GANCICLOVIR- ganciclovir injection, solution
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- Hematologic Toxicity: Granulocytopenia, anemia, thrombocytopenia, and pancytopenia have been reported in patients treated with ganciclovir [see Warnings and Precautions (5.1)].
- Impairment of Fertility: Based on animal 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 cancer in humans [see Warnings and Precautions (5.5)].
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)].
- 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.
- Administration of GANCICLOVIR INJECTION should be accompanied by adequate hydration.
- GANCICLOVIR INJECTION should only be infused into veins with adequate blood flow to permit rapid dilution and distribution.
- Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
- Females of reproductive potential should undergo pregnancy testing before initiation of 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 or other nucleoside analogues have previously resulted in cytopenias, or in whom absolute neutrophil counts are less than 1000 cells/μL 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 dosage 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 to monitor disease status and for other retinal abnormalities [see Adverse Reactions (6.1)].
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 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 INJECTIONS 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.
For patients with renal impairment, 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 patients. Monitor serum creatinine or creatinine clearance during treatment to allow for dosage adjustments in patients with impaired renal function.
|CreatinineClearance*(mL/min)||GANCICLOVIRINJECTIONInductionDose (mg/kg)||DosingInterval(hours) for Induction||GANCICLOVIRINJECTIONMaintenanceDose (mg/kg)||DosingInterval(hours) for Maintenance|
|Greater than or equal to 70||5||12||5||24|
|Less than 10||1.25||3 times per week,followinghemodialysis||0.625||3 times per week,followinghemodialysis|
* Creatinine clearance can be related to serum creatinine by the formulas given below:
Dosing for patients undergoing hemodialysis should not exceed 1.25 mg per 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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