Valcyte: profile and news

Roche Sues to Block Approval of Ranbaxy Version of Valcyte May 3, 2006
Ranbaxy is seeking approval from the US Food and Drug Administration to sell a version of Valcyte, which contains the key ingredient valganciclovir ... - Bloomberg

Roche sues Ranbaxy over antiviral drug May 4, 2006
NEW DELHI, MAY 4 : Roche Holding AG has sued Ranbaxy Laboratories Ltd to prevent it from selling the generic version of antiviral drug Valcyte. ... - Financial Express,

Other information

Indication
For the treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS).

Pharmacology
Ganciclovir is a synthetic purine nucleoside analogue with in vitro and in vivo inhibitory activity against herpes simplex virus types 1 (HSV-1), Ganciclovir is highly selective due to its affinity for the enzyme thymidine kinase (TK) encoded by HSV and VZV. This viral enzyme converts Ganciclovir into Ganciclovir monophosphate, a nucleotide analogue. The monophosphate is further converted into diphosphate by cellular guanylate kinase and into triphosphate by a number of cellular enzymes. in vitro, Ganciclovir triphosphate stops replication of herpes viral DNA. When used as a substrate for viral DNA polymerase, Ganciclovir triphosphate competitively inhibits dATP leading to the formation of 'faulty' DNA. This is where Ganciclovir triphosphate is incorporated into the DNA strand replacing many of the adenosine bases. This results in the prevention of DNA synthesis, as phosphodiester bridges can longer to be built, destabilizing the strand.

Mechanism Of Action
Ganciclovir stops replication of herpes viral DNA in 3 ways: 1) competitive inhibition of viral DNA polymerase, 2) incorporation into and termination of the growing viral DNA chain, and 3) inactivation of the viral DNA polymerase. Ganciclovir targets HSV and VSV thymidine kinase

Drug Category
Antivirals; Nucleosides and Nucleotides (08:18.32); ATC:J05AB06; ATC:J05AB14;

Brand Names/Synonyms
Cytovene; Cytovene Iv; Cytovene-Iv; GA2; GCV & MSL; Ganciclovir; Ganciclovir Sodium; Gancyclovir; Hydroxyacyclovir; Valcyte; Vitrasert

Dosage Forms
CAPSULE; IMPOLANT; POWDER FOR SOLUTION

Absorption
Poorly absorbed orally, bioavailability is 6% to 9%

Interactions
Interactions for Ganciclovir:

No drug interactions have been observed with the Vitrasert Implant. There is limited experience with use of retinal tamponades in conjunction with the Vitrasert Implant.

Chemical IUPAC Name
2-[(2-amino-6-hydroxy-purin-9-yl)methoxy]propane-1,3-diol

Chemical Formula
C9H13N5O4

Half Life
2.5 to 3.6 hours

Drug Type
Approved Drug

# Accession No
APRD00263

CAS Registry Number
82410-32-0