Skip to main content Back to Top
Advertisement

2/20/2020

Nalbuphine Injection

Products Affected - Description

    • 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

Reason for the Shortage

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

Available Products

    • There is insufficient supply for usual ordering

Estimated Resupply Dates

    • Pfizer has nalbuphine 10 mg/mL 1 mL ampules and 20 mg/mL 1 mL ampules on back order and the company estimates a release date of June 2020. The 20 mg/mL 10 mL vials are on back order and the company estimates a release date of November 2020. The 10 mg/mL 10 mL vials are on back order and the company estimates a release date of August 2020.[1]

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, and February 20, 2020.
    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 February 20, 2020 by Michelle Wheeler, PharmD, Drug Information Specialist. Created October 1, 2019 by Michelle Wheeler, PharmD, Drug Information Specialist. © 2020, Drug Information Service, University of Utah, Salt Lake City, UT.

Disclaimer

Drug Shortage Bulletins are copyrighted by the Drug Information Service of the University of Utah and provided by ASHP as its exclusive authorized distributor. ASHP and the University of Utah make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information, and specifically disclaim all such warranties. Users of this information are advised that decisions regarding the use of drugs and drug therapies are complex medical decisions and that in using this information, each user must exercise his or her own independent professional judgment. Neither ASHP nor the University of Utah assumes any liability for persons administering or receiving drugs or other medical care in reliance upon this information, or otherwise in connection with this Bulletin. Neither ASHP nor the University of Utah endorses or recommends the use of any particular drug. Any application of this information for any purpose shall be limited to personal, non-commercial use.

« Back to Drug Shortage Product Bulletins