Ganciclovir

GANCICLOVIR- ganciclovir sodium injection, solution
Sagent Pharmaceuticals

WARNING: HEMATOLOGIC TOXICITY, IMPAIRMENT OF FERTILITY, FETAL TOXICITY, MUTAGENESIS AND CARCINOGENESIS

  • Hematologic Toxicity: Granulocytopenia, anemia, thrombocytopenia, and pancytopenia have been reported in patients treated with Ganciclovir Injection [see Warnings and Precautions (5.1)].
  • Impairment of Fertility: Based on animal data and limited human data, Ganciclovir Injection may cause temporary or permanent inhibition of spermatogenesis in males and suppression of fertility in females [see Warnings and Precautions (5.3)].
  • Fetal Toxicity: Based on animal data, Ganciclovir Injection has the potential to cause birth defects in humans [see Warnings and Precautions (5.4)].
  • Mutagenesis and Carcinogenesis: Based on animal data, Ganciclovir Injection has the potential to cause cancers in humans [see Warnings and Precautions (5.5)].

1 INDICATIONS AND USAGE

1.1 Treatment of CMV Retinitis

Ganciclovir Injection is indicated for the treatment of cytomegalovirus (CMV) retinitis in immunocompromised adult patients, including patients with acquired immunodeficiency syndrome (AIDS) [see Clinical Studies (14.1)].

1.2 Prevention of CMV Disease in Transplant Recipients

Ganciclovir Injection is indicated for the prevention of CMV disease in adult transplant recipients at risk for CMV disease [see Clinical Studies (14.2)].

2 DOSAGE AND ADMINISTRATION

2.1 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 (11)].
  • 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.

2.2 Testing Before and During Treatment

  • Females of reproductive potential should undergo pregnancy testing before initiation of treatment with Ganciclovir Injection [see Warnings and Precautions (5.4), Use in Specific Populations (8.1, 8.3)].
  • Complete blood counts with differential and platelet counts should be performed frequently, especially in patients in whom Ganciclovir Injection or other nucleoside analogues have previously resulted in cytopenias, or in whom absolute neutrophil counts are less than 1000 cells/mcL at the beginning of treatment [see Warnings and Precautions (5.1)].
  • All patients should be monitored for renal function before and during treatment with Ganciclovir Injection and dose should be adjusted as needed [see Dosage and Administration (2.5), Warnings and Precautions (5.2)].
  • Patients with CMV retinitis should have frequent ophthalmological examinations during treatment with Ganciclovir Injection solution to monitor disease status and for other retinal abnormalities [see Adverse Reactions (6.1)].

2.3 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.

2.4 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.

2.5 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.

Table 1. Recommended Induction and Maintenance Dosage for Adult Patients with Renal Impairment

* Creatinine clearance can be related to serum creatinine by the formulas given below.

Creatinine Clearance* (mL/min) Ganciclovir Injection InductionDose (mg/kg) Dosing Interval (hours) for Induction Ganciclovir Injection Maintenance Dose (mg/kg) Dosing Interval (hours) for Maintenance
Greater than or equal to 70 5 12 5 24
50 to 69 2.5 12 2.5 24
25 to 49 2.5 24 1.25 24
10 to 24 1.25 24 0.625 24
Less than 10 1.25 3 times per week, following hemodialysis 0.625 3 times per week, following hemodialysis
Creatinine clearance for males = (140 — age [yrs]) (body wt [kg])
(72) (serum creatinine [mg/dL])
Creatinine clearance for females = 0.85 x male value

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 (12.3)].

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