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CYTOVENE IV
Viral infections
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Drug Name:

CYTOVENE IV Rx

Generic Name and Formulations:
Ganciclovir sodium 500mg/vial; lyophilized pwd for IV infusion after reconstitution and dilution.

Company:
Genentech, Inc.

Therapeutic Use:

Indications for CYTOVENE IV:

Treatment of cytomegalovirus (CMV) retinitis in immunocompromised patients, including those with AIDS. Prevention of CMV disease in high-risk transplant recipients.

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.

Contraindications:

Valganciclovir hypersensitivity.

Boxed Warning:

Hematologic toxicity. Impairment of fertility. Fetal toxicity. Mutagenesis and carcinogenesis.

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.

Pharmacological Class:

Nucleoside analogue.

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.

Adverse Reactions:

Pyrexia, diarrhea, leukopenia, nausea, anemia, asthenia, headache, cough, decreased appetite, dyspnea, abdominal pain, sepsis, hyperhidrosis, blood creatinine increased, thrombocytopenia; retinal detachment.

How Supplied:

Single-use vials—5

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