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Infasurf® (calfactant) Intratracheal Suspension is a sterile, non-pyrogenic lung surfactant intended for intratracheal instillation only. It is an extract of natural surfactant from calf lungs which includes phospholipids, neutral lipids, and hydrophobic surfactant-associated proteins B and C (SP-B and SP-C). It contains no preservatives.
Infasurf is an off-white suspension of calfactant in 0.9% aqueous sodium chloride solution. It has a pH of 5.0 - 6.2 (target pH 5.7). Each milliliter of Infasurf contains 35 mg total phospholipids (including 26 mg phosphatidylcholine of which 16 mg is disaturatedphosphatidylcholine) and 0.7 mg proteins including 0.26 mg of SP-B.
INFASURF is indicated:
The recommended dose of INFASURF is 3 mL/kg body weight at birth administered intratracheally through an endotracheal tube. INFASURF can be administered every 12 hours for a total of up to three doses.
To reduce the risk of RDS in preterm neonates <29 weeks of gestational age at risk for RDS, administer INFASURF within 30 minutes after birth.
INFASURF should be administered by healthcare providers who are experienced in the acute care of neonates with RDS who require intubation. Two attendants should be present to facilitate dosing; one to instill the INFASURF, the other to monitor the neonate.
Administer INFASURF intratracheally through an endotracheal tube using the prepared syringe [see DOSAGE AND ADMINISTRATION] using either of the following two methods. Instill the INFASURF dose through a:
After INFASURF administration, frequently monitor neonate oxygenation and ventilatory status [see WARNINGS AND PRECAUTIONS].
Intratracheal Suspension: INFASURF (calfactant) is an off-white suspension available as:
INFASURF (calfactant) intratracheal suspension is an off-white suspension available in a sterile, rubber-stoppered glass single-dose vial packaged as one vial per carton:
105 mg/3 mL (35 mg/mL) (NDC 61938-456-03)
210 mg/6 mL (35 mg/mL) (NDC 61938-456-06)
Refrigerate INFASURF (calfactant) intratracheal suspension at 2°;C to 8°;C (36°;F to 46°;F) and protect from light. Must store the 105 mg/3 mL (35 mg/mL) vial upright. Do not remove INFASURF from the refrigerator for more than 24 hours. Unopened, unused INFASURF vials that have reached room temperature within 24 hours can be refrigerated for future use; however, do not re-refrigerate INFASURF more than once. Record the date and time on the carton when INFASURF is removed from the refrigerator.
Manufactured by: ONY Biotech Inc. 1576 Sweet Home Road Amherst, NY 14228. Revised: Aug 2024
The following clinically significant adverse reactions are described elsewhere in the labeling:
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety of INFASURF is based on the pooled safety population from three, randomized, active-controlled clinical trials that evaluated INFASURF to reduce the risk of respiratory distress syndrome (RDS) and rescue treatment of RDS [see Clinical Studies], which included 1554 preterm neonates who received at least one dose of INFASURF.
The most common INFASURF administration-related adverse reactions were cyanosis (65%), airway obstruction (39%), bradycardia (34%), reflux of surfactant into the endotracheal tube (21%), requirement for manual ventilation (16%), and reintubation (3%).
The controlled trials of INFASURF included the incidence of common complications of prematurity and RDS as safety endpoints. Tables 1 and 2 display the results in the INFASURF vs. colfosceril palmitate trials and the INFASURF and beractant trials, respectively. Trials 1, 2, and 3 were not designed to evaluate meaningful comparisons of the incidence of adverse reactions in the INFASURF and the colfosceril palmitate and beractant treatment groups.
