Prescribing Information

DOSAGE AND ADMINISTRATION

FOR INTRATRACHEAL ADMINISTRATION ONLY

Curosurf should be administered by, or under the supervision of, clinicians experienced in intubation, ventilatory management, and general care of premature infants.

Marked improvements in oxygenation and lung compliance may occur within minutes of administration of Curosurf. Therefore, the infant should receive frequent clinical and laboratory assessments such that oxygen and ventilator support can be modified to respond to respiratory status changes.

Physiological endpoints have not proven to impact key clinical outcomes such as mortality due to RDS.

Dosage

The initial dose of Curosurf is 2.5 mL per kg birth weight. Up to two subsequent does of 1.25 mL/kg birth weight can be administered 12-hour intervals if needed. more...

Directions for Use

Curosurf should be inspected visually for discoloration prior to administration. The color of Curosurf is white to creamy white. more...

General

Initial Dose

The initial recommended dose of Curosurf is 2.5 mL/kg birth weight. This dose may be determined from the Curosurf dosing chart above. more...

Repeat Doses

Up to two repeat doses of 1.25 mL/kg birth weight each may be administered, using the same technique described for the initial dose. more...

Dosing Precautions

How Supplied

Dosage

The initial dose of Curosurf is 2.5 mL per kg birth weight. Up to two subsequent does of 1.25 mL/kg birth weight can be administered at 12-hour intervals if needed (i.e., in infants who remain intubated and require mechanical ventilation and supplemental oxygen). Dosages may be determined from the following Curosurf dosing chart for a range of birth weights:

Curosurf Dosing Chart

WEIGHT (grams)	INITIAL DOSE 2.5 mL/kg	REPEAT DOSE 1.25 mL/kg
	EACH DOSE (mL)
600-650	1.60	0.80
651-700	1.70	0.85
701-750	1.80	0.90
751-800	2.00	1.00
801-850	2.10	1.05
851-900	2.20	1.10
901-950	2.30	1.15
951-1000	2.50	1.25
1001-1050	2.60	1.30
1051-1100	2.70	1.35
1101-1150	2.80	1.40
1151-1200	3.00	1.50
1201-1250	3.10	1.55
1251-1300	3.20	1.60

WEIGHT (grams)	INITIAL DOSE 2.5 mL/kg	REPEAT DOSE 1.25 mL/kg
	EACH DOSE (mL)
1301-1350	3.30	1.65
1351-1400	3.50	1.75
1401-1450	3.60	1.80
1451-1500	3.70	1.85
1501-1550	3.80	1.90
1551-1600	4.10	2.00
1601-1650	4.20	2.05
1651-1700	4.30	2.10
1701-1750	4.40	2.15
1751-1800	4.50	2.25
1801-1850	4.60	2.30
1851-1900	4.70	2.35
1901-1950	4.80	2.40
1951-2000	5.00	2.50

Directions for Use

Curosurf should be inspected visually for discoloration prior to administration. The color of Curosurf is white to creamy white. Curosurf should be stored in a refrigerator at +2 to +8°C (36 to 46°F). 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, unused vials of Curosurf 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. Each single-use vial should be entered only once and the vial with any unused material should be discarded after the initial entry.

General

Curosurf is administered intratracheally by instillation through a dual Lumen tube or a 5 French end-hole catheter (cut to a standard length of 8 cm) inserted into the infant's endotracheal tube, with the tip positioned distally in the endotracheal tube. The catheter tip should not extend beyond the distal tip of the endotracheal tube. Each dose of Curosurf should be administered as two aliquots, with each aliquot administered into one of the two main bronchi by positioning the infant with either the right or Left side dependent.

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. The infant should be allowed to stabilize before proceeding with dosing.

Initial Dose

The initial recommended dose of Curosurf is 2.5 mL/kg birth weight. This dose may be determined from the Curosurf dosing chart above.

Slowly withdraw the entire contents of the vial of Curosurf into a 3 or 5 mL plastic syringe through a large-gauge needle (e.g., at least 20 gauge). Attach the pre-cut 8 cm 5 French 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, the infant’s ventilator settings should be changed to rate of 40-60 breaths/minute, inspiratory time 0.5 second, and supplemental oxygen sufficient to maintain SaO₂>92%. Keep 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 5 French 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 of surfactant is instilled, remove the catheter from the endotracheal tube and manually ventilate the infant with 100% oxygen at a rate of 40-60 breaths/minute for one 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. After instillation of the second aliquot, remove the catheter without flushing. Do not suction airways for one hour after surfactant instillation unless signs of significant airway obstruction occur.

After completion of the dosing procedure, resume usual ventilator management and clinical care. In the clinical trials, ventilator management was modified to maintain a PaO₂ of about 55 mmHg, PaCO₂ of 35-45, and pH>7.3.

Repeat Doses

Up to two repeat doses of 1.25 mL/kg birth weight each may be administered, using the same technique described for the initial dose. Repeat doses should 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. The maximum recommended total dose (sum of the initial and up to two repeat doses) is 5 mL/kg.

Dosing Precautions

Transient episodes of bradycardia, decreased oxygen saturation, reflux of the surfactant into the endotracheal tube, and airway obstruction have occurred during the dosing procedure of Curosurf. These events require interrupting the administration of Curosurf and taking the appropriate measures to alleviate the condition. After stabilization, dosing may resume with appropriate monitoring.

How Supplied

Curosurf (poractant alfa) Intratracheal Suspension (NDC Numbers: 49502-180-01 [1.5 mL]; 49502-180-03 [3 mL]) is available in sterile, ready-to-use rubber-sToppered clear glass vials containing 1.5 mL (120 mg phospholipids) or 3 mL (240 mg phospholipids) of suspension. One vial per carton.

Store Curosurf Intratracheal Suspension in a refrigerator at +2 to +8°C (36 to 46°F). 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. PROTECT FROM LIGHT. Do not shake. Vials are for single use only. After opening the vial discard the unused portion of the drug.

Rx only.