Eisai has launched Lusedra (fospropofol disodium) injection CIV for use by persons trained in the administration of general anesthesia. Lusedra, an aqueous solution, is an intravenous sedative-hypnotic agent for monitored anesthesia care (MAC) sedation in adult patients undergoing diagnostic or therapeutic procedures.
Lusedra was approved by the US Food and Drug Administration in December 2008. Lusedra is designated as a Schedule IV drug. The company has also released safety information regarding the usage of the drug.
The company said that Lusedra should be administered only by persons trained in the administration of general anesthesia and not involved in the conduct of the diagnostic or therapeutic procedure. Patients should be continuously monitored during sedation and through the recovery process for early signs of hypotension, apnea, airway obstruction, and/or oxygen desaturation. Facilities for providing cardiopulmonary resuscitation must be immediately available.
Some serious adverse reactions have been reported with the use of Lusedra, which are respiratory depression, reported in 1/455 (< 1%) patients treated with Lusedra using the standard or modified dosing regimen. Hypoxemia was reported in 20/455 (4%) patients treated with Lusedra using the standard or modified dosing regimen. Retention of purposeful responsiveness did not prevent patients from becoming hypoxemic following administration of Lusedra. Loss of purposeful responsiveness was also observed.
Lusedra has not been studied for use in general anesthesia. However, administration of Lusedra may inadvertently cause patients to become unresponsive or minimally responsive to vigorous tactile or painful stimulation. The incidence of patients who became minimally responsive or unresponsive to vigorous tactile or painful stimulation was 7/183 (4%) for colonoscopy and 24/149 (16%) for bronchoscopy. The duration of minimal or complete unresponsiveness ranged from 2 to 16 minutes in colonoscopy patients and from 2 to 20 minutes in bronchoscopy patients
Hypotension was reported in 18/455 (4%) patients treated with Lusedra using the standard or modified dosing regimen. Patients with compromised myocardial function, reduced vascular tone, or who have reduced intravascular volume may be at an increased risk for hypotension.
The use of supplemental oxygen is recommended in all patients receiving Lusedra. Airway assistance maneuvers may be required. Lusedramay produ ce additive cardiorespiratory effects when administered with other cardiorespiratory depressants such as benzodiazepines and narcotic analgesics. When Lusedra is used at greater than the recommended doses, the incidence of serious adverse reactions is increased.