[17 April 2013]
Products Affected - Description
Acyclovir lyophilized powder for injection, Bedford Laboratories
500 mg vial (NDC 55390-0612-10)
1 g vial (NDC 55390-0613-20)
Acyclovir lyophilized powder for injection, APP
500 mg vial (NDC 63323-0105-10)
Acyclovir 50 mg/mL solution for injection, APP
10 mL vial (NDC 63323-0325-10)
20 mL vial (NDC 63323-0325-20)
Reason for the Shortage
- APP is not manufacturing acyclovir lyophilized powder to concentrate on supplying the solution for injection.1
- Ben Venue voluntarily entered into a consent decree with FDA in late-January, 2013. The terms allow Ben Venue to continue to manufacture over 100 medications as long as they are compliant with the decree. FDA will continue to work with Ben Venue to ensure the products are being made with federal current good manufacturing practice requirements. Ben Venue supplies multiple products for Bedford Laboratories, a division of Ben Venue.2
There are no acyclovir for injection products readily available.
Estimated Resupply Dates
- APP has acyclovir lyophilized powder on long-term back order and the company cannot estimate a release date. Both solution presentations are on allocation.1
- Bedford has acyclovir lyophilized powder for injection 500 mg available in limited quantities after allocation approval. The 1000 mg vials are on long-term back order and will not be manufactured until capacity permits.2
Implications for Patient Care
Acyclovir injection is labeled for treatment of initial and recurrent herpes simplex (mucosal and cutaneous) in immunocompromised patients, herpes simplex encephalitis, neonatal herpes infections, varicella zoster infection in immunocompromised patients, and severe initial episodes of herpes genitalis in immunocompetent patients.3
Alternative Agents & Management
- There are no alternative manufacturers of acyclovir injection.
- Conserve use of current supplies of acyclovir injection for patients with herpes simplex encephalitis and neonatal herpes infections.
- The table lists potential alternatives for acyclovir injection in selected situations.
- APP. Customer Service (personal communications). January 12, February 9 and 23, March 2, 9, and 31, April 6, 20, and 27, 2009; March 3, 12, and 17, April 5, 20 and 27, May 19, June 30, July 22, August 12 and 27, September 22, October 28, December 1 and 20, 2010; February 4, March 9, April 12 and 29, May 18, July 11 and 26, August 8, September 16, November 8, December 12, 2011; February 8, April 11, May 14, July 9, August 21, October 15, and November 5, 2012; January 15, February 11, March 8, and April 16, 2013.
- Bedford Laboratories. Customer Service (personal communications). January 12, February 23, March 2, 9, and 31, April 6, and 27, 2009; March 3 and 12, April 5 and 20, May 19, June 30, August 10 and 30, September 10 and 22, October 28, November 24, December 27, 2010; February 8, March 8, April 12, May 2, 11, and 20, June 1, 16, and 29, July 12 and 27, August 10, September 15, November 7 and 21, December 2, 2011; January 9, April 9, May 11, July 3, August 16, October 15, and November 5, 2012; January 15, February 11, and March 4 and April 16, 2013.
- Acyclovir injection [product information]. Bedford, OH: Bedford Laboratories; 2005.
- Tunkel AR, Glaser CA, Bloch KC, et al. The management of encephalitis: clinical practice guidelines by the Infectious Diseases Society of America. Clin Infect Dis. Aug 1 2008;47(3):303-327.
- Mandell GL, Bennett JE, Dolin R, eds. Mandell, Douglas, and Bennett's Principles and Practice of Infectious Diseases. Philadelphia, PA: Elsevier; 2005.
- Nucleosides and Nucleotides. In: McEvoy GK, Snow EK, Kester L, Litvak K, Miller J, Welsh OH, eds. AHFS 2008 Drug Information. Bethesda, MD: American Society of Health-System Pharmacists; 2008:791-798.
- Ziai WC, Lewin JJ, 3rd. Update in the diagnosis and management of central nervous system infections. Neurol Clin. May 2008;26(2):427-468, viii.
- Poscher ME. Successful treatment of varicella zoster virus meningoencephalitis in patients with AIDS: report of four cases and review. AIDS. Aug 1994;8(8):1115-1117.
- Segal BH, Freifeld AG, Baden LR, et al. Prevention and treatment of cancer-related infections. J Natl Compr Canc Netw. Feb 2008;6(2):122-174.
- Dworkin RH, Johnson RW, Breuer J, et al. Recommendations for the management of herpes zoster. Clin Infect Dis. Jan 1 2007;44 Suppl 1:S1-26.
- Stevens DL, Bisno AL, Chambers HF, et al. Practice guidelines for the diagnosis and management of skin and soft-tissue infections. Clin Infect Dis. Nov 15 2005;41(10):1373-
- American Academy of Pediatrics. Herpes Simplex. In: Pickering L, Baker CJ, Long SS, McMillan JA,. ed. Red Book: 2006 Report of the Committee on Infectious Diseases. 27th ed. Elk Grove Village, IL: American Academy of Pediatrics; 2006:361-371.
- Workowski KA, Berman SM. Sexually transmitted diseases treatment guidelines, 2006. MMWR Recomm Rep. Aug 4 2006;55(RR-11):1-94.
- Foscavir (foscarnet injection) [product information]. Wilmington, DE: AstraZeneca; 2006 August.
- Mandell LA, Bartlett JG, Dowell SF, File TM, Jr., Musher DM, Whitney C. Update of practice guidelines for the management of community-acquired pneumonia in immunocompetent adults. Clin Infect Dis. Dec 1 2003;37(11):1405-1433.
- Martinez E, de Diego A, Paradis A, Perpina M, Hernandez M. Herpes simplex pneumonia in a young immunocompetent man. Eur Respir J. Jun 1994;7(6):1185-1188.
- Suh J, Sepkowitz K. Opportunistic infections in HIV disease. In: Betts R, Chapman SW, Penn RL, ed. Reese and Betts': A Practical Approach to Infectious Diseases. Philadelphia, PA: Lippincott Williams and Wilkins; 2003:649-718.
- Weller S, Blum MR, Doucette M, et al. Pharmacokinetics of the acyclovir pro-drug valaciclovir after escalating single- and multiple-dose administration to normal volunteers. Clin Pharmacol Ther. Dec 1993;54(6):595-605.
- Mori T, Shimizu T, Yamazaki R, et al. Varicella-zoster virus infection under administration of ganciclovir after allogeneic bone marrow transplantation. Scand J Infect Dis. 2006;38(3):227-228.
- Haake DA, Zakowski PC, Haake DL, Bryson YJ. Early treatment with acyclovir for varicella pneumonia in otherwise healthy adults: retrospective controlled study and review. Rev Infect Dis. Sep-Oct 1990;12(5):788-798.
Updated Apri 17, 2013, by Michelle Wheeler, PharmD, Drug Information Service. Created February 3, 2009 by Jane Chandramouli, PharmD, Drug Information Specialist. Edited by M. Christina Beckwith, PharmD, Drug Information Specialist. Copyright 2013, Drug Information Service, University of Utah, Salt Lake City, UT.
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