Ganciclovir

Recommended Dosage for Treatment of CMV Retinitis in Adult Patients with Normal Renal Function Induction Dosage: The recommended initial dosage of Ganciclovir Injection for patients with normal renal function is 5 mg/kg (given intravenously at a constant rate over 1 hour) every 12 hours for 14 to 21 days. Maintenance Dosage: Following induction treatment, the recommended maintenance dosage of Ganciclovir Injection is 5 mg/kg (given intravenously at a constant rate over 1 hour) once daily for 7 days per week, or 6 mg/kg once daily for 5 days per week.

Recommended Dosage for the Prevention of CMV Disease in Adult Transplant Recipients with Normal Renal Function Induction Dosage: The recommended initial dosage of Ganciclovir Injection for patients with normal renal function is 5 mg/kg (given intravenously at a constant rate over 1 hour) every 12 hours for 7 to 14 days.

Maintenance Dosage: Following induction, the recommended maintenance dosage of Ganciclovir Injection is 5 mg/kg (given intravenously at a constant rate over 1 hour) once daily for 7 days per week, or 6 mg/kg once daily for 5 days per week until 100 to 120 days post-transplantation.

Recommended Dosage in Adult Patients with Renal Impairment For patients with impairment of renal function, refer to Table 1 for recommended doses of Ganciclovir Injection for induction and maintenance dosage for treatment of CMV retinitis and prevention of CMV disease in transplant recipients. Carefully monitor serum creatinine or creatinine clearance before and during treatment to allow for dosage adjustments in patients with impaired renal function. [See table below.] 0.625 3 times per week, following hemodialysis [See table below.] Patients Undergoing Hemodialysis Induction dosing for Ganciclovir Injection in patients undergoing hemodialysis should not exceed 1.25 mg/kg 3 times per week; and maintenance dosing should not exceed 0.625 mg/kg 3 times per week following each hemodialysis session.

Ganciclovir Injection should be given shortly after completion of the hemodialysis session, since hemodialysis has been shown to reduce plasma levels by approximately 50% [see Clinical Pharmacology] .

Hepatic Impairment The safety and efficacy of Ganciclovir Injection have not been studied in patients with hepatic impairment.

Important Dosing and Administration Information To avoid phlebitis/pain at the infusion site, Ganciclovir Injection must only be administered by intravenous infusion over 1 hour, preferably via plastic cannula, into a vein with adequate blood flow to permit rapid dilution and distribution. Do not administer Ganciclovir Injection by rapid or bolus intravenous injection which may increase toxicity as a result of excessive plasma levels.

The recommended dosage and infusion rate for Ganciclovir Injection should not be exceeded. Do not administer the reconstituted Ganciclovir Injection solution intramuscularly or subcutaneously because it may result in severe tissue irritation due to high pH [see Description]. Administration of Ganciclovir Injection should be accompanied by adequate hydration.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Preparation of Ganciclovir Injection Ganciclovir Injection solution must be diluted under the supervision of a healthcare provider and administered as intravenous infusion. Each 10 mL clear glass vial contains 543 mg ganciclovir sodium equivalent to 500 mg of ganciclovir. Wearing disposable gloves is recommended during reconstitution and when wiping the outer surface of the vial and the table after reconstitution.

The contents of the vial should be prepared for administration in the following manner: Sterile Solution of Ganciclovir Injection Instructions: a) Shake the vial b) Visually inspect the solution for particulate matter and discoloration prior to proceeding with infusion. Discard the vial if particulate matter or discoloration is observed.

Infusion Instructions: a) Based on patient weight, the appropriate volume of the solution (ganciclovir concentration 50 mg per mL) should be removed from the vial and added to an acceptable infusion fluid (typically 100 mL) for delivery over the course of 1 hour. Infusion concentrations greater than 10 mg per mL are not recommended.

The following infusion fluids have been determined to be chemically and physically compatible with Ganciclovir Injection: 0.9% Sodium Chloride, 5% Dextrose, Ringer's Injection and Lactated Ringer's Injection, USP. b) Ganciclovir Injection, when further diluted with 0.9% sodium chloride injection or other acceptable infusion fluid as specified above, should be used within 24 hours of dilution to reduce the risk of bacterial contamination.

The diluted infusion solution should be refrigerated (2° to 8°C (36° to 46°F)). Do not freeze.

Handling and Disposal Caution should be exercised in the handling and preparation of solutions of Ganciclovir Injection. Solutions of Ganciclovir Injection are alkaline (pH 11). Avoid direct contact of the skin or mucous membranes with Ganciclovir Injection solution. If such contact occurs, wash thoroughly with soap and water; rinse eyes thoroughly with plain water.

Wearing disposable gloves is recommended. Because ganciclovir shares some of the properties of antitumor agents (i.e., carcinogenicity and mutagenicity), consideration should be given to handling and disposal according to guidelines issued for antineoplastic drugs 1 . Discard any unused portion of the reconstituted solution [see How Supplied/Storage and Handling].