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Valcyte Generic Name & Formulations
Legal Class
Rx
General Description
Valganciclovir (as HCl) (prodrug of ganciclovir) 450mg; tabs.
Pharmacological Class
Nucleoside analogue.
See Also
How Supplied
Tabs—60; Soln—100mL (after constitution)
Manufacturer
Generic Availability
YES
Valcyte Indications
Indications
Treatment of AIDS-related cytomegalovirus (CMV) retinitis. Prevention of CMV disease in kidney, heart, or kidney-pancreas transplant adult patients at high risk. Prevention of CMV disease in kidney transplant patients (4mos-16yrs old) and heart transplant patients (1mo-16yrs old) at high risk.
Valcyte Dosage and Administration
Adult
Take with food. ≥16yrs: Treatment: induction: 900mg twice daily for 21 days; maintenance: 900mg once daily. Prevention (heart or kidney-pancreas): 900mg once daily starting within 10 days of transplantation until 100 days post-op. Prevention (kidney): 900mg once daily starting within 10 days of transplantation until 200 days post-op. Renal impairment (CrCl <60mL/min): reduce dose; see full labeling. Hemodialysis (CrCl <10mL/min): not recommended (use ganciclovir).
Children
Take with food once daily. Dose (mg)= 7 x BSA x Creatinine Clearance (if calculated Schwartz CrCl >150mL/min/1.73m2, then use max value of 150mL/min/1.73m2 in equation). Kidney transplant: <4mos: not recommended; ≥4mos: start within 10 days of transplantation until 200 days post-op. Heart transplant: <1mo: not recommended; ≥1mo: start within 10 days of transplantation until 100 days post-op. Round calculated dose to the nearest 10mg increment; max 900mg. If calculated dose within 10% of tablet strength, tablets may be used.
Valcyte Contraindications
Contraindications
Ganciclovir allergy.
Valcyte Boxed Warnings
Boxed Warning
Hematologic toxicity. Impairment of fertility. Fetal toxicity. Mutagenesis and carcinogenesis.
Valcyte Warnings/Precautions
Warnings/Precautions
Risk of hematologic toxicity; monitor CBCs and platelets frequently esp. in infants, patients with renal dysfunction, history of leukopenia with ganciclovir or other nucleoside analogues, baseline ANC <1000cells/microliter. ANC <500cells/microliter, hemoglobin <8g/dL, platelets <25,000cells/microliter: not recommended. Pre-existing cytopenias or history of cytopenic reactions to other drugs, chemicals, or irradiation. Potential to cause impairment of fertility, fetal toxicity, cancer. Renal impairment. Monitor ophthalmic and renal function. Maintain adequate hydration. Avoid direct contact with broken tabs, powder, oral soln with skin or mucous membranes. Do not substitute on a mg-per-mg basis for ganciclovir. Elderly. Pregnancy: exclude status prior to initiation. Use effective contraception during and for at least 30 days (females) or 90 days (males) after treatment. Nursing mothers: not recommended.
Valcyte Pharmacokinetics
See Literature
Valcyte Interactions
Interactions
Increased risk of seizures with imipenem-cilastatin; not recommended. Concomitant cyclosporine, amphotericin B: monitor renal function. May be potentiated by probenecid; reduce valganciclovir dose. May potentiate mycophenolate mofetil (MMF) metabolites or be potentiated by MMF in patients with renal impairment (monitor). Caution with nephrotoxic or myelosuppressive drugs (eg, adriamycin, dapsone, doxorubicin, flucytosine, hydroxyurea, pentamidine, tacrolimus, trimethoprim/sulfamethoxazole, vincas, zidovudine). Monitor for toxicity with didanosine.
Valcyte Adverse Reactions
Adverse Reactions
Diarrhea, pyrexia, fatigue, nausea, tremor, neutropenia, anemia, leukopenia, thrombocytopenia, headache, insomnia, UTI, vomiting; children: also upper RTI.
Valcyte Clinical Trials
See Literature
Valcyte Note
Not Applicable
Valcyte Patient Counseling
See Literature
