Lusedra® (Fospropofol) Presentation

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Lusedra® (Fospropofol) Presentation

  1. 1. Lusedra ® (Fospropofol) Gustavo Llerena, PharmD Candidate Pharmacy Services Department Memorial Regional Hospital March 31, 2009
  2. 2. Background 5 <ul><li>Benzodiazepines with opioids have been the only choice for sedation in minor outpatient flexible bronchoscopes and colonoscopies. </li></ul><ul><ul><li>AE of Benzodiazepines: </li></ul></ul><ul><ul><ul><li>Prolonged sedation </li></ul></ul></ul><ul><ul><ul><li>Cognitive impairment </li></ul></ul></ul><ul><li>Lusedra ® is being introduced to the market as a better alternative. </li></ul>
  3. 3. Drug Class 3 <ul><li>Sedatives/Hypnotics </li></ul><ul><li>Other Drugs in this Class </li></ul><ul><ul><li>Versed ® (Midazolam) </li></ul></ul><ul><ul><li>Diprivan ® (Propofol) </li></ul></ul><ul><ul><li>Inapsine ® (Droperidol) </li></ul></ul>
  4. 4. Indication 3 <ul><li>“Lusedra ® is a sedative-hypnotic agent indicated for monitored anesthesia care (MAC) sedation in adult patients undergoing diagnostic or therapeutic procedures.” </li></ul>
  5. 5. Monitored Anesthesia Care (MAC) 1 <ul><li>American Society of Anesthesiologists (ASA) Definition </li></ul><ul><ul><li>Monitored Anesthesia Care (MAC) is a planned procedure during which the patient undergoes local anesthesia together with sedation and analgesia. </li></ul></ul>
  6. 6. Monitored Anesthesia Care (MAC) <ul><li>Examples of In-office Procedures requiring the use of MAC: </li></ul><ul><ul><li>Flexible Bronchoscopy (Silvestri et al.) </li></ul></ul><ul><ul><ul><li>Conclusion: 6.5mg/kg used for induction of sedation is a safe and efficacious dose for use in flexible bronchoscopy. </li></ul></ul></ul><ul><ul><li>Colonoscopy (Rex et al.) </li></ul></ul><ul><ul><ul><li>Conclusion: “6.5 mg dosing regimen is safe and effective in providing minimal to moderate sedation to patients undergoing colonoscopy.” </li></ul></ul></ul>
  7. 7. Contraindications 3 <ul><li>No contraindications </li></ul><ul><li>Precaution: </li></ul><ul><ul><li>The use of concurrent sedatives/hypnotics which may increase the risk for respiratory depression </li></ul></ul>
  8. 8. Pharmacology
  9. 9. Mechanism of Action 3 <ul><li>Fospropofol disodium is a prodrug of propofol. </li></ul><ul><li>Following intravenous injection, fospropofol is metabolized by alkaline phosphatases into propofol. </li></ul><ul><li>1 mmole of fospropofol disodium administered, 1 mmole of propofol is produced </li></ul><ul><ul><li>(1.86 mg of fospropofol disodium is the molar equivalent of 1 mg propofol). </li></ul></ul>
  10. 10. Metabolism 2,3 **Highly Protein Bound (98%) to albumin.
  11. 11. Pharmacokinetics 2
  12. 12. Standard Dosing 3 <ul><li>Used in patients that are healthy and between the ages of 18-65 or those patients with mild systemic disease. </li></ul><ul><li>Sedation Induction </li></ul><ul><ul><li>6.5mg/kg fospropofol IV bolus (Max 16.5mL) </li></ul></ul><ul><ul><li>50 μ g Fentanyl (admin. 5min prior to fospropofol) </li></ul></ul><ul><ul><li>Supplemental Oxygen Therapy </li></ul></ul><ul><li>Sedation Maintenance: </li></ul><ul><ul><li>1.6mg/kg as needed to maintain sedation (Max 4mL) </li></ul></ul><ul><li>Limited by Weight </li></ul><ul><ul><li>If <60 = must dose as if the patient were 60kg </li></ul></ul><ul><ul><li>If >90kg – must dose as If the patient were 90kg </li></ul></ul><ul><li>Renal Dose Adjustment </li></ul><ul><ul><li>CrCl >30mg/dL = no adjustment </li></ul></ul><ul><ul><li>CrCl <30mg/dL = limited data </li></ul></ul>
