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, 20 mg/mL, 1 mL ampule, 10 count, NDC 00409-1465-01

Reason for the Shortage

• • Pfizer has nalbuphine on shortage due to increased demand and manufacturing delays.

Available Products

• • 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, 10 mL vial, 25 count, NDC 00409-1467-01

• • Pfizer has nalbuphine 10 mg/mL 1 mL ampules on back order and the company estimates a release date of January 2025. The 20 mg/mL 1 mL ampules are on back order and the company estimates a release date of March 2025.

• • Nalbuphine is indicated for the management of severe pain requiring an opioid analgesic and for which alternative treatments are inadequate.[1]
  • Nalbuphine is utilized adjunctively in balanced anesthesia, for preoperative and postoperative analgesia, and obstetrical analgesia during labor and delivery.[1]
  • Off-label applications include addressing opioid-induced pruritus.[2-4]

• • Nalbuphine can result in respiratory depression, due to its antagonism of the mu-opioid receptor.[1]
  • However, it antagonizes the respiratory depressant effects of other opioid medications while concomitantly adding to the analgesic activities of these drugs.[5]

• • 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.[6-9] 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.[6-8] Naloxone doses greater than 2 mcg/kg/h may require additional analgesia or result in decreased pain relief.[8-9]

• 1. Nalbuphine hydrochloride injection [prescribing information]. Lake Forest, IL; Hospira Inc; 2024 Jan.
  2. Cohen SE, Ratner EF, Kreitzman TR, Archer JH, Mignano LR. Nalbuphine is better than naloxone for treatment of side effects after epidural morphine. Anesth Analg. 1992 Nov;75(5):747-52. PMID: 1416128.
  3. Somrat C, Oranuch K, Ketchada U, Siriprapa S, Thipawan R. Optimal dose of nalbuphine for treatment of intrathecal-morphine induced pruritus after caesarean section. J Obstet Gynaecol Res. 1999 Jun;25(3):209-13. doi: 10.1111/j.1447-0756.1999.tb01149.x. PMID: 10467795.
  4. Jannuzzi, Rose G. DNP, RN-C, FNP-BC. Nalbuphine for Treatment of Opioid-induced Pruritus: A Systematic Review of Literature. The Clinical Journal of Pain 32(1):p 87-93, January 2016. | DOI: 10.1097/AJP.0000000000000211
  5. Schmidt WK, Tam SW, Shotzberger GS, Smith DH Jr, Clark R, Vernier VG. Nalbuphine. Drug Alcohol Depend. 1985 Feb;14(3-4):339-62. doi: 10.1016/0376-8716(85)90066-3. PMID: 2986929.
  6. 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. doi: 10.1097/00000542-199711000-00011. PMID: 9366459.
  7. 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.
  8. Kjellberg F, Tramèr MR. Pharmacological control of opioid-induced pruritus: a quantitative systematic review of randomized trials. Eur J Anaesthesiol. 2001 Jun;18(6):346-57. doi: 10.1046/j.0265-0215.2000.00826.x. PMID: 11412287.
  9. Vrchoticky T, "Naloxone for the Treatment of Narcotic Induced Pruritus," Journal of Pediatric Pharmacy Practice, 2000, 5(2):92-7.