HOW SUPPLIED

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

CUROSURF 1.5 mL vial and 3 mL vial

Each vial of CUROSURF has a color-coded cap that corresponds with the volume of surfactant supplied in each vial1:

  • 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 our Full Prescribing Information.

Dosing instructions1

Initial recommended dose = 2.5 mL/kg birth weight

  • Administered as one or two aliquots depending upon the instillation procedure

Repeat Doses

  • Up to two repeat doses of 1.25 mL/kg birth weight each may be administered at approximately 12-hour intervals in infants who remain intubated and in whom 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) = 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

CUROSURF can be administered intratracheally by 2 different methods:

Method 1: Through a 5 French end-hole catheter after briefly disconnecting the endotracheal tube from the ventilator

Method 2: Through the secondary lumen of a dual lumen endotracheal tube without interruption of mechanical ventilation

Note: 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.

Slowly withdraw the entire contents of the vial of CUROSURF into a 3-mL or 5-mL plastic syringe through a large-gauge needle (e.g., at least 20 gauge).

If Using a 5 French End-hole Catheter
  • Determine the dose of CUROSURF to be administered based on birth weight
  • Attach a pre-cut 8-cm 5 French end-hole catheter to the syringe
  • Fill the catheter with CUROSURF
  • Discard excess CUROSURF through the catheter so that only the total dose to be given remains in the syringe
  • Immediately before CUROSURF administration, it is recommended to adjust ventilator settings considering the CUROSURF product labeling and your institution’s protocols
  • While keeping the infant in a neutral position (head and body in alignment without inclination), briefly disconnect the endotracheal tube from the ventilator
  • Insert the pre-cut 8-cm 5 French end-hole catheter into the endotracheal tube and instill the first aliquot (1.25 mL/kg birth weight) of CUROSURF
  • The infant should be positioned such that either the right or left side is dependent for this aliquot
  • After the first aliquot is instilled, remove the catheter from the endotracheal tube and manually ventilate the infant for 1 minute
  • When the infant is stable, reposition the infant such that the other side is dependent and administer the remaining aliquot using the same procedures
  • Do not suction airways for 1 hour after surfactant instillation unless signs of significant airway obstruction occur

After completion of the dosing procedure, resume usual ventilator management and clinical care

If Using the Secondary Lumen of a Dual Lumen Endotracheal Tube
  • Determine the dose of CUROSURF to be administered based on birth weight
  • Do not attach a pre-cut 8-cm 5 French end-hole catheter to the syringe
  • Keep the infant in a neutral position (head and body in alignment without inclination)
  • Administer CUROSURF through the proximal end of the secondary lumen of the endotracheal tube as a single dose, given over 1 minute, and without interrupting mechanical ventilation

After completion of this dosing procedure, ventilatory management may require transient increases in FiO2, ventilatory rate, or PIP.

For full administration instructions, please see Full Prescribing Information.

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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Storing CUROSURF1

CUROSURF 1.5 mL vial and 3 mL vial
Ready-to-use CUROSURF comes in 2 vial sizes
  • Each carton contains one 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 refrigerator more than once

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

1. Locate the notch (FLIP UP) on colored plastic cap

2. Lift notch and pull upward

3. Pull plastic cap with aluminum portion downward

4—5. Remove the whole ring by pulling off the aluminum wrapper

6—7. Remove the rubber stopper to extract content

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Watch User Guide video on storing and preparing CUROSURF

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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 our 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. December 2014.