Gemcitabine

Gemcitabine Manufacturers

• Sun Pharma Global Fze
  

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  Gemcitabine | Sun Pharma Global Fze

  

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  2.1 Ovarian Cancer
  

  Recommended Dose and Schedule
  The recommended dose of gemcitabine for injection, USP is 1,000 mg/m2 as an intravenous infusion over 30 minutes on Days 1 and 8 of each 21-day cycle, in combination with carboplatin AUC 4 intravenously after gemcitabine for injection administration on Day 1 of each 21-day cycle. Refer to carboplatin prescribing information for additional information.
  
  
  Dose Modifications
  Recommended gemcitabine for injection, USP dose modifications for myelosuppression are described in Table 1 and Table 2 [see Warnings and Precautions (5.2)]. Refer to Dosage and Administration (2.5) for recommendations for non-hematologic adverse reactions.

  
  
  
  Table 1: Dosage Reduction Guidelines for Gemcitabine for Injection for Myelosuppression on Day of Treatment in Ovarian Cancer
  Treatment
  Day
  Absolute granulocyte count (x 106/L)
   
  Platelet count (x 106/L)
  % of full dose
  Day 1
  ≥1,500
  and
  ≥100,000
  100%
   
  <1,500
  or
  <100,000
  Delay Treatment Cycle
  Day 8
  ≥1,500
  and
  ≥100,000
  100%
   
  1,000 to 1,499
  or
  75,000 to 99,999
  50%
   
  <1,000
  or
  <75,000
  Hold
  
  
  Table 2: Gemcitabine for Injection Dose Modification for Myelosuppression in Previous Cycle In Ovarian Cancer Occurrence
  Myelosuppression During Treatment Cycle
  Dose Modification
  Initial Occurrence
  Absolute granulocyte count less than 500 x 106/L for more than 5 days
  Absolute granulocyte count less than 100 x 106/L for more than 3 days
  Febrile neutropenia
  Platelets less than 25,000x106/L
  Cycle delay of more than one week due to toxicity
  Permanently reduce gemcitabine for injection to 800 mg/m2 on
  Days 1 and 8
  Subsequent
  Occurrence
  If any of the above toxicities occur after the initial dose reduction
  Permanently reduce gemcitabine for injection dose to 800 mg/m2 on Day 1 only
  
  
  2.2 Breast Cancer
  
  

  Recommended Dose and Schedule
  The recommended dose of gemcitabine for injection, USP is 1,250 mg/m2 intravenously over 30 minutes on Days 1 and 8 of each 21-day cycle that includes paclitaxel. Paclitaxel should be administered at 175 mg/m2 on Day 1 as a 3 hour intravenous infusion before gemcitabine for injection administration.
  
  Dose Modifications
  Recommended dose modifications for gemcitabine for injection, USP for myelosuppression are described in Table 3 [see Warnings and Precautions (5.2)]. Refer to Dosage and Administration (2.5) for recommendations for non-hematologic adverse reactions.

  
  
  
  Table 3: Recommended Dose Reductions for Gemcitabine for Injection for Myelosuppression on Day of Treatment in Breast Cancer Treatment Day
  Absolute granulocyte count
  (x 106/L)
   
  Platelet count
  (x 106/L)
  % of full dose
  Day 1
  ≥1,500
  and
  ≥100,000
  100%
   
  less than 1,500
  or
  less than 100,000
  Hold
  Day 8
  ≥1,200
  and
  >75,000
  100%
   
  1,000 to 1,199
  or
  50,000 to 75,000
  75%
   
  700 to 999
  and
  ≥50,000
  50%
   
  <700
  or
  <50,000
  Hold
  
  
  
  
  2.3 Non-Small Cell Lung Cancer
  

  Recommended Dose and Schedule 
  Every 4-week schedule
  The recommended dose of gemcitabine for injection, USP is 1,000 mg/m2 intravenously over 30 minutes on Days 1, 8, and 15 in combination with cisplatin therapy. Administer cisplatin intravenously at 100 mg/m2 on Day 1 after the infusion of gemcitabine for injection, USP.
  
  
  Every 3-week schedule
  The recommended dose of gemcitabine for injection, USP is 1,250 mg/m2 intravenously over 30 minutes on Days 1 and 8 in combination with cisplatin therapy. Administer cisplatin intravenously at 100 mg/m2 on Day 1 after the infusion of gemcitabine for injection, USP.
  
  
  Dose Modifications
  Recommended dose modifications for gemcitabine for injection, USP myelosuppression are described in Table 4 [see Warnings and Precautions (5.2)]. Refer to Dosage and Administration (2.5) for gemcitabine for injection, USP recommendations for non-hematologic adverse reactions.

  2.4 Pancreatic Cancer
  

  Recommended Dose and Schedule
  The recommended dose of gemcitabine for injection, USP is 1,000 mg/m2 over 30 minutes intravenously. The recommended treatment schedule is as follows:

  
  Weeks 1 to 8: weekly dosing for the first 7 weeks followed by one week rest. After week 8: weekly dosing on Days 1, 8, and 15 of 28-day cycles. 
  

  Dose Modifications
  Recommended dose modifications for gemcitabine for injection, USP for myelosuppression are described in Table 4 [see Warnings and Precautions (5.2)]. Refer to Dosage and Administration (2.5) for recommendations for non-hematologic adverse reactions.
  
  Patients receiving gemcitabine for injection, USP should be monitored prior to each dose with a complete blood count (CBC), including differential and platelet count. If marrow suppression is detected, therapy should be modified or suspended according to the guidelines in Table 4.

  
  
  Table 4: Recommended Dose Reductions for Gemcitabine for Injection, USP for Myelosuppression in Pancreatic Cancer and Non-Small Cell Lung Cancer Absolute granulocyte count
  (x 106/L)
   
  Platelet count
  (x 106/L)
  % of full dose
  ≥1,000
  And
  ≥100,000
  100%
  500 to 999
  Or
  50,000 to 99,999
  75%
  <500
  Or
  <50,000
  Hold
  
  2.5 Dose Modifications for Non-Hematologic Adverse Reactions
  

  Permanently discontinue gemcitabine for injection, USP for any of the following:

  
  Unexplained dyspnea or other evidence of severe pulmonary toxicity Severe hepatic toxicity Hemolytic-uremic syndrome Capillary leak syndrome Posterior reversible encephalopathy syndrome 
  

  Withhold gemcitabine for injection, USP or reduce dose by 50% for other severe (Grade 3 or 4) non-hematological toxicity until resolved. No dose modifications are recommended for alopecia, nausea, or vomiting.

