Cymevene Dosage/Direction for Use

General: 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: 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 Cymevene. (See Special Instructions for Use, Handling and Disposal under Cautions for Usage.)
The recommended dosage, frequency, or infusion rates should not be exceeded.
Standard dosage for treatment of CMV disease: Dosage for patients with normal renal function: Induction treatment: 5 mg/kg given as an IV infusion over one hour, every 12 hours for 14-21 days.
Maintenance treatment: For immunocompromised patients at risk of relapse maintenance therapy may be given. 5 mg/kg given as an IV infusion over one hour, once daily on 7 days per week or 6 mg/kg once daily on 5 days per week.
The duration of maintenance treatment should be determined on an individual basis.
Treatment of disease progression: Any patient, in whom CMV disease progresses, either while on maintenance treatment or because treatment with Cymevene has been withdrawn, may be re-treated using the induction treatment regimen.
Standard dosage for prevention of CMV disease using prophylaxis or pre-emptive therapy: Dosage for patients with normal renal function: Prophylaxis: 5 mg/kg given as an IV infusion over one hour, once daily on 7 days per week or 6 mg/kg once daily on 5 days per week.
The duration of prophylaxis is based on the risk of CMV disease and should be determined on an individual basis.
Pre-emptive therapy: Induction treatment: 5 mg/kg given as an IV infusion over one hour, every 12 hours for 7 - 14 days.
Maintenance treatment: 5 mg/kg given as an IV infusion over one hour, once daily on 7 days per week or 6 mg/kg once daily on 5 days per week.
The duration of maintenance treatment is based on the risk of CMV disease and should be determined on an individual basis.
Special dosage instructions: Children: Safety and efficacy of ganciclovir in pediatrics have not been established, including use for the treatment of congenital or neonatal CMV infections. The use of Cymevene in children warrants extreme caution due to the potential for long-term carcinogenicity and reproductive toxicity. The benefits of treatment should outweigh the risks (see Pharmacology: Pharmacokinetics: Pharmacokinetics in Special Populations: Children under Actions).
Elderly: No studies have been conducted in adults older than 65 years of age. Since renal clearance decreases with age, Cymevene should be administered to elderly patients with special consideration of their renal status (see Table 1 and Pharmacology: Pharmacokinetics: Pharmacokinetics in Special Populations: Elderly under Actions).
Renal impairment: For patients with renal impairment, the dose of Cymevene should be modified as shown in the table as follows. (See Table 1.)

Click on icon to see table/diagram/image

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

Click on icon to see table/diagram/image

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 Cymevene have not been studied in patients with hepatic impairment (see Pharmacology: Pharmacokinetics: Pharmacokinetics in Special Populations: Hepatic impairment under Actions).