Ganciclovir

Ganciclovir Manufacturers

• App Pharmaceuticals, Llc
  

  ×

  Ganciclovir | App Pharmaceuticals, Llc

  

  ---

  CAUTION – DO NOT ADMINISTER GANCICLOVIR FOR INJECTION, USP SOLUTION BY RAPID OR BOLUS INTRAVENOUS INJECTION.  THE TOXICITY OF GANCICLOVIR FOR INJECTION, USP MAY BE INCREASED AS A RESULT OF EXCESSIVE PLASMA LEVELS.

  CAUTION – INTRAMUSCULAR OR SUBCUTANEOUS INJECTION OF RECONSTITUTED GANCICLOVIR FOR INJECTION, USP SOLUTION MAY RESULT IN SEVERE TISSUE IRRITATION DUE TO HIGH pH (11).

  Dosage

  THE RECOMMENDED DOSE FOR GANCICLOVIR FOR INJECTION, USP SOLUTION SHOULD NOT BE EXCEEDED.  THE RECOMMENDED INFUSION RATE FOR GANCICLOVIR FOR INJECTION SOLUTION SHOULD NOT BE EXCEEDED.

  
  For Treatment of CMV Retinitis in Patients with Normal Renal Function
  

  Induction Treatment

  The recommended initial dosage 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 Treatment

  Following induction treatment, the recommended maintenance dosage of ganciclovir for injection solution is 5 mg/kg given as a constant-rate intravenous infusion over 1 hour once daily, 7 days per week or 6 mg/kg once daily, 5 days per week.

  For patients who experience progression of CMV retinitis while receiving maintenance treatment with either formulation of ganciclovir, reinduction treatment is recommended.

  For the Prevention of CMV Disease in Transplant Recipients with Normal Renal Function
  

  The recommended initial dosage of ganciclovir for injection solution 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, followed by 5 mg/kg once daily, 7 days per week or 6 mg/kg once daily, 5 days per week.

  The duration of treatment with ganciclovir for injection solution and in transplant recipients is dependent upon the duration and degree of immunosuppression.  In controlled clinical trials in bone marrow allograft recipients, treatment with ganciclovir for injection was continued until day 100 to 120 posttransplantation.  CMV disease occurred in several patients who discontinued treatment with ganciclovir for injection solution prematurely.  In heart allograft recipients, the onset of newly diagnosed CMV disease occurred after treatment with ganciclovir for injection was stopped at day 28 posttransplant, suggesting that continued dosing may be necessary to prevent late occurrence of CMV disease in this patient population (see INDICATIONS AND USAGE section for a more detailed discussion).

  
  Renal Impairment
  

  For patients with impairment of renal function, refer to Table 8 for recommended doses of ganciclovir solution and adjust the dosing interval as indicated:

  Table 8  Dosing for Patients with Renal Impairment

  
  

  Creatinine
  

  Clearance*
  

  (mL/min)

  Ganciclovir for Injection
  

  Induction
  

  Dose (mg/kg)

  Dosing
  

  Interval
  

  (hours)

  Ganciclovir for Injection
  

  Maintenance
  

  Dose (mg/kg)

  Dosing
  

  Interval
  

  (hours)

  ≥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

  <10

  1.25

  3 times per week, following hemodialysis

  0.625

  3 times per week, following hemodialysis

  *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 creatinine [mg/dL])

  Creatinine clearance for females = 0.85 x male value

  Dosing for patients undergoing hemodialysis should not exceed 1.25 mg/kg 3 times per week, following each hemodialysis session.  Ganciclovir for injection should be given shortly after completion of the hemodialysis session, since hemodialysis has been shown to reduce plasma levels by approximately 50%.

  Patient Monitoring
  

  Due to the frequency of granulocytopenia, anemia and thrombocytopenia in patients receiving ganciclovir (see ADVERSE EVENTS), it is recommended that complete blood counts and platelet counts be performed frequently, especially in patients in whom ganciclovir or other nucleoside analogues have previously resulted in cytopenia, or in whom neutrophil counts are less than 1000 cells/mcL at the beginning of treatment.  Patients should have serum creatinine or creatinine clearance values followed carefully to allow for dosage adjustments in renally impaired patients (see DOSAGE AND ADMINISTRATION).