  2.6 Preparation and Administration Precautions

  Exercise caution and wear gloves when preparing gemcitabine for injection, USP solutions. Immediately wash the skin thoroughly or rinse the mucosa with copious amounts of water if gemcitabine for injection, USP contacts the skin or mucus membranes. Death has occurred in animal studies due to dermal absorption. For further guidance on handling gemcitabine for injection, USP go to “OSHA Hazardous Drugs” (refer to antineoplastic weblinks including OSHA Technical Manual) at OSHA. http://www.osha.gov/SLTC/hazardousdrugs/index.html

  2.7 Preparation for Intravenous Infusion Administration
  

  Reconstitute the vials with 0.9% Sodium Chloride Injection without preservatives.
  Add 5 mL to the 200 mg vial or 25 mL to the 1 g vial. These dilutions each yield a gemcitabine for injection, USP concentration of 38 mg/mL. Complete withdrawal of the vial contents will provide 200 mg or 1 g of gemcitabine for injection, USP. Prior to administration the appropriate amount of drug must be diluted with 0.9% Sodium Chloride Injection. Final concentrations may be as low as 0.1 mg/mL.
  
  
  Reconstituted gemcitabine for injection is a clear, colorless to light straw-colored solution. Inspect visually prior to administration and discard for particulate matter or discoloration. Gemcitabine for injection solutions are stable for 24 hours at controlled room temperature of 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Do not refrigerate as crystallization can occur.
  
  
  No incompatibilities have been observed with infusion bottles or polyvinyl chloride bags and administration sets.

  
  
  

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• Sagent Pharmaceuticals
  

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  Gemcitabine | Sagent Pharmaceuticals

  

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  2.1 Ovarian Cancer

  Recommended Dose and Schedule

  The recommended dose of Gemcitabine for Injection, USP is 1000 mg/m2 as an intravenous infusion over 30 minutes on Days 1 and 8 of each 21-day cycle, in combination with carboplatin AUC 4 intravenously after Gemcitabine for Injection, USP administration on Day 1 of each 21-day cycle. Refer to carboplatin prescribing information for additional information.

  Dose Modifications

  Recommended Gemcitabine for Injection, USP dose modifications for myelosuppression are described Table 1 and Table 2 [see Warnings and Precautions (5.2)]. Refer to Dosage and Administration (2.5) for recommendations for non-hematologic adverse reactions.

  Table 1: Dosage Reduction Guidelines for Gemcitabine for Injection, USP for Myelosuppression on Day of Treatment in Ovarian Cancer Treatment Absolute granulocyte count Platelet count % of full dose Day (x 106/L) (x 106/L) Day 1 ≥1500 and ≥100,000 100% <1500 or <100,000 Delay Treatment Cycle Day 8 ≥1500 and ≥100,000 100 1000 to 1499 or 75,000 to 99,999 50 <1000 or <75,000 Hold Table 2: Gemcitabine for Injection, USP Dose Modification for Myelosuppression in Previous Cycle In Ovarian Cancer Occurrence Myelosuppression During Treatment Cycle Dose Modification Initial Occurrence Absolute granulocyte count less than 500 x 106/L for more than 5 days
  Absolute granulocyte count less than 100 x 106/L for more than 3 days
  Febrile neutropenia
  Platelets less than 25,000x106/L
  Cycle delay of more than one week due to toxicity Permanently reduce Gemcitabine for Injection, USP to 800 mg/m2 on Days 1 and 8 Subsequent Occurrence If any of the above toxicities occur after the initial dose reduction Permanently reduce Gemcitabine for Injection, USP dose to 800 mg/m2 on Day 1 only 2.2 Breast Cancer

  Recommended Dose and Schedule

  The recommended dose of Gemcitabine for Injection, USP is 1250 mg/m2 intravenously over 30 minutes on Days 1 and 8 of each 21-day cycle that includes paclitaxel. Paclitaxel should be administered at 175 mg/m2 on Day 1 as a 3 hour intravenous infusion before Gemcitabine for Injection, USP administration.

  Dose Modifications

  Recommended dose modifications for Gemcitabine for Injection, USP for myelosuppression are described in Table 3 [see Warnings and Precautions (5.2)]. Refer to Dosage and Administration (2.5) for recommendations for non-hematologic adverse reactions.

  Table 3: Recommended Dose Reductions for Gemcitabine for Injection, USP for Myelosuppression on Day of Treatment in Breast Cancer Treatment Day Absolute granulocyte count
  (x 106/L) Platelet count
  (x 106/L) % of full dose Day 1 ≥1500 and ≥100,000 100% less than 1500 or less than 100,000 Hold Day 8 ≥1200 and >75,000 100% 1000 to 1199 or 50,000 to 75,000 75% 700 to 999 and ≥50,000 50% <700 or <50,000 Hold 2.3 Non-Small Cell Lung Cancer

  Recommended Dose and Schedule

  Every 4-week schedule

  The recommended dose of Gemcitabine for Injection, USP is 1000 mg/m2 intravenously over 30 minutes on Days 1, 8, and 15 in combination with cisplatin therapy. Administer cisplatin intravenously at 100 mg/m2 on Day 1 after the infusion of Gemcitabine for Injection, USP.

  Every 3-week schedule

  The recommended dose of Gemcitabine for Injection, USP is 1250 mg/m2 intravenously over 30 minutes on Days 1 and 8 in combination with cisplatin therapy. Administer cisplatin intravenously at 100 mg/m2 on Day 1 after the infusion of Gemcitabine for Injection, USP.

  Dose Modifications

  Recommended dose modifications for Gemcitabine for Injection, USP myelosuppression are described in Table 4 [see Warnings and Precautions (5.2)]. Refer to Dosage and Administration (2.5) for Gemcitabine for Injection, USP recommendations for non-hematologic adverse reactions.

  2.4 Pancreatic Cancer

  Recommended Dose and Schedule

  The recommended dose of Gemcitabine for Injection, USP is 1000 mg/m2 over 30 minutes intravenously. The recommended treatment schedule

  Weeks 1 to 8: weekly dosing for the first 7 weeks followed by one week rest. After week 8: weekly dosing on Days 1, 8, and 15 of 28-day cycles.

