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 Guide Editors
 Editor In Chief
    Joel E. Gallant, MD, MPH

Pharmacology Editor
    Paul Pham, PharmD, BCPS

Zambia Guideline Team
   Peter Mwaba MMed PhD FRCP
   Alywn Mwinga MMed
   Isaac Zulu MMed MPH
   Velepie Mtonga MMed
   Albert Mwango MBChB
   Jabbin Mulwanda MMed FCS
 

 

 

Drugs>Antimicrobial Agents>
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Ganciclovir

Paul A. Pham Pharm.D. and John G. Bartlett M.D.
11-23-2010

Zambia Specific Information

  • Available formulation in Zambia: IV: 500 mg/vial (as sodium)
  • CMV retinitis: intravitreal ganciclovir 200 mcg once a week (until CD4 >100)

REFERENCES

Zambia Information Author: Paul A. Pham Pharm.D.

INDICATIONS

FDA

  • Treatment of CMV retinitis (IV) in immunocompromised pts.
  • Prophylaxis and prevention of CMV disease reoccurrence in pts with AIDS and solid organ transplant recipients (use for primary prophylaxis in HIV is FDA approved but not currently recommended)
  • Herpes keratitis (ophthalmic gel)
NON-FDA APPROVED USES

  • Castleman's disease (limited data)

FORMS

brand 
name
 
generic 
Mfg 
brand 
forms
 
cost* 
Cytovene Ganciclovir Roche

      IV
vial
500 mg
$81.06
     

Gancicovir (generic) Ganciclovir Ranbaxy oral
capsule
250 mg, 500 mg
$4.72, $9.44
Vitrasert ocular implant Ganciclovir Bausch & Lombocular
ocular implant
4.5 mg
$19,200.00 /per implant
Zirgan  Ganciclovir Sirion Therapeutics ocular
ophthalmic gel
0.15%
tba

*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.

USUAL ADULT DOSING

  • CMV retinitis induction: 5 mg/kg IV q12h x 2 wks (alternative is valganciclovir 900 mg po twice-daily x 3 wks) + implant then maintenance valganciclovir.
  • CMV retinitis maintenance: 5 mg/kg IV daily until immune reconstitution (CD4 >150 for 3-6 mos with inactive disease and follow-up by ophthalmologist). Decision to stop ganciclovir maintenance should take into account anatomic location of the retinal lesions, vision in contralateral eye, and feasibility of regular opthalmologic monitoring.
  • Preferred maintenance regimen is valganciclovir (900 mg po once-daily). Provides serum concentrations comparable to those achieved with IV ganciclovir). IV reserved for pts unable to take po or for seriously ill pts. For pts with small peripheral lesions oral valganciclovir alone may be adequate.
  • IV foscarnet, IV cidofovir, valganciclovir, and ganciclovir (IV,implant) are all effective, but longest time to relapse with ocular implant.
  • Implant: 4.5 mg ocular implant every 6-9 mos (+valganciclovir). Many opthalmologists recommend initial intravitreous injection of ganciclovir ASAP, until the ganciclovir implant can be placed.
  • CMV encephalitis and CMV polyradiculitis: 5mg/kg IV q12h (consider combination therapy with foscarnet), then 5mg/kg q24h until immune reconstitution.
  • CMV (GI): 5 mg/kg q12h x 3-6 wks. The role of maintenance ganciclovir is unclear. In an open label study, after an initial response, time to progression not significantly different between recipients (16 wks) and non-recipients (13 wks) of maintenance therapy (J Infect Dis. 1995;172:622-8)
  • Herpes keratitis: ganciclovir ophthalmic gel 1 drop 5x daily, until corneal ulcer heals, then 1 drop 3x daily x 7 days.

RENAL DOSING

DOSING FOR GLOMERULAR FILTRATION OF 50-80

Induction dose: CrCL >80 ml/min-5mg/kg IV q12h; 1000 mg po 3 times daily. CrCL 50-79 ml/min-2.5mg/kg q12h or 500 mg po 3 times daily .

DOSING FOR GLOMERULAR FILTRATION OF 10-50

Induction dose: CrCL 25-49 ml/min-2.5 mg/kg IV q 24h or 1000 mg PO once-daily. CrCL 10-25 ml/min-1.25 mg/kg IV q24h or 500mg po once-daily .

DOSING FOR GLOMERULAR FILTRATION OF <10 ML/MIN

Induction dose: 1.25 mg/kg IV 3 times a week or 500 mg PO 3 times a week ; HD: 50% of dose removed after 4 hrs of HD. Dose 1.25 m g/kg IV or 500 mg po 3 times a week given post-HD

DOSING IN HEMODIALYSIS

50% of dose removed after 4 hrs of HD. Induction dose: 1.25 mg/kg IV or 500 mg po 3 times a week given post HD

DOSING IN PERITONEAL DIALYSIS

No data, likely to be removed

DOSING IN HEMOFILTRATION

Removed in CVVHD. Limited data, consider 5 mg/kg q48h (induction) or 2.5 mg/kg q48h (maintenance).

ADVERSE DRUG REACTIONS

COMMON

  • NEUTROPENIA (reversible and responds to G-CSF)
  • Reversible THROMBOCYTOPENIA
  • Monitor CBC 2-3/wk & discontinue or add G-CSF if ANC <500; discontinue for PLT <25,000.
OCCASIONAL

  • ANEMIA
  • Fever
  • Rash
  • Headache, seizures, confusion, change in mental status
  • Hepatoxicity
  • GI intolerance
RARE

  • Coma

DRUG INTERACTIONS

  • AZT: additive risk of neutropenia with co-administration.
  • ddI: ddI AUC increased 111% with oral ganciclovir and 50-70% with IV ganciclovir. Avoid or use with close monitoring for ddI-induced toxicity.
  • Imipenem-cilastatin: potential for generalized seizures
  • Pyrimethamine, 5-FC, interferon: potential for additive bone marrow suppression.

SPECTRUM

CMV, HSV-1, HSV-2, EBV, VZV, HHV-8, and HHV-6.

PHARMACOLOGY

Pharmacology

COMMENTS

An agent of choice for CMV infection due to better side effect profile vs. foscarnet and cidofovir. Acyclovir-resistant HSV usually cross-resistant to ganciclovir. Oral ganciclovir replaced by valganciclovir for maintenance therapy of CMV retinitis due to poor absorption, high pill burden. Neutropenia (ANC < 500) or thrombocytopenia (<25,000) are contraindications to initial use.

Basis for Recommendations

  • 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 ; http://AIDSinfo.nih.gov. ; 2008 ; Vol.
    Rating: Basis for recommendation
    Comments:Valganciclovir, IV ganciclovir, IV ganciclovir followed by valganciclovir, IV foscarnet, IV cidofovir, and ganciclovir intraocular implant + valganciclovir are all effective treatments for CMV retinitis.

REFERENCES

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