Nalbuphine Injection Shortage

• • Pfizer had nalbuphine on shortage due to manufacturing delays.[1]

• • Nalbuphine solution for injection, Pfizer, 10 mg/mL, 1 mL ampule, 10 count, NDC 00409-1463-01
  • Nalbuphine solution for injection, Pfizer, 10 mg/mL, 10 mL vial, 25 count, NDC 00409-1464-01
  • Nalbuphine solution for injection, Pfizer, 20 mg/mL, 1 mL ampule, 10 count, NDC 00409-1465-01
  • Nalbuphine solution for injection, Pfizer, 20 mg/mL, 10 mL vial, 25 count, NDC 00409-1467-01

Estimated Resupply Dates

• • Pfizer has all nalbuphine presentations available.

Alternative Agents & Management

• • Low-dose naloxone continuous IV infusion is commonly used for treatment or prevention of opioid-induced pruritus and is the most evidence-based alternative to nalbuphine.[2-5] The majority of published data support a naloxone dose of 0.25 mcg/kg/h to 1 mcg/kg/h administered as a continuous IV infusion for children and adults receiving IV opioids.[6-9] Naloxone doses greater than 1 mcg/kg/h may require additional analgesia or result in decreased pain relief.[8-9] Monitor patients for signs of decreased pain control.

References

• 1. Pfizer (personal communications and website). January 7 and 24, February 20, May 1 and 15, June 5, August 28, December 9, 2020; January 15, February 1 and 28, April 1 and 26, May 28, July 13, and August 27, 2021.
  2. Lexicomp Online: Wolters Kluwer Clinical Drug Information, Inc; 2020.
  3. Drugdex system. IBM Micromedex [database online]. http://www.micromedexsolutions.com. Greenwood Village, CO, USA: Truven Health Analytics; Accessed January 6, 2020.
  4. Miller JL, Hagemann TM. Use of pure opioid antagonists for management of opioid-induced pruritus. Am J Health Syst Pharm. 2011 Aug 1;68(15):1419-25.
  5. He F, Jiang Y, Li L. The effect of naloxone treatment on opioid-induced side effects: A meta-analysis of randomized and controlled trails. Medicine (Baltimore). 2016 Sep;95(37):e4729.
  6. Monitto CL, Kost-Byerly S, White E, et al. The optimal dose of prophylactic intravenous naloxone in ameliorating opioid-induced side effects in children receiving intravenous patient-controlled analgesia morphine for moderate to severe pain: a dose finding study. Anesth Analg. 2011 Oct;113(4):834-42. (peds 1 mcg)
  7. Maxwell LG, Kaufmann SC, Bitzer S, et al. The effects of a small-dose naloxone infusion on opioid-induced side effects and analgesia in children and adolescents treated with intravenous patient-controlled analgesia: a double-blind, prospective, randomized, controlled study. Anesth Analg. 2005 Apr;100(4):953-8. (peds 0.25 mcg)
  8. Gan TJ, Ginsberg B, Glass PS, Fortney J, Jhaveri R, Perno R. Opioid-sparing effects of a low-dose infusion of naloxone in patient-administered morphine sulfate. Anesthesiology. 1997 Nov;87(5):1075-81.(adults 0.25 mcg, 1 mcg)
  9. Kjellberg F, Tramr MR. Pharmacological control of opioid-induced pruritus: a quantitative systematic review of randomized trials. Eur J Anaesthesiol. 2001 Jun;18(6):346-57. (systematic review)