  Dose Modifications

  Recommended dose modifications for Gemcitabine for Injection, USP for myelosuppression are described in Table 4 [see Warnings and Precautions (5.2)]. Refer to Dosage and Administration (2.5) for recommendations for non-hematologic adverse reactions.

  Patients receiving Gemcitabine for Injection, USP should be monitored prior to each dose with a complete blood count (CBC), including differential and platelet count. If marrow suppression is detected, therapy should be modified or suspended according to the guidelines in Table 4.

  Table 4: Recommended Dose Reductions for Gemcitabine for Injection, USP for Myelosuppression in Pancreatic Cancer and Non-Small Cell Lung Cancer Absolute granulocyte count Platelet count % of full dose (x 106/L) (x 106/L) ≥1000 And ≥100,000 100 500 to 999 Or 50,000 to 99,999 75 <500 Or <50,000 Hold 2.5 Dose Modifications for Non-Hematologic Adverse Reactions

  Permanently discontinue Gemcitabine for Injection, USP for any of the following

  Unexplained dyspnea or other evidence of severe pulmonary toxicity Severe hepatic toxicity Hemolytic-Uremic Syndrome Capillary Leak Syndrome

  Withhold Gemcitabine for Injection, USP or reduce dose by 50% for other severe (Grade 3 or 4) non-hematological toxicity until resolved. No dose modifications are recommended for alopecia, nausea, or vomiting.

  2.6 Preparation and Administration Precautions

  Exercise caution and wear gloves when preparing Gemcitabine for Injection, USP solutions. Immediately wash the skin thoroughly or rinse the mucosa with copious amounts of water if Gemcitabine for Injection, USP contacts the skin or mucus membranes. Death has occurred in animal studies due to dermal absorption. For further guidance on handling Gemcitabine for Injection, USP go to “OSHA Hazardous Drugs” (refer to antineoplastic weblinks including OSHA Technical Manual) at OSHA. http://www.osha.gov/SLTC/hazardousdrugs/index.html

  2.7 Preparation for Intravenous Infusion Administration

  Reconstitute the vials with 0.9% Sodium Chloride Injection without preservatives.

  Add 5 mL to the 200-mg vial or 25 mL to the 1-g vial. These dilutions each yield a Gemcitabine for Injection, USP concentration of 38 mg/mL. Complete withdrawal of the vial contents will provide 200 mg or 1 g of Gemcitabine for Injection, USP. Prior to administration the appropriate amount of drug must be diluted with 0.9% Sodium Chloride Injection. Final concentrations may be as low as 0.1 mg/mL.

  Reconstituted Gemcitabine for Injection, USP is a clear, colorless to light straw-colored solution. Inspect visually prior to administration and discard for particulate matter or discoloration. Gemcitabine for Injection, USP solutions are stable for 24 hours at controlled room temperature of 20° to 25°C (68° to 77°F). Do not refrigerate as crystallization can occur.

  No incompatibilities have been observed with infusion bottles or polyvinyl chloride bags and administration sets.

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• Hospira, Inc.
  

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  Gemcitabine | Pd-rx Pharmaceuticals, Inc.

  

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  For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested: in adults, 50 mg to 100 mg q.i.d.; children under 6 years, 50 mg daily in divided doses; and over 6 years, 50 mg to 100 mg daily in divided doses.

  For use in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses and in histamine-mediated pruritus: in adults: 25 mg t.i.d. or q.i.d.; children under 6 years, 50 mg daily in divided doses; and over 6 years, 50 mg to 100 mg daily in divided doses.

  As a sedative when used as a premedication and following general anesthesia: 50 mg to 100 mg in adults and 0.6 mg/kg in children. When treatment is initiated by the intramuscular route of administration, subsequent doses may be administered orally.

  As with all medications, the dosage should be adjusted according to the patient’s response to therapy.

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• Hospira, Inc.
  

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  Gemcitabine | Hospira, Inc.

  

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  2.1 Ovarian Cancer

  Recommended Dose and Schedule

  The recommended dose of Gemcitabine is 1000 mg/m2 as an intravenous infusion over 30 minutes on Days 1 and 8 of each 21-day cycle, in combination with carboplatin AUC 4 intravenously after gemcitabine administration on Day 1 of each 21-day cycle. Refer to carboplatin prescribing information for additional information.

  Dose Modifications

  Recommended Gemcitabine dose modifications for myelosuppression are described in Table 1 and Table 2 [see Warnings and Precautions (5.2)]. Refer to Dosage and Administration (2.5) for recommendations for non-hematologic adverse reactions.

  Table 1: Dosage Reduction Guidelines for Gemcitabine for Myelosuppression on Day of Treatment in Ovarian Cancer

  Treatment
  Day

  Absolute granulocyte count
  (x 106/L)

   

  Platelet count
  (x 106/L)

  % of full dose

  Day 1

  ≥1500

  less than 1500

  and

  or

  ≥100,000

  less than 100,000

  100%

  Delay Treatment Cycle

  Day 8

  ≥1500

  1000-1499

  less than 1000

  and

  or

  or

  ≥100,000

  75,000-99,999

  less than 75,000

  100

  50

  Hold

  Table 2: Gemcitabine Dose Modification for Myelosuppression in Previous Cycle in Ovarian Cancer

  Occurrence

  Myelosuppression During Treatment Cycle

  Dose Modification

  Initial
  Occurrence

  Absolute granulocyte count less than 500 x 106/L for more than 5 days

  Absolute granulocyte count less than 100 x 106/L for more than 3 days

  Febrile neutropenia

  Platelets less than 25,000 x 106/L

  Cycle delay of more than one week due to toxicity

  Permanently reduce
  Gemcitabine to 800 mg/m2
  on Days 1 and 8

  Subsequent
  Occurrence

  If any of the above toxicities occur after the initial dose reduction

  Permanently reduce
  Gemcitabine dose to 800 mg/m2
  on Day 1 only

  2.2 Breast Cancer

  Recommended Dose and Schedule

  The recommended dose of Gemcitabine is 1250 mg/m2 intravenously over 30 minutes on Days 1 and 8 of each 21-day cycle that includes paclitaxel. Paclitaxel should be administered at 175 mg/m2 on Day 1 as a 3 hour intravenous infusion before gemcitabine administration.

  Dose Modifications

  Recommended dose modifications for Gemcitabine for myelosuppression are described in Table 3 [see Warnings and Precautions (5.2)]. Refer to Dosage and Administration (2.5) for recommendations for non-hematologic adverse reactions.

