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valganciclovir (Rx)Brand and Other Names:Valcyte

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet

  • 450mg

powder for oral solution

  • 50mg/mL when reconstituted
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Cytomegalovirus Retinitis

Indicated for treatment of CMV retinitis in patients with AIDS

Induction dose: 900 mg PO q12hr for 21 days

Maintenance dose: 900 mg PO qDay

CMV Prevention in Solid Organ Transplant

Indicated for the prevention of CMV disease in kidney, heart, and kidney-pancreas transplant patients at high risk (donor CMV seropositive/recipient CMV seronegative [D+/R-])

Kidney transplantation

  • 900 mg PO qDay
  • Begin within 10 days of transplant until 200 days post-transplant

Kidney-pancreas transplantation

  • 900 mg PO qDay
  • Begin within 10 days of transplant until 100 days posttransplant

Heart transplantation

  • 900 mg PO qDay
  • Begin within 10 days of transplant until 100 days posttransplant

Renal Impairment

CrCl 40-59 mL/min: 450 mg PO q12hr (induction), THEN 450 mg qDay

CrCl 25-39 mL/min: 450 mg PO qDay (induction), THEN 450 mg q2days

CrCl 10-24 mL/min: 450 mg PO q2days (induction), THEN 450 mg 2 times/week

<10 mL/min (on hemodialysis): Not recommended

Dosage Forms & Strengths

tablet

  • 450mg

powder for oral solution

  • 50mg/mL when reconstituted
more...

CMV Prevention in Kidney & Heart Transplant

Kidney transplantation

  • <4 months: Safety and efficacy not established
  • 4 months to16 years: Daily dose (mg) = 7 x BSA x CrCl; not to exceed 900 mg/day
  • Begin within 10 days of transplant and continue until 200 days post-transplant

Heart transplantation

  • <1 month: Safety and efficacy not established
  • 1 month to16 years: Daily dose (mg) = 7 x BSA x CrCl; not to exceed 900 mg/day
  • Begin within 10 days of transplant and continue until 100 days post-transplant

Dosing Considerations

Calculation of creatinine clearance for the dose in children is by a modified Schwartz formula

The oral solution is the preferred formulation for children since it provides the ability to administer a dose calculated according to the Schwartz formula

Tablets may be used if the calculated doses are within 10% of available tablet strength (450 mg)

For example, if the calculated dose is between 405 mg and 495 mg, one 450 mg tablet may be taken

Assess children for the ability to swallow tablets

Calculate BSA by Mosteller equation

  • BSA (m²) = height (cm) X weight (kg) divided by 3600  

Calculate CrCl by Schwartz equation

  • CrCl (mL/min/1.73 m²) = K x height (cm) divided by serum Cr (mg/dL)
  • If CrCl exceeds 150 mL/min/1.73 m², then use maximum value of 150 mL/min/1.73 m²; an upper limit of 150 mL/min/1.73 m² helps prevent the potential for over dosing
  • If the calculated pediatric dose exceeds 900 mg, a dose of 900 mg should be given to the child
  • Where K =
    • 0.33 for infants aged <1 yr with low birth weight for gestational age
    • 0.45 for infants aged <1 yr with birth weight appropriate for gestational age
    • 0.45 for aged 4 months to <1-2 yr
    • 0.55 for boys aged 2 to <13 yr and girls aged 2 to <16 yr
    • 0.7 for boys aged 13-16 yr
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Interactions

Interaction Checker

valganciclovir and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Abdominal pain (15%)

            Anemia (8-26%)

            Diarrhea (16-41%)

            Fever (31%)

            Granulocytopenia (11-27%)

            Headache (9-22%)

            Insomnia (16%)

            Nausea (8-30%)

            Retinal detachment (15%)

            Vomiting (21%)

            1-10%

            Peripheral neuropathy (9%)

            Paresthesia (8%)

            Seizures (<5%)

            Psychosis, hallucinations (<5%)

            Confusion (<5%)

            Agitation (<5%)

            Thrombocytopenia (8%)

            Pancytopenia (<5%)

            Bone marrow depression (<5%)

            Aplastic anemia (<5%)

            Bleeding, potentially life-threatening due to thrombocytopenia (<5%)

            Decr renal function (<5%),

            Local & systemic infections, incl sepsis (<5%)

            Allergic reaction (<5%)

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            Warnings

            Black Box Warnings

            Valganciclovir metabolized to ganciclovir

            Severe leukopenia, neutropenia, anemia, thrombocytopenia, pancytopenia, bone marrow aplasia, and aplastic anemia reported

            Animal studies showed cidofovir was carcinogenic, teratogenic, and caused hypospermia

            Contraindications

            Hypersensitivity to valganciclovir, ganciclovir

            Hemodialysis patients (use ganciclovir instead)

            ANC <500/cu.mm, Patients <25,000/cu.mm, Hgb <8 g/dL

            Liver transplant patients

            Concomitant zidovudine: increases hematological toxicity

            Cautions

            Preexisting cytopenias

            May be teratogenic or embryotoxic, avoid pregnancy; male patients advised to use barrier method during and for 90 days after treatment

            Risk of: hematologic toxicity, female infertility; aspermatogenesis

            Maintain adequate hydration

            Concomitant nephrotoxic drugs

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            Pregnancy & Lactation

            Pregnancy Category: C

            Lactation: not known if distributed in breast milk; do not nurse

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

            more...
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            Pharmacology

            Mechanism of Action

            Prodrug, converted to ganciclovir in intestine and liver

            Inhibits viral DNA polymerases resulting in chain termination

            Pharmacokinetics

            Absorption: Well absorbed; high-fat meal increases AUC by 30%

            Vdss: ; 0.7 L/kg (gancyclovir); widely to all tissues including CSF and ocular tissue

            Metabolism: converted to ganciclovir by intestinal mucosal cells and hepatocytes

            Vd: Ganciclovir: 15.26 L/1.73 sq.meter

            Protein Bound: Ganciclovir 1-2%

            Half-life, elimination: ganciclovir: 4 hr in nontransplant patients; 6-7 hr in transplant patients; prolonged with renal impairment; severe renal impairment: up to 68 hr

            Bioavailability: With food: 60%

            Excretion: urine (primarily as ganciclovir)

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            Administration

            Instructions

            Take with food (improved bioavailability)

            Handle and dispose according to guidelines for antineoplastic drugs because ganciclovir (active metabolite) shares some of the properties of antitumor agents (ie, carcinogenicity and mutagenicity)

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            Images

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            Formulary

            FormularyPatient Discounts

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            • Compare formulary status to other drugs in the same class.
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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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