  13. 13. Standard Dosing 3
  14. 14. Modified Dosing 3 <ul><li>Used in patients who are ≥ 65 years of age with severe systemic disease. </li></ul><ul><li>The dose used in these patients is 75% that of standard dosing </li></ul><ul><li>Limited by Weight </li></ul><ul><ul><li>If <60 = must dose as if the patient were 60kg </li></ul></ul><ul><ul><li>If >90kg – must dose as If the patient were 90kg </li></ul></ul><ul><li>Renal Dose Adjustment </li></ul><ul><ul><li>CrCl >30mg/dL = no adjustment </li></ul></ul><ul><ul><li>CrCl <30mg/dL = limited data </li></ul></ul>
  15. 15. Modified Dosing 3
  16. 16. Side Effects 3 <ul><li>Serious </li></ul><ul><ul><li>Respiratory depression </li></ul></ul><ul><ul><li>Hypoxemia </li></ul></ul><ul><ul><li>Loss of purposeful responsiveness </li></ul></ul><ul><ul><li>Hypotension </li></ul></ul><ul><li>Common </li></ul><ul><ul><li>Nausea/Vomitting </li></ul></ul><ul><ul><li>Paresthesia </li></ul></ul><ul><ul><li>Headache </li></ul></ul><ul><ul><li>Pruritus </li></ul></ul><ul><ul><li>Hypotension </li></ul></ul>
  17. 17. Monitoring 3 <ul><li>Monitor for </li></ul><ul><ul><li>early signs of hypotension, apnea, airway obstruction, and/or oxygen desaturation. </li></ul></ul>
  18. 18. Therapeutic Alternatives 4,5 <ul><li>Diprivan ® (Propofol) </li></ul><ul><ul><li>Lipid formulation = rapid onset </li></ul></ul><ul><ul><li>Deep sedation </li></ul></ul><ul><ul><li>Less predictable pharmacokinetics/ pharmacodynamics </li></ul></ul><ul><ul><li>Vd = high (5.8L/kg) </li></ul></ul><ul><li>Lusedra ® (Fospropofol) </li></ul><ul><ul><li>Water Soluble = moderate onset </li></ul></ul><ul><ul><li>Moderate sedation </li></ul></ul><ul><ul><li>More predictable pharmacokinetics/ pharmacodynamics </li></ul></ul><ul><ul><li>Vd = low (0.33L/kg) </li></ul></ul>
  19. 19. Counseling 3 <ul><li>Paresthesias (including burning, tingling, stinging) are usually experienced at the injection site. </li></ul><ul><ul><li>They are mild in severity </li></ul></ul><ul><ul><li>Have a short duration </li></ul></ul><ul><ul><li>Do not require treatment </li></ul></ul><ul><li>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. </li></ul>
  20. 20. Dispensing/Preparation Considerations 3 <ul><li>Supplied in pre-mixed 35mg/mL injection solution, 30mL ready-to-use vial intended for single patient use. </li></ul><ul><li>Do not mix with any other drugs or fluids prior to injection. (compatible with most IV fluids) </li></ul><ul><li>Intended to be administered via a peripheral IV line. (flush using NS before and after administration) </li></ul>
  21. 21. Cost/Cost Comparison <ul><li>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. </li></ul>
  22. 22. References <ul><li>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] </li></ul><ul><li>Levitzky BE, Vargo JJ. Fospropofol disodium injection for the sedation of patients undergoing colonoscopy. Ther Clin Risk Manag. 2008 August; 4(4): 733–738. </li></ul><ul><li>LUSEDRA (Fospropofol) Full Prescribing Information. Woodcliff Lake, NJ. Eisai Inc, 2008. </li></ul><ul><li>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 </li></ul><ul><li>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. </li></ul>

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