  Reduction of Dose
  

  Dosage reductions in renally impaired patients are required for ganciclovir for injection (see Renal Impairment).  Dosage reductions should also be considered for those with neutropenia, anemia and/or thrombocytopenia (see ADVERSE EVENTS).  Ganciclovir for injection should not be administered in patients with severe neutropenia (ANC less than 500/mcL) or severe thrombocytopenia (platelets less than 25,000/mcL).

  Method of Preparation of Ganciclovir for Injection Solution
  

  Each 10 mL clear glass vial contains ganciclovir sodium equivalent to 500 mg of ganciclovir and 46 mg of sodium.  The contents of the vial should be prepared for administration in the following manner:

      1.  Reconstituted Solution:

           a.  Reconstitute lyophilized ganciclovir for injection by injecting 10 mL of Sterile Water for Injection, USP into the vial.

                DO NOT USE BACTERIOSTATIC WATER FOR INJECTION

                CONTAINING PARABENS.  IT IS INCOMPATIBLE WITH

                GANCICLOVIR FOR INJECTION AND MAY CAUSE PRECIPITATION.

           b.  Shake the vial to dissolve the drug.

           c.  Visually inspect the reconstituted solution for particulate matter and discoloration prior to proceeding with infusion solution.  Discard the

                vial if particulate matter or discoloration is observed.

           d.  Reconstituted solution in the vial is stable at room temperature for 12 hours.  It should not be refrigerated. 

        2.  Infusion Solution:

           Based on patient weight, the appropriate volume of the reconstituted solution (ganciclovir concentration 50 mg/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/mL are not recommended.  The following infusion fluids have been determined to be chemically and physically compatible with

           ganciclovir for injection solution: 0.9% Sodium Chloride, 5% Dextrose, Ringer’s Injection and Lactated Ringer’s Injection, USP.

           Ganciclovir for injection, when reconstituted with sterile water for injection, further diluted with 0.9% sodium chloride injection, and stored

           refrigerated at 5°C in polyvinyl chloride (PVC) bags, remains physically and chemically stable for 14 days. 

            However, because ganciclovir for injection is reconstituted with non-bacteriostatic sterile water, it is recommended that the infusion solution be

            used within 24 hours of dilution to reduce the risk of bacterial contamination.  The infusion should be refrigerated.  Freezing is not

           recommended.

  Handling and Disposal
  

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

  Because ganciclovir shares some of the properties of anti-tumor agents (ie, carcinogenicity and mutagenicity), consideration should be given to handling and disposal according to guidelines issued for antineoplastic drugs.  Several guidelines on this subject have been published.7-9

  There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate.

  Dosage

  THE RECOMMENDED DOSE FOR GANCICLOVIR FOR INJECTION, USP SOLUTION SHOULD NOT BE EXCEEDED.  THE RECOMMENDED INFUSION RATE FOR GANCICLOVIR FOR INJECTION SOLUTION SHOULD NOT BE EXCEEDED.

  
  For Treatment of CMV Retinitis in Patients with Normal Renal Function
  

  Induction Treatment

  The recommended initial dosage 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 Treatment

  Following induction treatment, the recommended maintenance dosage of ganciclovir for injection solution is 5 mg/kg given as a constant-rate intravenous infusion over 1 hour once daily, 7 days per week or 6 mg/kg once daily, 5 days per week.

  For patients who experience progression of CMV retinitis while receiving maintenance treatment with either formulation of ganciclovir, reinduction treatment is recommended.

  For the Prevention of CMV Disease in Transplant Recipients with Normal Renal Function
  

  The recommended initial dosage of ganciclovir for injection solution 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, followed by 5 mg/kg once daily, 7 days per week or 6 mg/kg once daily, 5 days per week.

  The duration of treatment with ganciclovir for injection solution and in transplant recipients is dependent upon the duration and degree of immunosuppression.  In controlled clinical trials in bone marrow allograft recipients, treatment with ganciclovir for injection was continued until day 100 to 120 posttransplantation.  CMV disease occurred in several patients who discontinued treatment with ganciclovir for injection solution prematurely.  In heart allograft recipients, the onset of newly diagnosed CMV disease occurred after treatment with ganciclovir for injection was stopped at day 28 posttransplant, suggesting that continued dosing may be necessary to prevent late occurrence of CMV disease in this patient population (see INDICATIONS AND USAGE section for a more detailed discussion).