  Table 3: Recommended Dose Reductions for Gemcitabine for Myelosuppression on Day of Treatment in Breast Cancer

  Treatment Day

  Absolute granulocyte count

   

  Platelet count 

  % of full dose

  Day 1

  ≥1500

  less than 1500

  and

  or

  ≥100,000

  less than 100,000

  100%

  Hold

  Day 8

  ≥1200

  1000-1199

  700-999

  less than 700

  and

  or

  and

  or

  greater than 75,000

  50,000-75,000

  ≥50,000

  less than 50,000

  100%

  75%

  50%

  Hold

  2.3 Non-Small Cell Lung Cancer

  Recommended Dose and Schedule

  Every 4-week schedule

  The recommended dose of gemcitabine is 1000 mg/m2 intravenously over 30 minutes on Days 1, 8, and 15 in combination with cisplatin therapy. Administer cisplatin intravenously at 100 mg/m2 on Day 1 after the infusion of gemcitabine.

  Every 3-week schedule

  The recommended dose of gemcitabine is 1250 mg/m2 intravenously over 30 minutes on Days 1 and 8 in combination with cisplatin therapy. Administer cisplatin intravenously at 100 mg/m2 on Day 1 after the infusion of gemcitabine.

  Dose Modifications

  Recommended dose modifications for gemcitabine myelosuppression are described in Table 4 [see Warnings and Precautions (5.2)]. Refer to Dosage and Administration (2.5) for gemcitabine recommendations for non-hematologic adverse reactions.

  2.4 Pancreatic Cancer

  Recommended Dose and Schedule

  The recommended dose of gemcitabine is 1000 mg/m2 over 30 minutes intravenously. The recommended treatment schedule:

  • Weeks 1-8: weekly dosing for the first 7 weeks followed by one week rest. • After week 8: weekly dosing on Days 1, 8, and 15 of 28-day cycles.

  Dose Modifications

  Recommended dose modifications for gemcitabine for myelosuppression are described in Table 4 [see Warnings and Precautions (5.2)]. Refer to Dosage and Administration (2.5) for recommendations for non-hematologic adverse reactions.

  Patients receiving gemcitabine should be monitored prior to each dose with a complete blood count (CBC), including differential and platelet count. If marrow suppression is detected, therapy should be modified or suspended according to the guidelines in Table 4.

  Table 4: Recommended Dose Reductions for Gemcitabine for Myelosuppression in Pancreatic Cancer and Non-Small Cell Lung Cancer

  Absolute granulocyte count

  (x 106/L)

   

  Platelet count

  (x 106/L)

  % of full dose

  ≥1000

  500-999

  less than 500

  and

  or

  or

  ≥100,000

  50,000-99,999

  less than 50,000

  100

  75

  Hold

  2.5 Dose Modifications for Non-Hematologic Adverse Reactions

  Permanently discontinue Gemcitabine for any of the following

  • Unexplained dyspnea or other evidence of severe pulmonary toxicity • Severe hepatic toxicity • Hemolytic-Uremic Syndrome • Capillary Leak Syndrome

  Withhold gemcitabine or reduce dose by 50% for other severe (Grade 3 or 4) non-hematological toxicity until resolved. No dose modifications are recommended for alopecia, nausea, or vomiting.

  2.6 Preparation and Administration Precautions

  Exercise caution and wear gloves when preparing gemcitabine solutions. Immediately wash the skin thoroughly or rinse the mucosa with copious amounts of water if gemcitabine contacts the skin or mucus membranes. Death has occurred in animal studies due to dermal absorption. For further guidance on handling gemcitabine go to “OSHA Hazardous Drugs” (refer to antineoplastic weblinks including OSHA Technical Manual) at OSHA.

  http://www.osha.gov/SLTC/hazardousdrugs/index.html

  2.7 Preparation for Intravenous Infusion Administration

  Reconstitute the vials with 0.9% Sodium Chloride Injection without preservatives.

  Add 5 mL to the 200-mg vial or 25 mL to the 1-g vial. These dilutions each yield a gemcitabine concentration of 38 mg/mL. Complete withdrawal of the vial contents will provide 200 mg or 1 g of gemcitabine. Prior to administration the appropriate amount of drug must be diluted with 0.9% Sodium Chloride Injection. Final concentrations may be as low as 0.1 mg/mL.

  Reconstituted Gemcitabine for Injection, USP is a clear, colorless to light straw-colored solution. Inspect visually prior to administration and discard for particulate matter or discoloration.

  Gemcitabine solutions are stable for 24 hours at controlled room temperature of 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Discard unused portion. Do not refrigerate as crystallization can occur.

  No incompatibilities have been observed with infusion bottles or polyvinyl chloride bags and administration sets.

  2.1 Ovarian Cancer

  Recommended Dose and Schedule

  The recommended dose of Gemcitabine is 1000 mg/m2 as an intravenous infusion over 30 minutes on Days 1 and 8 of each 21-day cycle, in combination with carboplatin AUC 4 intravenously after gemcitabine administration on Day 1 of each 21-day cycle. Refer to carboplatin prescribing information for additional information.

  Dose Modifications

  Recommended Gemcitabine dose modifications for myelosuppression are described in Table 1 and Table 2 [see Warnings and Precautions (5.2)]. Refer to Dosage and Administration (2.5) for recommendations for non-hematologic adverse reactions.

  Table 1: Dosage Reduction Guidelines for Gemcitabine for Myelosuppression on Day of Treatment in Ovarian Cancer

  Treatment
  Day

  Absolute granulocyte count
  (x 106/L)

   

  Platelet count
  (x 106/L)

  % of full dose

  Day 1

  ≥1500

  less than 1500

  and

  or

  ≥100,000

  less than 100,000

  100%

  Delay Treatment Cycle

  Day 8

  ≥1500

  1000-1499

  less than 1000

  and

  or

  or

  ≥100,000

  75,000-99,999

  less than 75,000

  100

  50

  Hold

  Table 2: Gemcitabine Dose Modification for Myelosuppression in Previous Cycle in Ovarian Cancer

  Occurrence

  Myelosuppression During Treatment Cycle

  Dose Modification

  Initial
  Occurrence

  Absolute granulocyte count less than 500 x 106/L for more than 5 days

  Absolute granulocyte count less than 100 x 106/L for more than 3 days

  Febrile neutropenia

  Platelets less than 25,000 x 106/L

  Cycle delay of more than one week due to toxicity

  Permanently reduce
  Gemcitabine to 800 mg/m2
  on Days 1 and 8

  Subsequent
  Occurrence

  If any of the above toxicities occur after the initial dose reduction

  Permanently reduce
  Gemcitabine dose to 800 mg/m2
  on Day 1 only

  2.2 Breast Cancer

  Recommended Dose and Schedule

  The recommended dose of Gemcitabine is 1250 mg/m2 intravenously over 30 minutes on Days 1 and 8 of each 21-day cycle that includes paclitaxel. Paclitaxel should be administered at 175 mg/m2 on Day 1 as a 3 hour intravenous infusion before gemcitabine administration.

