Cytovene


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Related to Cytovene: Ganciclovir sodium

ganciclovir (DHPG)

Cymevene (UK), Cytovene, Valcyte (CA), Vitrasert

Pharmacologic class: Acyclic purine nucleoside analog of 2′-deoxyguanosine

Therapeutic class: Antiviral

Pregnancy risk category C

Action

Inhibits binding of deoxyguanosine triphosphate to DNA polymerase by terminating DNA synthesis, thereby inhibiting viral replication

Availability

Capsules: 250 mg, 500 mg

Injection: 500 mg/vial

Intravitreal implant: 4.5 mg

Indications and dosages

Prevention of CMV in advanced human immunodeficiency virus (HIV) infection

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

Prevention of CMV in transplant recipients

Adults: 5 mg/kg I.V. q 12 hours for 7 to 14 days; then 5 mg/kg/day 7 days per week or 6 mg/kg/day 5 days per week

CMV retinitis in immunocompromised patients

Adults and children ages 9 and older: Intravitreal implant (4.5 mg) placed during intraocular surgery

Adults and children older than 3 months: Initially, 5 mg/kg I.V. q 12 hours for 14 to 21 days, followed by a maintenance dosage of 5 mg/kg/day 7 days per week or 6 mg/kg 5 days per week. For P.O. maintenance, 1,000 mg P.O. t.i.d. or 500 mg P.O. q 3 hours while patient is awake.

Dosage adjustment

• Renal impairment
• Elderly patients

Off-label uses

• CMV gastroenteritis, CMV pneumonia

Contraindications

• Hypersensitivity to drug or acyclovir
• Neutropenia or thrombocytopenia
• Contraindications for intraocular surgery, such as external infections or thrombocytopenia (with intravitreal implant)
• Breastfeeding

Precautions

Use cautiously in:
• renal impairment
• history of cytopenic reactions
• pregnant patients
• children younger than age 9 (with intravitreal implant).

Administration

Follow facility policy for handling and disposing of antineoplastic drugs. (Drug shares some properties with antitumor agents.)
• Be aware that safety and efficacy of I.V. use haven't been established for congenital or neonatal CMV disease, treatment of established CMV disease other than retinitis, or use in nonimmunocompromised individuals.

Don't let powder in capsules or I.V. solution contact skin, eyes, or mucous membranes. If contact occurs, wash skin thoroughly with soap and water, or flush eyes with water.
• Reconstitute 500-mg vial with 10 ml of sterile water; shake vial to dissolve drug. Then dilute drug again in 50 to 250 ml of compatible I.V. solution.
• If patient is on fluid restriction, dilute to a concentration of 10 mg/ml or less.

Administer a single dose by I.V. infusion slowly (over at least 1 hour), using infusion pump or microdrip (60 gtt/ml).
• Give I.V. solution within 24 hours of dilution to reduce risk of bacterial contamination.

Don't give by I.V. bolus or by I.M. or subcutaneous route.
• Administer oral doses with food.
• Be aware that intravitreal implant is designed to release drug over 5 to 8 months. Once drug is depleted (as shown by retinitis progression), implant may be removed and replaced.

Handle intravitreal implant carefully by suture tab only, to avoid damage to polymer coating. (Damage could increase rate of drug release.)

Adverse reactions

CNS: ataxia, confusion, dizziness, headache, drowsiness, tremor, abnormal thinking, agitation, amnesia, neuropathy, paresthesia, seizures, coma

CV: hypertension, hypotension, phlebitis, arrhythmias

EENT: vision loss for 2 to 4 weeks, vitreous loss, vitreous hemorrhage, cataract, retinal detachment, uveitis, endophthalmitis (all with intravitreal implant)

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

Hematologic: anemia, agranulocytosis, thrombocytopenia, leukopenia

Respiratory: pneumonia

Skin: rash, diaphoresis, pruritus

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

Interactions

Drug-drug.Amphotericin B, cyclosporine, other nephrotoxic drugs: increased risk of renal impairment and ganciclovir toxicity

