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Valacyclovir

Class
Antiviral agents
Subclass
Nucleoside analogs
Generic name
valACYclovir hydrochloride, valaciclovir
Brand names
Valtrex®
Common formulations
Film-coated tablet
Dosage and administration
Adults patients
Treatment
Genital herpes • Initial episode
•
1 g PO BID for 10 days
Genital herpes • Recurrent episode
•
500 mg PO BID for 3 days
Genital herpes • Suppressive therapy
•
1 g PO daily
Herpes zoster
•
1 g PO TID for 7 days
HSV infection • Orolabial
•
2 g PO BID for 1 day
Start treatment at the earliest symptom of a cold sore (e.g., tingling, itching, or burning).
Genital herpes in patients with HIV infection • Off-label
•
1 g PO BID for 7-10 days (initial episode) or 5-10 days (recurrent episode)
Herpes zoster ophthalmicus • Off-label
•
1 g PO TID for 7 days
Herpes zoster ophthalmicus in patients with HIV infection • Off-label
•
1 g PO TID for 7-14 days
HSV infection • Meningitis • Off-label
•
1 g PO TID for 10-14 days, after an initial successful treatment with IV acyclovir
VZV infection • Off-label
•
1 g PO TID for 7 days
VZV infection in patients with HIV infection • Off-label
•
1 g PO TID for at least 5 to 7 days and until all lesions have crusted
Ideally initiate therapy within 24 hours of symptom onset.
Adjunctive treatment
Adjunctive treatment for Bell's palsy • Off-label
•
1 g PO TID for 7 days
Administered in combination with oral corticosteroids. Begin within 3 days of symptom onset.
Alternative
•
1,000 mg PO BID for 7 days
Prevention
B virus infection • Post-exposure prophylaxis • Off-label
•
1 g PO TID for 14 days
HSV infection in patients with immunocompromising conditions • Off-label
•
500 mg PO BID
In seropositive HCT recipients.
VZV infection in patients with immunocompromising conditions • Off-label
•
500 mg PO BID for 3 to 6 months
Solid organ transplant recipients (patients who are VZV-seropositive who do not require CMV prophylaxis).
Other off-label uses
•
Treatment of VZV infection in patients with HIV infection (acute retinal necrosis)
•
Prevention of CMV infection (associated with transplantation of kidney)
•
Prevention of CMV infection (receiving bone marrow transplantation)
Indications for use
Labeled indications
Adults
•
Treatment of genital herpes (initial episode)
•
Treatment of genital herpes (recurrent episode)
•
Treatment of genital herpes (recurrent with ≤ 9 episodes/year, reduction of transmission)
•
Treatment of genital herpes (suppressive therapy)
•
Treatment of genital herpes in patients with HIV infection (suppressive therapy)
•
Treatment of HSV infection (orolabial)
•
Treatment of herpes zoster
Children
•
Treatment of chickenpox
•
Treatment of herpes labialis (in patients ≥ 12 years)
Off-label indications
Adults
•
Treatment of genital herpes in patients with HIV infection
•
Treatment of HSV infection (meningitis)
•
Treatment of herpes zoster ophthalmicus
•
Treatment of herpes zoster ophthalmicus in patients with HIV infection
•
Treatment of VZV infection
•
Treatment of VZV infection in patients with HIV infection
•
Treatment of VZV infection in patients with HIV infection (acute retinal necrosis)
•
Adjunctive treatment for Bell's palsy
•
Prevention of B virus infection (post-exposure prophylaxis)
•
Prevention of CMV infection (associated with transplantation of kidney)
•
Prevention of CMV infection (receiving bone marrow transplantation)
•
Prevention of HSV infection in patients with immunocompromising conditions
•
Prevention of VZV infection in patients with immunocompromising conditions
Safety risks
Contraindications
A clinically significant hypersensitivity to valacyclovir or any of its components.
Warnings and precautions
Agitation, hallucinations, acute confusional state, delusion, seizure, encephalopathy
•
Use caution in patients with advanced age and underlying renal disease. Monitor patients for neuropsychiatric symptoms regularly and adjust the dosage. Discontinue Valacyclovir hydrochloride if CNS adverse reactions occur, assess the patient's condition thoroughly, and provide appropriate psychiatric evaluation and management.
Renal failure
•
Use extreme caution in elderly patients (with or without reduced renal function), patients with underlying renal disease who receive higher-than-recommended doses of valacyclovir tablets for their level of renal function, patients who receive concomitant nephrotoxic drugs, or inadequately hydrated patients. Monitor renal function regularly, especially in patients with pre-existing renal impairment, volume depletion, or concurrent use of other nephrotoxic medications. Discontinue Valacyclovir immediately; initiate appropriate supportive measures, including fluid and electrolyte management, and consultation with a nephrologist for further evaluation and management.