  
  Renal Impairment
  

  For patients with impairment of renal function, refer to Table 8 for recommended doses of ganciclovir solution and adjust the dosing interval as indicated:

  Table 8  Dosing for Patients with Renal Impairment

  
  

  Creatinine
  

  Clearance*
  

  (mL/min)

  Ganciclovir for Injection
  

  Induction
  

  Dose (mg/kg)

  Dosing
  

  Interval
  

  (hours)

  Ganciclovir for Injection
  

  Maintenance
  

  Dose (mg/kg)

  Dosing
  

  Interval
  

  (hours)

  ≥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

  <10

  1.25

  3 times per week, following hemodialysis

  0.625

  3 times per week, following hemodialysis

  *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 creatinine [mg/dL])

  Creatinine clearance for females = 0.85 x male value

  Dosing for patients undergoing hemodialysis should not exceed 1.25 mg/kg 3 times per week, following each hemodialysis session.  Ganciclovir for injection should be given shortly after completion of the hemodialysis session, since hemodialysis has been shown to reduce plasma levels by approximately 50%.

  Patient Monitoring
  

  Due to the frequency of granulocytopenia, anemia and thrombocytopenia in patients receiving ganciclovir (see ADVERSE EVENTS), it is recommended that complete blood counts and platelet counts be performed frequently, especially in patients in whom ganciclovir or other nucleoside analogues have previously resulted in cytopenia, or in whom neutrophil counts are less than 1000 cells/mcL at the beginning of treatment.  Patients should have serum creatinine or creatinine clearance values followed carefully to allow for dosage adjustments in renally impaired patients (see DOSAGE AND ADMINISTRATION).

  Reduction of Dose
  

  Dosage reductions in renally impaired patients are required for ganciclovir for injection (see Renal Impairment).  Dosage reductions should also be considered for those with neutropenia, anemia and/or thrombocytopenia (see ADVERSE EVENTS).  Ganciclovir for injection should not be administered in patients with severe neutropenia (ANC less than 500/mcL) or severe thrombocytopenia (platelets less than 25,000/mcL).

  Method of Preparation of Ganciclovir for Injection Solution
  

  Each 10 mL clear glass vial contains ganciclovir sodium equivalent to 500 mg of ganciclovir and 46 mg of sodium.  The contents of the vial should be prepared for administration in the following manner:

      1.  Reconstituted Solution:

           a.  Reconstitute lyophilized ganciclovir for injection by injecting 10 mL of Sterile Water for Injection, USP into the vial.

                DO NOT USE BACTERIOSTATIC WATER FOR INJECTION

                CONTAINING PARABENS.  IT IS INCOMPATIBLE WITH

                GANCICLOVIR FOR INJECTION AND MAY CAUSE PRECIPITATION.

           b.  Shake the vial to dissolve the drug.

           c.  Visually inspect the reconstituted solution for particulate matter and discoloration prior to proceeding with infusion solution.  Discard the

                vial if particulate matter or discoloration is observed.

           d.  Reconstituted solution in the vial is stable at room temperature for 12 hours.  It should not be refrigerated. 

        2.  Infusion Solution:

           Based on patient weight, the appropriate volume of the reconstituted solution (ganciclovir concentration 50 mg/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/mL are not recommended.  The following infusion fluids have been determined to be chemically and physically compatible with

           ganciclovir for injection solution: 0.9% Sodium Chloride, 5% Dextrose, Ringer’s Injection and Lactated Ringer’s Injection, USP.

           Ganciclovir for injection, when reconstituted with sterile water for injection, further diluted with 0.9% sodium chloride injection, and stored

           refrigerated at 5°C in polyvinyl chloride (PVC) bags, remains physically and chemically stable for 14 days. 

            However, because ganciclovir for injection is reconstituted with non-bacteriostatic sterile water, it is recommended that the infusion solution be

            used within 24 hours of dilution to reduce the risk of bacterial contamination.  The infusion should be refrigerated.  Freezing is not

           recommended.

