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This Manual has been designed for use in the NICU at London Health Sciences Centre (LHSC), London, Ontario, Canada, and represents clinical practice at this institution. The information contained within the Manual may not be applicable to other centres. If users of this Manual are not familiar with a drug, it is recommended that the official monograph be consulted before it is prescribed and administered. Any user of this information is advised that the contributors, Editor and LHSC are not responsible for any errors or omissions, and / or any consequences arising from the use of the information in this Manual.

Cytotoxic (See Precautions)

GANCICLOVIR

Indication

  • in adults, ganciclovir is indicated for the treatment of cytomegalovirus (CMV) in immuno compromised individuals(73)
  • there are case reports of ganciclovir use in infants with CMV retinitis and the acquired immunodeficiency syndrome(74), congenital CMV infections (75,76) and acquired disseminated CMV(77)

Pharmacology

  • ganciclovir is a synthetic nucleoside analogue of guanine. Ganciclovir is preferentially phosphorylated in CMV - infected cells; phosphorylated ganciclovir interferes with viral DNA synthesis. Ganciclovir also inhibits mammalian cell proliferation; bone marrow colony forming cells are the most sensitive.
  • the major excretion pathway for ganciclovir is renal (greater than 90% of an administered dose is recovered unchanged in the urine); dosage must be reduced in patients with impaired renal function
  • the effects of impaired hepatic function on the pharmacokinetics of ganciclovir are unknown
  • ganciclovir is 1 to 2% bound to plasma proteins

Side Effects

  • neutropenia: this has occurred in approximately 40% of patients who have received ganciclovir. It is recommended that ganciclovir not be administered if the absolute neutrophil count falls below 0.5 x 109/L
  • thrombocytopenia: a platelet count of less than 50 x 109/L has been seen in approximately 19% of patients who have received ganciclovir.
  • less frequent adverse effects include anemia, fever, rash and abnormal liver function values. These adverse effects have occurred in approximately 2% of patients
  • other side effects which have occurred in 1% or less of patients include arrhythmias, hyper/hypotension, vomiting, diarrhea, hematuria, increased serum creatinine, increased BUN, and inflammation, pain and phlebitis at the site of injection.
  • animal data indicate that ganciclovir caused inhibition of spermatogenesis and infertility; it is considered likely that ganciclovir will cause temporary or permanent male infertility.
  • decreased fertility and increased embryolethality have occurred in female mice after daily IV doses of 90mg/kg.

Precautions

Dose

  • there are no official dosage recommendation nor are there controlled studies of ganciclovir use in infants. However, there are case reports of use in this population, which are listed below:
  • a 6 month old term infant, 6.9 kg, received 5mg/kg IV Q12H x 21 days for treatment of AIDS - related CMV retinitis.(74) The infant experienced transient vomiting and microscopic hematochezia (passage of bloody stools) during the first week which resolved without intervention
  • a neonate with congenital CMV (rash, hepatosplenomegaly, abnormal neuro - CT scan) received ganciclovir (4mg/kg Q12H) for 6 weeks.(75)
  • a 4.2 kg, term infant received two 14-day courses of ganciclovir 5mg/kg IV Q12H for treatment of congenital CMV pneumonia.(76) The half-life of ganciclovir in this infant was 3.1h. Peak plasma concentrations exceeded 2.75 mcg/mL, the in vitro concentration at which ganciclovir inhibits most clinical isolates
  • on day 68 a 27 week, 1.01kg (birth weight) infant received ganciclovir 5mg/kg IV Q12H for 14 days to treat disseminated CMV (77); there were no apparent side effects reported
  • BECAUSE THE MAJOR EXCRETION PATHWAY FOR GANCICLOVIR IS VIA THE KIDNEY AND BECAUSE LITTLE IS KNOWN REGARDING GANCICLOVIR PHARMACOKINETICS, IT WOULD BE PRUDENT TO DECREASE THE FREQUENCY OF ADMINISTRATION (EG. Q18H OR LONGER) IN PREMATURE INFANTS
  • the drug should be infused over 1 hour because crystals (identified as an anti-oxidant component of the rubber stoppers on the vials) have been occasionally observed in reconstituted vials, a 0.22 micron in-line filter is required when infusing ganciclovir (CYTOVENE(R)-Syntex) solution

Supplied

  • Pharmacy will prepare all ganciclovir syringes in a ready to administer dose specific format.
  • Concentration supplied is 5mg/mL; kept refrigerated.(7)

References

  1. Krogh CME et al (ed): Compendium of Pharmaceuticals and Specialties, Canadian Pharmaceutical Association, 1992.
  2. Anon, "CytoveneR", Formulary Facts, Syntex, June 1989.
  3. Levin AV, Zeichner S, Duker JS et al: Cytomegalovirus retinitis in an infant with acquired immunodeficiancy syndrome, Pediatrics 1989; 84: 683-687.
  4. Lynk A and Ford-Jones L: Treatment of congential CMV with ganciclovir (abstract), Royal College of Physicians and Surgeons Meeting (Canada), 1990.
  5. Hocker JR and Adams G: Ganciclovir therapy of congenital cytomegalovirus pneumonia, The Pediatric Infectious Disease Journal 1990; 9: 743-745.
  6. Amin H, Jadavji T, Sauve R et al: Use of ganciclovir in the treatment of acquired cytomegalovirus disease in a preterm infant, Can J Infect Dis 1990; 1: 28-30.
  7. Trissel's "Handbook on Injectable Drugs", 16th Edition.
  8. LHSC Corporate Policy Manual. Safe Handling of Hazardous Drugs. https://apps.lhsc.on.ca/lhsc-policy/search_res.php?polid=PCC091&live=1



Last Updated: Thursday, 07--May-2015
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