BOXED WARNING Renal impairment is the major toxicity — monitor serum creatinine frequently, adjust dose, hydrate. Seizures from mineral/electrolyte changes — monitor. Indicated ONLY in immunocompromised patients (CMV retinitis, acyclovir-resistant HSV).
FDA dosing
Population
Start
Target
Max
CMV retinitis — induction
Immunocompromised adults, normal renal function
90 mg/kg IV Q12H (1.5-2 h infusion) or 60 mg/kg IV Q8H (>=1 h infusion) x 2-3 wk
2-3 wk induction per clinical response
180 mg/kg/day; individualize for renal function
CMV retinitis — maintenance
Immunocompromised adults
90 mg/kg IV QD over 2 h
90-120 mg/kg IV QD (escalate to 120 for retinitis progression/good tolerance)
120 mg/kg/day
Acyclovir-resistant mucocutaneous HSV
Immunocompromised adults, normal renal function
40 mg/kg IV Q8H or Q12H (>=1 h infusion)
2-3 wk or until healed
120 mg/kg/day
Renal Dose-adjust per CrCl (mL/min/kg) nomogram — required even with normal serum creatinine; discontinue if CrCl <0.4 mL/min/kg; not recommended on hemodialysis (no guidelines)
Hepatic Undefined
Do not exceed recommended dose, frequency, or infusion rate; all doses individualized for renal function
Instructions
NEVER rapid or bolus IV — infusion pump required; max rate 1 mg/kg/min
Central line: 24 mg/mL undiluted; peripheral vein: dilute to 12 mg/mL with D5W or NS; use within 24 h
Hydrate: 750-1,000 mL NS/D5W before first infusion; then 750-1,000 mL with each 90-120 mg/kg dose, 500 mL with 40-60 mg/kg dose
Administer only with NS or D5W; no other drug in same catheter; incompatible with calcium-containing solutions (LR, TPN), ganciclovir, many IV drugs
Monitor CrCl at baseline, 2-3x/wk during induction, weekly during maintenance; monitor Ca, Mg, K, phosphate on same schedule
Cautions
Nephrotoxicity — most patients have some renal function decline; hydration reduces risk
Seizures assoc. with electrolyte/mineral changes (esp. hypocalcemia); caution in low baseline Ca, neurologic/cardiac disease, seizure-predisposing conditions
Electrolyte disturbances: hypocalcemia, hypomagnesemia, hypokalemia, hypo-/hyperphosphatemia — supplement as needed
Limited data if baseline SCr >2.8 mg/dL or CrCl <50 mL/min
Accidental skin/eye contact: flush with water (local irritation/burning)