Data from FDA (Food and Drug Administration, USA) - Curated by EPG Health - Last updated 01 April 2018

Indication(s)

1 INDICATIONS AND USAGE 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. CUROSURF is a surfactant indicated for the rescue treatment, including the reduction of mortality and pneumothoraces, of Respiratory Distress Syndrome (RDS) in premature infants. (1)

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Advisory information

contraindications
4 CONTRAINDICATIONS None. None.
Adverse reactions
6 ADVERSE REACTIONS 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 FiO2 ≥ 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 effects 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 2. Table 2: Most Common Serious Complications Associated with Prematurity and RDS in Study 1 CUROSURF 2.5 mL/kg n=78 CONTROL* n=66 Acquired Pneumonia 17% 21% Acquired Septicemia 14% 18% Bronchopulmonary Dysplasia 18% 22% Intracranial Hemorrhage 51% 64% Patent Ductus Arteriosus 60% 48% Pneumothorax 21% 36% Pulmonary Interstitial Emphysema 21% 38% *Control patients were disconnected from the ventilator and manually ventilated for 2 minutes. No surfactant was instilled. Seventy-six infants (45 treated with CUROSURF) from study 1 were evaluated at 1 year of age and 73 infants (44 treated with CUROSURF) were evaluated at 2 years of age to assess for potential long-term adverse reactions. Data from follow-up evaluations for weight and length, persistent respiratory symptoms, incidence of cerebral palsy, visual impairment, or auditory impairment was similar between treatment groups. In 16 patients (10 treated with CUROSURF and 6 controls) evaluated at 5.5 years of age, the developmental quotient, derived using the Griffiths Mental Developmental Scales, was similar between groups. 6.2 Immunogenicity Immunological studies have not demonstrated differences in levels of surfactant-anti-surfactant immune complexes and anti-CUROSURF antibodies between patients treated with CUROSURF and patients who received control treatment. 6.3 Postmarketing Experience Pulmonary hemorrhage, a known complication of premature birth and very low birth-weight, has been reported both in clinical trials with CUROSURF and in postmarketing adverse event reports in infants who had received CUROSURF.

Usage information

Dosing and administration
2 DOSAGE AND ADMINISTRATION Before administering CUROSURF, assure proper placement and patency of endotracheal tube (2.1) Administer intratracheally either in (2.1): Two divided aliquots after briefly disconnecting endotracheal tube from ventilator; or A single aliquot 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 intracheal 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 after briefly disconnecting the endotracheal tube from the ventilator; or Intratracheally in a single aliquot through the secondary lumen of a dual lumen endotracheal tube without interrupting mechanical ventilation. 2.2 Recommended Dosage The initial recommended dose is 2.5 mL/kg birth weight (see Table 1), administered as one or two aliquots depending upon the instillation procedure [see Dosage and Administration (2.3)]. 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. The maximum recommended total dosage (sum of the initial and up to two repeat doses) is 5 mL/kg. Table 1: CUROSURF Weight-Based Dosing Chart for Rescue Treatment of RDS Weight (grams) Initial Dose 2.5 mL/kg Repeat Dose 1.25 mL/kg Weight (grams) Initial Dose 2.5 mL/kg Repeat Dose 1.25 mL/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 2.3 Preparation of the CUROSURF Suspension Remove the vial of CUROSURF suspension from a refrigerator at +2 to +8°C (36 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. 2.4 Administration 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 (e.g., at least 20 gauge). Enter each single-use vial only once. Attach the pre-cut 8-cm 5 end-hole French catheter to the syringe. Fill the catheter with CUROSURF suspension. Discard excess CUROSURF through the catheter so that only the dose to be given remains in the syringe. When administering CUROSURF using a 5 French end-hole catheter, administer in two divided aliquots: For the first dose: 1.25 mL/kg (birth weight) per aliquot For each repeated dose: 0.635 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, change the infant’s ventilator settings to a rate of 40-60 breaths/minute, inspiratory time 0.5 second, and supplemental oxygen sufficient to maintain SaO2 > 92%. Briefly disconnect the endotracheal tube from the ventilator. Insert the pre-cut 5 French 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 manually ventilate the infant with 100% oxygen at a rate of 40-60 breaths/minute for one minute. 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, resume usual ventilator management and clinical care. Do not suction airways for 1 hour after surfactant instillation unless signs of significant airway obstruction occur. Post dosing, consider maintenance of PaO2 of about 55 mmHg, PaCO2 of 35-45, and pH > 7.3 [see Clinical Studies (14.1)]. For endotracheal instillation using the secondary lumen of a dual lumen endotracheal tube Slowly withdraw the entire contents of the vial of CUROSURF suspension 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. 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 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, ventilator management may require transient increases in FiO2 , ventilator rate, or PIP. Do not suction airways for 1 hour after surfactant instillation unless signs of significant airway obstruction occur.
Use in special populations
8 USE IN SPECIFIC POPULATIONS 8.4 Pediatric Use CUROSURF is indicated for the rescue treatment, including the reduction of mortality and pneumothoraces, of Respiratory Distress Syndrome (RDS) in premature infants [see Indications and Usage (1) and Dosage Administration (2)]. The safety and efficacy of CUROSURF in the treatment of full term infants or older pediatric patients with respiratory failure has not been established.

More information

Category Value
Authorisation number NDA020744
Agency product number KE3U2023NP
Orphan designation No
Product NDC 10122-510
Date Last Revised 23-03-2018
Type HUMAN PRESCRIPTION DRUG
RXCUI 261329
Marketing authorisation holder Chiesi USA, Inc.