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Lusedra® (Fospropofol) Presentation Lusedra® (Fospropofol) Presentation Presentation Transcript

  • Lusedra ® (Fospropofol) Gustavo Llerena, PharmD Candidate Pharmacy Services Department Memorial Regional Hospital March 31, 2009
  • Background 5
    • Benzodiazepines with opioids have been the only choice for sedation in minor outpatient flexible bronchoscopes and colonoscopies.
      • AE of Benzodiazepines:
        • Prolonged sedation
        • Cognitive impairment
    • Lusedra ® is being introduced to the market as a better alternative.
  • Drug Class 3
    • Sedatives/Hypnotics
    • Other Drugs in this Class
      • Versed ® (Midazolam)
      • Diprivan ® (Propofol)
      • Inapsine ® (Droperidol)
  • Indication 3
    • “Lusedra ® is a sedative-hypnotic agent indicated for monitored anesthesia care (MAC) sedation in adult patients undergoing diagnostic or therapeutic procedures.”
  • Monitored Anesthesia Care (MAC) 1
    • American Society of Anesthesiologists (ASA) Definition
      • Monitored Anesthesia Care (MAC) is a planned procedure during which the patient undergoes local anesthesia together with sedation and analgesia.
  • Monitored Anesthesia Care (MAC)
    • Examples of In-office Procedures requiring the use of MAC:
      • Flexible Bronchoscopy (Silvestri et al.)
        • Conclusion: 6.5mg/kg used for induction of sedation is a safe and efficacious dose for use in flexible bronchoscopy.
      • Colonoscopy (Rex et al.)
        • Conclusion: “6.5 mg dosing regimen is safe and effective in providing minimal to moderate sedation to patients undergoing colonoscopy.”
  • Contraindications 3
    • No contraindications
    • Precaution:
      • The use of concurrent sedatives/hypnotics which may increase the risk for respiratory depression
  • Pharmacology
  • Mechanism of Action 3
    • Fospropofol disodium is a prodrug of propofol.
    • Following intravenous injection, fospropofol is metabolized by alkaline phosphatases into propofol.
    • 1 mmole of fospropofol disodium administered, 1 mmole of propofol is produced
      • (1.86 mg of fospropofol disodium is the molar equivalent of 1 mg propofol).
  • Metabolism 2,3 **Highly Protein Bound (98%) to albumin.
  • Pharmacokinetics 2
  • Standard Dosing 3
    • Used in patients that are healthy and between the ages of 18-65 or those patients with mild systemic disease.
    • Sedation Induction
      • 6.5mg/kg fospropofol IV bolus (Max 16.5mL)
      • 50 μ g Fentanyl (admin. 5min prior to fospropofol)
      • Supplemental Oxygen Therapy
    • Sedation Maintenance:
      • 1.6mg/kg as needed to maintain sedation (Max 4mL)
    • Limited by Weight
      • If <60 = must dose as if the patient were 60kg
      • If >90kg – must dose as If the patient were 90kg
    • Renal Dose Adjustment
      • CrCl >30mg/dL = no adjustment
      • CrCl <30mg/dL = limited data
  • Standard Dosing 3
  • Modified Dosing 3
    • Used in patients who are ≥ 65 years of age with severe systemic disease.
    • The dose used in these patients is 75% that of standard dosing
    • Limited by Weight
      • If <60 = must dose as if the patient were 60kg
      • If >90kg – must dose as If the patient were 90kg
    • Renal Dose Adjustment
      • CrCl >30mg/dL = no adjustment
      • CrCl <30mg/dL = limited data
  • Modified Dosing 3
  • Side Effects 3
    • Serious
      • Respiratory depression
      • Hypoxemia
      • Loss of purposeful responsiveness
      • Hypotension
    • Common
      • Nausea/Vomitting
      • Paresthesia
      • Headache
      • Pruritus
      • Hypotension
  • Monitoring 3
    • Monitor for
      • early signs of hypotension, apnea, airway obstruction, and/or oxygen desaturation.
  • Therapeutic Alternatives 4,5
    • Diprivan ® (Propofol)
      • Lipid formulation = rapid onset
      • Deep sedation
      • Less predictable pharmacokinetics/ pharmacodynamics
      • Vd = high (5.8L/kg)
    • Lusedra ® (Fospropofol)
      • Water Soluble = moderate onset
      • Moderate sedation
      • More predictable pharmacokinetics/ pharmacodynamics
      • Vd = low (0.33L/kg)
  • Counseling 3
    • Paresthesias (including burning, tingling, stinging) are usually experienced at the injection site.
      • They are mild in severity
      • Have a short duration
      • Do not require treatment
    • Due to the sedative effects of Lusedra ® , the patient may need a caretaker until the effects of the drug have subsided enough to allow for the operation of a motor vehicle.
  • Dispensing/Preparation Considerations 3
    • Supplied in pre-mixed 35mg/mL injection solution, 30mL ready-to-use vial intended for single patient use.
    • Do not mix with any other drugs or fluids prior to injection. (compatible with most IV fluids)
    • Intended to be administered via a peripheral IV line. (flush using NS before and after administration)
  • Cost/Cost Comparison
    • Cost comparisons between Fospropofol and its comparator Diprivan ® (Propofol) cannot be made at this point in time given that it is currently undergoing an FDA review for controlled substance scheduling.
  • References
    • American Society of Anesthesiologists. Distinguishing Monitored Anesthesia Care (“MAC”) from Moderate Sedation/Analgesia (Conscious Sedation) 2008 Sept, http://www.asahq.org/publicationsAndServices/standards/35.pdf [Accessed on March 12th 2009]
    • Levitzky BE, Vargo JJ. Fospropofol disodium injection for the sedation of patients undergoing colonoscopy. Ther Clin Risk Manag. 2008 August; 4(4): 733–738.
    • LUSEDRA (Fospropofol) Full Prescribing Information. Woodcliff Lake, NJ. Eisai Inc, 2008.
    • Rex DK, Cohen LB, Kline J, Wang C. Fospropofol Disodium Is Effective and Safe for Minimal to Moderate Sedation in Patients Undergoing Colonoscopy: Results of a Phase 3, Randomized, Double-Blind, Trial. Gastrointestinal Endoscopy. 2007 Apr, 65(5):AB369-AB369
    • Silvestri GA, Vincent BD, Wahidi MM, Robinette E, Hansbrough JR, Downie GH . A Phase 3, Randomized, Double-Blind Study To Assess the Efficacy and Safety of Fospropofol Disodium Injection for Moderate Sedation in Patients Undergoing Flexible Bronchoscopy. Chest. 2009 Jan; 135(1):41-7.