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U.S. Department of Health and Human Services

Safety

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Famvir (famciclovir) tablets

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)-December 2009, January 2011 and February 2012

 

February 2012

Summary View

 

ADVERSE REACTIONS

Postmarketing Experience
  • Skin and subcutaneous tissue disorders: angioedema (e.g. face, eyelid, periorbital, and pharyngeal edema.)

 

USE IN SPECIFIC POPULATIONS

Pediatric Use
  • Herpes labialis…no efficacy data have been obtained in children 1 to <12 years of age with recurrent herpes labialis…
Patients with Hepatic Impairment
  • Conversion of famciclovir to the active metabolite penciclovir may be impaired in these patients resulting in a lower penciclovir plasma concentrations, and thus possibly a decrease of efficacy of famciclovir

 

January 2011

Summary View

 

8 USE IN SPECIAL POPULATIONS

8.8 Black and African American Patients
  • In a randomized, double-blind, placebo-controlled trial conducted in 304 immunocompetent Black and African American adults with recurrent genital herpes there was no difference in median time to healing between patients receiving FAMVIR or placebo. In general, the adverse reaction profile was similar to that observed in other FAMVIR clinical trials for adult patients [see Adverse Reactions (6.1)]. The relevance of these study results to other indications in Black and African American patients is unknown [see Clinical Studies (14.2)]

 

December 2009

Summary View

 

USE IN SPECIFIC POPULATIONS

Pediatric Use
  • The efficacy and safety of Famvir tablets have not been established in pediatric patients. The pharmacokinetic profile and safety of famciclovir experimental granules mixed with OraSweet were studied in two open-label studies...