TTP, HUS
•
Use extreme caution in patients with advanced HIV disease and those with allogeneic bone marrow transplant and renal transplant. Monitor patients for any signs or symptoms of thrombotic microangiopathy, such as unexplained thrombocytopenia, renal dysfunction, and neurological changes. Discontinue Valacyclovir immediately; initiate appropriate medical management for thrombotic microangiopathy, including plasma exchange and supportive care; consult a hematologist or nephrologist for specialized management.
Specific populations
Renal impairment
CrCl > 50 mL/min
•
Use acceptable. No dose adjustment required.
CrCl 30-50 mL/min
•
Reduce dose. No dose adjustment required. Maximal dose of 1g. Do not exceed frequency of BID. Monitor for signs of toxicity. Dose adjustment only recommended in the following usage: If usual recommended dose is 1 g every 8 hours: Reduce dose to 1 g every 12 hours. If usual recommended dose is 2 g every 12 hours for 2 doses: Reduce dose to 1 g every 12 hours for 2 doses.
CrCl 10-30 mL/min
•
Reduce dose. Cap frequency. Monitor for signs of toxicity. Dose adjust as below: If usual recommended dose is 500 mg every 24 hours: Reduce dose to 500 mg every 48 hours. If usual recommended dose is 1 g every 24 hours or 500 mg every 12 hours: Reduce dose to 500 mg every 24 hours. If usual recommended dose is 1 g every 12 hours: Reduce dose to 1 g every 24 hours. If usual recommended dose is 1 g every 8 hours: Reduce dose to 1 g every 24 hours. If usual recommended dose is 2 g every 12 hours for 2 doses: Reduce dose to 500 mg every 12 hours for 2 doses.
CrCl < 10 mL/min
•
Reduce dose. Cap frequency. Dose adjust as below: If usual recommended dose is 500 mg every 24 hours: Reduce dose to 500 mg every 48 hours. If usual recommended dose is 1 g every 8 to 24 hours or 500 mg every 12 hours: Reduce dose to 500 mg every 24 hours. If usual recommended dose is 2 g every 12 hours for 2 doses: Reduce dose to 500 mg as a single dose.
Renal replacement therapy
Continuous renal replacement
•
Reduce dose. Dose as in eGFR 10-30 mL/min/1.73 m².
Intermittent hemodialysis
•
Reduce dose. Dose as in eGFR < 10 mL/min/1.73 m². Patients requiring hemodialysis should receive the recommended dose of VALTREX after hemodialysis. During hemodialysis, the half-life of acyclovir after administration of is approximately 4 hours. About one-third of acyclovir in the body is removed by dialysis during a 4-hour hemodialysis session.
Peritoneal dialysis
•
Reduce dose. Dose as in eGFR < 10 mL/min/1.73 m². 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 VALTREX should not be required following CAPD or CAVHD.
Hepatic impairment
Any severity
•
Use acceptable. No dose adjustment required.
Pregnancy and breastfeeding
Pregnancy
All trimesters • Australia Category: B3
•
Generally acceptable for use. Evidence of fetal harm in animals. Clinical data over several decades with valacyclovir and its metabolite, acyclovir, in pregnant women, have not identified a drug associated risk of major birth defects. There are insufficient data on the use of valacyclovir regarding miscarriage or adverse maternal or fetal outcomes. There are risks to the fetus associated with untreated herpes simplex during pregnancy.
Breastfeeding
Acceptable for use during breastfeeding.
•
Patients with HSV infection taking valacyclovir may breastfeed as long as there are not lesions on the breast, body lesions are covered, and strict hand hygiene is practiced; patients with herpetic lesions near or on the breast should not breastfeed.
Very low levels in breastfed infants (< 5%).
No overt adverse effects reported in breastfed infants.
Adverse reactions
Very common > 10%
•
↓ WBC count, ↑ liver enzymes, pharyngitis, headache, nausea
Common 1-10%
•
↓ platelet count, dehydration, abdominal pain, arthralgia, depression, diarrhea, dizziness, dysmenorrhea, fatigue, fever, rhinorrhea, skin rash, vomiting, sinusitis
Uncommon < 1%
•
Anemia, dyspnea
Unknown frequency
•
Agitation, agitation, anaphylactoid reactions, angioedema, anuria, aplastic anemia, ataxia, cognitive impairment, coma, dysarthria, encephalopathy, erythema multiforme, hemolytic uremic syndrome, hepatitis, hypertension, photosensitivity of skin, renal failure, confusion, dyspnea, hair loss, hallucinations, itching, mania, seizure, visual disturbances, thrombotic thrombocytopenic purpura, tachycardia, tremor, urticaria, vasculitis
Interactions
Drug(s)
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