Table 1 : Common Complications of Prematurity and RDS in Controlled Trials of INFASURF vs colfosceril palmitate
| Complication | INFASURF (N=1001)% |
colfosceril palmitate (N=978)% |
| Apnea | 61 | 61 |
| Patent ductus arteriosus | 47 | 48 |
| Intracranial hemorrhage | 29 | 31 |
| Severe intracranial hemorrhagea | 12 | 10 |
| IVH and PVLb | 7 | 3 |
| Sepsis | 20 | 22 |
| Pulmonary air leaks | 12 | 22 |
| Pulmonary interstitial emphysema | 7 | 17 |
| Pulmonary hemorrhage | 7 | 7 |
| Necrotizing enterocolitis | 5 | 5 |
| aGrade III and IV by the method of Papile. b Patients with both intraventricular hemorrhage and periventricular leukomalacia. |
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Table 2 : Common Complications of Prematurity and RDS Controlled Trials of INFASURF vs beractant
| Complication | INFASURF (N=553) % |
beractant (N=566) % |
| Apnea | 76 | 76 |
| Patent ductus arteriosus | 45 | 48 |
| Intracranial hemorrhage | 36 | 36 |
| Severe intracranial hemorrhagea | 9 | 7 |
| IVH and PVLb | 5 | 5 |
| Sepsis | 28 | 27 |
| Necrotizing enterocolitis | 17 | 18 |
| Pulmonary air leaks | 15 | 15 |
| Pulmonary interstitial emphysema | 10 | 10 |
| Pulmonary hemorrhage | 7 | 6 |
| aGrade III and IV by the method of Papile. b Patients with both intraventricular hemorrhage and periventricular leukomalacia. |
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Two-year follow-up data of neurodevelopmental outcomes in 415 neonates who enrolled in the INFASURF vs. colfosceril palmitate controlled-trials demonstrated significant developmental delays in both the INFASURF and colfosceril palmitate groups; however, there was no significant differences between the groups.
No Information provided
Included as part of the PRECAUTIONS section.
The administration of exogenous surfactants, including INFASURF, can rapidly affect oxygenation and lung compliance. Frequently monitor neonates who receive INFASURF so that oxygen and ventilatory support can be modified in response to changes in respiratory status. INFASURF should only be administered by those trained and experienced in the care, resuscitation, and stabilization of preterm neonates with RDS who require intubation.
Administration-related adverse reactions associated with INFASURF use included cyanosis, bradycardia, airway obstruction, and reflux of INFASURF into the endotracheal tube. These adverse reactions occurred more frequently in neonates who received repeat doses of INFASURF at 12-hour intervals than neonates that received colfosceril palmitate, the comparator, in randomized controlled trials (Trials 1 and 3) [see Clinical Studies]. If these adverse reactions occur during INFASURF administration, stop INFASURF and institute appropriate measures to alleviate these adverse reactions and resume INFASURF with appropriate monitoring.
An increased proportion of INFASURF-treated neonates compared to colfosceril palmitate-treated neonates in randomized clinical trials (Trials 1 and 3) [see Clinical Studies] developed intraventricular hemorrhage and periventricular leukomalacia. These adverse reactions were not associated with increased mortality in those studies. In contrast, the same proportion of INFASURF-treated neonates compared to beractant-treated neonates in randomized clinical trials (Trials 2) developed intraventricular hemorrhage and periventricular leukomalacia [see ADVERSE REACTIONS]. While there is no specific treatment for these complications, affected infants may be at increased risk for neurologic complications, including seizures and neurodevelopmental impairment, and should be monitored as per local guidelines.
Studies to assess potential carcinogenic effects of calfactant have not been conducted. Calfactant was not mutagenic in a single bacterial reverse mutation assay (Ames test). No studies to assess reproductive effects of calfactant have been performed.
The safety and effectiveness of INFASURF have been established to reduce the risk of RDS in preterm neonates < 29 weeks of gestational age at risk for RDS and for the rescue treatment of RDS in preterm neonates ≤72 hours of age with RDS who require endotracheal intubation, and the information on these uses is discussed throughout the labeling. The safety and effectiveness of INFASURF have not been established in older pediatric patients.
If respiration, ventilation, or oxygenation is clearly affected after an accidental overdose, aspirate as much of the intratracheal suspension as possible and provide the neonate with supportive treatment.
None.
Endogenous lung surfactant is essential for effective ventilation because it modifies alveolar surface tension thereby stabilizing the alveoli. Lung surfactant deficiency is the cause of Respiratory Distress Syndrome (RDS) in preterm neonates. INFASURF is a lung surfactant that restores lung surface activity in preterm neonates with RDS by adsorbing to the surface of the air:liquid interface and modifying surface tension similarly to natural lung surfactant.
Calfactant dose-response relationships and the time course of pharmacodynamic response are unknown. In vitro, INFASURF lowered minimum surface tension to ≤ 3 mN/m as measured on a pulsating bubble surfactometer. Ex vivo, INFASURF restored the pressure volume mechanics and compliance of surfactant-deficient rat lungs. In vivo, INFASURF improved lung compliance, respiratory gas exchange, and survival in preterm lambs with profound surfactant deficiency.
