Acyclovir Injection

27 April 2009

Products Affected - Description

Acyclovir lyophilized powder for injection, Bedford Laboratories

Reason for the Shortage

• APP’s acyclovir for injection is on back order due to increased demand.¹
• Bedford’s acyclovir for injection was on back order due to manufacturing delays.²

Estimated Resupply Dates

• APP has all presentations of acyclovir injection available including their 50 mg/mL solution 10 mL vial (NDC 63323-0325-10) and 20 mL vial (NDC 63323-0325-20), and their lyophilized powder for injection 500 mg vial (NDC 63323-0105-10).¹
• Bedford has all presentations of acyclovir injection available including their lyophilized powder for injection 500 mg vial (NDC 55390-0612-10) and 1gram vial (NDC55390-0613-20).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.

Related Shortages

• Ganciclovir Capsules
• Oseltamivir Phosphate
• Ribavirin Inhalation— Resolved

1. APP. Customer Service (personal communications). January 12, February 9 and 23, and March 2, 9, and 31, and April 6, 20, and 27, 2009.
2. Bedford Laboratories. Customer Service (personal communications). January 12, February 23, and March 2, 9, and 31, and April 6, and 27, 2009.
3. Acyclovir injection [product information]. Bedford, OH: Bedford Laboratories; 2005.
4. 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.
5. Mandell GL, Bennett JE, Dolin R, eds. Mandell, Douglas, and Bennett's Principles and Practice of Infectious Diseases. Philadelphia, PA: Elsevier; 2005.
6. 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.
7. 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.
8. 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.
9. 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.
10. 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.
11. 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):1373-1406. Copyright 2009, Drug Information Service, University of Utah, Salt Lake City, UT. 1406
12. 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.
13. Workowski KA, Berman SM. Sexually transmitted diseases treatment guidelines, 2006. MMWR Recomm Rep. Aug 4 2006;55(RR-11):1-94.
14. Foscavir (foscarnet injection) [product information]. Wilmington, DE: AstraZeneca; 2006 August.
15. 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.
16. 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.
17. 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.
18. 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.
19. 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.
20. 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

Updated April 27, 2009 by Michelle Wheeler, Pharm.D., Drug Information Service. Created February 3, 2009 by Jane Chandramouli, Pharm.D., Drug Information Specialist. Edited 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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