Valacyclovir

VALTREX is a deoxynucleoside analogue DNA polymerase inhibitor indicated for: Adult Patients. • Cold Sores (Herpes Labialis) • Genital Herpes • Treatment in immunocompetent patients (initial or recurrent episode) • Suppression in immunocompetent or HIV-1−infected patients • Reduction of transmission • Herpes Zoster Pediatric Patients. • Cold Sores (Herpes Labialis) • Chickenpox Limitations of Use. The efficacy and safety of VALTREX have not been established in immunocompromised patients other than for the suppression of genital herpes in HIV-1−infected patients.

Valacyclovir is an antiviral drug active against α-herpes viruses.

• VALTREX may be given without regard to meals. • Valacyclovir oral suspension (25 mg/mL or 50 mg/mL) may be prepared extemporaneously from 500-mg VALTREX tablets for use in pediatric patients for whom a solid dosage form is not appropriate. Adult Dosage. Cold Sores 2 grams every 12 hours for 1 day Genital Herpes Initial episode 1 gram twice daily for 10 days Recurrent episodes 500 mg twice daily for 3 days Suppressive therapy Immunocompetent patients 1 gram once daily Alternate dose in patients with less than or equal to 9 recurrences/year 500 mg once daily HIV-1−infected patients 500 mg twice daily Reduction of transmission 500 mg once daily Herpes Zoster 1 gram 3 times daily for 7 days Pediatric Dosage.

VALTREX is contraindicated in patients who have had a demonstrated clinically significant hypersensitivity reaction [e.g., anaphylaxis, severe cutaneous adverse reactions (SCARs)] to valacyclovir, acyclovir, or any component of the formulation. Hypersensitivity to valacyclovir (e.g., anaphylaxis), acyclovir, or any component of the formulation.

• Thrombotic thrombocytopenic purpura/hemolytic uremic syndrome (TTP/HUS): Has occurred in patients with advanced HIV-1 disease and in allogenic bone marrow transplant and renal transplant patients receiving 8 grams per day of VALTREX in clinical trials. Discontinue treatment if clinical symptoms and laboratory findings consistent with TTP/HUS occur. • Acute renal failure: May occur in elderly patients (with or without reduced renal function), patients with underlying renal disease who receive higher-than-recommended doses of VALTREX for their level of renal function, patients who receive concomitant nephrotoxic drugs, or inadequately hydrated patients. Use with caution in elderly patients and reduce dosage in patients with renal impairment.

The following serious adverse reactions are discussed in greater detail in other sections of the labeling: • Thrombotic Thrombocytopenic Purpura/Hemolytic Uremic Syndrome. • Acute Renal Failure. • Central Nervous System Effects. • Severe Cutaneous Adverse Reactions. The most common adverse reactions reported in at least 1 indication by greater than 10% of adult subjects treated with VALTREX and observed more frequently with VALTREX compared with placebo are headache, nausea, and abdominal pain. The only adverse reaction reported in greater than 10% of pediatric subjects aged less than 18 years was headache. • The most common adverse reactions reported in at least one indication by greater than 10% of adult subjects treated with VALTREX and more commonly than in subjects treated with placebo are headache, nausea, and abdominal pain.

No clinically significant drug-drug or drug-food interactions with VALTREX are known.

Store at 15°C to 25°C (59°F to 77°F).