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Cytovene Iv Generic Name & Formulations
Legal Class
Rx
General Description
Ganciclovir sodium 500mg/vial; lyophilized pwd for IV infusion after reconstitution and dilution.
Pharmacological Class
Nucleoside analogue.
How Supplied
Single-use vials—5
Manufacturer
Cytovene Iv Indications
Indications
Treatment of cytomegalovirus (CMV) retinitis in immunocompromised patients, including those with AIDS. Prevention of CMV disease in high-risk transplant recipients.
Cytovene Iv Dosage and Administration
Adult
Give by IV infusion over 1 hour. Induction for CMV retinitis: 5mg/kg every 12 hours for 14–21 days. Maintenance: 5mg/kg once daily for 7 days per week or 6mg/kg once daily for 5 days per week. Prevention of CMV (transplant): 5mg/kg every 12 hours for 7–14 days, then 5mg/kg once daily for 7 days per week or 6mg/kg once daily for 5 days per week. Renal impairment, hemodialysis: adjust or reduce dose; see full labeling.
Children
Not established.
Cytovene Iv Contraindications
Contraindications
Valganciclovir hypersensitivity.
Cytovene Iv Boxed Warnings
Boxed Warning
Hematologic toxicity. Impairment of fertility. Fetal toxicity. Mutagenesis and carcinogenesis.
Cytovene Iv Warnings/Precautions
Warnings/Precautions
Risk of hematologic toxicity; monitor CBCs and platelets frequently esp. in 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 contact with skin, mucous membranes. 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.
Cytovene Iv Pharmacokinetics
See Literature
Cytovene Iv Interactions
Interactions
Avoid imipenem-cilastatin (seizures). Monitor renal function with concomitant cyclosporine, amphotericin B. Caution with myelosuppressive or other nephrotoxic drugs (eg, dapsone, doxorubicin, flucytosine, hydroxyurea, pentamidine, tacrolimus, trimethoprim/sulfamethoxazole, vinblastine, vincristine, zidovudine). Monitor for toxicity with didanosine, mycophenolate mofetil. May be potentiated by probenecid.
Cytovene Iv Adverse Reactions
Adverse Reactions
Pyrexia, diarrhea, leukopenia, nausea, anemia, asthenia, headache, cough, decreased appetite, dyspnea, abdominal pain, sepsis, hyperhidrosis, blood creatinine increased, thrombocytopenia; retinal detachment.
Cytovene Iv Clinical Trials
See Literature
Cytovene Iv Note
Not Applicable
Cytovene Iv Patient Counseling
See Literature
