 1.80 (144) 0.90 (72) 1401–1450 3.60 (288) 1.80 (144)
751–800 2.00 (160) 1.00 (80) 1451–1500 3.70 (296) 1.85 (148)
801–850 2.10 (168) 1.05 (84) 1501–1550 3.80 (304) 1.90 (152)
851–900 2.20 (176) 1.10 (88) 1551–1600 4.00 (320) 2.00 (160)
901–950 2.30 (184) 1.15 (92) 1601–1650 4.10 (328) 2.05 (164)
951–1000 2.50 (200) 1.25 (100) 1651–1700 4.20 (336) 2.10 (168)
1001–1050 2.60 (208) 1.30 (104) 1701–1750 4.30 (344) 2.15 (172)
1051–1100 2.70 (216) 1.35 (108) 1751–1800 4.50 (360) 2.25 (180)
1101–1150 2.80 (224) 1.40 (112) 1801–1850 4.60 (368) 2.30 (184)
1151–1200 3.00 (240) 1.50 (120) 1851–1900 4.70 (376) 2.35 (188)
1201–1250 3.10 (248) 1.55 (124) 1901–1950 4.80 (384) 2.40 (192)
1251–1300 3.20 (256) 1.60 (128) 1951–2000 5.00 (400) 2.50 (200)
WEIGHT (grams) INITIAL DOSE REPEAT DOSE
EACH DOSE in mL (mg)
600–650 1.60 (128) 0.80 (64)
651–700 1.70 (136) 0.85 (68)
701–750 1.80 (144) 0.90 (72)
751–800 2.00 (160) 1.00 (80)
801–850 2.10 (168) 1.05 (84)
851–900 2.20 (176) 1.10 (88)
901–950 2.30 (184) 1.15 (92)
951–1000 2.50 (200) 1.25 (100)
1001–1050 2.60 (208) 1.30 (104)
1051–1100 2.70 (216) 1.35 (108)
1101–1150 2.80 (224) 1.40 (112)
1151–1200 3.00 (240) 1.50 (120)
1201–1250 3.10 (248) 1.55 (124)
1251–1300 3.20 (256) 1.60 (128)
1301–1350 3.30 (264) 1.65 (132)
1351–1400 3.50 (280) 1.75 (140)
1401–1450 3.60 (288) 1.80 (144)
1451–1500 3.70 (296) 1.85 (148)
1501–1550 3.80 (304) 1.90 (152)
1551–1600 4.00 (320) 2.00 (160)
1601–1650 4.10 (328) 2.05 (164)
1651–1700 4.20 (336) 2.10 (168)
1701–1750 4.30 (344) 2.15 (172)
1751–1800 4.50 (360) 2.25 (180)
1801–1850 4.60 (368) 2.30 (184)
1851–1900 4.70 (376) 2.35 (188)
1901–1950 4.80 (384) 2.40 (192)
1951–2000 5.00 (400) 2.50 (200)
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How to administer CUROSURF1

Before administration, assure proper placement and patency of the endotracheal tube. At the discretion of the clinician, the endotracheal tube may be suctioned before administering CUROSURF. The infant should be allowed to stabilize before proceeding with dosing.

CUROSURF can be administered intratracheally by 2 different methods:

For endotracheal tube instillation using a 5 French end-hole catheter*

  • Slowly withdraw the entire contents of the vial of CUROSURF suspension into a 3- or 5-mL plastic syringe through a large-gauge needle (eg, at least 20 gauge). Enter each single-use vial only once
  • Attach the 5 French catheter of the appropriate length to the syringe and advance the catheter into the endotracheal tube without going past the premeasured depth. Fill the catheter with CUROSURF suspension. Discard excess CUROSURF through the catheter so that only the dose to be given remains in the syringe
    • For the first dose: 1.25 mL/kg (birth weight) per aliquot
    • For each repeated dose: 0.625 mL/kg (birth weight) per aliquot
  • First aliquot of CUROSURF suspension:
    • Position the infant in a neutral position (head and body in alignment without inclination), with either the right or left side dependent
    • Immediately before CUROSURF administration, ventilate the infant with supplemental oxygen sufficient to maintain SaO2 > 92%
    • Insert the catheter into the endotracheal tube and instill the first aliquot of CUROSURF suspension
    • After the first aliquot is instilled, remove the catheter from the endotracheal tube and resume ventilation of the infant with supplemental oxygen until clinically stable
  • Second aliquot of CUROSURF suspension:
    • When the infant is stable, reposition the infant such that the other side is dependent
    • Administer the remaining aliquot using the same procedures as the first aliquot
  • After completion of the dosing procedure, do not suction airways for 1 hour after surfactant instillation unless signs of significant airway obstruction occur [see Clinical Studies (14.1) in Full Prescribing Information]

