Valtrex

[Valacyclovir]

Side Effects & Drug Interactions
ADVERSE REACTIONS

Frequently reported adverse events in clinical trials of VALTREX in healthy
patients are listed in Tables 4 and 5.

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Laboratory abnormalities reported in clinical trials of VALTREX in otherwise healthy patients are listed in Table 6.

Table 6. Incidence (%) of Laboratory Abnormalities in Herpes Zoster and Genital Herpes Study Populations
Herpes Zoster Genital Herpes Treatment Genital Herpes Suppression
Laboratory Abnormality

VALTREX 1 gram t.i.d. Place-bo VALTREX 1 gram b.i.d.

VALTREX 500 mg b.i.d. Place-bo VALTREX 1 gram q.d.

VALTREX 500 mg q.d. Place-bo
Hemoglobin
(<0.8 x LLN)
0.8% 0% 0.3% 0.2% 0% 0% 0.8% 0.8%

White blood cells
(<0.75 x LLN)
1.3% 0.6% 0.7% 0.6% 0.2% 0.7% 0.8% 1.5%

Platelet count
(<100,000/mm 3 )
1.0% 1.2% 0.3% 0.1% 0.7% 0.4% 1.1% 1.5%

AST (SGOT)
(>2 x ULN)
1.0% 0% 1.0% * 0.5% 4.1% 3.8% 3.0%

Serum creatinine
(>1.5 x ULN)
0.2% 0% 0.7% 0% 0% 0% 0% 0%

*Data were not collected prospectively.
LLN = Lower limit of normal.
ULN = Upper limit of normal.

Suppression of Genital Herpes in HIV-Infected Patients: In HIV-infected patients, frequently reported adverse events for VALTREX (500 mg twice daily; n = 194, median days on therapy = 172) and placebo (n = 99, median days on therapy = 59), respectively, included headache (13% vs. 8%), fatigue (8% vs. 5%), and rash (8% vs. 1%). Post-randomization laboratory abnormalities that were reported more frequently in valacyclovir subjects versus placebo included elevated alkaline phosphatase (4% vs. 2%), elevated ALT (14% vs. 10%), elevated AST (16% vs. 11%), decreased neutrophil counts (18% vs. 10%), and decreased platelet counts (3% vs. 0%).

Reduction of Transmission:

In a clinical study for the reduction of transmission of genital herpes, the adverse events reported by patients receiving VALTREX 500 mg once daily (n = 743) or placebo once daily (n = 741) included headache (VALTREX 29%, placebo 26%), nasopharyngitis (VALTREX 16%, placebo 15%), and upper respiratory tract infection (VALTREX 9%, placebo 10%). In this 8-month study, there were no clinically significant changes from baseline laboratory parameters in subjects receiving VALTREX compared with placebo.

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