Valcyte

Treatment of cytomegalovirus (CMV) retinitis in adult patients w/ AIDS. Prevention of CMV disease in adult & ped solid organ transplant patients.

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

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

Hypersensitivity to valganciclovir or ganciclovir.

Patients w/ known hypersensitivity to acyclovir or penciclovir (or their prodrugs, valaciclovir or famciclovir, respectively); pre-existing hematological cytopenia or history of drug-related hematological cytopenia & patients receiving RT. Do not initiate therapy if ANC is <500 cells/microliter, or platelet count <25,000/microliter, or Hb <8 g/dL. Monitor CBC & platelet counts during therapy, particularly in patients w/ renal impairment, in neonates & infants. Patients w/ severe leukopenia, neutropenia, anemia &/or thrombocytopenia treatment w/ hematopoietic growth factors &/or interruption of therapy is recommended. Concomitant use w/ imipenem-cilastatin; zidovudine; didanosine; other myelosuppressive drugs or drugs associated w/ renal impairment. May affect tasks requiring alertness including patient's ability to drive & operate machinery. Not recommended in patients w/ CrCl <10 mL/min. Safety & efficacy have not been established in patients w/ hepatic impairment, in elderly ≥65 yr, & for treatment of CMV retinitis in ped patients. Potential teratogen & carcinogen. May cause temporary or permanent inhibition of spermatogenesis. Women of reproductive potential should use effective contraception during & for at least 30 days after treatment. Sexually active men should use condoms during & for at least 90 days after cessation of treatment, unless female partner is not at risk of becoming pregnant. Avoid in pregnant women unless benefit outweighs potential risk. Decision should be made to discontinue the drug or discontinue breastfeeding during therapy. Higher risk of hematological cytopenias in neonates & infants. Monitoring of liver function abnormalities, renal function & GI fluid loss is recommended in ped patients.

Candida infections including oral candidiasis, URTI; neutropenia, anemia; decreased appetite; headache; cough, dyspnea; diarrhea, 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, seizures, dysgeusia; visual impairment, retinal detachment, vitreous floaters, eye pain, conjunctivitis, macular edema; ear pain; hypotension; dyspepsia, flatulence, upper abdominal pain, constipation, mouth ulceration, dysphagia, abdominal distention, pancreatitis; increased blood alkaline phosphatase, abnormal hepatic function, increased AST & ALT; night sweats, pruritus, rash, alopecia; back pain, myalgia, arthralgia, muscle spasms; renal impairment, decreased renal CrCl, increased blood creatinine; pain, chills, malaise, asthenia.

Reports of seizures w/ imipenem-cilastatin. Enhanced toxicity w/ drugs known to be myelosuppressive or associated w/ renal impairment eg, nucleoside analogues (eg, zidovudine, didanosine, stavudine), immunosuppressants (eg, ciclosporin, tacrolimus, mycophenolate mofetil), antineoplastic agents (eg, doxorubicin, vinblastine, vincristine, hydroxyurea) & anti-infective agents (trimethoprim/sulphonamides, dapsone, amphotericin B, flucytosine, pentamidine). May potentially cause neutropenia & anemia w/ zidovudine. Increased plasma conc of didanosine. Decreased renal clearance w/ probenecid.

Antivirals

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

Rx