Dosing & Administration

Dosing Instructions

Each dose of Infasurf is 3 mL/kg body weight at birth.
• Dosing frequency of Infasurf is every 12 hours for a total of up to 3 doses, if needed.

Dosing Chart to come

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Infasurf Administration

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Infasurf Storage:

Infasurf Preparation:

Calculate total dose as 3 mL/kg body weight at birth.
- Warming not required. For patient comfort, Infasurf® (calfactant) can be warmed to room temperature.
- NEVER use radiant/artificial warming devices to warm Infasurf® (calfactant).
Repeatedly invert the vial(s) to homogenize settled suspension – DO NOT SHAKE.
Draw each aliquot through a 20-gauge needle into separate syringes with care taken to avoid excessive foaming*.
Each syringe should contain an amount of air EQUAL to the liquid volume.
- Unopened, unused vials of Infasurf® (calfactant) that have warmed to room temperature can be returned to refrigerated storage within 24 hours for future use.
- Infasurf® (calfactant) should not be returned to the refrigerator more than once.

Infant Preparation:

Position infant supine with the head midline.
ET Tube MUST BE:
- IN PROPER POSITION – confirm presence of expired CO2, bilateral chest rise and equal bilateral breath sounds.
- UNOBSTRUCTED – suction as needed.
- SECURELY FIXED IN PLACE – use extra care if only manual retention is used during instillation.
INFANT MUST BE CLINICALLY STABLE – Confirm SpO2, Expired CO2, HR, and BP are at acceptable levels.

Instillation:

Attach a syringe to instillation catheter.
Advance catheter to the distal tip of ET Tube.
- DO NOT advance catheter beyond the carina into either main stem bronchus.
- During instillation, hold the plunger up and the outlet down – air must be above liquid during instillation.
Instill surfactant suspension quickly and smoothly over 1-2 seconds followed immediately by the air. (Air will clear surfactant out of catheter.)
- DO NOT pause between the liquid and air instillation.

Ventilation

Withdraw instillation catheter rapidly and gently turn infant to left or right side to optimize surfactant distribution. With newer neuroprotective protocols, can we state baby can be left midline?
Initiate ventilation with a flow inflating bag or a T-piece resuscitation device (i.e. Neopuff™, Neo-Tee®, ventilator).
Effective gas exchange will require the use of effective peak inspiratory pressure (PIP), inspiratory time (IT), inspiratory plateau pressures, and positive end-expiratory pressure (PEEP).

Continue ventilation for 1-2 minutes or until adequate ventilation is established.

Use:

Initial peak inspiratory pressure sufficient enough to overcome high inertia and flow resistance of liquid in the airway – this will propel surfactant to the distal lung.*
Initial inspiratory time sufficient to create a plateau pressure (proximal airway pressure is equilibrated throughout the lung).*
- This promotes uniform ventilation and rapid surfactant distribution to the distal lung.
Maintain positive end-expiratory pressure.*

Infant Assessment

Look for signs that instillation has been completed successfully: normal chest rise, color, expired CO2, SpO2, HR and BP.
Listen for clear breath sounds – MINIMAL REFLUX AND ABSENCE OF RHONCHI ARE PHYSICAL SIGNS that surfactant is out of airways and absorbed by the alveoli.
Adjust ventilatory support up or down as needed.
Subsequent aliquots are given once cardiopulmonary stability is established.
Never hesitate to suction the ET Tube and airway whenever airway obstruction is suspected. Suctioning is not contraindicated after surfactant instillation.

For full administration instructions, please see Full Prescribing Information.

Comparative Trials

Animal-derived surfactants for the treatment and prevention of neonatal respiratory distress syndrome: summary of clinical trials

J Wells Logan and Fernando R Moya

Clinical trials suggest that the higher surfactant protein-B content in calfactant, and perhaps the higher phospholipid content in poractant (at higher initial dose), are the factors that most likely confer the observed advantage over other surfactant preparations.