  Dose Modifications

  Recommended dose modifications for Gemcitabine for myelosuppression are described in Table 3 [see Warnings and Precautions (5.2)]. Refer to Dosage and Administration (2.5) for recommendations for non-hematologic adverse reactions.

  Table 3: Recommended Dose Reductions for Gemcitabine for Myelosuppression on Day of Treatment in Breast Cancer

  Treatment Day

  Absolute granulocyte count

   

  Platelet count 

  % of full dose

  Day 1

  ≥1500

  less than 1500

  and

  or

  ≥100,000

  less than 100,000

  100%

  Hold

  Day 8

  ≥1200

  1000-1199

  700-999

  less than 700

  and

  or

  and

  or

  greater than 75,000

  50,000-75,000

  ≥50,000

  less than 50,000

  100%

  75%

  50%

  Hold

  2.3 Non-Small Cell Lung Cancer

  Recommended Dose and Schedule

  Every 4-week schedule

  The recommended dose of gemcitabine is 1000 mg/m2 intravenously over 30 minutes on Days 1, 8, and 15 in combination with cisplatin therapy. Administer cisplatin intravenously at 100 mg/m2 on Day 1 after the infusion of gemcitabine.

  Every 3-week schedule

  The recommended dose of gemcitabine is 1250 mg/m2 intravenously over 30 minutes on Days 1 and 8 in combination with cisplatin therapy. Administer cisplatin intravenously at 100 mg/m2 on Day 1 after the infusion of gemcitabine.

  Dose Modifications

  Recommended dose modifications for gemcitabine myelosuppression are described in Table 4 [see Warnings and Precautions (5.2)]. Refer to Dosage and Administration (2.5) for gemcitabine recommendations for non-hematologic adverse reactions.

  2.4 Pancreatic Cancer

  Recommended Dose and Schedule

  The recommended dose of gemcitabine is 1000 mg/m2 over 30 minutes intravenously. The recommended treatment schedule:

  • Weeks 1-8: weekly dosing for the first 7 weeks followed by one week rest. • After week 8: weekly dosing on Days 1, 8, and 15 of 28-day cycles.

  Dose Modifications

  Recommended dose modifications for gemcitabine for myelosuppression are described in Table 4 [see Warnings and Precautions (5.2)]. Refer to Dosage and Administration (2.5) for recommendations for non-hematologic adverse reactions.

  Patients receiving gemcitabine should be monitored prior to each dose with a complete blood count (CBC), including differential and platelet count. If marrow suppression is detected, therapy should be modified or suspended according to the guidelines in Table 4.

  Table 4: Recommended Dose Reductions for Gemcitabine for Myelosuppression in Pancreatic Cancer and Non-Small Cell Lung Cancer

  Absolute granulocyte count

  (x 106/L)

   

  Platelet count

  (x 106/L)

  % of full dose

  ≥1000

  500-999

  less than 500

  and

  or

  or

  ≥100,000

  50,000-99,999

  less than 50,000

  100

  75

  Hold

  2.5 Dose Modifications for Non-Hematologic Adverse Reactions

  Permanently discontinue Gemcitabine for any of the following

  • Unexplained dyspnea or other evidence of severe pulmonary toxicity • Severe hepatic toxicity • Hemolytic-Uremic Syndrome • Capillary Leak Syndrome

  Withhold gemcitabine or reduce dose by 50% for other severe (Grade 3 or 4) non-hematological toxicity until resolved. No dose modifications are recommended for alopecia, nausea, or vomiting.

  2.6 Preparation and Administration Precautions

  Exercise caution and wear gloves when preparing gemcitabine solutions. Immediately wash the skin thoroughly or rinse the mucosa with copious amounts of water if gemcitabine contacts the skin or mucus membranes. Death has occurred in animal studies due to dermal absorption. For further guidance on handling gemcitabine go to “OSHA Hazardous Drugs” (refer to antineoplastic weblinks including OSHA Technical Manual) at OSHA.

  http://www.osha.gov/SLTC/hazardousdrugs/index.html

  2.7 Preparation for Intravenous Infusion Administration

  Reconstitute the vials with 0.9% Sodium Chloride Injection without preservatives.

  Add 5 mL to the 200-mg vial or 25 mL to the 1-g vial. These dilutions each yield a gemcitabine concentration of 38 mg/mL. Complete withdrawal of the vial contents will provide 200 mg or 1 g of gemcitabine. Prior to administration the appropriate amount of drug must be diluted with 0.9% Sodium Chloride Injection. Final concentrations may be as low as 0.1 mg/mL.

  Reconstituted Gemcitabine for Injection, USP is a clear, colorless to light straw-colored solution. Inspect visually prior to administration and discard for particulate matter or discoloration.

  Gemcitabine solutions are stable for 24 hours at controlled room temperature of 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Discard unused portion. Do not refrigerate as crystallization can occur.

  No incompatibilities have been observed with infusion bottles or polyvinyl chloride bags and administration sets.

  Close
  No Recall

  More Info
• Hospira, Inc.
  

  ×

  Gemcitabine | Hospira, Inc.

  

  ---

  Gemcitabine Injection is for intravenous use only. Gemcitabine Injection may be administered on an outpatient basis.

  2.1 Ovarian Cancer

  Gemcitabine Injection should be administered intravenously at a dose of 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle. Carboplatin AUC 4 should be administered intravenously on Day 1 after Gemcitabine Injection administration. Patients should be monitored prior to each dose with a complete blood count, including differential counts. Patients should have an absolute granulocyte count ≥1500 x 106/L and a platelet count ≥100,000 x 106/L prior to each cycle.

