Surfaxin

Your doctor or pharmacist can provide more information about lucinactant.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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A doctor or other trained health professional will give your child this medicine in a hospital. This medicine is given directly into your child's lungs through his endotracheal (breathing) tube.

• If your child has an allergy to Surfaxin (lucinactant solution) or any part of this medicine.
• If your child is allergic to any drugs like this one or any other drugs, foods, or other substances. Tell the doctor about the allergy and what signs your child had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Surfaxin with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Trouble breathing.
• Wheezing.
• Slow heartbeat.
• Pale skin.

Surfaxin® (lucinactant) Intratracheal Suspension is indicated for the prevention of respiratory distress syndrome (RDS) in premature infants at high risk for RDS. Surfaxin reduces the incidence of RDS at 24 hours and mortality due to RDS.

For intratracheal administration only.

Surfaxin should be administered by or under the supervision of clinicians experienced in intubation, ventilator management, and general care of premature infants.

Dosing

The recommended dose of Surfaxin is 5.8 mL per kg birth weight. Up to 4 doses of Surfaxin can be administered in the first 48 hours of life. Doses should be given no more frequently than every 6 hours.

No information is available on doses greater than 5.8 mL per kg birth weight, the effects of more than 4 doses, or dosing more frequently than every 6 hours.

Dosage may be determined from Table 1.

Table 1. Dosing Chart

Directions for Use

Preparation

Before use, warm the vial for 15 minutes in a preheated dry block heater set at 44°C (111°F). After warming, shake the vial vigorously until Surfaxin is a uniform and free-flowing suspension. The temperature of the product will be approximately 37°C (99°F) or less after the product is drawn into a syringe for administration.

For each vial of Surfaxin that is warmed, record the date and time of warming in the space provided on the carton. If not used immediately after warming, Surfaxin can be stored protected from light (i.e., in the carton) at room temperature for up to 2 hours. Do not return Surfaxin to the refrigerator after warming. Discard the product if not used within 2 hours of warming. Vials are for single use only. Discard any unused portion of Surfaxin.

Administration

Visually inspect Surfaxin before use. After being warmed and vigorously shaken, Surfaxin should be free-flowing and opaque white to off-white. Use aseptic technique to slowly draw up the appropriate amount of Surfaxin into a single, appropriately sized syringe, depending on the total dose volume, using a 16- or 18-gauge needle.

Before administering Surfaxin, assure proper placement and patency of the endotracheal tube. At the discretion of the clinician, the endotracheal tube may be suctioned before administering Surfaxin. The infant should be allowed to stabilize before proceeding with dosing.

Position the infant in the right lateral decubitus position with head and thorax inclined upward 30°. Attach the syringe containing Surfaxin to a 5-French end-hole catheter. Thread the catheter through a Bodai valve or equivalent device that allows maintenance of positive end-expiratory pressure and then advance the tip of the catheter into the endotracheal tube. Position the catheter such that its tip is slightly distal to the end of the endotracheal tube.

Each Surfaxin dose should be delivered in 4 aliquots. Instill the first aliquot of the dose (one-quarter of the total volume) as a bolus while continuing positive pressure mechanical ventilation and maintaining positive end-expiratory pressure of 4 to 5 cm H2O. Ventilator settings may be adjusted at the discretion of the clinician to maintain appropriate oxygenation and ventilation. Ventilate until the infant is stable, that is, has an oxygen saturation of at least 90% and a heart rate greater than 120 beats per minute. Repeat the procedure with the infant in the left decubitus position while maintaining adequate positive pressure ventilation. Repeat the procedure with the infant in the right, then left decubitus position to deliver a total of 4 aliquots. A pause should separate administration of the aliquots to allow for an evaluation of the infant’s respiratory status.

After instillation of the last aliquot, remove the catheter and resume usual ventilator management and critical care while keeping the head of the infant’s bed elevated at least 10 degrees for at least 1-2 hours. Do not suction the infant during the first hour after dosing unless signs of significant airway obstruction occur.

Use the same technique for additional doses, if indicated.

Surfaxin (lucinactant) is a lung surface acting agent, or "surfactant." It helps the lungs function normally.

Surfaxin is used to treat or prevent respiratory distress syndrome (RDS) in a premature baby whose lungs have not fully developed.

Surfaxin may also be used for purposes not listed in this medication guide.

Surfaxin is given directly into the baby's lungs through a breathing tube. Your baby will receive this medication in a neonatal intensive care unit (NICU) or similar hospital setting.

The breathing tube is connected to a ventilator (a machine that moves air in and out of the lungs to help your baby breathe easier and get enough oxygen).

Surfaxin is given as soon as possible after the baby's birth, usually within 30 minutes.

Your baby's breathing, blood pressure, oxygen levels, and other vital signs will be watched closely during treatment with Surfaxin.

Your baby's caregivers will manage and monitor all medications given to your baby during treatment in the NICU. A drug interaction between Surfaxin and other medications is not expected to occur.

Do not give any medications to your baby that have not been prescribed by the baby's doctor. This includes vitamins, minerals, or herbal products.

Common side effects of Surfaxin include: sepsis, bradycardia, hypotension, and oxygen desaturation. Other side effects include: pneumothorax. See below for a comprehensive list of adverse effects.