The absorption, distribution, metabolism, and excretion of calfactant in humans following intratracheal administration of INFASURF is unknown.
The immunogenicity of INFASURF is unknown.
The efficacy of INFASURF to reduce the risk of respiratory distress syndrome (RDS) in preterm neonates <29 weeks of gestational age at risk for RDS and for the rescue treatment of RDS in preterm neonates ≤72 hours of age with RDS who required endotracheal intubation was based on three randomized, active-controlled clinical trials that enrolled 3,098 neonates:
INFASURF vs beractant trial (Trial 2) was one trial that included two cohorts that assessed the efficacy of INFASURF to reduce the risk of RDS (cohort #1) and for the rescue treatment of RDS (cohort #2).
While efficacy cannot be established from uncontrolled trials, there were four uncontrolled trials that included 15,500 preterm neonates who were treated with INFASURF. However, efficacy results are presented only for the three controlled trials described below.
A total of 853 neonates <29 weeks gestation were enrolled in a randomized, double-blind, active-controlled, parallel group trial (Trial 1) that compared INFASURF (3 mL/kg) to colfosceril palmitate (5 mL/kg). The initial dose was administered within 30 minutes of birth. If the patient remained intubated, repeat doses were administered every 12 hours (for up to a total of 3 doses). Each dose was divided in 2 equal aliquots and administered intratracheally in small bursts over 20 to 30 inspiratory cycles through a side port adapter into the proximal end of the endotracheal tube. After each aliquot was instilled, the neonate was positioned with either the right or the left side dependent.
The primary efficacy endpoints for this trial were incidence of RDS, incidence of bronchopulmonary dysplasia (BPD) at day 28, and death due to RDS evaluated at 14 days for all treated patients. Select secondary endpoints included death at 28 days or prior to discharge, incidence of air leaks due to RDS, and the cross over to other surfactant treatment. Table 3 displays the efficacy results in this trial.
Table 3 : Efficacy Results in Preterm Neonates (< 29 weeks of gestational age) (Trial 1)
| INFASURF (N=431) % |
Colfosceril palmitate (N=422) % |
p- Value | |
| Primary Endpoints | |||
| Incidence of RDS | 15 | 47 | <0.001 |
| Bronchopulmonary dysplasiaa | 16 | 17 | 0.60 |
| Death due to RDS | 2 | 5 | <0.01 |
| Secondary Endpoints | |||
| Any death to 28 days | 12 | 16 | 0.10 |
| Any death before discharge | 18 | 19 | 0.56 |
| Incidence of air leaksb | 10 | 15 | 0.01 |
| Crossover to other surfactantc | 0.2 | 3 | <0.001 |
| aBronchopulmonary dysplasia, diagnosed by positive X-ray and oxygen dependence at 28 days. b Pneumothorax and/or pulmonary interstitial emphysema. c If the neonate failed to respond to the three doses of the initial randomized surfactant, was <72 hours of age, and had an a/A PO2 ratio <0.1, the neonate was permitted to receive the comparator surfactant. |
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A total of 1,119 neonates were enrolled in the INFASURF vs beractant trial (Trial 2) which included two cohorts that evaluated INFASURF to reduce the risk of RDS (cohort #1) and for the rescue treatment of RDS (cohort #2) [see Clinical Studies]. Cohort #1 was a randomized, double-blind, active-controlled, trial in 457 neonates ≤ 30 weeks gestation and ≤ 1,250 grams birth weight that compared the 4 mL/kg (100 mg phospholipids/kg) dose of INFASURF to the 4 mL/kg dose of beractant. Note that the INFASURF formulation and dose used in this trial were different from the marketed INFASURF formulation and the recommended dose of 3 mL/kg (105 mg phospholipid/kg). The initial dose was administered intratracheally within 15 minutes of birth and if the patient required ≥30% oxygen repeat doses were administered intratracheally at ≥6 hours following the previous INFASURF dose (for a total of 3 repeat doses before 96 hours of age (a total of 4 doses including the initial dose and the repeat doses)); the recommended frequency of INFASURF repeat dosing is every 12 hours and the maximum number of doses including the initial and repeat doses is three [see DOSAGE AND ADMINISTRATION]. The surfactant treatments were administered through a 5-French feeding catheter inserted into the endotracheal tube. Each dose was instilled in four equal aliquots (between each of the instillations, the catheter was removed and mechanical ventilation resumed for 0.5 to 2 minutes). Each of the aliquots was administered with the patient in one of four different positions (prone, supine, right, and left lateral).
