CYTOVENE IV- ganciclovir sodium injection, powder, lyophilized, for solution
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 CYTOVENE-IV [see Warnings and Precautions (5.1)].
- Impairment of Fertility: Based on animal data and limited human data, CYTOVENE-IV 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, CYTOVENE-IV has the potential to cause birth defects in humans [see Warnings and Precautions (5.4)].
- Mutagenesis and Carcinogenesis: Based on animal data, CYTOVENE-IV has the potential to cause cancers in humans [see Warnings and Precautions (5.5)].
CYTOVENE-IV 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)].
CYTOVENE-IV is indicated for the prevention of CMV disease in adult transplant recipients at risk for CMV disease [see Clinical Studies (14.2)].
- To avoid phlebitis/pain at the infusion site, CYTOVENE-IV 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 CYTOVENE-IV by rapid or bolus intravenous injection which may increase toxicity as a result of excessive plasma levels.
- The recommended dosage and infusion rate for CYTOVENE-IV should not be exceeded.
- Do not administer the reconstituted CYTOVENE-IV solution intramuscularly or subcutaneously because it may result in severe tissue irritation due to high pH [see Description 11].
- Administration of CYTOVENE-IV 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.
- Females of reproductive potential should undergo pregnancy testing before initiation of treatment with CYTOVENE-IV [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 CYTOVENE-IV 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 CYTOVENE-IV 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 CYTOVENE-IV solution to monitor disease status and for other retinal abnormalities [see Adverse Reactions (6.1)].
Induction Dosage: The recommended initial dosage of CYTOVENE-IV 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 CYTOVENE-IV 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 CYTOVENE-IV 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 CYTOVENE-IV 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 impairment of renal function, refer to Table 1 for recommended doses of CYTOVENE-IV 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.
|Creatinine Clearance *(mL/min)||CYTOVENE-IVInduction Dose (mg/kg)||Dosing Interval (hours) for Induction||CYTOVENE-IVMaintenance Dose (mg/kg)||Dosing Interval (hours) for Maintenance|
|Greater than or equal to 70||5||12||5||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 × male value
Patients Undergoing Hemodialysis
Induction dosing for CYTOVENE-IV 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. CYTOVENE-IV 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)].
All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.