Cymevene

Cytomegalovirus (CMV) disease in immunocompromised individuals ≥12 yr. Prevention of CMV disease using pre-emptive therapy in patients w/ drug-induced immunosuppression following organ transplantation or cancer chemotherapy in patients ≥12 yr; using universal prophylaxis in patients w/ drug-induced immunosuppression following organ transplantation or cancer chemotherapy from birth.

Administer as IV infusion over 1 hr into a vein w/ adequate blood flow. Treatment of CMV disease in patient ≥12 yr w/ normal renal function Induction treatment: 5 mg/kg every 12 hr for 14-21 days. Maintenance treatment: 5 mg/kg once daily on 7 days wkly or 6 mg/kg once daily on 5 days wkly may be given in immunocompromised patient at risk of relapse. Prevention of CMV disease using pre-emptive therapy in patient ≥12 yr w/ normal renal function Induction treatment: 5 mg/kg every 12 hr for 7-14 days. Maintenance treatment: 5 mg/kg once daily on 7 days wkly or 6 mg/kg once daily on 5 days wkly. Prevention of CMV disease using universal prophylaxis in patient >16 yr w/ normal renal function 5 mg/kg once daily on 7 days wkly or 6 mg/kg once daily on 5 days wkly. Patient ≥12 yr w/ renal impairment CrCl ≥70 mL/min Induction dose: 5 mg/kg every 12 hr. Maintenance dose: 5 mg/kg daily, 50-69 mL/min Induction dose: 2.5 mg/kg every 12 hr. Maintenance dose: 2.5 mg/kg daily, 25-49 mL/min Induction dose: 2.5 mg/kg daily. Maintenance dose: 1.25 mg/kg daily, 10-24 mL/min Induction dose: 1.25 mg/kg daily. Maintenance dose: 0.625 mg/kg daily, <10 mL/min 1.25 mg/kg 3 times wkly after hemodialysis. Maintenance dose: 0.625 mg/kg 3 times wkly after hemodialysis.

Hypersensitivity to ganciclovir or valganciclovir.

Hypersensitivity to aciclovir or penciclovir (or to their prodrugs, valaciclovir or famciclovir respectively). Do not administer by rapid or bolus IV inj. Do not initiate therapy if ANC <500 cells/µL or platelet count <25,000 cells/µL or Hb <8 g/dL. Potential teratogen & carcinogen. Patients w/ pre-existing hematological cytopenia or a history of drug-related hematological cytopenia & in those receiving RT. Monitor CBC including platelet counts in all patients particularly those w/ renal impairment, neonates & infants during therapy. Not to be concomitantly used w/ imipenem-cilastatin. Concomitant use w/ zidovudine; didanosine; other drugs that are known to be myelosuppressive or associated w/ renal impairment. May have minor influence on ability to drive & use machines. Safety & efficacy have not been studied in hepatic impairment. Women of reproductive potential should use effective contraception during & for at least 30 days after treatment. Sexually active men are recommended to use condoms during & for at least 90 days after cessation of treatment. Safe use during labor & delivery has not been established. Avoid use during pregnancy. Lactation. Limited data on treatment & pre-emptive therapy in childn <12 yr. Monitor CBC, liver function abnormalities, renal function & GI fluid loss in childn. No studies have been conducted in elderly >65 yr.

Hematological reactions including neutropenia, anemia & thrombocytopenia.

Convulsions w/ imipenem-cilastatin. Toxicity may be enhanced w/ other drugs known to be myelosuppressive or associated w/ renal impairment including nucleoside analogues (eg, zidovudine, didanosine, stavudine), immunosuppressants (eg, ciclosporin, tacrolimus, mycophenolate mofetil), antineoplastic agents (eg, doxorubicin, vincristine, vinblastine, hydroxyurea), & anti-infectives (eg, trimethoprim/sulphonamides, dapsone, amphotericin B, flucytosine, pentamidine). Potential neutropenia & anemia w/ zidovudine. Raised plasma conc of didanosine. Decreased renal clearance w/ probenecid.

Antivirals

J05AB06 - ganciclovir ; Belongs to the class of nucleosides and nucleotides excluding reverse transcriptase inhibitors. Used in the systemic treatment of viral infections.

Rx