Registered Kenya · PPB

VAGACYTE 450 TABLETS

VALGANCYCLOVIR HYDROCHLORIDE

H2016/CTD2417/217 VALGANCYCLOVIR HYDROCHLORIDE 450MG GENERIC/BIOSIMILARS

What it does

Valgancyclovir is an antiviral medication used to treat infections caused by certain viruses.

Commonly used for: cytomegalovirus (CMV) infection, herpes virus infections

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Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

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Registration & product details

Registration no.
H2016/CTD2417/217
Registration date
-
Expiry date
-
Status
Registered
Active ingredient
VALGANCYCLOVIR HYDROCHLORIDE
Dosage form
VALGANCYCLOVIR HYDROCHLORIDE 450MG
Strength
-
Pack size
5X2S
Therapeutic class
GENERIC/BIOSIMILARS
Manufacturer / MAH
Europa Healthcare
Applicant / LTR
PANACEA BIOTEC LIMITED
Country of origin
FOREIGN

Source: Pharmacy and Poisons Board · fetched 2026-01-28 20:34:36 · updated 2026-07-26 11:25:19

Disclaimer: This information is sourced from Pharmacy and Poisons Board (Kenya). Always consult a qualified healthcare professional before using any medication.

About this medicine

Valgancyclovir is an antiviral medication used to treat infections caused by certain viruses.

What it treats

  • cytomegalovirus (CMV) infection
  • herpes virus infections

How it works

It helps to stop the growth of viruses in the body.

Who it's for

It is typically prescribed for people with weakened immune systems or those at risk of viral infections.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: valgancyclovir

BNF-referenced

Valganciclovir is an antiviral medication that is an ester prodrug of ganciclovir, primarily used to prevent and treat infections caused by cytomegalovirus (CMV) in immunocompromised patients, including those undergoing organ transplantation. It is indicated in the prevention of CMV disease in high-risk patients and in the treatment of CMV retinitis in patients with AIDS.

Indications

  • Prevention of cytomegalovirus (CMV) disease in high-risk organ transplant recipients
  • Treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS)

Dosage

Children: For paediatric patients, the dosage varies based on the condition being treated and the patient's body surface area. Refer to the BNF for Children for specific dosing recommendations.

Adults: The usual adult dose for the prevention of CMV disease is 900 mg orally once daily, starting within 10 days before transplantation and continuing for 100 days post-transplant.

Mechanism of action

Valganciclovir is converted in the body to ganciclovir, which is phosphorylated by viral and cellular kinases to form ganciclovir triphosphate. This active form inhibits viral DNA synthesis by competitively inhibiting viral DNA polymerase and incorporating into the viral DNA chain, leading to chain termination.

Pharmacodynamics

As an antiviral agent, valganciclovir exhibits activity against CMV by interfering with viral replication. The pharmacodynamic effects include a dose-dependent reduction in viral load and prevention of CMV-related complications in immunocompromised patients.

Pharmacokinetics

Valganciclovir is rapidly absorbed after oral administration, with peak plasma concentrations occurring approximately 1 to 2 hours post-dose. The bioavailability is significantly enhanced when taken with food. It is primarily eliminated by renal excretion, with a half-life of about 4 hours in patients with normal renal function. Dose adjustments are necessary in patients with renal impairment.

Adverse effects

  • Diarrhea
  • Nausea
  • Vomiting
  • Headache
  • Dizziness
  • Fatigue
  • Anemia
  • Leukopenia
  • Thrombocytopenia
  • Neutropenia

Interactions

  • Caution with drugs that cause bone marrow suppression.
  • Caution with nephrotoxic agents.

Precautions

  • Monitor renal function regularly.
  • Use with caution in patients with a history of seizures.
  • Ensure adequate hydration during treatment.

Pregnancy

Valganciclovir should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus. It is classified as a Category C drug.

Breast-feeding

Valganciclovir is excreted in breast milk, and caution is advised when administering to nursing mothers.

Storage

Store at room temperature, away from light and moisture. Keep out of reach of children.

Formulations

  • Tablets
  • Oral solution
PubChem / pathway

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Molecular reference: valgancyclovir

PubChem CID 135398519

Molecular formula: C14H22N6O5

Source: PubChem (NCBI) · pathways from PathBank, Reactome, WikiPathways & PharmGKB.