Concise Prescribing Info
Prevention & treatment of life- or sight-threatening cytomegalovirus (CMV) disease in immunocompromised individuals.
Dosage/Direction for Use
CMV retinitis Induction: 5 mg/kg IV infusion over 1 hr every 12 hr for 14-21 days. Maintenance: 5 mg/kg IV infusion over 1 hr once daily, 7 days a wk or 6 mg/kg once daily on 5 days a wk. Patient w/ renal impairment CrCl ≥70 mL/min Induction: 5 mg/kg every 12 hr, maintenance: 5 mg/kg/day; 50-69 mL/min Induction: 2.5 mg/kg every 12 hr, maintenance: 2.5 mg/kg/day; 25-49 mL/min Induction: 2.5 mg/kg/day, maintenance: 1.25 mg/kg/day; 10-24 mL/min Induction: 1.25 mg/kg/day, maintenance: 0.625 mg/kg/day; <10 mL/min Induction: 1.25 mg/kg 3 times/wk after hemodialysis, maintenance: 0.625 mg/kg 3 times/wk after hemodialysis.
Should be taken with food.
Hypersensitivity to ganciclovir or valganciclovir. Possible cross-hypersensitivity w/ aciclovir & valaciclovir.
Special Precautions
Do not administer by rapid or bolus IV inj. IM or SC inj may result in severe tissue irritation. Do not initiate therapy if absolute neutrophil count is <500 cells/microlitre or the platelet count is <25,000 cells/microlitre or the Hb is <8 g/dL. Monitor complete blood & platelet counts during therapy. Patients w/ severe leukopenia, neutropenia, anemia &/or thrombocytopenia; renal impairment. Convulsion, sedation, dizziness, ataxia, confusion &/or coma may occur & may affect ability to drive or operate machinery. Women of childbearing potential should use effective contraception during treatment. Male patients should practice barrier contraception during & for at least 90 days following treatment. Pregnancy & lactation. Childn (potential for long-term carcinogenicity & reproductive toxicity). Elderly.
Adverse Reactions
Leukopenia; sepsis, anorexia; diarrhea; increased blood creatinine. Anaphylaxis, decreased fertility in males. HIV-infected patients: Neutropenia, anemia, thrombocytopenia, lymphadenopathy; abdominal pain, dysphagia, esophageal candidiasis; pyrexia, candida, inj site infection or inflammation, secondary sepsis, Mycobacterium avium complex, pain, chest pain, +ve blood culture; hypoesthesia, anxiety; pruritus; cough, Pneumocystis carinii pneumonia, productive cough, sinus congestion; increased blood alkaline phosphatase; arthralgia. Transplant patients: Pancytopenia; headache, mucous membrane disorder, pyrexia, rigors, face edema; nausea, dyspepsia, abdominal distension; abnormal hepatic function, decreased blood Mg, hypocalcemia, hypokalemia; tremor, confusion; exfoliative dermatitis; rhinitis, dyspnea; tachycardia, hypotension; hematuria; eye hemorrhage; mylagia.
Drug Interactions
Increased AUC of didanosine & zidovudine. Risk of convulsions w/ imipenem-cilastin. Increased conc w/ mycophenolate mofetil. Decreased renal clearance w/ probenecid. May enhance toxicity w/ other drugs known to be myelosuppressive or associated w/ renal impairment (eg, dapsone, pentamidine, flucytosine, vincristine, vinblastine, adriamycin, amphotericin B, nucleoside analogues & hydroxyurea).
MIMS Class
ATC Classification
J05AB06 - ganciclovir ; Belongs to the class of nucleosides and nucleotides excluding reverse transcriptase inhibitors. Used in the systemic treatment of viral infections.
Cymevene powd for soln for inj 500 mg
Exclusive offer for doctors
Register for a MIMS account and receive free medical publications worth $139 a year.
Sign up for free
Already a member? Sign in