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Rocuronium Injection

[29 October 2014]

Products Affected - Description

Rocuronium 10 mg/mL injection, Hospira
5 mL vials, package of 10 (NDC 00409-9558-05)
 
Rocuronium 10 mg/mL injection, Teva
5 mL vials, package of 10 (NDC 00703-2394-03)
10 mL vials, package of 10 (NDC 00703-2395-03)
 
Zemuron 10 mg/mL, Merck
5 mL vials, package of 10 (NDC 00052-0450-15) - discontinued
 
Rocuronium 10 mg/mL injection, Sagent
5 mL vials, package of 10 (NDC 25021-0662-05)
10 mL vials, package of 10 (NDC 25021-0662-10)

Reason for the Shortage

  • Merck discontinued Zemuron 10 mL multidose vials in the 3rd Quarter of 2013. Merck discontinued Zemuron 5 mL vials in June 2014.1
  • Mylan Institutional states the reason for the shortage was increased demand.2,3
  • Hospira has rocuronium on shortage due to manufacturing delays.4
  • Teva has rocuronium on shortage due to manufacturing delays.5
  • Fresenius Kabi and Sagent cited increased demand as the reason for this shortage.6,8
  • The Medicines Company launched rocuronium in early 2014.9

Available Products

Rocuronium 10mg/mL injection, Fresenius Kabi
5 mL vials, package of 10 (NDC 63323-0426-05)
10 mL vials, package of 10 (NDC 63323-0426-10)
 
Rocuronium 10 mg/mL injection, Hospira
10 mL vials, package of 10 (NDC 00409-9558-10)
 
Rocuronium 10 mg/mL injection, Mylan Institutional
5 mL vials, package of 10 (NDC 67457-0228-05)
10 mL vials, package of 10 (NDC 67457-0228-10)
 
Rocuronium 10 mg/mL injection, Sandoz7
5 mL vials, package of 10 (NDC 00781-3220-95)
10 mL vials, package of 10 (NDC 00781-3220-92)
 
Rocuronium 10 mg/mL injection, The Medicines Company9
5 mL vials, package of 10 (NDC 65293-0426-10)
10 mL vials, package of 10 (NDC 65293-0427-10)
 
Rocuronium 10 mg/mL injection, X-Gen10
5 mL vials, package of 10 (NDC 39822-4200-02)
10 mL vials, package of 10 (NDC 39822-4200-06)

Estimated Resupply Dates

  • Hospira has rocuronium 10 mg/mL 5 mL vials on back order and the company estimates a release date in December 2014.4
  • Sagent has rocuronium 5 mL and 10 mL vials available with an expiration date of February 2015.8
  • Teva has rocuronium 5 mL vials and 10 mL vials on long-term back order and the company estimates a release date in 1st quarter 2015.5

Implications for Patient Care

Rocuronium is a rapid- to intermediate-acting neuromuscular blocking agent (NMBA) used to facilitate intubation and relax skeletal muscles as an adjunct to general anesthesia during surgery or mechanical ventilation.11

Safety

Clinicians must use extreme caution to prevent dosing errors if 10 mL vials are used in place of 5 mL vials.

Alternative Agents & Management

  • Alternative NMBAs vary in onset time and duration of action, particularly based on dose; see the table below. Times to re-dose also differ based on agent and dose. Doxacurium, mivacurium, and tubocurarine have been discontinued.12-14
  • Non-depolarizing neuromuscular blocking agents may be reversed with neostigmine or edrophonium. Depolarizing NMBAs (ie, succinylcholine) are not reversed by these agents and their toxicity may be worsened by concomitant administration.12-14
  • Some presentations of alternative agents including atracurium, pancuronium and vecuronium are in short supply.15

Characteristics of NMBAs11-14  

NMBA

Type of NMBA

Onset of Action (min)

Clinical Duration After Initial Dose (min)

Atracurium

Nondepolarizing

2 – 3 

20 – 35

Cisatracurium

Nondepolarizing

1.5 – 2

20 – 35

Pancuronium

Nondepolarizing

2 – 3 

60 – 100

Rocuronium

Nondepolarizing

1 – 2

22 – 67 (depending on initial bolus dose)

