[10 May 2013]
Products Affected - Description
Foscarnet sodium 24 mg/mL injection, Hospira
250 mL, package of 12 (NDC 00409-3863-02) - discontinued
500 mL, package of 12 (NDC 00409-3863-05) - discontinued
Reason for the Shortage
- Hospira discontinued generic foscarnet in January 2013.1
- AstraZeneca discontinued Foscavir in April, 2009.2
- Hospira is supplying Clinigen’s Foscavir which has been FDA approved.4
Foscavir 24 mg/mL injection, Hospira
250 mL bottle (NDC 76310-0024-25), item number 1182-02
Estimated Resupply Dates
Hospira has Clinigen Healthcare’s Foscavir available.3,4
Implications for Patient Care
- Foscarnet sodium for injection is labeled for the treatment of cytomegalovirus (CMV) retinitis in patients with acquired immunodeficiency syndrome (AIDS) and in patients with CMV retinitis relapse in combination with ganciclovir. Foscarnet sodium for injection is also labeled for the treatment of mucocutaneous herpes simplex virus (HSV) infections resistant to acyclovir in immunocompromised patients.5
- Foscarnet injection has also been used for the treatment of ganciclovir-resistant CMV infections other than retinitis, such as those which may occur in transplant recipients.6-8
- Foscarnet injection has been given off-label by the intravitreal route for the treatment of CMV retinitis.9,10 To minimize wastage of foscarnet, health-systems may consider off-label use of ganciclovir by intravitreal injection as an alternative in these patients.9-11
Renal dysfunction is common with foscarnet injection and cidofovir. Dosage adjustment may be necessary. Monitor renal function at baseline and periodically during therapy with these agents. Patients treated with cidofovir must also receive concomitant probenecid to reduce risk of severe renal toxicity.5,12,13
Alternative Agents & Management
- There are no alternative manufacturers of foscarnet sodium for injection.
- The choice of antiviral agent for CMV retinitis should be based on location and severity of lesion, level of underlying immune suppression, concomitant medications, and ability to adhere to treatment. No one regimen has been proven in a clinical trial to have superior efficacy for protecting vision. Systemic antiviral therapy is recommended, whether alone or in combination with localized therapies.14,15 Use oral valganciclovir when possible and reserve intravenous ganciclovir for use when oral therapy is inappropriate or patients cannot take oral therapy. Extemporaneous oral liquid preparations made from ganciclovir capsules or valganciclovir tablets may be administered via a nasoenteral feeding tube. The procedure for compounding the ganciclovir suspension was outlined by Anaizi, Swenson, and Dentinger in the September 1, 1999 issue of the American Journal of Health-System Pharmacy.16 The procedure for compounding the valganciclovir suspension was outlined by the same authors in the July 1, 2002 issue of the American Journal of Health-System Pharmacy.17 After removal of the feeding tube from the patient, it must be treated as cytotoxic waste.18,19 Consider reserving foscarnet for patients with high-level ganciclovir resistance. High-level ganciclovir resistance is frequently associated with cidofovir cross-resistance and occasionally demonstrates cross-resistance to foscarnet. Patients with CMV retinitis and low-level ganciclovir resistance may still respond to a ganciclovir implant because of the higher local levels of ganciclovir achieved with this dosage form.15 Table 1 summarizes potential systemic alternatives for the treatment of CMV retinitis.
- Cidofovir may be an alternative to intravenous foscarnet for acyclovir-resistant HSV mucocutaneous infections,12,13,20,21 as shown in Table 2.
- Cidofovir may be an alternative to foscarnet in patients with ganciclovir-resistant CMV infections (see Table 2), depending on the results of viral genotype testing.6-8 Consult an Infectious Disease specialist for treatment options for specific patients. Consider reserving foscarnet for patients with high-level ganciclovir resistance. High-level ganciclovir resistance is frequently associated with cidofovir cross-resistance and occasionally demonstrates cross-resistance to foscarnet.15
- Hospira, Customer Service (personal communication). July 12, August 26, September 29, October 5 and 20, November 3, December 2 and 7, 2010; January 4, February 7 and 25, March 23, April 29, June 6, July 18, August 8 and 29, September 14 and 19, October 20, and December 5, 2011; January 30, March 21, April 6, June 18, July 24, September 5 and 20, October 24, and December 7, 2012; January 23 and 29, and February 27, 2013.
- AstraZeneca, Customer Service (personal communication). July 12, 2010.
- FDA (personal communication). September 27, 2010 and September 16, 2011; and January 29, 2013.
- Clinigen Healthcare UK (personal communication). September 29 and 30, 2010.
- Foscarnet Injection [product information]. Lake Forest, IL: Hospira, Inc.; February 2008.
