NDC 61938-0456-03 — INFASURF calfactant 35.7 mg/mL Suspension

🆔 Identity & classification

FDA NDC (as labeled) 61938-456-03

Product NDC 61938-456

11-digit billing NDC 61938045603

NCPDP billing unit ML — per mL (volume)

RxCUI 259611, 994039

UNII Q4K217VGA9

UPC 0361938456063, 0361938456032

Application # BLA020521

SPL Set ID 315c128a-272d-4c57-bfbe-1a8b3402af08

Established class (EPC) Surfactant

Mechanism of action Surfactant Activity

Physiologic effect Alveolar Surface Tension Reduction

DEA schedule Non-controlled

Marketing category BLA

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 1999-10-18

Route ENDOTRACHEAL

Dosage form SUSPENSION

Substance CALFACTANT

GPI-14 45000060111820

GPI class Infasurf

GCN Seq No 043195

GCN 92809

HICL code 020409

Ingredient (HICL) Calfactant

HIC1 code B

Therapeutic class — broad (HIC1) Respiratory System

HIC2 code B1

Therapeutic class — intermediate (HIC2) Affect Primarily Lungs

HIC3 code B1A

Therapeutic class — specific (HIC3) Lung Surfactants

AHFS code 48:36.00.00

AHFS class Pulmonary Surfactants

FDB label name INFASURF 35 MG/ML VIAL

FDB brand name Infasurf

Legend status F — Federal legend — prescription drug or device

Biologic (Purple Book) 351(a)

Why two NDCs? The FDA registers this code as 61938-456-03 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 61938-0456-03. Same drug, same package — only the format differs.

Where does this data come from?

Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Surfactant class.

Pharmacologic class Surfactant

How it works Surfactant Activity

Where does this data come from?

Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerONY Biotech Inc.

FDA applicationBLA020521 (BLA)

Labeler code61938

First marketedOct 1999

Product typeHuman Prescription Drug

🔎 All NDCs from ONY Biotech Inc.

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).

Where does this data come from?

Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name INFASURF 35 MG/ML VIAL Ingredient Calfactant

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →

Where does this data come from?

Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

UNII VR5Y7PDT5W
A saltwater solution with the same concentration as blood. It's used as a vehicle or diluent in injectable medicines to help distribute the active drug and maintain proper fluid balance in the body.
UNII N762921K75
A colorless, odorless gas that makes up most of the air we breathe. In medicines, it's used as a packaging gas or propellant to protect products from oxidation and maintain freshness.
UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

3 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?

Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?

No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.

Why might an inactive ingredient be missing?

Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.

Can inactive ingredients matter?

Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price system	Per mL	Per package
Retail pharmacies payNADAC · weekly	Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo	No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly	No Part D plan price is available for this NDC in our data.

ℹ️

No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.

Try another pack size: 6 mL

Where does this data come from?

NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Infasurf 35.7 mg/mLthis 61938-0456-03	ONY	1 vial	—	—	FDA listed	—

About this product: this is a biologic. Biologics don't have small-molecule generics — competition comes from FDA-licensed biosimilars (shown above), not generics.

Where does this data come from?

Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & biosimilar status

🏛️

1998

First FDA approval

Jul 1998

📍

2026

Currently FDA-listed

28 years listed

🧬

·

Biosimilars

see Purple Book

🧬Biologic — competition comes from biosimilars

Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.

FDA Purple Book — biosimilars & interchangeables ⓘ

Reference product

Infasurfcalfactant

🔒 No FDA-licensed biosimilars or interchangeable biosimilars are listed yet for this biologic. It currently has no biosimilar competition in the FDA Purple Book.

Source: FDA Purple Book (purplebooksearch.fda.gov), matched on the reference product’s active ingredient.

Where does this data come from?

Patents and exclusivity from the FDA Purple Book (biologics), refreshed from public FDA data. Biosimilar launch timing is an estimate, not a guarantee.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for INFASURF (this brand).

