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Ganciclovir Capsules

Last Updated: May 24, 2013
Status: Discontinued

Products Affected - Description

Ganciclovir sodium capsules, Ranbaxy
250 mg capsules, 180 count bottles (NDC 63304-0636-28) -discontinued
500 mg capsules, 180 count bottles (NDC 63304-0637-28)-discontinued

Reason for the Shortage

  • Ganciclovir capsules are one of 30 generic products from Ranbaxy that had an FDA import ban.1
  • Ranbaxy requested withdrawal of approval for the current ganciclovir ANDA in 2012.
  • There are no other suppliers of ganciclovir capsules.

 

Available Products

No presentations are available.

Estimated Resupply Dates

  • There are no presentations currently available.1

Implications for Patient Care

  • Ganciclovir capsules are labeled for the prevention of CMV disease in patients at risk for CMV disease, including solid organ transplant recipients and patients with AIDS. Oral ganciclovir is also indicated as an alternative to intravenous ganciclovir for maintenance therapy of stable CMV retinitis in immunocompromised patients, including patients with AIDS.2
  • Ganciclovir sodium for injection is labeled for the treatment of cytomegalovirus (CMV) retinitis in immunocompromised patients, including patients with acquired immunodeficiency syndrome (AIDS). Intravenous ganciclovir is also indicated for the prevention of CMV disease in transplant recipients at risk for CMV disease.2
  • Valganciclovir tablets (Valcyte®) are labeled for the treatment of CMV retinitis in patients with AIDS. Valganciclovir tablets are also labeled for the prevention of CMV disease in kidney, heart, and kidney-pancreas transplant recipients at risk for CMV disease.3 Valganciclovir tablets are not indicated for prevention of CMV disease in liver transplant recipients as clinical trials have not demonstrated its efficacy in this patient group.3

Safety

Use caution when switching patients from ganciclovir to valganciclovir as the bioavailability of valganciclovir is much higher and overdose could result.3

Table. Comparison of Oral Ganciclovir and Valganciclovir2,3

Property

Ganciclovir capsules*

Valganciclovir tablets

Prevention of CMV disease in patients with HIV

Dose for normal renal function: 1000 mg by mouth three times daily with food

Not labeled for this indication. CDC does not recommend prophylaxis of CMV in patients with HIV because of resistance development, cost and no increase in survival rates.4

Prevention of CMV disease in transplant patients

Dose for normal renal function: 1000 mg by mouth three times daily with food

Dose for normal renal function: 900 mg once daily with food.
Valganciclovir is not recommended for this indication in liver transplant recipients.

Induction treatment for CMV retinitis

Do not use oral ganciclovir for this indication.

Dose for normal renal function: 900 mg by mouth twice daily with food for 21 days.

Maintenance treatment of CMV retinitis

Dose for normal renal function: 1000 mg by mouth three times daily with food OR 500 mg by mouth 6 times daily with food, while awake.

Dose for normal renal function: 900 mg by mouth once daily with food.

Renal dysfunction

Dose reductions required for creatinine clearance less than 70 mL/minute.

Dose reductions required for creatinine clearance less than 60 mL/minute.

Hemodialysis patients

Dose: 500 mg three times per week, following hemodialysis

Not recommended for use in hemodialysis patients as the daily dose is less than one whole 450 mg tablet.

How supplied

250 mg capsules,
500 mg capsules

450 mg tablets (NDC 00004-0038-22)

Suspension preparation 5-8

An extemporaneous suspension can be prepared from ganciclovir capsules for administration via a nasoenteral feeding tube. The suspension must be prepared in a fume or vertical-laminar-airflow hood, and the preparer must use protective measures, such as wearing gloves. When the feeding tube is removed, it must be treated as cytotoxic waste.

An extemporaneous suspension can be prepared from valganciclovir tablets for administration via a nasoenteral feeding tube. The suspension must be prepared in a fume or vertical-laminar-airflow hood, and the preparer must use protective measures, such as wearing gloves. When the feeding tube is removed, it must be treated as cytotoxic waste.

Abbreviations: CMV = cytomegalovirus.
*Ganciclovir capsules are in short supply.

Alternative Agents & Management

  • Valganciclovir tablets (Valcyte®) are an alternative to ganciclovir capsules for most indications.
  • The Table above compares oral ganciclovir and valganciclovir.

Related Shortages

References

  1. 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, June 23, July 28, September 8 and October 27, 2010; January 4, February 23, May 5, July 27, October 5, December 14, 2011; March 6, June 4, September 5, and December 4, 2012; and March 20, 2013.
  2. Ganciclovir. In: Maheswaran AM, ed. Mosby's Drug Consult. 16th ed. St. Louis, MO: Elsevier Mosby; 2006.
  3. Valganciclovir (Valcyte) Tablets [Product information]. Nutley, NJ: Roche Pharmaceuticals; 2006 January.
  4. Centers for Disease Control. Guidelines for prevention and treatment of opportunistic infections in HIV-infected adults and adolescents. MMWR 2009:58 (RR-4): 1-216
  5. Anaizi NH, Swenson CF, Dentinger PJ. Stability of ganciclovir in extemporaneously compounded oral liquids. Am J Health-Syst Pharm. 1999;56:1738-1741.
  6. Anaizi NH, Dentinger PJ, Swenson CF. Stability of valganciclovir in an extemporaneously compounded oral liquid. Am J Health-Syst Pharm. 2002;59:1267-1270.
  7. Sample guidelines for preparing cytotoxic drugs. In: Beckwith MC, Tyler LS, eds. Cancer Chemotherapy Manual. St. Louis, MO: Facts and Comparisons; 2001.
  8. Sample policy: Safe handling of cytotoxic drugs such as chemotherapy. In: Beckwith MC, Tyler LS, eds. Cancer Chemotherapy Manual. St. Louis, MO: Facts and Comparisons; 2001.

Updated

Updated May 24, 2013, by Jane Chandramouli, PharmD, Drug Information Specialist, Drug Information Service. Created May 21, 2009 by Jane Chandramouli, PharmD, Drug Information Specialist. Edited by Erin Fox, PharmD, Manager, Drug Information Service. Copyright 2013, Drug Information Service, University of Utah, Salt Lake City, UT.

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