Cilastatin, imipenem: increased seizure activity

Cytotoxic drugs: increased toxic effects

Immunosuppressants: increased immunologic and bone marrow depression

Probenecid: increased ganciclovir blood level

Zidovudine: increased risk of agranulocytosis

Drug-diagnostic tests.Alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, creatinine, gamma-glutamyltransferase: increased values

Granulocytes, hemoglobin, neutrophils, platelets, white blood cells: decreased values

Liver function tests: abnormal results

Patient monitoring

• Monitor liver function test results.
• Monitor neutrophil and platelet counts.
• Assess fluid intake and output to ensure adequate hydration.
• Make sure patient has regular ophthalmic examinations during both induction and maintenance therapy.

Monitor neurologic status closely; watch for seizures and coma.

Check for signs and symptoms of infection, particularly sepsis.

Patient teaching

Advise patient to immediately report signs and symptoms of infection, including those at infusion site.

Instruct patient to immediately report easy bruising or bleeding.
• Instruct patient to avoid driving and other hazardous activities until he knows how drug affects concentration and alertness.
• Caution female patient not to breastfeed.
• Inform patient that drug may cause birth defects. Tell females to use effective birth control during therapy; advise males to use barrier contraception during and for 90 days after therapy.

Caution patient not to open or crush capsule. If powder from capsule contacts skin or eyes, tell him to wash skin thoroughly with soap and water or flush eyes with water.
• Instruct patient to minimize GI upset by eating frequent, small servings of healthy food.
• Tell patient he'll undergo regular blood testing during therapy.
• Explain that drug doesn't cure CMV retinitis and that patient should have eye exams every 4 to 6 weeks during therapy.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs and tests mentioned above.

Cytovene

(sī′tə-vēn′)
A trademark for the drug ganciclovir.

Cytovene

a trademark for an antiviral (ganciclovir).

Cytovene®

Ganciclovir Virology An agent approved for prophylaxis against CMV in at-risk Pts who receive heart, lung, pancreas, kidney, or liver transplants See AIDS.
References in periodicals archive ?
Valcyte has superior bioavailability to Cytovene in the body, which ultimately translates into fewer daily doses for patients," said Dr.
Oral Cytovene 1,000 mg three times daily was used in 92 patients.
The 6-month, double-blind, double-dummy, active comparator trial of Valcyte versus Cytovene (oral ganciclovir) involved 364 heart, liver, kidney and kidney-pancreas patients at high-risk for CMV disease (donors were seropositive for CMV; recipients did not have antibodies to CMV).
However, in liver transplant patients the incidence of tissue-invasive CMV disease was significantly higher in the Valcyte group compared to the Cytovene group.
The goal of the study was to compare the efficacy and safety of Valcyte to Cytovene in preventing CMV disease; the study was designed and powered to establish non-inferiority of Valcyte to Cytovene.
Roche scientists presented the AVAC with data from a randomized, controlled study in patients with AIDS and newly diagnosed CMV retinitis which compared the efficacy of valganciclovir and CYTOVENE IV in CMV induction therapy.
Pharmacokinetic studies demonstrated that the oral bioavailability of ganciclovir from valganciclovir increased 10-fold compared to oral CYTOVENE, and two 450 mg valganciclovir tablets once or twice daily achieved systemic exposure of ganciclovir comparable to that achieved with the recommended doses of CYTOVENE-IV of 5mg/kg once or twice daily, respectively.
Patients on CYTOVENE capsules in addition to the implant also required fewer hospitalizations (p=0.
Prior to today's clearance of oral Cytovene, intravenous ganciclovir (Cytovene(R)-I.
Based on these data, oral Cytovene would be a good alternative, even for those transplant recipients at highest risk for CMV disease.
Hoffmann-La Roche, a research-based health care company, has a long history in the area of HIV that includes Invirase, Hivid, Cytovene, Vitrasert (Vitrasert is a trademark of Chiron Vision), Roferon-A and Bactrim.