View study: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2697515/

Efficacy of surfactant-TA, calfactant and poractant alfa for preterm infants with respiratory distress syndrome: a retrospective study

J Wells Logan and Ga Won Jeon 1, Minkyung Oh 2, Jong Beom Sin 3

Calfactant is equally as effective as surfactant-TA and poractant alfa. This was the first study comparing the efficacy of surfactant-TA, calfactant, and poractant alfa in a large number of preterm infants in Korea. Further randomized prospective studies on these surfactants are needed.

View study: https://pubmed.ncbi.nlm.nih.gov/25683992/

Comparative effectiveness of surfactant preparations in premature infants

J Andrea Trembath 1, Christoph P Hornik, Reese Clark, P Brian Smith, Julie Daniels, Matthew Laughon; Best Pharmaceuticals for Children Act—Pediatric Trials Network

Beractant, calfactant, and poractant alfa demonstrated similar effectiveness in prevention of air leak syndromes, death, and BPD or death in premature infants when adjusted for site. Previously described differences in mortality between surfactants likely do not represent true differences in effectiveness but may relate to site variation in outcomes.

View study: https://pubmed.ncbi.nlm.nih.gov/23769501/

Comparison of the Pharmacoeconomics of Calfactant and Poractant Alfa in Surfactant Replacement Therapy

Michael M. Zayek, MD,corresponding author Fabien G. Eyal, MD, and Robert C. Smith, BScPharm, MS

Our experience showed a strong pharmacoeconomic advantage for the use of calfactant compared to the use of poractant alfa because of similar average dosing and lower per patient drug costs.

View study: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5916443/

Comparison of Infasurf (calf lung surfactant extract) to Survanta (Beractant) in the treatment and prevention of respiratory distress syndrome

B T Bloom 1, J Kattwinkel, R T Hall, P M Delmore, E A Egan, J R Trout, M H Malloy, D R Brown, I R Holzman, C H Coghill, W A Carlo, A K Pramanik, M A McCaffree, P L Toubas, S Laudert, L L Gratny, K B Weatherstone, J H Seguin, L D Willett, G R Gutcher, D H Mueller, W H Topper

Infants treated with Infasurf have a modest benefit in the acute phase of RDS. Infasurf seems to produce a longer duration of effect than Survanta.

View study: https://pubmed.ncbi.nlm.nih.gov/9200357/#:~:text=The%20inspired%20oxygen%20concentration%20and,infants%20after%20the%20second%20dose

FAQ’s About Infasurf® (calfactant)

What is Infasurf® (calfactant)?

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).

Who can receive Infasurf® (calfactant)?

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 <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 ≤72 hours of age with RDS (confirmed by clinical and radiologic findings) and requiring endotracheal intubation.

What color should Infasurf® (calfactant) be?

Infasurf® is an off-white suspension.

Does Infasurf® (calfactant) contain any preservatives?

No, Infasurf® contains no preservatives. Each vial of Infasurf® contains a ratio of approximately 97% saline and 3% Calf Lung Surfactant Extract (CLSE). See the detailed composition of Infasurf® here.

What is the dose for Infasurf® (calfactant)?

Each dose of Infasurf® is 3 mL/kg body weight at birth.

How soon can I re-dose with Infasurf® (calfactant)?

Infasurf® can be re-dosed every 12 hours or at the discretion of a Medical Doctor.

What is the maximum indicated dose per patient?

Infasurf® can be administered every 12 hours for a total of up to 3 doses.

Does Infasurf® (calfactant) contain any preservatives?

Should you shake Infasurf® (calfactant) before administration?

Infasurf® is a suspension which settles during storage. Gentle swirling or agitation of the vial is often necessary for resuspension. DO NOT SHAKE.

Is it necessary to warm Infasurf® (calfactant) before administration?

Warming of Infasurf® before administration is not necessary.

Can you warm an unopened vial of Infasurf® (calfactant) more than once?

Repeated warming of Infasurf® to room temperature should be avoided. Unopened, unused vials of Infasurf® that have warmed to room temperature can be returned to refrigerated storage within 24 hours for future use. Infasurf® should not be removed from the refrigerator for more than 24 hours. Infasurf® should not be returned to the refrigerator more than once.

