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Curosurf

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Curosurf

INDICATIONS

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

DOSAGE AND ADMINISTRATION

FOR INTRATRACHEAL ADMINISTRATION ONLY.

General

CUROSURF (poractant alfa) is administered intratracheally by instillation through a 5 French end-hole catheter, and briefly disconnecting the endotracheal tube from the ventilator. Alternatively, CUROSURF (poractant alfa) may be administered through the secondary lumen of a dual lumen endotracheal tube without interrupting mechanical ventilation.

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

Initial Dose

The initial recommended dose of CUROSURF (poractant alfa) is 2.5 mL/kg birth weight. This dose may be determined from the CUROSURF (poractant alfa) dosing chart below.

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

Slowly withdraw the entire contents of the vial of CUROSURF (poractant alfa) 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 end-hole French catheter to the syringe. Fill the catheter with CUROSURF (poractant alfa) . Discard excess CUROSURF (poractant alfa) through the catheter so that only the total dose to be given remains in the syringe. Immediately before CUROSURF (poractant alfa) administration, the infant's ventilator settings should be changed to a 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 (poractant alfa) . 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 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 dependant 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. In the clinical trials, ventilator management was modified to maintain a Pa02 of about 55 mmHg, PaC02 of 35-45, and pH > 7.3.

For endotracheal instillation using the secondary lumen of a dual lumen endotracheal tube

Slowly withdraw the entire contents of the vial of CUROSURF (poractant alfa) into a 3 or 5 mL plastic syringe through a large-gauge needle (e.g., at least 20 gauge). Do not attach 5 French end-hole catheter. Keep the infant in a neutral position (head and body in alignment without inclination). Administer CUROSURF (poractant alfa) 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 Fi02, ventilatory rate, or PIP.

Repeat doses

Up to two repeat doses of 1.25 mLlkg birth weight each may be administered, using the same techniques 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.

TABLE 4

CUROSURF DOSING CHART
WEIGHT
(grams)
INITIAL DOSE
2.5 mL/kg
REPEAT DOSE 1.25 mL/kg WEIGHT (grams) INITIAL DOSE 2.5mL/kg REPEAT DOSE 1.25mL/kg
EACH DOSE (mL) EACH DOSE (mL)
600-650 1.60 0.80 1301-1350 3.30 1.65
651-700 1.70 0.85 1351-1400 3.50 1.75
701-750 1.80 0.90 1401-1450 3.60 1.80
751-800 2.00 1.00 1451-1500 3.70 1.85
801-850 2.10 1.05 1501-1550 3.80 1.90
851-900 2.20 1.10 1551-1600 4.00 2.00
901-950 2.30 1.15 1601-1650 4.10 2.05
951-1000 2.50 1.25 1651-1700 4.20 2.10
1001-1050 2.60 1.30 1701-1750 4.30 2.15
1051-1100 2.70 1.35 1751-1800 4.50 2.25
1101-1150 2.80 1.40 1801-1850 4.60 2.30
1151-1200 3.00 1.50 1851-1900 4.70 2.35
1201-1250 3.10 1.55 1901-1950 4.80 2.40
1251-1300 3.20 1.60 1951-2000 5.00 2.50

Directions for Use

CUROSURF (poractant alfa) should be inspected visually for discoloration prior to administration. The color of CUROSURF (poractant alfa) is white to creamy white. CUROSURF (poractant alfa) should be stored in a refrigerator at +2 to +8°C (36-46°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.

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

Locate the notch - illustration

2) Lift the notch and pull upwards.

Lift the notch and pull upwards - illustration.

3) Pull the plastic cap with the aluminium portion downwards.

Pull the plastic cap with the aluminium portion downwards - illustration

4 and 5) Remove the whole ring by pulling off the aluminium wrapper.

Remove the whole ring by pulling off the aluminium wrapper - illustration 1 Remove the whole ring by pulling off the aluminium wrapper - illustration 2

6 and 7) Remove the rubber cap to extract content.

Remove the rubber cap to extract content - illustration 1 Remove the rubber cap to extract content - illustration 2

Unopened, unused vials of CUROSURF (poractant alfa) 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.

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 (poractant alfa) .

These events require interrupting the administration of CUROSURF (poractant alfa) 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 surfactant (extract) or 3 mL (240 mg surfactant (extract)] of suspension. One vial per carton.

Store CUROSURF (poractant alfa) Intratracheal Suspension in a refrigerator at +2 to +8°C (36-46°F). Unopened vials of CUROSURF (poractant alfa) may be warmed to room temperature for up to 24 hours prior to use.

CUROSURF (poractant alfa) 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.

Manufactured for: DEY, Napa, CA 94558. Manufactured by and licensed from: Chiesi Farmaceutici, S.p.A. Parma, Italy 43100. 3/2008. FDA Rev date: 9/26/2008

Last reviewed on RxList: 12/4/2008
This monograph has been modified to include the generic and brand name in many instances.

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