  Handling and Disposal
  

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

  Because ganciclovir shares some of the properties of anti-tumor agents (ie, carcinogenicity and mutagenicity), consideration should be given to handling and disposal according to guidelines issued for antineoplastic drugs.  Several guidelines on this subject have been published.7-9

  There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate.

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• Fresenius Kabi Usa, Llc
  

  ×

  Ganciclovir | Fresenius Kabi Usa, Llc

  

  ---

  CAUTION – DO NOT ADMINISTER GANCICLOVIR FOR INJECTION, USP SOLUTION BY RAPID OR BOLUS INTRAVENOUS INJECTION. THE TOXICITY OF GANCICLOVIR FOR INJECTION, USP MAY BE INCREASED AS A RESULT OF EXCESSIVE PLASMA LEVELS.

  CAUTION – INTRAMUSCULAR OR SUBCUTANEOUS INJECTION OF RECONSTITUTED GANCICLOVIR FOR INJECTION, USP SOLUTION MAY RESULT IN SEVERE TISSUE IRRITATION DUE TO HIGH pH (11).

  Dosage

  THE RECOMMENDED DOSE FOR GANCICLOVIR FOR INJECTION, USP SOLUTION SHOULD NOT BE EXCEEDED.  THE RECOMMENDED INFUSION RATE FOR GANCICLOVIR FOR INJECTION SOLUTION SHOULD NOT BE EXCEEDED.

  
  For Treatment of CMV Retinitis in Patients with Normal Renal Function
  

  Induction Treatment

  The recommended initial dosage 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 Treatment

  Following induction treatment, the recommended maintenance dosage of ganciclovir for injection solution is 5 mg/kg given as a constant-rate intravenous infusion over 1 hour once daily, 7 days per week or 6 mg/kg once daily, 5 days per week.

  For patients who experience progression of CMV retinitis while receiving maintenance treatment with either formulation of ganciclovir, reinduction treatment is recommended.

  For the Prevention of CMV Disease in Transplant Recipients with Normal Renal Function
  

  The recommended initial dosage of ganciclovir for injection solution 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, followed by 5 mg/kg once daily, 7 days per week or 6 mg/kg once daily, 5 days per week.

  The duration of treatment with ganciclovir for injection solution and in transplant recipients is dependent upon the duration and degree of immunosuppression. In controlled clinical trials in bone marrow allograft recipients, treatment with ganciclovir for injection was continued until day 100 to 120 posttransplantation.  CMV disease occurred in several patients who discontinued treatment with ganciclovir for injection solution prematurely. In heart allograft recipients, the onset of newly diagnosed CMV disease occurred after treatment with ganciclovir for injection was stopped at day 28 posttransplant, suggesting that continued dosing may be necessary to prevent late occurrence of CMV disease in this patient population (see INDICATIONS AND USAGE section for a more detailed discussion).

  
  Renal Impairment
  

  For patients with impairment of renal function, refer to Table 8 for recommended doses of ganciclovir solution and adjust the dosing interval as indicated:

  Table 8  Dosing for Patients with Renal Impairment

  
  

  Creatinine
  

  Clearance*
  

  (mL/min)

  Ganciclovir for Injection
  

  Induction
  

  Dose (mg/kg)

  Dosing
  

  Interval
  

  (hours)

  Ganciclovir for Injection
  

  Maintenance
  

  Dose (mg/kg)

  Dosing
  

  Interval
  

  (hours)

  ≥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

  <10

  1.25

  3 times per week, following hemodialysis

  0.625

  3 times per week, following hemodialysis

  *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 creatinine [mg/dL])

  Creatinine clearance for females = 0.85 x male value

  Dosing for patients undergoing hemodialysis should not exceed 1.25 mg/kg 3 times per week, following each hemodialysis session. Ganciclovir for injection should be given shortly after completion of the hemodialysis session, since hemodialysis has been shown to reduce plasma levels by approximately 50%.

