Calfactant

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Calfactant
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1];

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Overview

Calfactant is a that is FDA approved for the {{{indicationType}}} of of Respiratory Distress Syndrome (RDS) in premature infants at high risk for RDS and for the treatment (“rescue”) of premature infants who develop RDS. Common adverse reactions include .

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Respiratory Distress Syndrome (RDS)
  • Infasurf is indicated for the prevention of Respiratory Distress Syndrome (RDS) in premature infants at high risk for RDS and for the treatment (“rescue”) of premature infants who develop RDS. Infasurf decreases the incidence of RDS, mortality due to RDS, and air leaks associated with RDS.
Prophylaxis
  • Prophylaxis therapy at birth with Infasurf is indicated for premature infants less than 29 weeks of gestational age at significant risk for RDS. Infasurf prophylaxis should be administered as soon as possible, preferably within 30 minutes after birth.
Treatment
  • Infasurf therapy is indicated for infants less than or equal to 72 hours of age with RDS (confirmed by clinical and radiologic findings) and requiring endotracheal intubation.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Calfactant in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Calfactant in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding FDA-Labeled Use of Calfactant in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Calfactant in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Calfactant in pediatric patients.

Contraindications

  • Condition1

Warnings

  • Infasurf is intended for intratracheal use only.
  • THE ADMINISTRATION OF EXOGENOUS SURFACTANTS, INCLUDING INFASURF, OFTEN RAPIDLY IMPROVES OXY GENATION AND LUNG COMPLIANCE. Following administration of Infasurf, patients should be carefully monitored so that oxygen therapy and ventilatory support can be modified in response to changes in respiratory status. Infasurf therapy is not a substitute for neonatal intensive care. Optimal care of premature infants at risk for RDS and new born infants with RDS who need endotracheal intubation requires an acute care unit organized, staffed, equipped, and experienced with intubation, ventilator management, and general care of these patients.
  • TRANSIENT EPISODES OF REFLUX OF INFASURF INTO THE ENDOTRACHEAL TUBE, CYANOSIS, BRADYCARDIA, OR AIRWAY OBSTRUCTION HAVE OCCURRED DURING THE DOSING PROCEDURES. These events require stopping Infasurf administration and taking appropriate measures to alleviate the condition. After the patient is stable, dosing can proceed with appropriate monitoring.

Precautions

  • DescriptionWhen repeat dosing was given at fixed 12-hour intervals in the Infasurf vs. Exosurf Neonatal® trials, transient episodes of cyanosis, bradycardia, reflux of surfactant into the endotracheal tube, and airway obstruction were observed more frequently among infants in the Infasurf-treated group.
  • An increased proportion of patients with both intraventricular hemorrhage (IVH) and periventricular leukomalacia (PVL) was observed in Infasurf-treated infants in the Infasurf-Exosurf Neonatal® controlled trials. These observations were not associated with increased mortality.
  • No data are available on the use of Infasurf in conjunction with experimental therapies of RDS, e.g., high-frequency ventilation. Data from controlled trials on the efficacy of Infasurf are limited to doses of approximately 100 mg phospholipid/kg body weight and up to a total of 4 doses.

Adverse Reactions

Clinical Trials Experience

  • The most common adverse reactions associated with Infasurf dosing procedures in the controlled trials were cyanosis (65%), airway obstruction (39%), bradycardia (34%), reflux of surfactant into the endotracheal tube (21%), requirement for manual ventilation (16%), and reintubation (3%). These events were generally transient and not associated with serious complications or death. The incidence of common complications of prematurity and RDS in the four controlled Infasurf trials are presented in Table3.Prophylaxis and treatment study results for each surfactant are combined.

table03

  • Follow-up Evaluations
  • Two-year follow-up data of neurodevelopmental outcomes in 415 infants enrolled in 5 centers that participated in the Infasurf vs.