Top reported reactions

Endotracheal Intubation Complication25

Oxygen Saturation Decreased13

Bradycardia6

Cardio-respiratory Arrest5

Pneumothorax4

Death3

Heart Rate Decreased3

Age at onset

Neonate5

Reporter sex

Male · 41%

Female · 46%

Unknown · 13%

Serious outcomes

Life-threatening24

Hospitalization7

Reports over time (by year) — tap or hover for the count & year

Most recent year is provisional (FAERS lags ~3 months).

Where does this data come from?

Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDC	Description	Marketing start	Status
61938-0456-03 You're viewing this	1 VIAL, GLASS in 1 CARTON (61938-456-03) / 3 mL in 1 VIAL, GLASS	2011-07-21	Active
61938-0456-06	1 VIAL, GLASS in 1 CARTON (61938-456-06) / 6 mL in 1 VIAL, GLASS	2011-07-21	Active

Pack size FAQ

What quantity is in NDC 61938-0456-03?

NDC 61938-0456-03 is listed by the FDA — 1 vial, glass in 1 carton / 3 ml in 1 vial, glass.

What NDC number is used to bill for this package of INFASURF calfactant 35.7 mg/mL Suspension?

Bill NDC 61938-0456-03 — the 11-digit billing format is 61938045603. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Finished prescription product

What data is (and isn’t) available for this NDC — tap to expand

NDC identity (package / product / labeler codes)	✓ Available
Labeler	✓ Available
Product & package description	✓ Available
Marketing category & status	✓ Available
Active ingredient / dosage form / route	✓ Available
FDA label (SPL via DailyMed)	✓ Available
Package photos	✓ Available
Inactive ingredients (structured)	✓ Available
NADAC pharmacy acquisition price (CMS)	— Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data	— Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk	— Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD)	— Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.

“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?

The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.

Is the NDC printed on the package the same as the 11-digit billing NDC?

Yes, they identify this exact package in different formats. The FDA registers it as 61938-456-03, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 61938-0456-03, written without dashes as 61938045603. The Identity section at the top of this page lists every form of this code.

What do the three segments of this NDC mean?

In 61938-0456-03, the first segment (61938) is the labeler code FDA assigned to ONY Biotech Inc.; the middle segment (0456) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (03) identifies this exact package size and type. Together they name one specific package of one specific product.

Is this package still being marketed?

Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by ONY Biotech Inc.. Listing status can change — the directory data on this page refreshes weekly.

Does this product come in other package sizes?

Yes — the FDA directory lists 1 other package presentation of this same product, including 1 vial (61938-0456-06). Each has its own NDC and its own page — see the package list near the top of this page.

Who lists this product with the FDA?

ONY Biotech Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.

Do I need a prescription for this product?

This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.

This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.

Where does this data come from?

Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.

🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 👥 Use in Specific Populations 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Patient Medication Information

🎯 Indications and Usage 93 words ▾

1 INDICATIONS AND USAGE INFASURF is indicated: to reduce the risk of respiratory distress syndrome (RDS) in preterm neonates <29 weeks of gestational age at risk for RDS. for the rescue treatment of RDS in preterm neonates ≤72 hours of age with RDS who require endotracheal intubation. INFASURF ® is a surfactant indicated: to reduce the risk of respiratory distress syndrome (RDS) in preterm neonates < 29 weeks gestational age at risk for RDS. (1) for the rescue treatment of preterm neonates ≤72 hours of age with RDS who require endotracheal intubation.

(1)

⏱️ Dosage and Administration ~2 min read ▾

2 DOSAGE AND ADMINISTRATION

2.1Recommended Dosage 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.

2.2Preparation Instructions INFASURF does not require reconstitution. Do not dilute or sonicate. INFASURF does not need to reach room temperature before administration.

Gently swirl or agitate the INFASURF intratracheal suspension vial for redispersion. Do not shake. Visually inspect the INFASURF intratracheal suspension for discoloration prior to administration.

The color of the INFASURF intratracheal suspension should be off-white. Discard the INFASURF vial if the intratracheal suspension is discolored. Visible flecks in the intratracheal suspension and foaming at the surface are normal.

Using a 20-gauge or larger needle and syringe to avoid excessive foaming, withdraw INFASURF from the vial. Discard unopened INFASURF vials stored at room temperature for more than 24 hours. Discard unused INFASURF after the initial vial entry.

