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Surfaxin

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Surfaxin

Surfaxin

Surfaxin Side Effects Center

Medical Editor: Charles Patrick Davis, MD, PhD

Surfaxin (lucinactant) is a surfactant indicated for the prevention of respiratory distress syndrome (RDS), a breathing disorder that affects premature infants. The drug is not available in generic form. The most common side effects of Surfaxin are related to its administration down a premature infant's breathing tube (endotracheal tube) and include endotracheal tube reflux, skin paleness, endotracheal tube obstruction, and need for dose interruption. Surfaxin is intended for intratracheal use only.

Surfaxin Intratracheal Suspension is supplied sterile in single-use glass vials containing 8.5 mL suspension with each mL containing 30 mg phospholipids [22.50 mg dipalmitoylphosphatidylcholine (DPPC) and 7.50 mg palmitoyloleoylphosphatidylglycerol, sodium salt (POPG, Na)], 4.05 mg palmitic acid (PA), and 0.862 mg sinapultide.The recommended dose of Surfaxin is 5.8 mL per kg birth weight administered by intratracheal administration. 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. Serious side effects include intraventricular hemorrhage, sepsis, patent ductus arteriosus, retinopathy, necrotizing enterocolitis and lung problems.

Our Surfaxin Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Surfaxin FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.

Clinical Trials Experience

Studies in Premature Infants at Risk for Respiratory Distress Syndrome

The safety data described below reflect exposure to SURFAXIN at a dose of 5.8 mL per kg (up to 4 doses) administered in either 4 aliquots (Study 1) or 2 aliquots (Study 2) in 643 infants 32 weeks gestational age or less in 2 randomized double-blind, active-controlled clinical studies in which infants could receive up to 4 doses of surfactant intratracheally [see Clinical Studies]. Study 1 was conducted in 1294 premature infants who weighed between 600 g and 1250 g at birth and were 32 weeks or less in gestational age. Infants received 1 of 3 surfactants, SURFAXIN (N = 524), colfosceril palmitate (N = 506), or beractant (N = 258). Study 2 was conducted in 252 premature infants who weighed between 600 g and 1250 g and were less than 29 weeks in gestational age. Infants received SURFAXIN (N = 119) or poractant alfa (N = 124).

Comparator surfactants colfosceril palmitate and beractant were administered at the recommended doses (5.0 and 4.0 mL per kg, respectively) while the first dose of poractant alfa administered (2.2 mL per kg) was less than the recommended dose of 2.5 mL per kg. Any subsequent doses of poractant alfa were at the recommended 1.25 mL per kg dose.

Administration-related adverse reactions (endotracheal tube reflux, pallor, endotracheal tube obstruction, and need for dose interruption) were assessed in both SURFAXIN controlled clinical studies. Overall, the incidence of administration-related adverse reactions was higher in infants who received SURFAXIN compared to other surfactants (Table 2) and resulted in a greater proportion of infants treated with SURFAXIN who experienced administration-related oxygen desaturation and bradycardia. For Study 1, oxygen desaturation was reported in 17%, 9%, and 13% and bradycardia for 5%, 2%, and 3% of infants treated with SURFAXIN, colfosceril palmitate, and beractant, respectively. For Study 2, oxygen desaturation was reported in 8% and 2% and bradycardia in 3% and 2% of infants treated with SURFAXIN and poractant alfa, respectively. These adverse reactions did not appear to be associated with an increased incidence of serious complications or mortality relative to the comparator surfactants (Table 3).

Table 2: Administration-Related Adverse Reactions in SURFAXIN Controlled Clinical Studiesa

  Study 1b Study 2c
SURFAXIN
(N = 524)
Colfosceril palmitate
(N = 506)
Beractant
(N = 258)
SURFAXIN
(N = 119)
Poractant alfa
(N = 124)
Total Doses Administered 994 1038 444 174 160
Total Number of Events (Events per 100 Doses)
ETT Reflux 183 (18) 161 (16) 67 (15) 47 (27) 31 (19)
Pallor 88 (9) 46 (4) 38 (9) 18 (10) 7 (4)
Dose Interruption 87 (9) 46 (4) 30 (7) 7 (4) 2 (1)
ETT Obstruction 55 (6) 21 (2) 19 (4) 27 (16) 1 (1)
aTable includes only infants who received study treatment.
b In Study 1 doses were administered in 4 aliquots.
c In Study 2 doses were administered in 2 aliquots.

Table 3: Common Serious Complications Associated with Prematurity and RDS in SURFAXIN Controlled Clinical Studies Through 36-Weeks Post-Conceptual Age (PCA)

  Study 1 Study 2
SURFAXIN
(N = 527)
%
Colfosceril palmitate
(N = 509)
%
Beractant
(N = 258)
%
SURFAXIN
(N = 119)
%
Poractant alfa
(N = 124)
%
Apnea 52 52 46 66 75
Intraventricular hemorrhage, all grades 52 57 54 39 38
  - Grade 3/4 19 18 21 13 8
Periventricular leukomalacia 10 10 12 4 9
Acquired sepsis 44 44 44 45 52
Patent ductus arteriosus 37 35 37 43 44
Retinopathy of prematurity, all grades 27 26 25 32 31
  -Grade 3/4 6 7 6 5 9
Necrotizing enterocolitis, all grades 17 17 19 13 15
  -Grade 2/3 6 8 14 8 8
Pulmonary air leak through Day 7, all types 15 17 14 9 7
  -Pulmonary interstitial emphysema 9 10 10 3 5
  -Pneumothorax 3 4 2 4 1
Pulmonary hemorrhage 10 12 14 6 9

All-cause mortality through 36-weeks PCA was similar regardless of which exogenous surfactant was administered.

Adverse reactions reported in the controlled clinical studies through 36-weeks PCA occurring in at least 10% of infants were anemia, jaundice, metabolic acidosis, oxygen desaturation, hyperglycemia, pneumonia, hyponatremia, hypotension, respiratory acidosis, and bradycardia. These reactions occurred at rates similar to the comparator surfactants.

No assessments for immunogenicity to SURFAXIN were performed in these clinical studies.

Follow-up Evaluations

Twelve-month corrected-age follow-up of 1546 infants enrolled in the 2 controlled clinical studies demonstrated no significant differences in mortality or gross neurologic findings between infants treated with SURFAXIN and those treated with the comparator surfactants (colfosceril palmitate, beractant, or poractant alfa).

Clinical Study in Adults with ARDS

The safety and efficacy of lucinactant administered in 2 doses separated by 48 hours via segmental bronchoscopic lavage in adults with ARDS was evaluated in a two-part clinical trial in 124 adult patients. Twenty-two patients were studied in the initial open-label portion of the trial (Part A) and 102 patients participated in a subsequent randomized controlled portion (Part B). Compared to standard of care, patients who received treatment with lucinactant via segmental bronchoscopic lavage at doses up to 50 mL per lung segment had an increased incidence of death, multi-organ failure, sepsis, anoxic encephalopathy, renal failure, hypoxia/decreased oxygen saturation, pneumothorax, hypotension, and pulmonary embolism compared to those patients receiving standard of care. SURFAXIN is not indicated for use in the treatment of ARDS.

Read the entire FDA prescribing information for Surfaxin (Lucinactant) »

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