Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
ADVERSE REACTIONS Nephrotoxicity: Renal toxicity, as manifested by ≥2+ proteinuria, serum creatinine elevations of ≥0.4 mg/dL, or decreased creatinine clearance ≤55 mL/min, occurred in 79 of 135 (59%) patients receiving cidofovir injection at a maintenance dose of 5 mg/kg every other week.
Maintenance dose reductions from 5 mg/kg to 3 mg/kg due to proteinuria or serum creatinine elevations were made in 12 of 41 (29%) patients who had not received prior therapy for CMV retinitis (Study 106) and in 19 of 74 (26%) patients who had received prior therapy for CMV retinitis (Study 107).
Prior foscarnet use has been associated with an increased risk of nephrotoxicity;
therefore, such patients must be monitored closely (see CONTRAINDICATIONS , WARNINGS , DOSAGE AND ADMINISTRATION ).
Neutropenia: In clinical trials, at the 5 mg/kg maintenance dose, a decrease in absolute neutrophil count to ≤500 cells/mm 3 occurred in 24% of patients.
Granulocyte colony stimulating factor (GCSF) was used in 39% of patients.
Decreased Intraocular Pressure/Ocular Hypotony : Among the subset of patients monitored for intraocular pressure changes, a ≥50% decrease from baseline intraocular pressure was reported in 17 of 70 (24%) patients at the 5 mg/kg maintenance dose.
Severe hypotony (intraocular pressure of 0 to 1 mm Hg) has been reported in 3 patients.
Risk of ocular hypotony may be increased in patients with preexisting diabetes mellitus.
Anterior Uveitis/Iritis: Uveitis or iritis has been reported in clinical trials and during postmarketing in patients receiving cidofovir injection therapy.
WARNINGS Nephrotoxicity Dose-dependent nephrotoxicity is the major dose-limiting toxicity related to cidofovir injection administration.
Cases of acute renal failure resulting in dialysis and/or contributing to death have occurred with as few as one or two doses of cidofovir injection.
Renal function (serum creatinine and urine protein) must be monitored within 48 hours prior to each dose of cidofovir injection.
Dose adjustment or discontinuation is required for changes in renal function (serum creatinine and/or urine protein) while on therapy.
Proteinuria, as measured by urinalysis in a clinical laboratory, may be an early indicator of cidofovir injection -related nephrotoxicity.
Like all medications, Cidofovir Dihydrate can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: