Poractant Alfa
FDA Drug Information • Also known as: Curosurf
- Brand Names
- Curosurf
- Drug Class
- Surfactant [EPC]
- Route
- ENDOTRACHEAL
- Dosage Form
- SUSPENSION
- Product Type
- HUMAN PRESCRIPTION DRUG
Description
11 DESCRIPTION Poractant alfa is an extract of natural porcine lung (pulmonary) surfactant consisting of 99% polar lipids (mainly phospholipids) and 1% hydrophobic low molecular weight surfactant associated proteins (SP). The molecular weight of SP-B is 8.7 KDa and the molecular weight of SP-C is 3.7 KDa. CUROSURF (poractant alfa) intratracheal suspension is a sterile, white to creamy white suspension provided in a single-dose vial for intratracheal use. Each milliliter of suspension contains 80 mg of poractant alfa (surfactant extract) that includes 76 mg of phospholipids and 1 mg of SP of which 0.45 mg is SP-B, a 79-amino acid protein and 0.59 mg is SP-C, a 35-amino acid peptide . The amount of phospholipids is calculated from the content of phosphorus and contains 55 mg of phosphatidylcholine of which 30 mg is dipalmitoylphosphatidylcholine. It is suspended in 0.9% sodium chloride solution. The pH is adjusted with sodium bicarbonate to a pH of 6.2 (5.5 to 6.5). Curosurf contains no preservatives.
What Is Poractant Alfa Used For?
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 )
Dosage 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 through a 5 French end-hole catheter; or A single bolus 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 intratracheal 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 or Intratracheally in a single bolus 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, administered as one or two aliquots depending upon the instillation procedure [see Dosage and Administration ( 2.4 )]. Up to two repeat doses of 1.25 mL/kg birth weight each may be administered at approximately 12-hour intervals in infants 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. 2.3 Preparation of the CUROSURF Suspension 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. 2.4...
Side Effects (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 FiO 2 ≥ 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 reactions 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 1. Table 1: Most Common Serious Complications Associated with Prematurity and RDS in Study 1 CUROSURF 2.5 mL/kgn=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. 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 FiO 2 ≥ 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...
Contraindications
4 CONTRAINDICATIONS None. None.
Overdosage
10 OVERDOSAGE There have been no reports of overdosage following the administration of CUROSURF. In the event of accidental overdosage, and if there are clear clinical effects on the infant's respiration, ventilation, or oxygenation, aspirate as much of the suspension as possible and provide the infant with supportive treatment, with particular attention to fluid and electrolyte balance.
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING CUROSURF (poractant alfa) intratracheal suspension is a white to creamy white suspension available in sterile, rubber-stoppered clear glass vials containing (one vial per carton): 120 mg/1.5 mL (80 mg/mL) poractant alfa (surfactant extract) of suspension: NDC Number: 10122-510-01 240 mg/3 mL (80 mg/mL) poractant alfa (surfactant extract) of suspension. NDC Number: 10122-510-03 Store CUROSURF intratracheal suspension in a refrigerator at +2°C to +8°C (36°F to 46°F). PROTECT FROM LIGHT. Do not shake. Vials are for single-dose only. After opening the vial discard the unused portion [see Dosage and Administration ( 2.3 )]. Manufactured by: Chiesi USA, Inc. Cary, NC 27518 U.S.License No. 2150 Manufactured at and licensed from: Chiesi Farmaceutici, S.p.A. Parma, Italy 43100 CTC-007-0320-03-SPL-2
About This Information
This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.
What are side effects?
Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.
What are drug interactions?
Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.