  Patient Monitoring
  

  Due to the frequency of granulocytopenia, anemia and thrombocytopenia in patients receiving ganciclovir (see ADVERSE EVENTS), it is recommended that complete blood counts and platelet counts be performed frequently, especially in patients in whom ganciclovir or other nucleoside analogues have previously resulted in cytopenia, or in whom neutrophil counts are less than 1,000 cells/mcL at the beginning of treatment.  Patients should have serum creatinine or creatinine clearance values followed carefully to allow for dosage adjustments in renally impaired patients (see DOSAGE AND ADMINISTRATION).

  Reduction of Dose
  

  Dosage reductions in renally impaired patients are required for ganciclovir for injection (see Renal Impairment).  Dosage reductions should also be considered for those with neutropenia, anemia and/or thrombocytopenia (see ADVERSE EVENTS). Ganciclovir for injection should not be administered in patients with severe neutropenia (ANC less than 500/mcL) or severe thrombocytopenia (platelets less than 25,000/mcL).

  Method of Preparation of Ganciclovir for Injection Solution
  

  Each 10 mL clear glass vial contains ganciclovir sodium equivalent to 500 mg of ganciclovir and 46 mg of sodium. The contents of the vial should be prepared for administration in the following manner:

  Reconstituted Solution:

            a.  Reconstitute lyophilized ganciclovir for injection by injecting 10 mL of Sterile Water for

                 Injection, USP into the vial.

                 DO NOT USE BACTERIOSTATIC WATER FOR INJECTION CONTAINING

                 PARABENS. IT IS INCOMPATIBLE WITH GANCICLOVIR FOR INJECTION AND MAY CAUSE PRECIPITATION.

             b.  Shake the vial to dissolve the drug.

             c.  Visually inspect the reconstituted solution for particulate matter and discoloration prior to proceeding with infusion solution. Discard the

                  vial if particulate matter or discoloration is observed.

             d.  Reconstituted solution in the vial is stable at room temperature for 12 hours.  It should not be refrigerated. 

       2.  Infusion Solution:

           Based on patient weight, the appropriate volume of the reconstituted solution (ganciclovir concentration 50 mg/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/mL are not recommended.  The following infusion fluids have been determined to be chemically and physically compatible with

           ganciclovir for injection solution: 0.9% Sodium Chloride, 5% Dextrose, Ringer’s Injection and Lactated Ringer’s Injection, USP.

                Ganciclovir for injection, when reconstituted with sterile water for injection, further diluted with 0.9% sodium chloride injection, and stored

           refrigerated at 5°C in polyvinyl chloride (PVC) bags, remains physically and chemically stable for 14 days.

                 However, because ganciclovir for injection is reconstituted with non-bacteriostatic sterile water, it is recommended that the infusion solution be

            used within 24 hours of dilution to reduce the risk of bacterial contamination. The infusion should be refrigerated. Freezing is not

           recommended.

  Handling and Disposal
  

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

  Because ganciclovir shares some of the properties of anti-tumor agents (ie, carcinogenicity and mutagenicity), consideration should be given to handling and disposal according to guidelines issued for antineoplastic drugs.  Several guidelines on this subject have been published.7-9

  There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate.

  Dosage

  THE RECOMMENDED DOSE FOR GANCICLOVIR FOR INJECTION, USP SOLUTION SHOULD NOT BE EXCEEDED.  THE RECOMMENDED INFUSION RATE FOR GANCICLOVIR FOR INJECTION SOLUTION SHOULD NOT BE EXCEEDED.

  
  For Treatment of CMV Retinitis in Patients with Normal Renal Function
  

  Induction Treatment

  The recommended initial dosage 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 Treatment

  Following induction treatment, the recommended maintenance dosage of ganciclovir for injection solution is 5 mg/kg given as a constant-rate intravenous infusion over 1 hour once daily, 7 days per week or 6 mg/kg once daily, 5 days per week.

  For patients who experience progression of CMV retinitis while receiving maintenance treatment with either formulation of ganciclovir, reinduction treatment is recommended.

  For the Prevention of CMV Disease in Transplant Recipients with Normal Renal Function
  

  The recommended initial dosage of ganciclovir for injection solution 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, followed by 5 mg/kg once daily, 7 days per week or 6 mg/kg once daily, 5 days per week.

