Valcyte Tablets / Film-coated

Valcyte Tablets / Film-coated is used for: Cytomegalovirus infections

Oral Cytomegaloviral retinitis in AIDS patients Adult: Induction: 900 mg bid for 21 days. Maintenance: 900 mg once daily. May repeat induction if retinitis deteriorates during maintenance but the possibility of viral resistance should be considered. Prophylaxis of cytomegaloviral infections in immunocompromised patients Adult: 900 mg once daily starting w/in 10 days and continuing until 100 days after transplantation, may continue until 200 days for kidney transplant. CMV Prevention in Solid Organ Transplant Indicated for the prevention of CMV disease in kidney, heart, and kidney-pancreas transplant patients at high risk (donor CMV seropositive/recipient CMV seronegative [D+/R-]) Kidney transplantation 900 mg PO qDay Begin within 10 days of transplant until 200 days post-transplant Kidney-pancreas transplantation 900 mg PO qDay Begin within 10 days of transplant until 100 days posttransplant Heart transplantation 900 mg PO qDay Begin within 10 days of transplant until 100 days posttransplant

CMV Prevention in Kidney & Heart Transplant Kidney transplantation <4 months: Safety and efficacy not established 4 months to16 years: Daily dose (mg) = 7 x BSA x CrCl; not to exceed 900 mg/day Begin within 10 days of transplant and continue until 200 days post-transplant Heart transplantation <1 month: Safety and efficacy not established 1 month to16 years: Daily dose (mg) = 7 x BSA x CrCl; not to exceed 900 mg/day Begin within 10 days of transplant and continue until 100 days post-transplant

Renal Impairment CrCl Dosage <10 and haemodialysis patients Not recommended. 10-24 450 mg every 2 days (or 225 mg once daily) for induction; 450 mg twice wkly (or 125 mg once daily) for maintenance. 25-39 450 mg once daily for induction; 450 mg every 2 days (or 225 mg once daily) for maintenance. 40-59 450 mg bid for induction; 450 mg once daily for maintenance. >60 900 mg bid for induction; 900 mg once daily for maintenance.

Should be taken with food. Take during or immediately after meals.

Hypersensitivity. Haemodialysis patients (CrCl <10 mL/min). Lactation. Should not be administered if the absolute neutrophil count is <500 cells/μL, platelet count is <25,000/μL, or Hb is <8 g/dL.

Patient w/ pre-existing haematological cytopenia, history of drug-related haematological cytopenia. Renal impairment. Pregnancy. Lactation: not known if distributed in breast milk; do not nurse

Pregnancy After oral administration, valganciclovir (prodrug) converts to ganciclovir (active drug) and, therefore, valganciclovir is expected to have reproductive toxicity Clinical considerations Most maternal CMV infections are asymptomatic or they may be associated with a self-limited mononucleosis-like syndrome; however, in immunocompromised patients (i.e., transplant patients or patients with AIDS) CMV infections may be symptomatic and may result in significant maternal morbidity and mortality; transmission of CMV to the fetus is a result of maternal viremia and transplacental infection; perinatal infection can also occur from exposure of the neonate to CMV shedding in the genital tract; approximately 10% of children with congenital CMV infection are symptomatic at birth; mortality in these infants is about 10% and approximately 50-90% of symptomatic surviving newborns experience significant morbidity, including mental retardation, sensorineural hearing loss, microcephaly, seizures, and other medical problems; risk of congenital CMV infection resulting from primary maternal CMV infection may be higher and of greater severity than that resulting from maternal reactivation of CMV infection Females of reproductive potential should undergo pregnancy testing before initiation of therapy Contraception Females: Because of mutagenic and teratogenic potential, females of reproductive potential should be advised to use effective contraception during treatment and for at least 30 days following treatment Males: Because of its mutagenic potential, males should be advised to use condoms during and for at least 90 days following, treatment Infertility Recommended doses may cause temporary or permanent female and male infertility Lactation No data available regarding presence of valganciclovir (prodrug) or ganciclovir (active drug) in human milk, effects on breastfed infant or on milk production; animal data indicate that ganciclovir is excreted in milk of lactating rats The Centers for Disease Control and Prevention recommend that HIV-infected mothers not breastfeed their infants to avoid risking postnatal transmission of HIV; advise nursing mothers that breastfeeding is not recommended during treatment because of potential for serious adverse events in nursing infants and because of potential for transmission of HIV

Convulsions may occur if taken concomitantly w/ imipenem-cilastatin. Increased exposure w/ probenecid. Increased risk of neutropenia and anaemia w/ zidovudine. May increase plasma concentrations of didanosine. Increased risk of neutropenia and leucopenia w/ mycophenolate mofetil. Increased risk of peripheral neuropathy w/ zalcitabine. Enhanced toxicity w/ other drugs that inhibit replication of rapidly dividing cells (e.g. dapsone, vincristine, vinblastine, amphotericin B, trimethoprim/sulfa combinations, nucleoside analogues, hydroxyurea), cidofovir, foscamet.

Side effects of Valganciclovir : >10% Abdominal pain (15%), Anemia (8-26%), Diarrhea (16-41%), Fever (31%), Granulocytopenia (11-27%), Headache (9-22%), Insomnia (16%), Nausea (8-30%), Retinal detachment (15%), Vomiting (21%) 1-10% Peripheral neuropathy (9%), Paresthesia (8%), Seizures (<5%), Psychosis, hallucinations (<5%), Confusion (<5%), Agitation (<5%), Thrombocytopenia (8%), Pancytopenia (<5%), Bone marrow depression (<5%), Aplastic anemia (<5%), Bleeding, potentially life-threatening due to thrombocytopenia (<5%), Decr renal function (<5%), , Local & systemic infections, incl sepsis (<5%), Allergic reaction (<5%)

Valganciclovir is an L-valyl ester (prodrug) of ganciclovir that exists as a mixture of 2 diastereomers. After oral admin, both diastereomers are rapidly converted to ganciclovir by intestinal and hepatic esterases. Ganciclovir is a synthetic analogue of 2'-deoxyguanosine, which inhibits replication of human cytomegalovirus (CMV) in cell culture and in vivo.

Valcyte 450mg Tablets / Film-coated manufactured by F. Hoffmann-La Roche Ltd.. Its generic name is Valganciclovir. Valcyte is availble in United Arab Emirates. Farmaco UAE drug index information on Valcyte Tablets / Film-coated is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.