2.3Administration Instructions 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 (2.2) ] using either of the following two methods.

Instill the INFASURF dose through a: Side-port adapter into the endotracheal tube as two equal aliquots of 1.5 mL/kg each. During and after each aliquot that is instilled, position the neonate with either the right or the left side dependent and maintain ventilation over 20 to 30 breaths for each aliquot, with small bursts timed only during the inspiratory cycles. Between aliquot administration evaluate the respiratory status and reposition to the other side.

5-French feeding catheter inserted into the endotracheal tube as four equal aliquots of 0.75 mL/kg each. During and after each aliquot is instilled, position the neonate in four different positions (i.e., prone, supine, right, and left lateral) to facilitate even distribution of INFASURF. Remove the catheter between each of the instillations and resume mechanical ventilation for 0.5 to 2 minutes.

After INFASURF administration, frequently monitor neonate oxygenation and ventilatory status [ see Warnings and Precautions (5.1) ]. For intratracheal administration only (2) The recommended dose of INFASURF is 3 mL/kg body weight at birth. (2.2) Up to 3 doses of INFASURF can be administered.

(2.2) Doses should not be given more frequently than every 12 hours. (2.2) Administration instructions: (2.3) Side-port adapter into the endotracheal tube : two equal aliquots while ventilation is continued over 20 to 30 breaths for each aliquot. 5-French feeding catheter inserted into the endotracheal tube : four equal aliquots with the catheter removed between each of the instillations and mechanical ventilation resumed for 0.5 to 2 minutes.

💊 Dosage Forms and Strengths 47 words ▾

3 DOSAGE FORMS AND STRENGTHS Intratracheal Suspension: INFASURF (calfactant) is an off-white suspension available as: 105 mg/3 mL (35 mg/mL) single-dose vial 210 mg/6 mL (35 mg/mL) single-dose vial Intratracheal Suspension: 105 mg/3 mL (35 mg/mL) single-dose vial (3) 210 mg/6 mL (35 mg/mL) single-dose vial (3)

⛔ Contraindications 4 words ▾

4 CONTRAINDICATIONS None. None.

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS

5.1Acute Changes in Oxygenation and Lung Compliance 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.

5.2Administration-Related Adverse Reactions 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 (14) ]. 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.

5.3Intraventricular Hemorrhage and Periventricular Leukomalacia An increased proportion of INFASURF-treated neonates compared to colfosceril palmitate-treated neonates in randomized clinical trials (Trials 1 and 3) [ see Clinical Studies (14) ] 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 (6.2) ].

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. Acute Changes in Oxygenation and Lung Compliance: INFASURF administration can rapidly affect oxygenation and lung compliance. Frequently monitor neonates after administration of INFASURF to adjust oxygen therapy and ventilator pressures appropriately.

(5.1) Administration-Related Adverse Reactions: Adverse reactions associated with INFASURF include cyanosis, bradycardia, airway obstruction, and reflux of INFASURF into the endotracheal tube. In the event of these adverse reactions, stop INFASURF administration, and take appropriate measures to alleviate the adverse reactions and resume INFASURF with appropriate monitoring. (5.2) Intraventricular Hemorrhage and Periventricular Leukomalacia: Some INFASURF-treated neonates developed intraventricular hemorrhage and periventricular leukomalacia in randomized clinical trials.

(5.3)

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Acute Changes in Oxygenation and Lung Compliance [ see Warnings and Precautions (5.1 )] Administration-Related Adverse Reactions [see Warnings and Precautions (5.2) ] Intraventricular Hemorrhage and Periventricular Leukomalacia [ see Warnings and Precautions (5.3) ]

6.1Clinical Trials Experience 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 (14) ], which included 1,554 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%).

