Valganciclovir hydrochloride indications and usage: Difference between revisions
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== | ==Indications and Usage== | ||
===Adult Patients=== | ===Adult Patients=== | ||
Treatment of Cytomegalovirus (CMV) Retinitis: Valcyte tablets are indicated for the treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS) [see Clinical Studies (14.1)]. | Treatment of Cytomegalovirus (CMV) Retinitis: Valcyte tablets are indicated for the treatment of [[CMV retinitis]] in patients with acquired immunodeficiency syndrome (AIDS) [see Clinical Studies (14.1)]. | ||
Prevention of CMV Disease: Valcyte tablets are indicated for the prevention of CMV disease in kidney, heart, or kidney-pancreas transplant patients at high risk (Donor CMV seropositive/Recipient CMV seronegative [D+/R-]) [see Clinical Studies (14.1)]. | Prevention of CMV Disease: Valcyte tablets are indicated for the prevention of CMV disease in kidney, heart, or kidney-pancreas transplant patients at high risk (Donor CMV seropositive/Recipient CMV seronegative [D+/R-]) [see Clinical Studies (14.1)]. | ||
Latest revision as of 23:41, 2 January 2014
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Sheng Shi, M.D. [2]
Indications and Usage
Adult Patients
Treatment of Cytomegalovirus (CMV) Retinitis: Valcyte tablets are indicated for the treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS) [see Clinical Studies (14.1)].
Prevention of CMV Disease: Valcyte tablets are indicated for the prevention of CMV disease in kidney, heart, or kidney-pancreas transplant patients at high risk (Donor CMV seropositive/Recipient CMV seronegative [D+/R-]) [see Clinical Studies (14.1)].
Pediatric Patients
Prevention of CMV Disease: Valcyte for oral solution and tablets are indicated for the prevention of CMV disease in kidney or heart transplant patients (4 months to 16 years of age) at high risk [see Clinical Studies (14.2)].
Limitations of Use
Valcyte is not indicated for use in either adult or pediatric liver transplant patients [see Clinical Studies (14.1, 14.2)].
The safety and efficacy of Valcyte have not been established for:
- Prevention of CMV disease in solid organ transplants other than those indicated [see Clinical Studies (14.1, 14.2)].
- Prevention of CMV disease in pediatric solid organ transplant patients < 4 months of age [see Clinical Studies (14.2)].
- Treatment of congenital CMV disease [see Use in Specific Populations (8.4)][1]
References
- ↑ "http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021304s008,022257s003lbl.pdf" (PDF). External link in
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Adapted from the FDA Package Insert.