- Göhring K, Feuchtinger T, Mikeler E, et al. Dynamics of the emergence of a human cytomegalovirus UL97 mutant strain conferring ganciclovir resistance in a pediatric stem-cell transplant recipient. J Mol Diagn. 2009 Jul;11(4):364-368.
- Razonable RR. Cytomegalovirus infection after liver transplantation: current concepts and challenges. World J Gastroenterol. 2008 Aug 21;14(31):4849-4860.
- Eid AJ, Arthurs SK, Deziel PJ, Wilhelm MP, Razonable RR. Emergence of drug-resistant cytomegalovirus in the era of valganciclovir prophylaxis: therapeutic implications and outcomes. Clin Transplant. 2008 Mar-Apr;22(2):162-170.
- Reynolds, LA, Closson RG, eds. Extemporaneous Ophthalmic Preparations. Vancouver, WA: Applied Therapeutics Inc.; 1993.
- Velez G, Roy CE, Whitcup SM, Chan CC, Robinson MR. High-dose intravitreal ganciclovir and foscarnet for cytomegalovirus retinitis. Am J Ophthalmol. 2001;131(3):396-397.
- Morlet N, Young S, Naidoo D, Graham G, Coroneo MT. High dose intravitreal ganciclovir injection provides a prolonged therapeutic intraocular concentration. Br J Ophthalmol. 1996;80(3):214-216.
- McEvoy GK, Snow EK, Miller J, eds. AHFS 2012 Drug Information. Bethesda, MD: American Society of Health-System Pharmacists; 2012.
- Lexi-Comp Online. Hudson, OH: Lexi-Comp Inc.; 2012.
- Centers for Disease Control and Prevention. Treating opportunistic infections among HIV-infected adults and adolescents: recommendations from CDC, the National Institutes of Health, and the HIV Medicine Association/Infectious Diseases Society of America. MMWR Recomm Rep. 2009; 58(RR-4):1-207.
- Kaplan JE, Benson C, Holmes KH, Brooks JT, Pau A, Masur H; Centers for Disease Control and Prevention (CDC); National Institutes of Health; HIV Medicine Association of the Infectious Diseases Society of America. Guidelines for prevention and treatment of opportunistic infections in HIV-infected adults and adolescents: recommendations from CDC, the National Institutes of Health, and the HIV Medicine Association of the Infectious Diseases Society of America. MMWR Recomm Rep. 2009 Apr 10;58(RR-4):1-207.
- Anaizi NH, Swenson CF, Dentinger PJ. Stability of ganciclovir in extemporaneously compounded oral liquids. Am J Health-Syst Pharm. 1999;56:1738-1741.
- Anaizi NH, Dentinger PJ, Swenson CF. Stability of valganciclovir in an extemporaneously compounded oral liquid. Am J Health-Syst Pharm. 2002;59:1267-1270.
- Sample policy: Preparing and reconstituting hazardous drugs. In: Beckwith MC, Tyler LS, eds. Cancer Chemotherapy Manual. St. Louis, MO: Facts and Comparisons; 2012.
- Sample policy: Safe handling of hazardous drugs. In: Beckwith MC, Tyler LS, eds. Cancer Chemotherapy Manual. St. Louis, MO: Facts and Comparisons; 2012.
- Andrei G, Fiten P, Goubau P, et al. Dual infection with polyomavirus BK and acyclovir-resistant herpes simplex virus successfully treated with cidofovir in a bone marrow transplant recipient. Transpl Infect Dis. 2007 Jun;9(2):126-131.
- Chilukuri S, Rosen T. Management of acyclovir-resistant herpes simplex virus. Dermatol Clin. 2003 Apr;21(2):311-320.
- Vistide (cidofovir injection) [product information]. Foster City, CA: Gilead Sciences; September 2000.
- Ganciclovir. In: Maheswaran AM, ed. Mosby's Drug Consult. 16th ed. St. Louis, MO: Elsevier Mosby; 2006.
- Cytovene (ganciclovir sodium for injection) [product information]. South San Francisco, CA: Genentech USA, Inc.; February 2010.
- Valcyte (valganciclovir HCl) tablets [product information]. South San Francisco, CA: Genentech USA, Inc.; November 2009.
- Ranbaxy, Customer Service (personal communications). May 21 June 29, August 4, September 21, November 6, and December 9, 2009; January 25, March 16, April 28, and June 23, 2010.
- Lexi-Comp Online. Infectious Diseases. Hudson, OH: Lexi-Comp Inc.; 2012.
Updated February 27, 2013 by Ginny Jones, RPh, Drug Information Specialist, Drug Information Service. Created July 15, 2010 by Megan Dryer, PharmD, and M. Christina Beckwith, Drug Information Specialists. Copyright 2013, Drug Information Service, University of Utah, Salt Lake City, UT.
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.
« Back to Drug Shortage Product Bulletins