  Dose Modifications

  Gemcitabine Injection dosage adjustments for hematological toxicity within a cycle of treatment is based on the granulocyte and platelet counts taken on Day 8 of therapy. If marrow suppression is detected, Gemcitabine Injection dosage should be modified according to guidelines in Table 1.

  
  Table 1: Day 8 Dosage Reduction Guidelines for Gemcitabine Injection in Combination with Carboplatin

  Absolute granulocyte count

  (x 106/L)

  
  

  Platelet count

  (x 106/L)

  % of full dose

  ≥1500

  And

  ≥100,000

  100

  1000-1499

  And/or

  75,000-99,999

  50

  <1000

  And/or

  <75,000

  Hold

  
  

  In general, for severe (Grade 3 or 4) non-hematological toxicity, except nausea/vomiting, therapy with Gemcitabine Injection should be held or decreased by 50% depending on the judgment of the treating physician. For carboplatin dosage adjustment, see manufacturer’s prescribing information.

  Dose adjustment for Gemcitabine Injection in combination with carboplatin for subsequent cycles is based upon observed toxicity. The dose of Gemcitabine Injection in subsequent cycles should be reduced to 800 mg/m2 on Days 1 and 8 in case of any of the following hematologic toxicities:

  Absolute granulocyte count <500 x 106/L for more than 5 days Absolute granulocyte count <100 x 106/L for more than 3 days Febrile neutropenia Platelets <25,000 x 106/L Cycle delay of more than one week due to toxicity

  If any of the above toxicities recur after the initial dose reduction, for the subsequent cycle, Gemcitabine Injection should be given on Day 1 only at 800 mg/m2.

  2.2 Breast Cancer

  Gemcitabine Injection should be administered intravenously at a dose of 1250 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle. Paclitaxel should be administered at 175 mg/m2 on Day 1 as a 3-hour intravenous infusion before Gemcitabine Injection administration. Patients should be monitored prior to each dose with a complete blood count, including differential counts. Patients should have an absolute granulocyte count ≥1500 x 106/L and a platelet count ≥100,000 x 106/L prior to each cycle.                                                               

  Dose Modifications

  Gemcitabine Injection dosage adjustment for hematological toxicity is based on the granulocyte and platelet counts taken on Day 8 of therapy. If marrow suppression is detected, Gemcitabine Injection dosage should be modified according to the guidelines in Table 2.

  Table 2: Day 8 Dosage Reduction Guidelines for Gemcitabine Injection in Combination with Paclitaxel

  Absolute granulocyte count

  (x 106/L)

  
  

  Platelet count

  (x 106/L)

  % of full dose

  ≥1200

  And

  >75,000

  100

  1000-1199

  Or

  50,000-75,000

  75

  700-999

  And

  ≥50,000

  50

  <700

  Or

  <50,000

  Hold

  
  

  In general, for severe (Grade 3 or 4) non-hematological toxicity, except alopecia and nausea/vomiting, therapy with Gemcitabine Injection should be held or decreased by 50% depending on the judgment of the treating physician. For paclitaxel dosage adjustment, see manufacturer’s prescribing information.

  2.3 Non-Small Cell Lung Cancer

  Two schedules have been investigated and the optimum schedule has not been determined [see Clinical Studies (14.3)]. With the 4-week schedule, Gemcitabine Injection should be administered intravenously at 1000 mg/m2 over 30 minutes on Days 1, 8, and 15 of each 28-day cycle. Cisplatin should be administered intravenously at 100 mg/m2 on Day 1 after the infusion of Gemcitabine Injection. With the 3-week schedule, Gemcitabine Injection should be administered intravenously at 1250 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle. Cisplatin at a dose of 100 mg/m2 should be administered intravenously after the infusion of Gemcitabine Injection on Day 1. See prescribing information for cisplatin administration and hydration guidelines.

  Dose Modifications

  Dosage adjustments for hematologic toxicity may be required for Gemcitabine Injection and for cisplatin. Gemcitabine Injection dosage adjustment for hematological toxicity is based on the granulocyte and platelet counts taken on the day of therapy. Patients receiving Gemcitabine Injection should be monitored prior to each dose with a complete blood count (CBC), including differential and platelet counts. If marrow suppression is detected, therapy should be modified or suspended according to the guidelines in Table 3. For cisplatin dosage adjustment, see manufacturer’s prescribing information.

  In general, for severe (Grade 3 or 4) non-hematological toxicity, except alopecia and nausea/vomiting, therapy with Gemcitabine Injection plus cisplatin should be held or decreased by 50% depending on the judgment of the treating physician. During combination therapy with cisplatin, serum creatinine, serum potassium, serum calcium, and serum magnesium should be carefully monitored (Grade 3/4 serum creatinine toxicity for Gemcitabine Injection plus cisplatin was 5% versus 2% for cisplatin alone).

  2.4 Pancreatic Cancer

  Gemcitabine Injection should be administered by intravenous infusion at a dose of 1000 mg/m2 over 30 minutes once weekly for up to 7 weeks (or until toxicity necessitates reducing or holding a dose), followed by a week of rest from treatment. Subsequent cycles should consist of infusions once weekly for 3 consecutive weeks out of every 4 weeks.

  Dose Modifications

  Dosage adjustment is based upon the degree of hematologic toxicity experienced by the patient [see Warnings and Precautions (5.2)]. Clearance in women and the elderly is reduced and women were somewhat less able to progress to subsequent cycles [see Warnings and Precautions (5.2) and Clinical Pharmacology (12.3)].

  Patients receiving Gemcitabine Injection should be monitored prior to each dose with a complete blood count (CBC), including differential and platelet count. If marrow suppression is detected, therapy should be modified or suspended according to the guidelines in Table 3. 

  
  Table 3: Dosage Reduction Guidelines

  Absolute granulocyte count

  (x 106/L)

  
  

  Platelet count

  (x 106/L)

  % of full dose

  ≥1000

  And

  ≥100,000

  100

  500-999

  Or

  50,000-99,999

  75

  <500

  Or

  <50,000

  Hold

  
  

  Laboratory evaluation of renal and hepatic function, including transaminases and serum creatinine, should be performed prior to initiation of therapy and periodically thereafter. Gemcitabine Injection should be administered with caution in patients with evidence of significant renal or hepatic impairment as there is insufficient information from clinical studies to allow clear dose recommendation for these patient populations.