Exosurf Neonatal® controlled trials demonstrated significant developmental delays in equal percentages of Infasurf and Exosurf Neonatal® patients.

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Calfactant in the drug label.

Drug Interactions

  • Drug
  • Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

  • Pregnancy Category


Pregnancy Category (AUS):

  • Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Calfactant in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Calfactant during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Calfactant with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Calfactant with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Calfactant with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Calfactant with respect to specific gender populations.

Race

There is no FDA guidance on the use of Calfactant with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Calfactant in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Calfactant in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Calfactant in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Calfactant in patients who are immunocompromised.

Administration and Monitoring

Administration

  • Oral
  • Intravenous

Monitoring

There is limited information regarding Monitoring of Calfactant in the drug label.

IV Compatibility

There is limited information regarding IV Compatibility of Calfactant in the drug label.

Overdosage

  • There have been no reports of overdosage with Infasurf. While there are no known adverse effects of excess lung surfactant, overdosage would result in overloading the lungs with an isotonic solution. Ventilation should be supported until clearance of the liquid is accomplished.

Pharmacology

There is limited information regarding Calfactant Pharmacology in the drug label.

Mechanism of Action

  • 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 premature infants. Infasurf restores surface activity to the lungs of these infants.

Structure

  • 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 disaturated phosphatidylcholine) and 0.7 mg proteins including 0.26 mg of SP-B.
This image is provided by the National Library of Medicine.

Pharmacodynamics

  • Infasurf adsorbs rapidly to the surface of the air:liquid interface and modifies surface tension similarly to natural lung surfactant. A minimum surface tension of less than or equal to 3 mN/m is produced in vitro by Infasurf as measured on a pulsating bubble surfactometer. Ex vivo, Infasurf restores the pressure volume mechanics and compliance of surfactant-deficient rat lungs. In vivo, Infasurf improves lung compliance, respiratory gas exchange, and survival in preterm lambs with profound surfactant deficiency

Pharmacokinetics

  • Animal Metabolism: Infasurf is administered directly to the lung lumen surface, its site of action. No human studies of absorption, biotransformation, or excretion of Infasurf have been performed. The administration of Infasurf with radiolabeled phospholipids into the lungs of adult rabbits results in the persistence of 50% of radioactivity in the lung alveolar lining and25% of radioactivity in the lung tissue 24 hours later. Less than 5% of the radioactivity is found in other organs. In premature lambs with lethal surfactant deficiency, less than 30% of instilled Infasurf is present in the lung lining after 24 hours.

Nonclinical Toxicology

  • Carcinogenesis studies and animal reproduction studies have not been performed with Infasurf. A single mutagenicity study (Ames assay) was negative.

Clinical Studies

  • Clinical Studies: The efficacy of Infasurf was demonstrated in two multiple-dose controlled clinical trials involving approximately 2,000 infants treated with Infasurf (approximately 100 mg phospholipid/kg) or Exosurf Neonatal®. In addition, two controlled trials of Infasurf versus Survanta®, and four uncontrolled trials were conducted that involved approximately 15,500 patients treated with Infasurf.
Infasurf versus Exosurf Neonatal®
  • Treatment Trial
  • A total of 1,126 infants less than or equal to 72 hours of age with RDS who required endotracheal intubation and had an a/A PO2 less than 0.22 were enrolled into a multiple-dose, randomized, double-blind treatment trial comparing Infasurf (3 mL/kg) and Exosurf Neonatal® (5 mL/kg). Patients were given an initial dose and one repeat dose 12 hours later if intubation was still required. The dose was instilled in two aliquots through a side port adapter into the proximal end of the endotracheal tube. Each aliquot was given in small bursts over 20-30 inspiratory cycles. After each aliquot was instilled, the infant was positioned with either the right or the left side dependent. Results for efficacy parameters evaluated at 28 days or to discharge for all treated patients from this treatment trial are shown in Table 1.