Succinylcholine

Depolarizing

0.5 – 1

4 – 6a

Vecuronium

Nondepolarizing

2.5 – 3

20 – 40

a Clinical duration of effects may increase or decrease with continued administration of succinylcholine; monitor patients carefully.11-14

Related Shortages

References

  1. Merck (formerly Schering-Plough), Customer Service (personal communications). July 14 and 28, August 11, September 2, 16, and 26, October 22, November 11, December 1, 2008; January 6, February 4, March 3 and 23, April 20, May 27, June 30, August 4, September 16 October 8, November 5, December 10, 2009; January 13, March 24, April 30, May 21, June 16, July 20, August 11, September 29, November 4 and 23, December 22, 2010; January 11, March 3, April 15, June 30, August 17, September 22, October 14, and December 22, 2011; January 31, April 17, August 8 and 24, September 10, October 19, November 2, December 3, 13, and 31, 2012; January 15, February 6 and 27, March 14, April 2, June 14, July 8 and 22, August 6 and 26, October 3 and 22, and December 2 and 16, 2013; January 31, March 24, April 28, June 2, July 18 and 29, and August 20, 2014.
  2. Generamedix, Customer Service (personal communications). December 2, 2008; January 6, February 4 and 26, March 23, April 21, May 27, June 30, August 3, September 15, November 5, December 10, 2009; and January 4, 2010.
  3. Mylan Institutional (formerly Bioniche), Customer Service (personal communications). February 22, March 24, April 27, May 21, June 16, July 20, August 11, September 29, November 4, 5, and 23, December 22, 2010; January 11 March 4, April 15, June 30, August 17, September 1, 22, 27, and 29, October 13 and 18, November 7, December 22, 2011; January 31, February 17 and 21, March 2, 19 and 27, April 17, May 7, June 19, July 3, August 10 and 28, September 10, October 19, November 7 and 28, December 3 and 13, 2012; January 3 and 17, March 14, April 5, June 14, July 11 and 22, August 26, September 30, October 22, December 2, 2013; January 7, March 4, April 28, July 22, August 20, September 22, and October 23, 2014.
  4. Hospira, Customer Service (personal communications). November 11 and 19, December 2 and 8, 2008; January 5, 6, and 28, February 4, 18, and 27, March 2, 10, 11, 23, and 31, April 13 and 20, May 18 and 27, June 9 and 22, July 1, 2, and 30, August 6 and 12, September 16, October 6, November 4, December 18, 2009; January 13, February 22, March 24, April 30, May 21, June 15 and 29, July 20 and 29, August 11, October 1, November 5, December 2 and 22, 2010; January 11, February 2, March 4, April 11, June 30, August 15 and 31, September 20, October 11 and 20, December 20, 2011; January 31, February 13 and 21, March 19, April 2 and 17, May 7, June 18, July 3, August 8 and 27, September 10, October 19, November 2, 7, and 27, December 10, and 31, 2012; January 17, February 6 and 27, March 14, April 1, June 12, July 10 and 22, August 6 and 26, September 3 and 30, October 16, November 4 and 23, December 2 and 19, 2013; January 7, February 6, March 4 and 24, April 28, June 2 and 24, July 21, August 4 and 18, September 3 and 22, and October 29, 2014.
  5. Teva, Customer Service (personal communications). November 11 and 19, and December 2 and 8, 2008; January 5, 6, and 28, February 4, 18, and 27, March 3, 11, 23, and 31, April 13 and 20, May 18 and 27, June 9, 22, and 30, July 2 and 30, August 3 and 12, September 14, October 6, November 3, December 16, 2009; January 20, February 22, March 24, April 27, May 21, June 2 and 16, July 20, August 11, September 30, November 3 and 23, December 22, 2010; January 11, April 11, July 1, August 17, September 22, October 10 and 18, November 7, December 22, 2011; January 31, February 15 and 22, March 22 and 27, April 17, and May 9, June 18, July 3, August 8, September 12, October 19, November 6 and 28, 2012; February 7, July 11, and September 30, 2013; March 27, June 5, August 18, and October 27, 2014.
