Valacyclovir Hydrochloride (Page 2 of 7)

3 DOSAGE FORMS AND STRENGTHS

Tablets:

  • 500 mg: blue, film-coated, capsule-shaped tablets debossed with “W PI ” on one side and “3248 ” on the other side.
  • 1 gram: blue, film-coated, capsule-shaped tablets, with a partial scorebar on both sides, debossed with “WPI ” on one side and “324 9 ” on the other side.

4 CONTRAINDICATIONS

Valacyclovir hydrochloride tablets are contraindicated in patients who have had a demonstrated clinically significant hypersensitivity reaction (e.g., anaphylaxis) to valacyclovir, acyclovir, or any component of the formulation [see Adverse Reactions (6.3)].

5 WARNINGS AND PRECAUTIONS

5.1 Thrombotic Thrombocytopenic Purpura/Hemolytic Uremic Syndrome (TTP/HUS)

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 valacyclovir hydrochloride tablets at doses of 8 grams per day. Treatment with valacyclovir hydrochloride tablets should be stopped immediately if clinical signs, symptoms, and laboratory abnormalities consistent with TTP/HUS occur.

5.2 Acute Renal Failure

Cases of acute renal failure have been reported in:

  • Elderly patients with or without reduced renal function. Caution should be exercised when administering valacyclovir hydrochloride tablets to geriatric patients, and dosage reduction is recommended for those with impaired renal function [see Dosage and Administration (2.4), Use in Specific Populations (8.5)].
  • Patients with underlying renal disease who received higher than recommended doses of valacyclovir hydrochloride tablets for their level of renal function. Dosage reduction is recommended when administering valacyclovir hydrochloride tablets to patients with renal impairment [see Dosage and Administration (2.4), Use in Specific Populations (8.6)].
  • Patients receiving other nephrotoxic drugs. Caution should be exercised when administering valacyclovir hydrochloride tablets to patients receiving potentially nephrotoxic drugs.
  • Patients without adequate hydration. Precipitation of acyclovir in renal tubules may occur when the solubility (2.5 mg/mL) is exceeded in the intratubular fluid. Adequate hydration should be maintained for all patients.

In the event of acute renal failure and anuria, the patient may benefit from hemodialysis until renal function is restored [see Dosage and Administration (2.4), Adverse Reactions (6.3)].

5.3 Central Nervous System Effects

Central nervous system adverse reactions, including agitation, hallucinations, confusion, delirium, seizures, and encephalopathy, have been reported in both adult and pediatric patients with or without reduced renal function and in patients with underlying renal disease who received higher than recommended doses of valacyclovir hydrochloride tablets for their level of renal function. Elderly patients are more likely to have central nervous system adverse reactions. Valacyclovir hydrochloride tablets should be discontinued if central nervous system adverse reactions occur [see Adverse Reactions (6.3), Use in Specific Populations ( 8.5, 8.6)].

6 ADVERSE REACTIONS

The following serious adverse reactions are discussed in greater detail in other sections of the labeling:

The most common adverse reactions reported in at least 1 indication by >10% of adult patients treated with valacyclovir hydrochloride tablets and observed more frequently with valacyclovir hydrochloride tablets compared to placebo are headache, nausea, and abdominal pain. The only adverse reaction reported in >10% of pediatric patients <18 years of age was headache.

6.1 Clinical Trials Experience in Adult Patients

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Cold Sores (Herpes Labialis): In clinical studies for the treatment of cold sores, the adverse reactions reported by patients receiving valacyclovir hydrochloride tablets 2 grams twice daily (n = 609) or placebo (n = 609) for 1 day, respectively, included headache (14%, 10%) and dizziness (2%, 1%). The frequencies of abnormal ALT (>2 x ULN) were 1.8% for patients receiving valacyclovir hydrochloride tablets compared with 0.8% for placebo. Other laboratory abnormalities (hemoglobin, white blood cells, alkaline phosphatase, and serum creatinine) occurred with similar frequencies in the 2 groups.

Genital Herpes:Initial Episode: In a clinical study for the treatment of initial episodes of genital herpes, the adverse reactions reported by ≥5% of patients receiving valacyclovir hydrochloride tablets 1 gram twice daily for 10 days (n = 318) or oral acyclovir 200 mg 5 times daily for 10 days (n = 318), respectively, included headache (13%, 10%) and nausea (6%, 6%). For the incidence of laboratory abnormalities see Table 2.

Recurrent Episodes: In 3 clinical studies for the episodic treatment of recurrent genital herpes, the adverse reactions reported by ≥5% of patients receiving valacyclovir hydrochloride tablets 500 mg twice daily for 3 days (n = 402), valacyclovir hydrochloride tablets 500 mg twice daily for 5 days (n = 1,136) or placebo (n = 259), respectively, included headache (16%, 11%, 14%) and nausea (5%, 4%, 5%). For the incidence of laboratory abnormalities see Table 2.

Suppressive Therapy: Suppression of Recurrent Genital Herpes in Immunocompetent Adults: In a clinical study for the suppression of recurrent genital herpes infections, the adverse reactions reported by patients receiving valacyclovir hydrochloride tablets 1 gram once daily (n = 269), valacyclovir hydrochloride tablets 500 mg once daily (n = 266), or placebo (n = 134), respectively, included headache (35%, 38%; 34%), nausea (11%, 11%, 8%), abdominal pain (11%, 9%, 6%), dysmenorrhea (8%, 5%, 4%), depression (7%, 5%, 5%), arthralgia (6%, 5%, 4%), vomiting (3%, 3%, 2%), and dizziness (4%, 2%, 1%). For the incidence of laboratory abnormalities see Table 2.

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

Reduction of Transmission: In a clinical study for the reduction of transmission of genital herpes, the adverse reactions reported by patients receiving valacyclovir hydrochloride tablets 500 mg once daily (n = 743) or placebo once daily (n = 741), respectively, included headache (29%, 26%), nasopharyngitis (16%, 15%), and upper respiratory tract infection (9%, 10%).

Herpes Zoster: In 2 clinical studies for the treatment of herpes zoster, the adverse reactions reported by patients receiving valacyclovir hydrochloride tablets 1 gram 3 times daily for 7 to 14 days (n = 967) or placebo (n = 195), respectively, included nausea (15%, 8%), headache (14%, 12%), vomiting (6%, 3%), dizziness (3%, 2%), and abdominal pain (3%, 2%). For the incidence of laboratory abnormalities see Table 2.

Table 2. Incidence (%) of Laboratory Abnormalities in Herpes Zoster and Genital Herpes Study Populations
Herpes Zoster Genital Herpes Treatment Genital Herpes Suppression
Laboratory Abnormality ValacyclovirHCl Tablets 1 gram3 times daily(n = 967) Placebo(n = 195) ValacyclovirHCl Tablets1 gramtwice daily(n = 1,194) ValacyclovirHCl Tablets 500 mgonce daily(n = 1,159) Placebo(n = 439) ValacyclovirHCl Tablets1 gramonce daily(n = 269) ValacyclovirHCl Tablets 500 mgonce daily(n = 266) Placebo(n = 134)
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/mm3) 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%

LLN = Lower limit of normal.

ULN = Upper limit of normal.

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