Adult Dosing

CMV retinitis in AIDS patients

• Induction treatment: 5 mg/kg IV administer over 1 hr qwk x 2 wks
• Maintenance Treatment: 5 mg/kg IV administer over 1 hr q2 wks

Note:

• Do not administer as intraocular injection
• Dilute in 100 mL 0.9% normal saline prior to administration
• Administer probenecid (2 gm PO 3 hr before dose and 1 gm PO at 2 hr and 8 hr after dose for total of 4 gm) and prehydrate with intravenous saline with each cidofovir infusion to minimize the potential neprotoxicity

Pediatric Dosing

• Safety and effectiveness in pediatric patients have not been established

[Outline]

• Adult Dosing
• Pediatric Dosing

• Treatment of CMV retinitis in AIDS patients

• Hypersensitivity to any of the ingredients of the product
• Hypersensitivity to probenecid or sulfa containing products
• Serum creatinine >1.5 mg/dL, or creatinine clearance 55 mL/min, or a urine protein 100 mg/dL
• Concomitant use of nephrotoxic agent within 7 days of therapy
• Intraocular injection of cidofovir

• Acute renal impairment resulting in dialysis and/or death has occurred with as few as 1-2 dose of cidofovir.
• Administer probenecid and rehydrate with intravenous normal saline with each cidofovir infusion, to minimize the possible risk of nephrotoxicity.
• Monitor renal function within 48 hrs prior to each dose of cidofovir and modify the dose for the changes in renal function as appropriate.
• Cidofovir is contraindicated in patients who are receiving other nephrotoxic agent
• Neutropenia has been reported with cidofovir treatment, hence monitor neutrophil count during the therapy
• Cidofovir is indicated only for the treatment of CMV retinitis in AIDS patients
• Cidofovir was carcinogenic, teratogenic and caused hyposermia in animal studies

Renal Dose Adjustment (Based on Serum creatinine)

During therapy

• For creatinine 0.3-0.4 mg/dL above baseline: Reduce to 3 mg/kg
• 0.5 mg/dL above baseline: Discontinue the treatment

Preexisting Renal Impairment

• >1.5 mg/dL or CrCl 55 mL/min: Contraindicated

Hepatic Dose Adjustment

• Hepatic impairment: Dose adjustments not defined

• Dose-dependent nephrotoxicity is the major dose-limiting toxicity related to cidofovir administration [US Black Box Warning]
• Proteinuria is an early sign of cidofovir related neporotoxicity, if administration of cidofovir is continued it can lead to additional proximal tubular cell injury resulting in glycosuria, decreases in serum phosphate, uric acid, and bicarbonate, elevations in serum creatinine, and/or acute renal failure
• Initiation of cidofovir therapy is contraindicated in patients with a baseline serum creatinine >1.5 mg/dL, a creatinine clearance 55 mL/min, or a urine protein 100 mg/dL (equivalent to 2+ proteinuria)
• Cidofovir therapy can cause neutropenia, monitor neutrophil count during the therapy [US Black Box Warning]
• Decreased intraocular pressure sometime associated with decreased visual acuity has been reported during cidofovir therapy. Monitor intraocular pressure during cidofovir therapy
• Metabolic acidosis in association with liver dysfunction and pancreatitis resulting in death have been reported in patients receiving cidofovir
• Decreased serum bicarbonate associated with proximal tubule injury and renal wasting syndrome (including Fanconi's syndrome) have been observed in patient receiving cidofovir
• Do not administer greater than the recommended dose and do not exceed the frequency or rate of administration

Cautions: Use cautiously in

• Diabetes mellitus
• Risk of dehydration

Pregnancy Category:C

Breastfeeding: Safety unknown; It is unknown whether cidofovir is excreted in human milk, but as many drugs are excreted in human milk and because of the potential for adverse reactions as well as the potential for tumorigenicity shown for cidofovir in animal studies, manufacturer recommends not administering the nursing mothers. The U.S. Public Health Service Centers for Disease Control and Prevention advises HIV-infected women not to breast-feed to avoid postnatal transmission of HIV to a child who may not yet be infected.

• CNS: Headache
• GI: Nausea, vomiting, diarrhea, anorexia, oral moniliasis, oral candidiasis, pancreatitis, liver dysfunction
• NEURO: Asthenia, headache
• GU: Nephrotoxicity, proteinuria, creatinine elevation, Fanconi's syndrome
• HEMA: Neutropenia, anemia
• RESP: Pneumonia, dyspnea, increased cough
• METABOLIC: Metabolic acidosis, decreased serum bicarbonate
• EENT: Decreased intraocular pressure, ocular hypotony, iritis, uveitis
• DERM: Rash, alopecia
• MISC: Fever, infection, pain, chills

• Antiviral agent; suppress CMV replication by selective inhibition of viral DNA synthesis
• Metabolism: Unknown
• Renally excreted (70-85% unchanged)
• Half-life: 2.4-3.2 hrs

US Trade Name(s)

• Vistide

US Availability

cidofovir (generic)

• INJ: 75 mg/mL

Vistide

• INJ: 75 mg/mL (5 mL vial)

Canadian Trade Name(s)

• N/A

Canadian Availability

• N/A

UK Trade Name(s)

• Vistide

UK Availability

Vistide

• INJ: 75 mg/mL (5 mL vial)

Australian Trade Name(s)

• Vistide

Australian Availability

Vistide

• INJ: 75 mg/mL (5 mL vial)

[Outline]

Antimicrobials

Antiviral Agents

Anti-Herpetics/Anti-CMV Agents

Infectious Disease

Antiviral Agents

Anti-Herpetics/Anti-CMV Agents

Pricing data from www.DrugStore.com in U.S.A.

• Vistide 75 MG/ML SOLN [Vial] (GILEAD SCIENCES)
  5 ml = $855.94
  15 ml = $2397.6

Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.