Zigang

Induction & maintenance treatment of cytomegalovirus (CMV) retinitis in adults w/ AIDS. Prevention of CMV disease in CMV -ve adults & childn (from birth to 18 yr) who have received solid organ transplant from CMV +ve donor.

CMV retinitis Adult Induction treatment: 900 mg (2 tab) bid for 21 days. Maintenance: 900 mg (2 tab) once daily. Prevention of CMV disease in solid organ transplantation Adult kidney transplant patient & those who received solid organ transplant other than kidney 900 mg (2 tab) once daily starting w/in 10 days post-transplantation & continuing until 100 days post-transplantation. May be continued until 200 days post-transplantation in kidney transplant patients. Paed (from birth) solid organ transplant patient Once daily dosing based on BSA (from Mosteller formula) & CrCl (from Schwartz formula). All calculated doses should be rounded to the nearest 25 mg increment for actual deliverable dose. Max: 900 mg. Paed kidney transplant patient Once daily mg dose starting w/in 10 days post-transplantation & continue until 200 days post-transplantation. Paed patient who received solid organ transplant other than kidney Once daily mg dose starting w/in 10 days post-transplantation & continue until 100 days post-transplantation. Renal impairment w/ CrCl ≥60 mL/min Induction: 900 mg (2 tab) bid, maintenance/prevention dose: 900 mg (2 tab) once daily, 40-59 mL/min Induction: 450 mg bid, maintenance/prevention dose: 450 mg once daily, 25-39 mL/min Induction: 450 mg once daily, maintenance/prevention dose: 450 mg every 2 days, 10-24 mL/min Induction: 450 mg every 2 days, maintenance/prevention dose: 450 mg twice wkly.

Should be taken with food: Do not break or crush.

Hypersensitivity to valganciclovir or ganciclovir. Lactation.

Cross-hypersensitivity reaction w/ aciclovir or penciclovir (or their prodrugs, valaciclovir or famciclovir, respectively). Not to be initiated if ANC is <500 cells/microliter, or platelet count <25,000/microliter, or Hb level <8 g/dL. Not to be substituted for ganciclovir cap on one-to-one basis. Severe leukopenia, neutropenia, anaemia, thrombocytopenia & pancytopenia. Seizures. Increased risk of bone marrow toxicity w/ prolonged treatment induction. Patients w/ pre-existing haematological cytopenia or history of drug-related haematological cytopenia & those receiving RT; switching from induction to maintenance therapy, & from oral ganciclovir to valganciclovir. Monitor CBC & platelet counts regularly during therapy especially in patients w/ renal impairment & paed patients. Closely monitor signs of added toxicity when concomitantly used w/ didanosine, zidovudine or substances affecting renal function. Not to be used concomitantly w/ imipenem-cilastatin. May affect ability to drive & operate machinery. Not to be used in patients on heamodialysis. Hepatic impairment. Potential risks to foetus. May cause temporary or permanent inhibition of spermatogenesis. Women of childbearing potential should use effective contraception during & for at least 30 days after treatment. Men should practice barrier contraception during treatment & for at least 90 days thereafter. Pregnancy. Discontinue lactation during treatment. Elderly >65 yr.

Candida infections including oral candidiasis, URTI; neutropenia, anaemia; decreased appetite; headache; cough, dyspnoea; diarrhoea, nausea, vomiting, abdominal pain; dermatitis; pyrexia, fatigue. Sepsis, flu, UTI, cellulitis; thrombocytopenia, leukopenia, pancytopenia; hypersensitivity; decreased wt; depression, confusional state, anxiety; insomnia, peripheral neuropathy, dizziness, paraesthesia, hypoaesthesia, seizure, dysgeusia; visual impairment, retinal detachment, vitreous floaters, eye pain, conjunctivitis, macular oedema; ear pain; hypotension; dyspepsia, flatulence, upper abdominal pain, constipation, mouth ulceration, dysphagia, abdominal distention, pancreatitis; increased blood alkaline phosphatase, AST & ALT, abnormal hepatic function; night sweats, pruritus, rash, alopecia; back pain, myalgia, arthralgia, muscle spasms; renal impairment, decreased renal CrCl, increased blood creatinine; pain, chills, malaise, asthenia.

Increased exposure w/ probenecid. Increased plasma conc of didanosine. Seizures w/ imipenem-cilastatin. Potential risk of neutropenia & anaemia w/ zidovudine. Enhanced toxicity w/ drugs known to be myelosuppressive or associated w/ renal impairment eg, nucleoside (eg, zidovudine, didanosine, stavudine) & nucleotide analogues (eg, tenofovir, adefovir), immunosuppressants (eg, ciclosporin, tacrolimus, mycophenolate mofetil), antineoplastic agents (eg, doxorubicin, vinblastine, vincristine, hydroxyurea) & anti-infective agents (trimethoprim/sulphonamides, dapsone, amphotericin B, flucytosine, pentamidine).

Antivirals

J05AB14 - valganciclovir ; Belongs to the class of nucleosides and nucleotides excluding reverse transcriptase inhibitors. Used in the systemic treatment of viral infections.

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