Alprostadil Products

28 September 2009

Products Affected - Description

Reason for the Shortage

• Bedford’s product is not available. The company has temporarily suspended manufacturing and distribution of all products while investigating a potential cross-contamination issue. Bedford cannot estimate when product will be available.¹
• Teva’s product was on back order due to manufacturing difficulties.²
• Pfizer’s Caverject Impulse is on back order while the product is reformulated. The company has discontinued Caverject injection 10 mcg lyophilized powder and 20 mcg/mL solution for injection. Prostin VR Pediatric was on back order for unknown reasons.³
• Schwarz could not meet demand for product.⁴
• Vivus has discontinued Muse 125 mcg urethral suppositories.⁵

Estimated Resupply Dates

• Bedford has their alprostadil 0.5 mg/mL ampules on back order and the company cannot estimate a release date.¹
• Teva has available their alprostadil 0.5 mg/mL ampule (NDC 00703-1501-02).²
• Pfizer estimates a release date of July 2010 for Caverject Impulse. Pfizer has available Caverject 20 mcg powder for injection (NDC 00009-3701-05) and Caverject 40 mcg powder for injection (NDC 00009-7686-04). The Caverject 20 mcg powder has an expiration date of March, 2010. Prostin VR Pediatric (NDC 00009-3169-06) is available.³
• Schwarz (UCB) has all Edex presentations available including 10 mcg cartridges in the 2 count size (NDC 00091-1110-16) and 6 count size (NDC 00091-1110-20), 20 mcg cartridges in the 2 count size (NDC 00091-1120-16) and 6 count size (NDC 00091-1120-20) and the 40 mcg cartridges in the 2 count size (NDC 00091-1140-16) and 6 count size (NDC 00091-1140-20).⁴
• Vivus has available all Muse urethral suppositories 250 mcg (NDC 62541-0120-06), 500 mcg (NDC 62541-0130-06) and 1000 mcg (NDC 62541-0140-06).⁵

Implications for Patient Care

• Alprostadil is prostaglandin E₁. It causes vasodilation and inhibits platelet aggregation.^6-8
• 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).^6-8

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.^6-8

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

• Doxazosin
• Isosorbide Tablets— Resolved
• Nitroglycerin— Resolved
• Nitroglycerin 2% Ointment— Resolved
• Nitroglycerin in Dextrose Injection
• Nitroglycerin Sublingual Tablets

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, and September 28, 2009.
2. Teva (personal communications). April 29, May 12, June 25, August 6, September 23, October 6 and 16, November 3 and 24, and December 8, 2008; January 5 and 28, February 23, April 13, and June 16, 2009.
3. Pfizer (personal communications). April 29, May 12, June 25, August 6, September 23, October 3, 6, and 16, November 3, 20, 24, 25, and December 8, 2008; January 5, 27, and 30, February 23, April 14, and June 15, 2009.
4. Schwarz Pharma (UCB) (personal communications). October 6, November 3 and 24, and December 8, 2008; January 6 and 30, February 23, April 13, and June 15, 2009.
5. Vivus (personal communications). October 6, November 3, and 24, 2008; January 7 and 30, February 23, April 13, and June 15, 2009.
6. Wickersham RM, Novak KK, managing eds. Drug Facts and Comparisons. St. Louis, MO: Wolters Kluwer Health, Inc.; 2008.
7. McEvoy GK, ed. AHFS 2008 Drug Information. Bethesda, MD: American Society of Health-Systems Pharmacists; 2008.
8. Lacy CF, Armstrong LL, Goldman MP, Lance LL. Drug Information Handbook. Hudson, OH: Lexi-Comp; 2007.

Updated

Updated on September 28, 2009, by Jane Chandramouli, Pharm.D., Drug Information Specialist. Created November 20, 2008, by M. Christina Beckwith, Pharm.D., Drug Information Specialist. Copyright 2009, Drug Information Service, University of Utah, Salt Lake City, UT.

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