Cymevene Dosage/Direction for Use

General: Caution: Do not administer by rapid or bolus IV injection. The toxicity of Cymevene may be increased as a result of excessive plasma levels.
I.M. or S.C. injection may result in severe tissue irritation due to the high pH (~11) of ganciclovir solutions.
The recommended dosage, frequency, or infusion rates should not be exceeded. See Special Instructions for Use, Handling and Disposal under Cautions for Usage for details of preparation and handling of Cymevene solution.
Standard dosage for treatment of CMV retinitis: Induction treatment: 5 mg/kg given as an IV infusion over one hour, every 12 hours for 14-21 days in patients with normal renal function.
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.
Standard dosage for prevention in transplant recipients: Induction treatment: 5 mg/kg given as an IV infusion over one hour, every 12 hours for 7-14 days in patients with normal renal function.
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.
Special dosage instructions: Pediatric patients: 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: Pediatric Population under Actions).
Geriatric patients: No studies have been conducted in adults older than 65 years of age. Since renal clearance decreases with age, Cymevene should be administered to geriatric patients with special consideration of their renal status (see Table 1 and Pharmacology: Pharmacokinetics: Pharmacokinetics in Special Populations: Geriatric population under Actions).
Patients with renal impairment: For patients with renal impairment, the dose of Cymevene should be modified as shown in Table 1 as follows. (See Table 1.)

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Estimated creatinine clearance can be related to serum creatinine by the following formulae: (See formula.)

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