Gancidovir

HOW SUPPLIED

Capsules: 250 mg Injection: 500 mg/vial

ACTION

Inhibits binding of deoxyguanosine triphosphate to DNA polymerase, resulting in inhibition of DNA synthesis.

INDICATIONS & DOSAGE

CMV retinitis in immunocompromised individuals, including patients with AIDS and normal renalfunction-

Dosage adjustment: Refer to package insert for very specific dose adjustments. Dosage is adjusted for patients with impaired renal function and is based on creatinine clearance levels.

Dosage adjustment is necessary in patients with creatinine clearance below 70 ml/minute.

Prevention of CMV disease in patients with advanced HIV infection and normal renal function -

Adults: 1,000 mg P.O. t.i.d. with food.

Prevention of CMV disease in transplant recipients with normal renal function-

Adults: 5 mg/kg I. V. (given at a constant rate over 1 hour) q 12 hours for 7 to 14 days; then 5 mg/kg daily for 7 days weekly, or 6 mg/kg daily for 5 days weekly. Duration of therapy depends on degree of immunosuppression.

ADVERSE REACTIONS

CNS: altered dreams, confusion, ataxia, headache, seizures, coma, dizziness, somnolence, tremor, abnormal thinking, agitation, amnesia, anxiety, neuropathy, paresthesia, asthenia.

EENT: retinal detachment in CMV retinitis patients.

GI: nausea, vomiting, diarrhea, anorexia, abdominal pain, flatulence, dyspepsia, dry mouth.

GU: increased serum creatinine levels.

Hematologic: agranulocytosis, thrombocytopenia, leukopenia, anemia.

Hepatic: abnormal liver function test results.

Respiratory: pneumonia.

Skin: rash, sweating, pruritus.

Other: fever, infection, chills, sepsis, and inflammation, pain, and phlebitis at injection site.

INTERACTIONS

Drug-drug. Cytotoxic drugs: increased toxic effects, especially hematologic effects and stomatitis. Monitor closely. Didanosine: increased plasma levels of didanosine when used concomitantly. Monitor closely.

Imipenemlcilastatin: heightened seizure activity with concomitant use. Monitor closely.

Immunosuppressants (such as azathioprine, corticosteroids, cyclosporine): enhanced immune and bone marrow suppression. Use together cautiously. Probenecid: increased ganciclovir blood levels. Monitor closely.

Zidovudine: increased incidence of agranulocytosis with concurrent use. Monitor closely.

EFFECTS ON DIAGNOSTIC TESTS

None reported.

CONTRAINDICATIONS

Contraindicated in patients with hyper­sensitivity to drug or acyclovir and in those with an absolute neutrophil count below 500 mm 3 or a platelet count below 25,000 mm 3 .

SPECIAL CONSIDERATIONS

Use cautiously and in reduced dosage in patients with renal dysfunction. Renal function tests must be monitored.

Ganciclovir solution is alkaline; use caution.



Alert: The drug is not for S.C. or I.M. administration.

Because of the frequency of agranulocytosis and thrombocytopenia, neutrophil and platelet counts are obtained every 2 days during twicedaily ganciclovir dosing and at least weekly thereafter.



I.V. administration

The infusion is administered over at least 1 hour. Too-rapid infusions will result in increased toxicity. An infusion pump must be used. Drug is not to be administered via I.V. bolus.



Patient teaching

Adequate hydration is important during therapy.

Report adverse reactions promptly.

Notify health care provider if discomfort occurs at I.V. insertion site.

The drug causes birth defects. If female, use effective birth control methods during treatment; if male, use barrier contraception during, and for at least 90 days following, treatment with ganciclovir.