  6. Fresenius Kabi (Formerly APP), Customer Service (personal communications). February 4, March 2, 12, and 23, April 20, May 27, June 30, August 4, September 14, October 6, November 3, December 10, 2009; January 20, February 22, March 24, April 27, May 21, June 16, July 20, August 11 and 20, September 30, November 2 and 24, December 22, 2010; January 11, April 14, June 30, July 13, August 16, September 20 and 29, November 8, December 20, 2011; January 4, February 1, 17, and 21, March 19, April 17, May 7, June 19, July 3, August 8 and 27, September 10, October 19, November 2 and 6, December 3, 7, and 19, 2012; January 15, February 6 and 26, March 14, April 3, June 10, July 8 and 22, August 6 and 27, October 3, 15, and 22, November 4, and December 3, 2013; January 8, February 4 and 28, March 27, May 1, June 2, July 23 and 29, August 14, September 2 and 22, and October 29, 2014.
  7. Sandoz, Customer Service (personal communications). March 5 and 23, April 20, May 29, June 30, July 7, August 4, September 14, October 6, November 3, December 14, 2009; January 22, February 23, April 29, May 24, June 2 and 15, July 22 and 30, August 11, October 1, November 2 and 29, December 22, 2010; January 10, March 1, April 12, June 30, August 16, September 22, October 12, November 7, December 21, 2011; January 3 and 31, February 23, March 22, April 18, May 8, June 15, July 3, August 8, September 10, October 19, December 3, 17, and 31, 2012; January 15, March 14, April 3, June 14, July 11 and 22, August 6 and 26, September 3 and 30, October 24, December 3 and 19, 2013; January 6, February 3, March 3, April 28, July 21, September 3, and October 23, 2014.
  8. Sagent Customer Service (personal communications). December 21, 2011; January 3, February 2, 17, and 21, March 19 and 28, April 4 and 17, May 7, June 19, July 3, August 8 and 20, September 12, October 19, November 2, 5, and 28, December 3 and 20, 2012; January 4 and 15, March 14 and 25, May 28, July 8, August 6, September 30, October 2, and November 20, 2013; January 6, February 3 and 26, March 27, April 28, June 5, July 18, August 1, 15, and 28, September 22, and October 23, 2014.
  9. The Medicines Company (personal communication). February 27, March 24, June 2, September 24, and October 23, 2014.
  10. X-Gen Pharmaceuticals Customer Service (personal communications). July 23, August 26, September 30, October 23, and December 2, 2013; January 7, March 24, June 2, August 4, September 3, and October 29, 2014.
  11. Organon. Zemuron (rocuronium bromide) Injection product label. Roseland, NJ; Organon; November 2010.
  12. Baughman VL, Golembiewski J, Gonzales JP, Alvarez, W, eds. Anesthesiology and Critical Care Drug Handbook. 9th ed. Hudson, OH: Lexi-Comp; 2010.
  13. Muscle Relaxants – Adjuncts to Anesthesia. In: Wickersham, R. M., Novak K. K., et al., Eds. (2011). Drug Facts and Comparisons (eFacts). St. Louis, MO, Wolters Kluwer Health, Inc.
  14. Neuromuscular Blocking Agents. In: McEvoy GK, Snow EK, Miller J, eds. AHFS 2011 Drug Information. Bethesda, MD: American Society of Health-System Pharmacists; 2011:1422-1441.
  15. American Society of Health-System Pharmacists. Drug Shortage Resource Center. Accessed on December 14, 2011.

Updated

Updated October 29, 2014 by Leslie Jensen, PharmD, Drug Information Specialist, Drug Information Service. Created by Jane Chandramouli, PharmD, Drug Information Specialist, and Erin R. Fox, PharmD, Drug Information Specialist, April 11, 2002. Copyright 2014, Drug Information Service, University of Utah, Salt Lake City, UT.

Disclaimer

This information is provided through the support of Novation to ASHP solely as a service to its members, which shall not use this information for their further commercial use. The content was prepared by the Drug Information Center of University of Utah. Novation, 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, which 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 Novation, 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 Novation, ASHP nor University of Utah endorses or recommends the use of any drug.

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