For endotracheal tube instillation using the secondary lumen of a dual-lumen endotracheal tube (medication administration lumen)*

  • Slowly withdraw the entire contents of the vial of CUROSURF suspension into a 3- or 5-mL plastic syringe through a large-gauge needle (eg, at least 20 gauge). Do not attach 5 French catheter. Remove the needle and discard excess CUROSURF so that only the dose to be given remains in the syringe
  • Keep the infant in a neutral position (head and body in alignment without inclination)
  • Administer CUROSURF suspension through the medication administration lumen of the dual-lumen endotracheal tube as a single dose, given over 1 minute, and without interrupting mechanical ventilation
  • After completion of this dosing procedure, resume management and adjust ventilator as needed. Do not suction airways for 1 hour after surfactant instillation unless signs of significant airway obstruction occur

*Methods are not interchangeable.

Please see Full Prescribing Information for full administration instructions.

While these administration instructions should be followed, clinical judgment should be used for individual scenarios.

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.

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How to prepare CUROSURF1

Before use, the vial should be slowly warmed to room temperature and gently turned upside down in order to obtain a uniform suspension.

  • DO NOT SHAKE
  • Unopened vials of CUROSURF may be warmed to room temperature for up to 24 hours prior to use
  • CUROSURF should not be warmed to room temperature and returned to the refrigerator more than once
  • Each single-use vial should be entered only once
  • Vials with unused surfactant should be discarded after initial entry
Steps to open the vial
  • Remove the vial of CUROSURF suspension from a refrigerator at +2°C to +8°C (36°F to 46°F) and slowly warm the vial to room temperature before use
  • Visually inspect the CUROSURF suspension for discoloration prior to administration. The color of the CUROSURF suspension should be white to creamy white. Discard the CUROSURF vial if the suspension is discolored
  • Gently turn the vial upside-down, in order to obtain a uniform suspension. DO NOT SHAKE
  • Locate the notch (FLIP UP) on the colored plastic cap and lift the notch and pull upwards
  • Pull the plastic cap with the aluminum portion downwards
  • Remove the whole ring by pulling off the aluminum wrapper
  • Remove the rubber cap to extract content
  • Unopened, unused vials of CUROSURF suspension that have warmed to room temperature can be returned to refrigerated storage within 24 hours for future use. Do not warm to room temperature and return to refrigerated storage more than once. Protect from light
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User Guide video

The User Guide video details the safety and efficacy data behind CUROSURF and walks through the storage, dosing, and administration procedures found in the Full Prescribing Information. This video may be particularly helpful during a Skills Day or for educating new staff.

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*It is important to note that the INSURE strategy may not be appropriate for all infants. Infants with RDS may vary markedly in the severity of respiratory disease, maturity, and presence of other complications, and thus it is necessary to individualize patient care.

IMPORTANT SAFETY INFORMATION

CUROSURF® (poractant alfa) is intended for intratracheal use only. 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 preterm infants.

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.

Pulmonary hemorrhage, a known complication of premature birth and very low birth-weight, has been reported with CUROSURF. The rates of common complications of prematurity observed in a multicenter single-dose study that enrolled infants 700–2000 g birth weight with RDS requiring mechanical ventilation and FiO2 ≥ 0.60 are as follows for CUROSURF 2.5 mL/kg (200 mg/kg) (n=78) and control (n=66; no surfactant) respectively: acquired pneumonia (17% vs. 21%), acquired septicemia (14% vs. 18%), bronchopulmonary dysplasia (18% vs. 22%), intracranial hemorrhage (51% vs. 64%), patent ductus arteriosus (60% vs. 48%), pneumothorax (21% vs. 36%) and pulmonary interstitial emphysema (21% vs. 38%).

INDICATION

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.

Please see Full Prescribing Information.

Reference: 1. CUROSURF® (poractant alfa) Intratracheal Suspension Prescribing Information, Chiesi USA, Inc. May 2021.