Names and pronunciation
(val-gan-sy′kloh-veer) Valcyte
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Drug reference
(val-gan-sy′kloh-veer) Valcyte
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Func. class.: Antiviral
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Chem. class.: Synthetic nucleoside
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Do not confuse: valGANciclovir/valACYclovir Valcyte/Valtrex
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ACTION: Metabolized to ganciclovir; inhibits replication of human cytomega lovirus by selective inhibition of viral DNA synthesis
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USES: Cytomegalovirus (CMV) retinitis in immunocompromised persons, including those with AIDS, after indirect ophthalmoscopy confirms diagnosis; prevention of CMV with transplantation; prevention of CMV in at-risk patient going through transplant (kidney, heart, pancreas)
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CONTRAINDICATIONS: Breast feeding, hypersensitivity to ganciclovir, valACYclovir; absolute neutrophil count <500/mm3; platelet count <25,000/ mm3; hemodialysis; liver transplantation Precautions: Children, geriatric patients, renal function impairment; hypersensitiv ity to acyclovir, penciclovir, famciclovir
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Black Box Warning: Preexisting cytope nias, new primary malignancy, infertility, anemia, pregnancy Black Box Warning: Leukopenia/ neutropenia/thrombocytopenia: WBCs, platelets q2days during 2×/day dos ing, then q1wk, do not use if ANC <500 mm3, platelets <25,000/mm3, HB <8 g/ dL; leukopenia with daily WBC count in patients with prior leukopenia with other nucleoside analogs or for whom leukope nia counts are <1000 cells/mm3 at start of treatment Black Box Warning: Malignancy: moni tor for malignancy, avoid accidental ex posure of broken, crushed tabs, powder; if these come in contact with skin, wash with soap and water • Monitor serum creatinine or CCr, BUN ≥q2wk, I&O, and increase in fluid intake Black Box Warning: Pregnancy/breast- feeding: Considered potentially terato genic; adequate contraception should be used; do not breastfeed, obtain pregnan cy test in those of childbearing potential prior to use Black Box Warning: Pregnancy/breast- feeding: To use contraception during treatment; that infertility may occur; that men should use barrier contraception for 90 days after treatment; not to breastfeed
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SIDE EFFECTS CNS: Fever, chills, confusion, dizzi ness, headache, insomnia, psychosis, tremors, paresthesia, weakness, sei- zures EENT: Retinal detachment with CMV retinitis GI: Nausea, vomiting, anorexia, diar rhea, abdominal pain GU: Hematuria, increased creatinine, BUN HEMA: Thrombocytopenia, irreversible neutropenia, anemia, pancytopenia INTEG: Rash, alopecia, pruritus, urti caria, pain at site, phlebitis, Stevens- Johnson syndrome MISC: Local and systemic infections, sepsis
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INTERACTIONS Increase: Severe granulocytopenia: im- munosuppressants, zidovudine, antineo- plastics, radiation; do not use together Increase: toxicity—dapsone, pentami dine, flucytosine, vinCRIStine, vinBLAS tine, adriamycin, DOXOrubicin, ampho tericin B, trimethoprim-sulfamethoxazole V combinations or other nucleoside ana logs, cycloSPORINE Increase: effect of both drugs— mycophenolate Increase: seizures—imipenem-cilastatin Increase: effect of didanosine; monitor for adverse effects, toxicity Decrease: renal clearance of valGANci clovir—probenecid Drug/Food Increase: absorption—high-fat meal Drug/Lab Test Increase: creatinine, BUN Decrease: RBC/WBC, Hct/HB
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DOSAGE AND ROUTES Treatment of CMV • Adult and adolescent: PO 900 mg bid × 21 days with food; maintenance 900 mg/day with food Transplant (CMV prophylaxis) • Adult/adolescent >16 yr: PO 900 mg/ day with food starting 10 days before transplantation until day 100 after trans plantation (kidney/pancreas/heart); con tinue for 200 days (kidney) • Infant ≥4 mo/child/adolescent ≤16 yr: PO give within 10 days of heart/kid ney transplant; calculate dose as 7 × BSA × CCr, give as single daily dose Renal dose • Adult: PO CCr ≥60 mL/min, same as above; CCr 40-59 mL/min, 450 mg bid for 21 days, then 450 mg/day; CCr 25-39 mL/min, 450 mg/day, then 450 mg q2days; CCr 10-24 mL/min, 450 mg q2days, then 450 mg 2×/wk
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Available forms: Tabs 450 mg, powder for oral sol 50 mg/mL
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Administer: • Do not get powder on skin, or handle broken tablets; potential carcinogen PO tab • With food for better absorption; avoid getting product on skin, wash hands if contact with skin; do not break, crush, or chew Oral solution • Oral with food • Measure 9 mL purified water in gradu ated cylinder, shake bottle to loosen pow der, add 1⁄2 liquid, shake well, add remaining water, shake; remove child- resistant cap and push bottle adapter into neck of bottle, close with cap, give using dispenser provided • Store liquid in refrigerator; do not freeze; throw away any unused after 49 days
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Assess: • CMV retinitis: determine diagnosis by ophthalmoscopy before beginning treat ment, culture may be used, negative re sults do not confirm that CMV retinitis is not present, use ophthalmoscopy q2wk during treatment
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Evaluate: • Therapeutic response: decreased symptoms of CMV
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CLINICAL CONSIDERATIONS
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Patient and caregiver information: • That product does not cure condi tion; that regular ophthalmologic q1mo and blood tests are necessary • That major toxicities may necessitate discontinuing product • To take with food, avoid high-fat meals • Blood dyscrasias: bruising, bleed- ing, petechiae; seizures, dizziness; to avoid driving, hazardous activities • To use sunscreen to prevent burns
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PHARMACOKINETICS 60% absorbed in GI tract, peak 1-3 hr, duration up to 24 hr. Metabolized to ganciclovir, which has a half-life of 3-41⁄2 hr; excreted by kidneys (unchanged); crosses blood-brain barrier, CSF
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• Adult and adolescent: PO 900 mg bid × 21 days with food; maintenance 900 mg/day with food Transplant (CMV prophylaxis)
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• Adult/adolescent >16 yr: PO 900 mg/ day with food starting 10 days before transplantation until day 100 after trans plantation (kidney/pancreas/heart); con tinue for 200 days (kidney)
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• Infant ≥4 mo/child/adolescent ≤16 yr: PO give within 10 days of heart/kid ney transplant; calculate dose as 7 × BSA × CCr, give as single daily dose Renal dose
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• Adult: PO CCr ≥60 mL/min, same as above; CCr 40-59 mL/min, 450 mg bid for 21 days, then 450 mg/day; CCr 25-39 mL/min, 450 mg/day, then 450 mg q2days; CCr 10-24 mL/min, 450 mg q2days, then 450 mg 2×/wk
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