• Treatment of cytomegalovirus (CMV) retinitis in patients with AIDS.
• Prevention of CMV disease in kidney, kidney/pancreas and heart transplant patients at risk.

Contraindicated in:

• Hypersensitivity to valganciclovir or ganciclovir
• Hemodialysis
• Undergoing liver transplantation
• Lactation: Lactation.

Use Cautiously in:

• Renal impairment (dosage ↓ recommended if CCr <60 mL/min)
• Pre-existing bone marrow depression
• Previous or concurrent myelosuppressive drug therapy or radiation therapy
• Women of reproductive potential and men with female partners of reproductive potential
• OB: Use during pregnancy only if potential maternal benefit justifies potential fetal risk
• Pedi: Children <4 mo (safety and effectiveness not established)
• Geri: Age-related ↓ in renal function requires dosage ↓ in older adults.

GI: abdominal pain, diarrhea, nausea, vomiting.

GU: ↓ fertility, renal impairment.

Hemat: anemia, aplastic anemia, bone marrow depression, NEUTROPENIA, pancytopenia, THROMBOCYTOPENIA.

Neuro: headache, insomnia, agitation, ataxia, confusion, dizziness, hallucinations, paresthesia, peripheral neuropathy, psychosis, sedation, SEIZURES.
Misc: fever, (INCLUDING ANAPHYLAXIS)HYPERSENSITIVITY REACTIONS , INFECTION.

Drug-Drug:

• ↑ risk of hematologic toxicity with zidovudine.
• Probenecid may ↑ levels and risk of toxicity.
• Patients with renal impairment may experience accumulation of metabolites of mycophenolate and valganciclovir.

Drug-Food:

• Food ↑ absorption.

(Generic available)

• Tablets: 450 mg;
• Oral solution (tutti-frutti flavor): 50 mg/mL;

Treatment of CMV Disease

• PO (Adults): Induction: 900 mg twice daily for 21 days; Maintenance treatment or patients with inactive CMV retinitis: 900 mg once daily.

Prevention of CMV Disease in Transplant Patients

• PO (Adults): Kidney/pancreas or heart transplant: 900 mg once daily, starting 10 days prior to transplant and continued for 100 days after; Kidney transplant: 900 mg once daily, starting 10 days prior to transplant and continued for 200 days after.
• PO (Children 4 mo–16 yr): Kidney transplant: Dose is based on body surface area (BSA) and CCr. Dose = 7 × BSA × CCr (see prescribing information for equations used for BSA and CCr); all calculated doses should be rounded to nearest 25 mg (max = 900 mg) and administered as oral solution; should be started 10 days prior to transplant and continued for 200 days after.
• PO (Children 4 mo–16 yr): Heart transplant: Dose is based on BSA and CCr. Dose = 7 × BSA × CCr (see prescribing information for equations used for BSA and CCr); all calculated doses should be rounded to nearest 25 mg (max = 900 mg) and administered as oral solution; should be started 10 days prior to transplant and continued for 100 days after.

Valcyte

• Valganciclovir is a prodrug, which is rapidly converted to ganciclovir by intestinal and hepatic enzymes. CMV virus converts ganciclovir to its active form (ganciclovir phosphate) inside host cell, where it inhibits viral DNA polymerase.

• Antiviral effect directed preferentially against CMV-infected cells.

Therapeutic Classification: antivirals

Absorption: 59.4% absorbed following oral administration, rapidly converted to ganciclovir.

Distribution: Widely distributed to tissues, including CSF.

Metabolism/Excretion: Rapidly converted to ganciclovir; ganciclovir is mostly excreted by the kidneys.

Half-life: 4.1 hr (intracellular half-life of ganciclovir phosphate is 18 hr).

(ganciclovir plasma concentrations)

• Instruct patient to take valganciclovir with food, as directed. Take missed doses as soon as remembered, unless almost time for next dose; do not double doses. Advise patient to read Patient Information before starting therapy and with each Rx refill in case of changes.
• Inform patient that valganciclovir is not a cure for CMV retinitis. Progression of retinitis may continue in immunocompromised patients during and following therapy. Advise patients to have regular ophthalmic exams at least every 4–6 wk. Duration of therapy for CMV prevention is based on the duration and degree of immunosuppression.
• May cause seizures, sedation, dizziness, ataxia, and/or confusion. Caution patient not to drive or do other activities requiring alertness until response to medication is known.
• Advise patient to notify health care professional if fever; chills; sore throat; other signs of infection; bleeding gums; bruising; petechiae; or blood in urine, stool, or emesis occurs. Caution patient to avoid crowds and persons with known infections. Instruct patient to use soft toothbrush and electric razor. Patient should be cautioned not to drink alcoholic beverages or take products containing aspirin or NSAIDs.
• Caution patient to use sunscreen and protective clothing to prevent photosensitivity reactions.
• May cause fetal harm. Advise females of reproductive potential to use effective contraception during and for at least 30 days following therapy and to avoid breastfeeding. Advise males with female partners of reproductive potential to use a barrier method of contraception during and for at least 90 days following therapy. Advise patient to notify health care professional immediately if pregnancy is suspected. May cause temporary or permanent infertility.
• Emphasize the importance of frequent follow-up exams to monitor blood counts.

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