There was increased mortality from any cause at 28 days (p=0.03) and in death due to respiratory causes (p=0.005) in INFASURF-treated neonates compared to beractant-treated neonates. For evaluable patients (patients who met the protocol-defined entry criteria), mortality from any cause and mortality due to respiratory causes were also higher in the INFASURF group (p = 0.07 and 0.03, respectively). However, these observations have not been replicated in other adequate and well-controlled trials and their relevance to the intended population is unknown. There was no significant difference in the incidence of RDS, air leaks, BPD, and treatment failure between INFASURF and beractant groups.
A total of 1,126 neonates ≤72 hours of age with RDS who required endotracheal intubation and had an arterial/Alveolar oxygen ratio (a/A) PO2 < 0.22 were enrolled into a randomized, double-blind, active-control, parallel group trial (Trial 3) that compared INFASURF (3 mL/kg) and colfosceril palmitate (5 mL/kg). Patients received an initial dose, and if intubation was still required, patients received one repeat dose 12 hours later (total of 2 doses). Each dose was instilled intratracheally in small bursts over 20 to 30 inspiratory cycles in two aliquots through a side-port adapter into the proximal end of the endotracheal tube. After each aliquot was instilled, the neonate was positioned with either the right or the left side dependent.
The primary efficacy endpoints for this trial were the incidence of RDS-related air leaks, incidence of BPD at 28 days, and mortality secondary to RDS. Select secondary endpoints included any death at day 28 or prior to hospital discharge and crossover to other surfactant. Table 4 describes the efficacy results of this trial.
Table 4 : Efficacy Results in Neonates ≤72 Hours of Age (Trial 3)
| INFASURF (N=570) % |
colfosceril palmitate (N=556) % |
p-Value | |
| Primary Endpoints | |||
| Air leaks a | 11 | 22 | <0.001 |
| BPD b | 5 | 6 | 0.41 |
| Death due to RDS | 4 | 4 | 0.95 |
| Secondary Endpoints | |||
| Any death to 28 days | 8 | 10 | 0.21 |
| Any death before discharge | 9 | 12 | 0.07 |
| Crossover to other surfactant c | 4 | 4 | 1 |
| a Pneumothorax and/or pulmonary interstitial emphysema. b BPD is bronchopulmonary dysplasia, diagnosed by positive X-ray and oxygen dependence at 28 days. c If the neonate failed to respond to the two doses of the initial randomized surfactant, was <96 hours of age, and had an a/A PO2 ratio <0.1, the neonate was permitted to receive the comparator surfactant. |
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A total of 1,119 neonates were enrolled in the INFASURF vs. beractant trial (Trial 2) which included two cohorts that evaluated INFASURF to reduce risk of RDS (cohort #1) [see Clinical Studies] and for rescue treatment of RDS (cohort #2). Cohort #2 was a randomized, double-blind, active-controlled trial in 662 neonates with RDS who required endotracheal intubation and had an a/A PO2 <0.22 that compared the 4 mL/kg (100 mg phospholipids/kg) dose of INFASURF to the 4 mL/kg dose of beractant. Note that the INFASURF formulation and dose used in this trial were different from the marketed INFASURF formulation and the recommended dose of 3 mL/kg (105 mg phospholipids/kg). If the neonate required ≥30% oxygen, repeat doses were administered at ≥6 hours following the previous treatment (for a total of four doses before 96 hours of age). Note that the recommended frequency of INFASURF repeat dosing is every 12 hours and the maximum number of doses including the initial and repeat doses is three [see DOSAGE AND ADMINISTRATION]. The surfactant was administered intratracheally through a 5-French feeding catheter inserted into the endotracheal tube. Each dose was instilled in four equal aliquots (the catheter was removed between each of the instillations and mechanical ventilation resumed for 0.5 to 2 minutes). Each of the aliquots was administered with the patient in one of four different positions (prone, supine, right, and left lateral) to facilitate even distribution of the surfactant.
The primary efficacy endpoints were the incidence of air leaks, death due to respiratory causes or to any cause, BPD, or treatment failure evaluated at 28 days or to discharge. There was no significant difference between the INFASURF and beractant groups in these efficacy endpoints.
Inform caregivers of the following risks of INFASURF:
