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Nalbuphine Injection

Last Updated: September 1, 2021
Status: Resolved

Reason for the Shortage
    • Pfizer had nalbuphine on shortage due to manufacturing delays.[1]
Available Products
    • 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)

Updated

Updated September 1, 2021 by Michelle Wheeler, PharmD, Drug Information Specialist. Created October 1, 2019 by Michelle Wheeler, PharmD, Drug Information Specialist. © 2021, Drug Information Service, University of Utah, Salt Lake City, UT.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.