SURFAXIN SIDE EFFECTS

Generic Name: lucinactant intratracheal suspension
Brand Name: Surfaxin
Drug Class: Lung Surfactants

Last updated on MDtodate: 10/12/2022

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. 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 2).

Table 1: Administration-Related Adverse Reactions in SURFAXIN Controlled Clinical Studies^a

	Study 1^b			Study 2^c
	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 2: 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.

SRC: NLM .

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