Ganciclovir

GANCICLOVIR- ganciclovir sodium injection, powder, lyophilized, for solution
Slate Run Pharmaceuticals, LLC

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 [see Warnings and Precautions (5.1)] .
  • Impairment of Fertility: Based on animal data and limited human data, Ganciclovir for Injection, USP 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 for Injection, USP has the potential to cause birth defects in humans [see Warnings and Precautions (5.4)] .
  • Mutagenesis and Carcinogenesis: Based on animal data, Ganciclovir for Injection, USP 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 for Injection, USP 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 for Injection, USP 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 for 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 for 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 for injection should not be exceeded.
  • Do not administer the reconstituted ganciclovir for injection solution intramuscularly or subcutaneously because it may result in severe tissue irritation due to high pH [see Description 11].
  • Administration of ganciclovir for 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 for 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 for 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 for injection 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 for 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 for 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 for 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 for 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 for injection for induction and maintenance dosage for treatment of CMV retinitis and prevention of CMV disease in 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 in Adult Patients with Renal Impairment
*
Creatinine clearance can be related to serum creatinine by the formulas given below. Creatinine clearance for males = (140-age[yrs])(body wt[kg])/(72)(serum creatine [mg/dL]) Creatinine clearance for females = 0.85 × male value

Creatinine Clearance * (mL/min)

Ganciclovir for Injection Induction Dose (mg/kg)

Dosing Interval (hours) for Induction

Ganciclovir for Injection Maintenance Dose (mg/kg)

Dosing Interval (hours) for Maintenance

Greater than or equal to 70

5

12

5

24

50-69

2.5

12

2.5

24

25-49

2.5

24

1.25

24

10-24

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

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.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2022. All Rights Reserved.