table01

  • Prophylaxis Trial
  • A total of 853 infants less than 29 weeks gestation were enrolled into a multiple-dose, randomized, double-blind prophylaxis trial comparing Infasurf (3 mL/kg) and Exosurf Neonatal® (5 mL/kg). The initial dose was administered within 30 minutes of birth. Repeat doses were administered at 12 and 24 hours if the patient remained intubated. Each dose was administered divided in 2 equal aliquots, and given through a side port adapter into the proximal end of the endotra cheal tube. Each aliquot was given in small bursts over 20-30 inspiratory cycles. After each aliquot was instilled, the infant was positioned with either the right or the left side dependent. Results for efficacy parameters evaluated to day 28 or to discharge for all treated patients from this prophylaxis trial are shown in Table 2.

table02

Infasurf versus Survanta®
  • Treatment Trial
  • A total of 662 infants with RDS who required endotracheal intubation and had an a/A PO2 less than 0.22 were enrolled into a multiple-dose, randomized, double-blind treatment trial comparing Infasurf (4 mL/kg of a formulation that contained 25 mg of phospholipids/mL rather than the 35 mg/mL in the marketed formulation) and Survanta® (4 mL/kg). Repeat doses were allowed Greater than or equal to 6 hours following the previous treatment (for up to three doses before 96 hours of age) if the patient required Greater than or equal to 30% oxygen. The surfactant was given through a 5 French feeding catheter inserted into the endo tracheal tube. The total dose was instilled in four equal aliquots with the catheter 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. Results for the major efficacy parameters evaluated at 28 days or to discharge (incidence of air leaks, death due to respiratory causes or to any cause, BPD, or treatment failure) for all treated patients from this treatment trial were not significantly different between Infasurf and Survanta®.
  • Prophylaxis Trial
  • A total of 457 infants less than or equal to 30 weeks gestation and less than 1251 grams birth weight were enrolled into a multiple-dose, randomized, double-blind trial comparing Infasurf (4 mL/kg of a formulation that contained 25 mg of phospholipids/mL rather than the 35 mg/mL in the marketed formulation) and Survanta® (4 mL/kg). The initial dose was administered within15 minutes of birth and repeat doses were allowed Greater than or equal to 6 hours following the previous treatment (for up to three doses before 96 hours of age) if the patient required Greater than or equal to 30% oxygen. The surfactant was given through a 5 French feeding catheter inserted into the endotracheal tube. The total dose was instilled in four equal aliquots with the catheter 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). Results for efficacy endpoints evaluated at 28 days or to discharge for all treated patients from this prophylaxis trial showed an increase in mortality from any cause at 28 days (p=0.03) and in death due to respiratory causes (p=0.005) in Infasurf-treated infants. 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. All other efficacy outcomes (incidence of RDS, air leaks, BPD, and treatment failure) were not significantly different between Infasurf and Survanta® when analyzed for all treated patients and for evaluable patients.
  • Acute Clinical Effects: As with other surfactants, marked improvements in oxygenation and lung compliance may occur shortly after the administration of Infasurf. All controlled clinical trials with Infasurf demonstrated significant improvements in fraction of inspired oxygen (FiO2) and mean airway pressure (MAP) during the first 24 to 48 hours following initiation of Infasurf therapy.

How Supplied

  • Infasurf (calfactant) Intratracheal Suspension is supplied sterile in single-use, rubber-stoppered glass vials containing 3 mL (NDC 61938-456-03) and 6 mL (NDC 61938-456-06) off-white suspension.
  • Store Infasurf (calfactant) Intratracheal Suspension at refrigerated temperature 2° to 8°C (36° to 46°F) and protect from light. THE 3mL VIAL MUST BE STORED UPRIGHT. Vials are for single use only. After opening, discard unused drug.

Storage

There is limited information regarding Calfactant Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of Calfactant in the drug label.

Precautions with Alcohol

  • Alcohol-Calfactant interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

Look-Alike Drug Names

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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