  Patients treated with Gemcitabine Injection who complete an entire cycle of therapy may have the dose for subsequent cycles increased by 25%, provided that the absolute granulocyte count (AGC) and platelet nadirs exceed 1500 x 106/L and 100,000 x 106/L, respectively, and if non-hematologic toxicity has not been greater than WHO Grade 1. If patients tolerate the subsequent course of Gemcitabine Injection at the increased dose, the dose for the next cycle can be further increased by 20%, provided again that the AGC and platelet nadirs exceed 1500 x 106/L and 100,000 x 106/L, respectively, and that non-hematologic toxicity has not been greater than WHO Grade 1.

  2.5 Dose Modifications for Non-Hematologic Adverse Reactions

  Permanently discontinue Gemcitabine for any of the following  

  Unexplained dyspnea or other evidence of severe pulmonary toxicity   Severe hepatic toxicity   Hemolytic-Uremic Syndrome   Capillary Leak Syndrome   Posterior reversible encephalopathy syndrome  

  Withhold Gemcitabine or reduce dose by 50% for other severe (Grade 3 or 4) non-hematological toxicity until resolved. No dose modifications are recommended for alopecia, nausea, or vomiting. 

  2.6 Preparation and Administration Precautions

  Caution should be exercised in handling and preparing Gemcitabine Injection and diluted solution. The use of gloves is recommended. If Gemcitabine Injection and diluted solution contacts the skin or mucosa, immediately wash the skin thoroughly with soap and water or rinse the mucosa with copious amounts of water. Although acute dermal irritation has not been observed in animal studies, 2 of 3 rabbits exhibited drug-related systemic toxicities (death, hypoactivity, nasal discharge, shallow breathing) due to dermal absorption.

  Procedures for proper handling and disposal of anti-cancer drugs should be considered. Several guidelines on this subject have been published [see References (15)].

  2.7 Preparation for Intravenous Infusion Administration

  Each vial contains a gemcitabine concentration of 38 mg/mL. Hence, withdrawing 5.26 mL, 26.3 mL, or 52.6 mL of the vial contents will provide 200 mg, 1 g, or 2 g of gemcitabine, respectively. The appropriate amount of drug should be further diluted with 0.9% Sodium Chloride Injection to concentrations as low as 0.1 mg/mL.

  After dilution with 0.9% Sodium Chloride Injection the solution should be inspected visually for particulate matter and discoloration, prior to administration, whenever solution or container permits. If particulate matter or discoloration is found, do not administer.

  When prepared as directed, diluted gemcitabine solutions are stable for 24 hours at controlled room temperature 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Discard unused portion.

  The compatibility of Gemcitabine Injection with other drugs has not been studied. No incompatibilities have been observed with infusion bottles or polyvinyl chloride bags and administration sets.

  2.1 Ovarian Cancer

  Gemcitabine Injection should be administered intravenously at a dose of 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle. Carboplatin AUC 4 should be administered intravenously on Day 1 after Gemcitabine Injection administration. Patients should be monitored prior to each dose with a complete blood count, including differential counts. Patients should have an absolute granulocyte count ≥1500 x 106/L and a platelet count ≥100,000 x 106/L prior to each cycle.

  Dose Modifications

  Gemcitabine Injection dosage adjustments for hematological toxicity within a cycle of treatment is based on the granulocyte and platelet counts taken on Day 8 of therapy. If marrow suppression is detected, Gemcitabine Injection dosage should be modified according to guidelines in Table 1.

  
  Table 1: Day 8 Dosage Reduction Guidelines for Gemcitabine Injection in Combination with Carboplatin

  Absolute granulocyte count

  (x 106/L)

  
  

  Platelet count

  (x 106/L)

  % of full dose

  ≥1500

  And

  ≥100,000

  100

  1000-1499

  And/or

  75,000-99,999

  50

  <1000

  And/or

  <75,000

  Hold

  
  

  In general, for severe (Grade 3 or 4) non-hematological toxicity, except nausea/vomiting, therapy with Gemcitabine Injection should be held or decreased by 50% depending on the judgment of the treating physician. For carboplatin dosage adjustment, see manufacturer’s prescribing information.

  Dose adjustment for Gemcitabine Injection in combination with carboplatin for subsequent cycles is based upon observed toxicity. The dose of Gemcitabine Injection in subsequent cycles should be reduced to 800 mg/m2 on Days 1 and 8 in case of any of the following hematologic toxicities:

  Absolute granulocyte count <500 x 106/L for more than 5 days Absolute granulocyte count <100 x 106/L for more than 3 days Febrile neutropenia Platelets <25,000 x 106/L Cycle delay of more than one week due to toxicity

  If any of the above toxicities recur after the initial dose reduction, for the subsequent cycle, Gemcitabine Injection should be given on Day 1 only at 800 mg/m2.

  2.2 Breast Cancer

  Gemcitabine Injection should be administered intravenously at a dose of 1250 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle. Paclitaxel should be administered at 175 mg/m2 on Day 1 as a 3-hour intravenous infusion before Gemcitabine Injection administration. Patients should be monitored prior to each dose with a complete blood count, including differential counts. Patients should have an absolute granulocyte count ≥1500 x 106/L and a platelet count ≥100,000 x 106/L prior to each cycle.                                                               

  Dose Modifications

  Gemcitabine Injection dosage adjustment for hematological toxicity is based on the granulocyte and platelet counts taken on Day 8 of therapy. If marrow suppression is detected, Gemcitabine Injection dosage should be modified according to the guidelines in Table 2.

  Table 2: Day 8 Dosage Reduction Guidelines for Gemcitabine Injection in Combination with Paclitaxel

  Absolute granulocyte count

  (x 106/L)

  
  

  Platelet count

  (x 106/L)

  % of full dose

  ≥1200

  And

  >75,000

  100

  1000-1199

  Or

  50,000-75,000

  75

  700-999

  And

  ≥50,000

  50

  <700

  Or

  <50,000

  Hold

  
  

  In general, for severe (Grade 3 or 4) non-hematological toxicity, except alopecia and nausea/vomiting, therapy with Gemcitabine Injection should be held or decreased by 50% depending on the judgment of the treating physician. For paclitaxel dosage adjustment, see manufacturer’s prescribing information.

