April 26, 2017
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Included as part of the PRECAUTIONS section.


Acute Changes in Lung Compliance

Administration of exogenous surfactants, including SURFAXIN, can rapidly affect lung compliance and oxygenation. SURFAXIN should be administered only by clinicians trained and experienced in the resuscitation, intubation, stabilization, and ventilatory management of premature infants in a clinical setting with the capacity to care for critically ill neonates. Infants receiving SURFAXIN should receive frequent clinical assessments so that oxygen and ventilatory support can be modified to respond to changes in respiratory status.

Administration-Related Adverse Reactions

Frequently occurring adverse reactions related to the administration of SURFAXIN include bradycardia, oxygen desaturation, reflux of drug into the endotracheal tube (ETT), and airway/ETT obstruction. If any of these events occur, dosing with SURFAXIN should be interrupted and the infant's clinical condition assessed and stabilized. Suctioning of the ETT or reintubation may be required if airway obstruction persists or is severe. After the patient is stable, dosing may proceed with appropriate monitoring.

Increased Serious Adverse Reactions in Adults with ARDS

In a two-part clinical trial in adult patients with ARDS, compared to standard of care, patients who received lucinactant via segmental bronchoscopic lavage had an increased incidence of death, multi-organ failure, sepsis, anoxic encephalopathy, renal failure, hypoxia, pneumothorax, hypotension, and pulmonary embolism. SURFAXIN is not indicated for use in the treatment of ARDS.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

Studies to assess potential carcinogenic effects of SURFAXIN have not been conducted.

Lucinactant was not mutagenic in the bacterial reverse mutation assay (Ames test), chromosomal aberration assay in Chinese hamster ovary cells, or mouse micronucleus assay. No studies to assess reproductive effects of SURFAXIN have been performed.

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 12/6/2016


Report Problems to the Food and Drug Administration


You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

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