6.2Complications of RDS and Neurodevelopmental Outcomes Incidence of Common Complications of Prematurity 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=1,001) % colfosceril palmitate (N=978) % Apnea 61 61 Patent ductus arteriosus 47 48 Intracranial hemorrhage 29 31 Severe intracranial hemorrhage a 12 10 IVH and PLV b 7 3 Sepsis 20 22 Pulmonary air leaks 12 22 Pulmonary interstitial emphysema 7 17 Pulmonary hemorrhage 7 7 Necrotizing enterocolitis 5 5 a Grade III and IV by the method of Papile. b Patients with both intraventricular hemorrhage and periventricular leukomalacia.

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 hemorrhage a 9 7 IVH and PVL b 5 5 Sepsis 28 27 Pulmonary air leaks 15 15 Pulmonary interstitial emphysema 10 10 Pulmonary hemorrhage 7 6 Necrotizing enterocolitis 17 18 a Grade III and IV by the method of Papile. b Patients with both intraventricular hemorrhage and periventricular leukomalacia.

Neurodevelopmental Outcomes 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. Most common adverse reactions associated with the use of INFASURF are cyanosis (65%), airway obstruction (39%), bradycardia (34%), reflux of surfactant into the endotracheal tube (21%), requirement for manual ventilation (16%), and reintubation (3%).

To report SUSPECTED ADVERSE REACTIONS, contact ONY Biotech Inc. at 1-877-663-4179 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . See 17 for PATIENT COUNSELING INFORMATION

👥 Use in Specific Populations 81 words ▾

8 USE IN SPECIFIC POPULATIONS

8.4Pediatric Use 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.

🆘 Overdosage 30 words ▾

10 OVERDOSAGE 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.

🧬 Clinical Pharmacology 163 words ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism 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 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.

12.2Pharmacodynamics 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.

12.3Pharmacokinetics The absorption, distribution, metabolism, and excretion of calfactant in humans following intratracheal administration of INFASURF is unknown.

12.6Immunogenicity The immunogenicity of INFASURF is unknown.

📦 How Supplied / Storage and Handling 120 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING 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.

📋 Description 161 words ▾

11 DESCRIPTION Calfactant is an extract of natural bovine lung (pulmonary) surfactant consisting of 85% phospholipids, 8% neutral lipids, and 7% hydrophobic surfactant-associated proteins B and C (SP-B and SP-C). The molecular weight of SP-B is 8.7 kDa and the molecular weight of SP-C is 3.7 kDa. INFASURF (calfactant) intratracheal suspension is a sterile, off-white suspension for intratracheal use.

INFASURF contains calfactant at a concentration of 35 mg/mL in either a 105 mg/3 mL or 210 mg/6 mL single-dose vial. Each milliliter of INFASURF contains 35 mg of phospholipids and 0.7 mg of surface-associated proteins of which 0.26 mg is SP-B, a 79-amino acid protein, and 0.44 mg is SP-C, a 35-amino acid peptide. The amount of phospholipids is calculated from the content of phosphorous and contains 26 mg of phosphatidylcholine of which 16 mg is disaturated phosphatidylcholine.

It is suspended in 0.9% Sodium Chloride Irrigation, USP. The pH is approximately 5.0 - 6.2 (target pH 5.7). INFASURF contains no preservatives.

💬 Patient Medication Information 219 words ▾

17 PATIENT COUNSELING INFORMATION Inform caregivers of the following risks of INFASURF: Advise patient’s caregivers of acute changes in oxygenation and/or lung function typically occur when a surfactant-deficient neonate with respiratory distress is given a surfactant, including INFASURF [ see Warnings and Precautions, (5.1) ]. Advise patient’s caregivers of temporary adverse reactions, including skin turning blue, heart rate slowing, airway blockage, or reflux of INFASURF into the infant’s breathing tube may occur when INFASURF is administered [ see Warnings and Precautions (5.2) ].

If any of these adverse reactions occurs, the healthcare provider will interrupt INFASURF administration and take appropriate measures to alleviate the adverse reactions. Advise patient’s caregivers that infants treated with INFASURF may have evidence of bleeding into the brain and/or loss of brain tissue [ see Warning and Precautions (5.3) ]. Bleeding into the brain and loss of brain tissue are sometimes seen in preterm infants, including those who do not receive surfactant treatment, since the main risk factor is being born at or before 32 weeks’ gestation.

