Cymevene Dosage/Direction for Use

General: Ganciclovir (Cymevene) must be reconstituted and diluted under the supervision of a healthcare professional and administered as an intravenous infusion (see Special Instructions for Use, Handling and Disposal under Cautions for Usage).
Caution: Ganciclovir (Cymevene) must only be administered by IV infusion over 1 hour, preferably via a plastic cannula, into a vein with adequate blood flow (intramuscular or subcutaneous injection may result in severe tissue irritation due to the high pH (~11) of ganciclovir solutions). Do not administer by rapid or bolus IV injection because the resulting excessive plasma levels may increase the toxicity of Ganciclovir (Cymevene) (see Special Instructions for Use, Handling and Disposal under Cautions for Usage).
The recommended dosage, frequency, or infusion rates should not be exceeded. (See Table 3.)

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Special Dosage Instructions: Pediatric patients: The once daily dose in mg for prevention of CMV disease using universal prophylaxis in patients from birth to 16 years of age is: 3 x BSA x CrCLS*.
The dose is based on body surface area (BSA) using the Mosteller BSA formula and creatinine clearance derived from Schwartz formula (CrCLS), and is calculated using the equations as follows. The duration of universal prophylaxis is based on the risk of CMV disease and should be determined on an individual basis.
*If the calculated Schwartz creatinine clearance exceeds 150 mL/min/1.73m², then a maximum value of 150 mL/min/1.73m² should be used in the equation: See Equation 1.

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where k = 0.33 for patients <1 year of age with low birth weight, 0.45 for patients aged <2 years, 0.55 for boys aged 2 to <13 years and girls aged 2 to 16 years, and 0.7 for boys aged 13 to 16 years.
The k values provided are based on the Jaffe method of measuring serum creatinine, and may require correction when enzymatic methods are used.
It is recommended that serum creatinine levels, height and weight are reviewed regularly and the dose amended as appropriate during prophylaxis.
There is limited data on treatment and pre-emptive therapy in children under 12 years of age. Therefore, a dose recommendation is not provided.
Geriatric patients: No studies have been conducted in adults older than 65 years of age. Since renal clearance decreases with age, Ganciclovir (Cymevene) should be administered to geriatric patients with special consideration of their renal status (see Table 3 and Pharmacology: Pharmacokinetics: Pharmacokinetics in Special Populations: Geriatric population under Actions).
Patients with renal impairment: Pediatric patients with renal impairment receiving a dose of Ganciclovir (Cymevene) for universal prophylaxis, calculated using the 3 x BSA x CrCLS dosing algorithm, do not require further dose modification because this dose is already adjusted for creatinine clearance.
For patients ≥12 years with renal impairment, treated on a mg/kg body weight base for pre-emptive therapy and treatment of CMV disease the mg/kg dose of Ganciclovir (Cymevene) should be modified as shown in the table as follows. (See Table 4.)

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Estimated creatinine clearance can be related to serum creatinine by the following formulae: See Equation 2.

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As dosage modifications are recommended in patients with renal impairment, serum creatinine or estimated creatinine-clearance levels should be monitored carefully.
Hepatic impairment: The safety and efficacy of Ganciclovir (Cymevene) have not been studied in patients with hepatic impairment (see Pharmacology: Pharmacokinetics: Pharmacokinetics in Special Populations: Hepatic impairment under Actions).
Route of Administration: Intravenous (IV) infusion.