Does Infasurf® (calfactant) require reconstitution?

Infasurf® does not require reconstitution. Do not dilute or sonicate.

Can more than one dose be drawn out of a vial of Infasurf® (calfactant)?

Vials of Infasurf® are intended for single use. Each single-use vial should be entered only once. Vials with any unused material should be discarded after the initial entry.

How should Infasurf® (calfactant) be stored?

Store Infasurf® (calfactant) Intratracheal Suspension upright at refrigerated temperature 2° to 8°C (36° to 46°F) and protected from light. THE 3mL VIAL MUST BE STORED UPRIGHT.

Can Infasurf® (calfactant) be reused once removed from the refrigerator?

Date and time need to be recorded on the carton when Infasurf® is removed from the refrigerator. Unopened, unused vials of Infasurf® that have warmed to room temperature can be returned to refrigerated storage within 24 hours for future use. Infasurf® should not be removed from the refrigerator for more than 24 hours. Infasurf® should not be returned to the refrigerator more than once. Repeated warming to room temperature should be avoided.

Can an opened vial of Infasurf® (calfactant) be returned to the refrigerator?

No. Vials of Infasurf® are intended for single use. Each single-use vial should be entered only once. Vials with any unused material should be discarded after the initial entry.

Unopened, unused vials of Infasurf® that have warmed to room temperature can be returned to refrigerated storage within 24 hours for future use. Infasurf® should not be removed from the refrigerator for more than 24 hours. Infasurf® should not be returned to the refrigerator more than once. Repeated warming to room temperature should be avoided.

Can Infasurf® (calfactant) still be used if it looks foamy when removed from carton?

Foaming at the surface and visible flecks in the suspension are normal for Infasurf®. Infasurf® is a suspension which settles during storage. Gentle swirling or agitation of the vial is necessary for resuspension. DO NOT SHAKE.

Can Infasurf® (calfactant) still be used if there are visible flecks in the suspension?

Visible flecks in the suspension and foaming at the surface are normal for Infasurf®. Infasurf® is a suspension which settles during storage. Gentle swirling or agitation of the vial is necessary for resuspension. DO NOT SHAKE.

What is the dose for Infasurf® (calfactant)?

Each dose of Infasurf is 3 mL/kg body weight at birth.

Can Infasurf® (calfactant) be administered for prophylaxis of RDS?

Infasurf® prophylaxis should be administered as soon as possible, preferably within 30 minutes after birth. Prophylaxis therapy at birth with Infasurf® is indicated for premature infants <29 weeks of gestational age at significant risk for RDS.

Can I use Infasurf® (calfactant) in a single bolus?

Administration of Infasurf® has been studied in clinical trials using 2 or 4 aliquots. Single bolus administration would be at the discretion of a Medical Doctor.

Can I give Infasurf® (calfactant) using methods like Minimally Invasive Surfactant Therapy (M.I.S.T.) or Least Invasive Surfactant Administration (L.I.S.A.)?

The only FDA approved method for the instillation of any FDA approved surfactant preparation is into the trachea through an endotracheal tube. While alternative methods of surfactant delivery have been published, none have been reviewed and approved by the FDA.

How can I order Infasurf® (calfactant)?

To order Infasurf® in the U.S., please contact your primary wholesaler. For more information on ordering, please call Customer Service at 866.398.0820 or submit an inquiry online by visiting our Request Information page.

How is Infasurf® (calfactant) supplied?

Infasurf® (calfactant) Intratracheal Suspension is supplied sterile in single-use, rubber-stoppered glass vials containing 3 mL (NDC 61938-456-03) or 6 mL (NDC 61938-456-06) off-white suspension.

Is Infasurf® (calfactant) available outside of the United States?

Yes, we are currently approved for use in 27 different countries around the world. If you’re interested in acquiring Infasurf® for use outside the United States, please contact us by calling 877.274.4669 or submit an inquiry online by visiting our Request Information page.