There is no treatment for these complications but affected infants may be at risk for later neurologic complications, including seizures and/or developmental delay, and may require additional evaluation after discharge from the hospital. Manufactured by: ONY Biotech Inc. 455 Commerce Drive Amherst, NY 14228 U.S.

License No. 2192

Glossary — plain-language definitions of medical terms used in this label:

in vitro: In a laboratory dish or test tube rather than in a living person or animal; results may not carry over to people.

in vivo: In a living person or animal rather than in a laboratory dish.

Absorption: How a medicine moves from where it is taken, such as the stomach or gut, into the bloodstream.

active-controlled: Describes a study that compares a new medicine against another medicine already known to work, instead of a dummy pill.

adverse reaction: An unwanted or harmful effect that a medicine causes in the body.

Adverse Reactions: Unwanted or harmful effects that people experienced while taking a medicine, listed on its official label.

apnea: A pause or temporary stop in breathing.

bradycardia: A slower-than-normal heart rate, usually under 60 beats per minute.

Clinical Pharmacology: The label section explaining how a medicine works in the body and how the body processes it.

Clinical Studies: The label section summarizing the research trials used to show that a medicine works and is acceptably safe.

Contraindications: A list of situations or health conditions in which a medicine should not be used because the chance of harm is too high.

cyanosis: A bluish color of the skin, lips, or nails caused by too little oxygen in the blood.

Distribution: How a medicine spreads from the blood into the body's tissues and organs after it is absorbed.

Dosage and Administration: The label section explaining how much of a medicine to use and how to take or give it.

dose-response: The relationship between the size of a dose and the strength of the body's reaction to it.

Excretion: How the body removes a medicine or its leftover pieces, mainly through the urine or stool.

gestational age: How far along a pregnancy is, usually counted in weeks from the mother's last menstrual period.

hemorrhage: Bleeding, especially heavy or uncontrolled bleeding, either inside the body or from an outside wound.

How Supplied/Storage and Handling: The label section describing the forms and strengths a medicine comes in and how to store it properly.

immunogenicity: The tendency of a medicine to make the body produce antibodies against it, which can affect how well it works or cause reactions.

incidence: How often a new event, such as a side effect, happens in a group of people over a set period of time.

Indications and Usage: The label section stating which medical conditions the FDA has officially approved the medicine to treat, prevent, or manage.

Mechanism of Action: How a medicine produces its effect in the body, described at the level of cells or body chemistry.

Metabolism: How the body chemically changes a medicine, usually in the liver, into other substances.

NDC: A unique number that identifies a specific medicine, its maker, strength, and package size.

Overdosage: The label section describing what can happen if too much of a medicine is taken and how it may be treated.

Patient Counseling Information: The label section telling health professionals what to explain to patients about using a medicine safely.

Pharmacokinetics: The study of how the body takes in a medicine, spreads it around, breaks it down, and removes it over time.

randomized: Assigned to a treatment group purely by chance, like a coin flip, so the groups being compared start out fair and similar.

reconstitution: Mixing a powdered medicine with a liquid to prepare it for use, following the label's directions.

sepsis: A serious, body-wide reaction to an infection in which the body's own response can start to injure its tissues and organs.

single-dose vial: A small container holding one dose of medicine, meant to be used once and then thrown away.

suspension: A liquid holding fine drug particles that are mixed in but not fully dissolved, so it must be shaken before use.

Use in Specific Populations: The label section describing how a medicine affects particular groups, such as pregnant people, children, or older adults.

Warnings and Precautions: The label section describing serious risks to know about and safety steps to follow while using a medicine.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

🔗 Related NDC lookups

🧪 All Calfactant NDCsSame ingredient 🏭 All ONY labeler NDCsLabeler code 61938 📚 All Surfactant NDCsDrug class

💊 Related drugs in this class

Other drugs that share this product’s specific therapeutic class — Lung Surfactants.

Beractant 00074-1040-04 Poractant Alfa 10122-0510-01

Where does this data come from?

Other drugs sharing this product’s First Databank therapeutic class (HIC3). Each links to that NDC’s page in our directory.