Valacyclovir (Page 2 of 8)

2.4 Patients with Renal Impairment

Dosage recommendations for adult patients with reduced renal function are provided in Table 1 [see Use in Specific Populations (8.5, 8.6), Clinical Pharmacology (12.3)]. Data are not available for the use of valacyclovir tablets in pediatric patients with a creatinine clearance less than 50 mL/min/1.73 m 2.

Table 1. Valacyclovir Tablets Dosage Recommendations for Adults with Renal Impairment

Indications

Normal Dosage

Regimen

(Creatinine

Clearance ≥50 mL/min)

Creatinine Clearance (mL/min)

30-49

10-29

<10

Cold sores (Herpes labialis )

Do not exceed 1 day of treatment.

Two 2-gram doses taken

12 hours apart

Two 1-gram

doses taken

12 hours apart

Two 500-mg

doses taken

12 hours apart

500-mg single dose

Genital herpes :

Initial episode

1 gram every 12 hours

no reduction

1 gram every

24 hours

500 mg every

24 hours

Genital herpes :

Recurrent episode

500 mg every 12 hours

no reduction

500 mg every

24 hours

500 mg every

24 hours

Genital herpes:

Suppressive therapy

Immunocompetent patients

1 gram every 24 hours

no reduction

500 mg every 24 hours

500 mg every 24 hours

Alternate dose for immunocompetent patients with less than or equal to 9 recurrences/year

500 mg every 24 hours

no reduction

500 mg every 48 hours

500 mg every 48 hours

HIV-1-infected patients

500 mg every 12 hours

no reduction

500 mg every 24 hours

500 mg every 24 hours

Herpes zoster

1 gram every 8 hours

1 gram every 12 hours

1 gram every 24 hours

500 mg every 24 hours

Hemodialysis

Patients requiring hemodialysis should receive the recommended dose of valacyclovir tablets after hemodialysis. During hemodialysis, the half-life of acyclovir after administration of valacyclovir tablets is approximately 4 hours. About one-third of acyclovir in the body is removed by dialysis during a 4-hour hemodialysis session.

Peritoneal Dialysis

There is no information specific to administration of valacyclovir tablets in patients receiving peritoneal dialysis. The effect of chronic ambulatory peritoneal dialysis (CAPD) and continuous arteriovenous hemofiltration/dialysis (CAVHD) on acyclovir pharmacokinetics has been studied. The removal of acyclovir after CAPD and CAVHD is less pronounced than with hemodialysis, and the pharmacokinetic parameters closely resemble those observed in patients with end-stage renal disease (ESRD) not receiving hemodialysis. Therefore, supplemental doses of valacyclovir tablets should not be required following CAPD or CAVHD.

3 DOSAGE FORMS AND STRENGTHS

Tablets:

  • Valacyclovir Tablets, USP 500-mg: Blue, film-coated, capsule-shaped tablets, debossed with “Y131” on one side contains 556.2 mg of valacyclovir hydrochloride equivalent to 500 mg of the free base.
  • Valacyclovir Tablets, USP 1-gram: Blue, film-coated, capsule-shaped tablets, with a partial scorebar on both sides, debossed with “Y132″ on one side contains 1.112 grams of valacyclovir hydrochloride equivalent to 1 gram of the free base.

4 CONTRAINDICATIONS

Valacyclovir 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-1 disease and also in allogeneic bone marrow transplant and renal transplant recipients participating in clinical trials of valacyclovir tablets at doses of 8 grams per day. Treatment with valacyclovir 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 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 tablets for their level of renal function. Dosage reduction is recommended when administering valacyclovir 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 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 tablets for their level of renal function. Elderly patients are more likely to have central nervous system adverse reactions. Valacyclovir 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:

  • Thrombotic Thrombocytopenic Purpura/Hemolytic Uremic Syndrome [see Warnings and Precautions (5.1)].
  • Acute Renal Failure [see Warnings and Precautions (5.2)].
  • Central Nervous System Effects [see Warnings and Precautions (5.3)].

The most common adverse reactions reported in at least 1 indication by greater than 10% of adult subjects treated with valacyclovir tablets and observed more frequently with valacyclovir tablets 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.

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