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LUSEDRA™ CIV

(fospropofol disodium) Injection
LUSEDRA is now available for use by persons trained in the administration of general anesthesia. LUSEDRA, an aqueous solution, is an intravenous sedative-hypnotic agent indicated for monitored anesthesia care (MAC) sedation in adult patients undergoing diagnostic or therapeutic procedures.

LUSEDRA is designated as a Schedule IV drug, which means that systems for carefully monitoring access to and distribution of the drug must be in place from the time of manufacture to the time of administration. Only facilities registered by the DEA can receive scheduled drugs. These types of measures are established in part to reduce the possibility of abuse of the drug. The U.S. Food and Drug Administration (FDA) approved LUSEDRA in December 2008.

LUSEDRA is a proprietary water-soluble prodrug of propofol that, after intravenous injection, is converted by alkaline phosphatase enzymes in the body into propofol. There are two dosing regimens for LUSEDRA: standard or modified. Standard dosing regimen is for patients 18 to <65 years of age who are healthy or have mild systemic disease. The modified dosing regimen is for patients who are ≥65 years of age or have severe systemic disease.

Important Safety Information
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.

The following serious adverse reactions have been reported with the use of LUSEDRA.


  • Respiratory depression

    • Apnea was reported in 1/455 (< 1%) patients treated with LUSEDRA using the standard or modified dosing regimen.


    • Hypoxemia

      • 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

        • 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

          • 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. LUSEDRA may produce 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.

      The most common adverse reactions (reported in greater than 20%) are paresthesia and pruritus.

      Please see the attached for full prescribing information.

      LUSEDRA™ (fospropofol disodium) Injection CIV prescribing information

      For more information about LUSEDRA, including full prescribing information, call Eisai Medical Services at (888) 422-4743. To report suspected adverse reactions, call (888) 422-4743. If you are a US Healthcare Professional you may also search for more information at www.eisaimedicalinformation.com.

      Package Insert: Lusedra PI.pdf

 

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