Calfactant

Calfactant is a lung surface acting agent (surfactant) used for the treatment of respiratory distress syndrome in a premature baby whose lungs have not fully developed.

• Calfactant is available under the following different brand names: Infasurf

Common side effects of Calfactant include:

• cyanosis (bluish skin coloration due to low oxygen)
• airway obstruction
• bradycardia (slow heartbeat)
• endotracheal tube reflux
• endotracheal tube blockage

Serious side effects of Calfactant include:

• patent ductus arteriosus (failure of fetal connection between the aorta and pulmonary artery to close, which normally closes at birth)
• intracranial hemorrhage
• pneumothorax (lung collapse)
• pulmonary interstitial emphysema (a condition in which air gets trapped in the tissue outside the alveoli)
• bronchopulmonary dysplasia (impaired lung development that causes chronic lung disease due to injury/irritation from oxygen exposure and positive pressure ventilation in preterm babies)
• acquired pneumonia
• sepsis
• acquired septicemia
• pulmonary hemorrhage
• hypotension (low blood pressure)
• hypertension (high blood pressure)
• hypercarbia (elevated carbon dioxide levels in the blood)
• vasoconstriction

Rare side effects of Calfactant include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, light-headedness, or passing out

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Pediatric dosage

Intratracheal suspension

• 35 mg phospholipid and 0.7 mg protein per mL (3 mL, 6 mL)

Respiratory Distress Syndrome

Pediatric dosage

• 3 mL/kg (birth weight) intratracheal every 12 hours up to 3 doses

Dosage Considerations – Should be Given as Follows:

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, healthcare provider, or pharmacist first.

• Calfactant has no noted severe interactions with any other drugs.
• Calfactant has no noted serious interactions with any other drugs.
• Calfactant has no noted moderate interactions with any other drugs.
• Calfactant has no noted minor interactions with any other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• None listed by the manufacturer

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Calfactant?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Calfactant?”

Cautions

• Infants may exhibit bradycardia, reflux, cyanosis, airway obstruction, ETT dislodgement, hypoventilation
• For endotracheal administration only
• Lung oxygenation may improve rapidly, which in turn will require adjustments in oxygen delivery and ventilator settings
• Do not chill & thaw more than once; single-use vials; keep 3 mL vial upright
• Administer only in a highly supervised clinical setting with immediate availability of clinicians experienced in intubation and ventilatory management of premature infants

Pregnancy and Lactation

• Not applicable
• Lactation
  • Not applicable