  The duration of treatment with ganciclovir for injection solution and in transplant recipients is dependent upon the duration and degree of immunosuppression. In controlled clinical trials in bone marrow allograft recipients, treatment with ganciclovir for injection was continued until day 100 to 120 posttransplantation.  CMV disease occurred in several patients who discontinued treatment with ganciclovir for injection solution prematurely. In heart allograft recipients, the onset of newly diagnosed CMV disease occurred after treatment with ganciclovir for injection was stopped at day 28 posttransplant, suggesting that continued dosing may be necessary to prevent late occurrence of CMV disease in this patient population (see INDICATIONS AND USAGE section for a more detailed discussion).

  
  Renal Impairment
  

  For patients with impairment of renal function, refer to Table 8 for recommended doses of ganciclovir solution and adjust the dosing interval as indicated:

  Table 8  Dosing for Patients with Renal Impairment

  
  

  Creatinine
  

  Clearance*
  

  (mL/min)

  Ganciclovir for Injection
  

  Induction
  

  Dose (mg/kg)

  Dosing
  

  Interval
  

  (hours)

  Ganciclovir for Injection
  

  Maintenance
  

  Dose (mg/kg)

  Dosing
  

  Interval
  

  (hours)

  ≥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

  <10

  1.25

  3 times per week, following hemodialysis

  0.625

  3 times per week, following hemodialysis

  *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 creatinine [mg/dL])

  Creatinine clearance for females = 0.85 x male value

  Dosing for patients undergoing hemodialysis should not exceed 1.25 mg/kg 3 times per week, following each hemodialysis session. Ganciclovir for injection should be given shortly after completion of the hemodialysis session, since hemodialysis has been shown to reduce plasma levels by approximately 50%.

  Patient Monitoring
  

  Due to the frequency of granulocytopenia, anemia and thrombocytopenia in patients receiving ganciclovir (see ADVERSE EVENTS), it is recommended that complete blood counts and platelet counts be performed frequently, especially in patients in whom ganciclovir or other nucleoside analogues have previously resulted in cytopenia, or in whom neutrophil counts are less than 1,000 cells/mcL at the beginning of treatment.  Patients should have serum creatinine or creatinine clearance values followed carefully to allow for dosage adjustments in renally impaired patients (see DOSAGE AND ADMINISTRATION).

  Reduction of Dose
  

  Dosage reductions in renally impaired patients are required for ganciclovir for injection (see Renal Impairment).  Dosage reductions should also be considered for those with neutropenia, anemia and/or thrombocytopenia (see ADVERSE EVENTS). Ganciclovir for injection should not be administered in patients with severe neutropenia (ANC less than 500/mcL) or severe thrombocytopenia (platelets less than 25,000/mcL).

  Method of Preparation of Ganciclovir for Injection Solution
  

  Each 10 mL clear glass vial contains ganciclovir sodium equivalent to 500 mg of ganciclovir and 46 mg of sodium. The contents of the vial should be prepared for administration in the following manner:

  Reconstituted Solution:

            a.  Reconstitute lyophilized ganciclovir for injection by injecting 10 mL of Sterile Water for

                 Injection, USP into the vial.

                 DO NOT USE BACTERIOSTATIC WATER FOR INJECTION CONTAINING

                 PARABENS. IT IS INCOMPATIBLE WITH GANCICLOVIR FOR INJECTION AND MAY CAUSE PRECIPITATION.

             b.  Shake the vial to dissolve the drug.

             c.  Visually inspect the reconstituted solution for particulate matter and discoloration prior to proceeding with infusion solution. Discard the

                  vial if particulate matter or discoloration is observed.

             d.  Reconstituted solution in the vial is stable at room temperature for 12 hours.  It should not be refrigerated. 

       2.  Infusion Solution:

           Based on patient weight, the appropriate volume of the reconstituted solution (ganciclovir concentration 50 mg/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/mL are not recommended.  The following infusion fluids have been determined to be chemically and physically compatible with

           ganciclovir for injection solution: 0.9% Sodium Chloride, 5% Dextrose, Ringer’s Injection and Lactated Ringer’s Injection, USP.

