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VALCYTE for ORAL SOLUTION
Viral infections
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Drug Name:

VALCYTE for ORAL SOLUTION Rx

Generic Name and Formulations:
Valganciclovir (as HCl) (prodrug of ganciclovir) 50mg/mL; pwd for reconstitution; tutti-frutti flavor.

Company:
Roche Diagnostics Corp.

Therapeutic Use:

Indications for VALCYTE for ORAL SOLUTION:

Prevention of CMV disease in kidney transplant patients (4mos-16yrs old) and heart transplant patients (1mo-16yrs old) at high risk.

Adult:

Use tablet form.

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.

Contraindications:

Ganciclovir allergy.

Warnings/Precautions:

Risk of severe hematologic toxicity; avoid if ANC <500 cells/microliter, platelets <25,000/microliter, or hemoglobin <8g/dL. Pre-existing cytopenias or receiving irradiation or myelosuppressive drugs. May impair fertility. Fetal toxicity; use effective contraception during and for at least 30 days (females) or 90 days (males) after treatment. Potential carcinogen; avoid direct contact with broken tabs, powder, oral soln with skin or mucous membranes. Renal impairment. Maintain adequate hydration. Monitor CBC with differential, platelets, ophthalmic, and renal function. Do not substitute on a mg-per-mg basis for ganciclovir. Elderly. Pregnancy; avoid. Nursing mothers: not recommended.

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.

See Also:

VALCYTE

Pharmacological Class:

Nucleoside analogue.

Adverse Reactions:

Diarrhea, pyrexia, fatigue, nausea, tremor, neutropenia, anemia, leukopenia, thrombocytopenia, headache, insomnia, UTI, vomiting; children: also upper RTI.

Generic Availability:

Tabs (YES); Soln (NO)

How Supplied:

Tabs—60; Soln—100mL (after constitution)

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