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Alprostadil Products

[10 November 2014]

Products Affected - Description

Alprostadil 0.5 mg/mL injection, Teva
1 mL ampule, package of 5 (NDC 00703-1501-02)

Reason for the Shortage

  • Bedford discontinued alprostadil in May, 2011 to concentrate on the manufacturing of other products.  
  • Teva’s product is on long-term back order due to manufacturing difficulties.2
  • Pfizer’s Caverject Impulse was on backorder while the product was reformulated. The company has discontinued Caverject injection 10 mcg lyophilized powder and 20 mcg/mL solution for injection.3
  • Actient has acquired several products from Schwarz (UCB) including Edex cartridges in 2010.4,5
  • Auxilium acquired Actient’s urology products including Edex cartridges in April 2013.6
  • Meda Pharmaceuticals has acquired Muse from Vivus.7,8

Available Products

Edex cartridges, Auxilium6
10 mcg cartridge, package of 2 (NDC 52244-0010-02)
10 mcg cartridge, package of 6 (NDC 52244-0010-06)
20 mcg cartridge, package of 2 (NDC 52244-0020-02)
20 mcg cartridge, package of 6 (NDC 52244-0020-06)
40 mcg cartridge, package of 2 (NDC 52244-0040-02)
40 mcg cartridge, package of 6 (NDC 52244-0040-06)

Muse urethral suppositories, Meda Pharmaceuticals7
125 mcg, package of 6 (NDC 00037-8110-06)
250 mcg, package of 6 (NDC 00037-8120-06)
500 mcg, package of 6 (NDC 00037-8130-06)
1000 mcg, package of 6 (NDC 00037-8140-06)

Prostin VR Pediatric, Pfizer3
0.5 mg/mL ampule, package of 5 (NDC 00009-3169-06)

Caverject, Pfizer3
20 mcg vial, package of 6 (NDC 00009-3701-05)
40 mcg vial, package of 6 (NDC 00009-7686-04)
 
Caverject Impulse injection cartridges, Pfizer3
10 mcg cartridge, package of 2 (NDC 00009-5181-01)
20 mcg cartridge, package of 2 (NDC 00009-5182-01)

Estimated Resupply Dates

Teva has alprostadil 0.5 mg/mL ampules on long-term back order and the company estimates a release date in June 2015.2

Implications for Patient Care

  • Alprostadil is prostaglandin E1. It causes vasodilation and inhibits platelet aggregation.9-11
  • Alprostadil injection (Prostin VR Pediatric, generic) is labeled for intravenous administration for temporary palliative therapy in neonates with congenital heart defects to maintain the patency of the ductus arteriosus until surgery is performed. Alprostadil is also labeled for the treatment of erectile dysfunction, when administered by intracavernosal injection (Caverject, Caverject Impulse, Edex) or intraurethral insertion (Muse).9-11

Safety

Administration route differs between Prostin VR Pediatric, Caverject lyophilized powder, Edex cartridges, and Muse urethral suppositories. Ensure that each specific product is administered via the correct route.9-11

Alternative Agents & Management

  • There are no alternatives to alprostadil injection for use in neonates to maintain the patency of the ductus arteriosus until surgery is performed.
  • Caverject lyophilized powder, Edex cartridges, or Muse urethral suppositories may be used in patients with erectile dysfunction who require alprostadil therapy.

Related Shortages

References

  1. Bedford (personal communications). April 29, May 12, June 25, August 6, September 22, October 6 and 16, November 3 and 24, December 8 and 12, 2008; January 5 and 28, February 23, April 14, June 15, July 29, September 28, December 16, 2009; February 11, April 7, June 23, August 16, September 1, October 13 and 26, 2010; January 5, March 30, and May 3, 2011.
  2. Teva (personal communications). April 29, May 12, June 25, August 6, September 23, October 6 and 16, November 3 and 24, December 8, 2008; January 5 and 28, February 23, April 13, June 16, December 16, 2009; February 12, April 7, June 23, August 16, September 3, October 25, 2010; January 6, March 31, June 21, and August 31, 2011; February 17, 2012; February 21, April 12, June 11, August 22, October 24, and December 11, 2013; February 10, April 14, May 29, August 1, and November 6, 2014.
  3. Pfizer (personal communications). April 29, May 12, June 25, August 6, September 23, October 3, 6, and 16, November 3, 20, 24, and 25, December 8, 2008; January 5, 27, and 30, February 23, April 14, June 15, and December 16, 2009; February 11, April 7, June 23, August 17, October 12, 2010; January 11, March 30, April 4, June 21, August 30, October 4, and December 12, 2011; February 14, April 17, June 27, August 14, November 2, and December 5 and 19, 2012; February 26 April 11, June 6, August 16, October 24, and December 6, 2013; February 7, April 14, May 29, August 1 and 7, and November 5, 2014.
  4. Schwarz Pharma (UCB) (personal communications). October 6, November 3 and 24, December 10, 2008; January 6 and 30, February 23, April 13, June 15, December 16, 2009; April 7, June 24, and August 18, 2010.
  5. Actient (personal communications). August 18, September 2, October 12, 2010; January 5, March 31, June 23, August 30, October 4, and December 12, 2011; February 15, April 17, June 27, and November 2, 2012; February 22, April 11, June 6, 2013.
  6. Auxilium (personal communications). August 22, October 24, and December 9, 2013; February 14, April 16, May 29, August 1, and November 5,  2014.
  7. Meda Pharmaceuticals (personal communications). June 28, August 30, October 4, and December 12, 2011; February 15, April 17, June 23, August 14, 2012; February 21, April 11, June 11, October 24, and December 9, 2013; April 14, May 29, and November 5, 2014.
  8. Vivus (personal communications). October 6, November 3 and 24, 2008; January 7 and 30, February 23, April 13, June 15, December 16, 2009; February 11, April 7, June 23, August 17, September 3, October 12 and 25, 2010; January 4 and March 31, 2011.
  9. Wickersham RM, Novak KK, managing eds. Drug Facts and Comparisons. St. Louis, MO: Wolters Kluwer Health, Inc.; 2008.
  10. McEvoy GK, ed. AHFS 2008 Drug Information. Bethesda, MD: American Society of Health-Systems Pharmacists; 2008.
  11. Lacy CF, Armstrong LL, Goldman MP, Lance LL. Drug Information Handbook. Hudson, OH: Lexi-Comp; 2007.

Updated

Updated November 10, 2014, by Leslie Jensen, PharmD, Drug Information Specialist. Created November 20, 2008, by M. Christina Beckwith, PharmD, Drug Information Specialist. 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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