Valtrex

[Valacyclovir]

Warnings & Precautions
WARNINGS

Thrombotic thrombocytopenic purpura/hemolytic uremic syndrome (TTP/HUS), in some cases resulting in death, has occurred in patients with advanced HIV disease and also in allogeneic bone marrow transplant and renal transplant recipients participating in clinical trials of VALTREX at doses of 8 grams per day.

PRECAUTIONS

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Dosage reduction is recommended when administering VALTREX to patients with renal impairment (see DOSAGE AND ADMINISTRATION). Acute renal failure and central nervous system symptoms have been reported in patients with underlying renal disease who have received inappropriately high doses of VALTREX for their level of renal function. Similar caution should be exercised when administering VALTREX to geriatric patients (see Geriatric Use) and patients receiving potentially nephrotoxic agents. Given the dosage recommendations for treatment of cold sores, special attention should be paid when prescribing VALTREX for cold sores in patients who are elderly or who have impaired renal function (see DOSAGE AND ADMINISTRATION and Geriatric Use). Treatment should not exceed 1 day (2 doses of 2 grams in 24 hours). Therapy beyond 1 day does not provide additional clinical benefit.

Precipitation of acyclovir in renal tubules may occur when the solubility (2.5 mg/mL) is exceeded in the intratubular fluid. In the event of acute renal failure and anuria, the patient may benefit from hemodialysis until renal function is restored (see DOSAGE AND ADMINISTRATION).
The safety and efficacy of VALTREX have not been established in immunocompromised patients other than for the suppression of genital herpes in HIV-infected patients.

The safety and efficacy of VALTREX for suppression of recurrent genital herpes in patients with advanced HIV disease (CD4 cell count <100 cells/mm 3 ) have not been established. The efficacy of VALTREX for the treatment of genital herpes in HIV-infected patients has not been established. The safety and efficacy of VALTREX have not been established for the treatment of disseminated herpes zoster. The efficacy of VALTREX for reducing transmission of genital herpes has not been established in individuals with multiple partners and non-heterosexual couples. Information for Patients: Herpes Zoster: There are no data on treatment initiated more than 72 hours after onset of the zoster rash. Patients should be advised to initiate treatment as soon as possible after a diagnosis of herpes zoster.

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