Paul A. Pham Pharm.D. and John G. Bartlett M.D.
Available formulation in Zambia: tablet: 450 mg
- Oral valganciclovir equivalent to IV ganciclovir for treatment of CMV disease.
- Due to additive bone marrow suppression, avoid co-administration with AZT.
Zambia Information Author: Paul A. Pham, Pharm.D.
- Treatment of CMV retinitis in pts with AIDS.
- Prevention of CMV disease in kidney, heart, and kidney-pancreas transplant pts at high risk for CMV disease (e.g., donor positive, recipient negative). Not indicated in liver transplant pts.
- Prevention of CMV retinitis of the contralateral eye in pts treated with intraocular ganciclovir implant.
- Treatment of GI CMV disease (in pts tolerating PO intake).
| Valcyte ||Valganciclovir||Roche||oral|
*Prices represent cost per unit specified and are representative of "Average Wholesale Price" (AWP).
AWP Prices were obtained and gathered by Lakshmi Vasist Pharm D using the Red Book, manufacturer's
information, and the McKesson database.
^Dosage is indicated in mg unless otherwise noted.
CMV retinitis (induction): 900 mg PO twice-daily with food x 3 wks (plus ganciclovir implant)
CMV retinitis (maintenance): 900 mg PO once-daily with food until immune reconstitution (CD4 >150 x 3-6 mos w/ ophthalmology consultation confirming quiescence).
Gastrointestinal CMV disease: 900 mg twice-daily with food x 3-6 wks (consider maintenance therapy with severe disease and/or with relapse)
- Prevention of CMV disease in kidney, heart, and kidney-pancreas transplant pts at high risk for CMV disease (e.g., donor [+] CMV/recipient negative): 900 mg daily with food beginning within 10 days of transplantation and continuing through day 100 post-transplantation.
- Monitor CBC 2-3x/wk. Discontinue drug or add G-CSF if ANC <500. Discontinue if platelet count <25,000 or consider D/C if Hgb <8g/dL.
>60 ml/min: 900 mg (induction); 900 mg once-daily (maintenance).
40-59 ml/min: 450 mg twice-daily (induction) then 450mg once-daily (maintenance). 25-39 ml/min: 450 mg once-daily (induction) then 450 mg every other day (maintenance). 10-24 ml/min: 450 mg every other day (induction) then 450 mg twice weekly (maintenance).
Not recommended by manufacturer.
Not recommended by manufacturer (HD removes approx. 50% of GCV). Consider using 1.25 mg/kg IV ganciclovir post-HD (induction)
- Mental status changes
CMV, HSV-1, HSV-2, EBV, VZV, HHV-8, and HHV-6.
ddI (buffered or EC): not studied with valganciclovir but ddI levels may be increased. PK study with ddI (buffered) and ganciclovir (GCV) resulted in a 111% increase in ddI AUC. GCV AUC decreased by 21%. Monitor closely for ddI toxicity. Consider ddI dose reduction or alternative NRTI.
- Drug Interactions with PIs, NNRTIs, RAL, MVC, and ENF unlikely.
- Myelosuppressive drugs (e.g., AZT, interferon, 5-FC, pyrimethamine, etc.): may increase risk of hematologic toxicity. Monitor closely with co-administration. Consider alternative agents or support with GCSF.
- Probenecid: may increase GCV serum levels. Monitor for GCV toxicity.
Trimethoprim: may increase GCV serum levels. Monitor for GCV toxicity.
Oral valganciclovir has 10-fold better absorption than oral GCV. AUC of oral valganciclovir 900 mg comparable to GCV 5mg/kg IV. Oral valganciclovir equivalent to IV GCV for treatment of CMV retinitis in HIV+ pts and is preferred due to oral administration. Contraindicated by manufacturer in pts with severe neutropenia (ANC <500/dL), thrombocytopenia (<25,000/dL), severe anemia (Hgb <8 g/dL) and renal failure. Neutropenia and anemia generally responsive to G-CSF and erythropoietin.
- Recommendations of the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC), and the HIV Medicine Association of the Infectious Diseases Society of America (HIVMA/IDSA) ;
Guidelines for Prevention and Treatment of Opportunistic Infections in HIV-Infected Adults and Adolescents ;
2008 ; Vol.
Basis for recommendation
Comments:In pts tolerating PO intake, oral valganciclovir + ganciclovir implant is recommended for the treatment of CMV retinitis.