infasurf preservative free
Infasurf Preservative Free (Calfactant) is a medication used to treat Newborn Respiratory Distress Syndrome.
Calfactant · by Ony
Key facts
- Active ingredient
- Calfactant
- Form
- Suspension
- Strength
- Calfactant 35MG/ML
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- Manufacturer
- Ony
- FDA application
- BLA020521
What is Infasurf Preservative Free?
From the FDA label: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.
How to use
2.1 Recommended 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. 2.2 Preparation 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. 2.3 Administration Instructions INFASURF should be administered by healthcare providers who are experienced in the acute care of neonates with RDS who require intubation. Two attendants…
Side effects
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) ] 6.1 Clinical 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%). 6.2 Complications of RDS and Neurodevelopmental Outcomes Incidence of Common Complications of Prematurity The controlled trials of INFASURF…
Warnings
Important safety information
5.1 Acute 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. 5.2 Administration-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. 5.3 Intraventricular 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)
Who should not take Infasurf Preservative Free
None. None.
Overdose — what happens if you take too much
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.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
May treat (source: NIH RxClass)
Dosage forms
Suspension
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
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Frequently asked questions
- What does Infasurf Preservative Free treat?
- Infasurf Preservative Free (Calfactant) may be used to treat newborn respiratory distress syndrome, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- Is there a coupon or discount for Infasurf Preservative Free?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Infasurf Preservative Free. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Infasurf Preservative Free?
- Infasurf Preservative Free is marketed by Ony. You can see Ony's full profile, rating, and other products on pharmaranks.
- Is Infasurf Preservative Free a brand-name or generic drug?
- Infasurf Preservative Free is a brand-name product with the active ingredient Calfactant.
- Is Infasurf Preservative Free available over the counter?
- No. Infasurf Preservative Free is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Infasurf Preservative Free come in?
- Infasurf Preservative Free is currently marketed as suspension, per the FDA's National Drug Code Directory.
- Is Infasurf Preservative Free FDA-registered?
- Infasurf Preservative Free is on record with the U.S. FDA under application number BLA020521. You can verify this on its official FDA label.
- Is Infasurf Preservative Free safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Infasurf Preservative Free. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Infasurf Preservative Free?
- Infasurf Preservative Free's side effects are taken directly from its FDA label. From the label: 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 Periv… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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