                Ganciclovir for injection, when reconstituted with sterile water for injection, further diluted with 0.9% sodium chloride injection, and stored

           refrigerated at 5°C in polyvinyl chloride (PVC) bags, remains physically and chemically stable for 14 days.

                 However, because ganciclovir for injection is reconstituted with non-bacteriostatic sterile water, it is recommended that the infusion solution be

            used within 24 hours of dilution to reduce the risk of bacterial contamination. The infusion should be refrigerated. Freezing is not

           recommended.

  Handling and Disposal
  

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

  Because ganciclovir shares some of the properties of anti-tumor agents (ie, carcinogenicity and mutagenicity), consideration should be given to handling and disposal according to guidelines issued for antineoplastic drugs.  Several guidelines on this subject have been published.7-9

  There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate.

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  Ganciclovir | Ranbaxy Pharmaceuticals Inc.

  

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  Dosage: THE RECOMMENDED DOSE FOR GANCICLOVIR CAPSULES SHOULD NOT BE EXCEEDED.

  For Treatment of CMV Retinitis in Patients WithNormal Renal Function:

  1. Induction Treatmen t

  Ganciclovir capsules should not be used for induction treatment.

  2. Maintenance Treatment

  Following induction treatment, the recommended maintenance dosage of ganciclovir capsules is 1000 mg tid with food. Alternatively, the dosing regimen of 500 mg 6 times daily every 3 hours with food, during waking hours, may be used.

  For patients who experience progression of CMV retinitis while receiving maintenance treatment with either formulation of ganciclovir, reinduction treatment is recommended.

  For the Prevention of CMV Disease in Patients With Advanced HIV Infection andNormalRenal Function:

  The recommended prophylactic dose of ganciclovir capsules is 1000 mg tid with food.

  For the Prevention of CMV Disease in Transplant Recipients With Normal Renal Function:

  The recommended prophylactic dosage of ganciclovir capsules is 1000 mg tid with food.

  The duration of treatment with ganciclovir capsules in transplant recipients is dependent upon the duration and degree of immunosuppression. In a controlled clinical trial of liver allograft recipients, treatment with ganciclovir capsules was continued through week 14 posttransplantation (see INDICATIONS AND USAGE section for a more detailed discussion).

  Renal Impairment:

  In patients with renal impairment, the dose of ganciclovir capsules should be modified as shown below:

  *Creatinine clearance can be related to serum creatinine by the following formulas:

  Creatinine Clearance* mL/min Ganciclovir capsule Doses ≥ 70 1000 mg tid or 500 mg q3h, 6x/day 50 to 69 1500 mg qd or 500 mg tid 25 to 49 1000 mg qd or 500 mg bid 10 to 24 500 mg qd < 10 500 mg 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

  Patient Monitoring: Due to the frequency of granulocytopenia, anemia and thrombocytopenia in patients receiving ganciclovir (see ADVERSE EVENTS), it is recommended that complete blood counts and platelet counts be performed frequently, especially in patients in whom ganciclovir or other nucleoside analogues have previously resulted in cytopenia, or in whom neutrophil counts are less than 1000 cells/µL at the beginning of treatment. Patients should have serum creatinine or creatinine clearance values followed carefully to allow for dosage adjustments in renally impaired patients (see DOSAGE AND ADMINISTRATION).

  Reduction of Dose: Dosage reductions in renally impaired patients should be considered for ganciclovir capsules (see Renal Impairment). Dosage reductions should also be considered for those with neutropenia, anemia and/or thrombocytopenia (see ADVERSE EVENTS). Ganciclovir should not be administered in patients with severe neutropenia (ANC less than 500/µL) or severe thrombocytopenia (platelets less than 25,000/µL).

  Handling and Disposal: Caution should be exercised in the handling of ganciclovir capsules. Avoid direct contact with the skin or mucous membranes of the powder contained in ganciclovir capsules. If such contact occurs, wash thoroughly with soap and water; rinse eyes thoroughly with plain water. Ganciclovir capsules should not be opened or crushed.

  Because ganciclovir shares some of the properties of antitumor agents (ie, carcinogenicity and mutagenicity), consideration should be given to handling and disposal according to guidelines issued for antineoplastic drugs. Several guidelines on this subject have been published.

  There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate.

  Close
  No Recall

  More Info