  2.3 Non-Small Cell Lung Cancer

  Two schedules have been investigated and the optimum schedule has not been determined [see Clinical Studies (14.3)]. With the 4-week schedule, Gemcitabine Injection should be administered intravenously at 1000 mg/m2 over 30 minutes on Days 1, 8, and 15 of each 28-day cycle. Cisplatin should be administered intravenously at 100 mg/m2 on Day 1 after the infusion of Gemcitabine Injection. With the 3-week schedule, Gemcitabine Injection should be administered intravenously at 1250 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle. Cisplatin at a dose of 100 mg/m2 should be administered intravenously after the infusion of Gemcitabine Injection on Day 1. See prescribing information for cisplatin administration and hydration guidelines.

  Dose Modifications

  Dosage adjustments for hematologic toxicity may be required for Gemcitabine Injection and for cisplatin. Gemcitabine Injection dosage adjustment for hematological toxicity is based on the granulocyte and platelet counts taken on the day of therapy. Patients receiving Gemcitabine Injection should be monitored prior to each dose with a complete blood count (CBC), including differential and platelet counts. If marrow suppression is detected, therapy should be modified or suspended according to the guidelines in Table 3. For cisplatin dosage adjustment, see manufacturer’s prescribing information.

  In general, for severe (Grade 3 or 4) non-hematological toxicity, except alopecia and nausea/vomiting, therapy with Gemcitabine Injection plus cisplatin should be held or decreased by 50% depending on the judgment of the treating physician. During combination therapy with cisplatin, serum creatinine, serum potassium, serum calcium, and serum magnesium should be carefully monitored (Grade 3/4 serum creatinine toxicity for Gemcitabine Injection plus cisplatin was 5% versus 2% for cisplatin alone).

  2.4 Pancreatic Cancer

  Gemcitabine Injection should be administered by intravenous infusion at a dose of 1000 mg/m2 over 30 minutes once weekly for up to 7 weeks (or until toxicity necessitates reducing or holding a dose), followed by a week of rest from treatment. Subsequent cycles should consist of infusions once weekly for 3 consecutive weeks out of every 4 weeks.

  Dose Modifications

  Dosage adjustment is based upon the degree of hematologic toxicity experienced by the patient [see Warnings and Precautions (5.2)]. Clearance in women and the elderly is reduced and women were somewhat less able to progress to subsequent cycles [see Warnings and Precautions (5.2) and Clinical Pharmacology (12.3)].

  Patients receiving Gemcitabine Injection should be monitored prior to each dose with a complete blood count (CBC), including differential and platelet count. If marrow suppression is detected, therapy should be modified or suspended according to the guidelines in Table 3. 

  
  Table 3: Dosage Reduction Guidelines

  Absolute granulocyte count

  (x 106/L)

  
  

  Platelet count

  (x 106/L)

  % of full dose

  ≥1000

  And

  ≥100,000

  100

  500-999

  Or

  50,000-99,999

  75

  <500

  Or

  <50,000

  Hold

  
  

  Laboratory evaluation of renal and hepatic function, including transaminases and serum creatinine, should be performed prior to initiation of therapy and periodically thereafter. Gemcitabine Injection should be administered with caution in patients with evidence of significant renal or hepatic impairment as there is insufficient information from clinical studies to allow clear dose recommendation for these patient populations.

  Patients treated with Gemcitabine Injection who complete an entire cycle of therapy may have the dose for subsequent cycles increased by 25%, provided that the absolute granulocyte count (AGC) and platelet nadirs exceed 1500 x 106/L and 100,000 x 106/L, respectively, and if non-hematologic toxicity has not been greater than WHO Grade 1. If patients tolerate the subsequent course of Gemcitabine Injection at the increased dose, the dose for the next cycle can be further increased by 20%, provided again that the AGC and platelet nadirs exceed 1500 x 106/L and 100,000 x 106/L, respectively, and that non-hematologic toxicity has not been greater than WHO Grade 1.

  2.6 Preparation and Administration Precautions

  Caution should be exercised in handling and preparing Gemcitabine Injection and diluted solution. The use of gloves is recommended. If Gemcitabine Injection and diluted solution contacts the skin or mucosa, immediately wash the skin thoroughly with soap and water or rinse the mucosa with copious amounts of water. Although acute dermal irritation has not been observed in animal studies, 2 of 3 rabbits exhibited drug-related systemic toxicities (death, hypoactivity, nasal discharge, shallow breathing) due to dermal absorption.

  Procedures for proper handling and disposal of anti-cancer drugs should be considered. Several guidelines on this subject have been published [see References (15)].

  2.7 Preparation for Intravenous Infusion Administration

  Each vial contains a gemcitabine concentration of 38 mg/mL. Hence, withdrawing 5.26 mL, 26.3 mL, or 52.6 mL of the vial contents will provide 200 mg, 1 g, or 2 g of gemcitabine, respectively. The appropriate amount of drug should be further diluted with 0.9% Sodium Chloride Injection to concentrations as low as 0.1 mg/mL.

  After dilution with 0.9% Sodium Chloride Injection the solution should be inspected visually for particulate matter and discoloration, prior to administration, whenever solution or container permits. If particulate matter or discoloration is found, do not administer.

  When prepared as directed, diluted gemcitabine solutions are stable for 24 hours at controlled room temperature 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Discard unused portion.

  The compatibility of Gemcitabine Injection with other drugs has not been studied. No incompatibilities have been observed with infusion bottles or polyvinyl chloride bags and administration sets.

  Close
  No Recall

  More Info
• Hospira, Inc.
  

  ×

  Gemcitabine | Hospira, Inc.

  

  ---

  Gemcitabine Injection is for intravenous use only. Gemcitabine Injection may be administered on an outpatient basis.

  2.1 Ovarian Cancer

  Gemcitabine Injection should be administered intravenously at a dose of 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle. Carboplatin AUC 4 should be administered intravenously on Day 1 after Gemcitabine Injection administration. Patients should be monitored prior to each dose with a complete blood count, including differential counts. Patients should have an absolute granulocyte count ≥1500 x 106/L and a platelet count ≥100,000 x 106/L prior to each cycle.

  Dose Modifications

  Gemcitabine Injection dosage adjustments for hematological toxicity within a cycle of treatment is based on the granulocyte and platelet counts taken on Day 8 of therapy. If marrow suppression is detected, Gemcitabine Injection dosage should be modified according to guidelines in Table 1.

  Table 1: Day 8 Dosage Reduction Guidelines for Gemcitabine Injection in Combination with Carboplatin

  Absolute granulocyte count

  (x 106/L)

   

  Platelet count

  (x 106/L)

  % of full dose

  ≥1500

  And

  ≥100,000

  100

  1000-1499

  And/or

  75,000-99,999

  50

  <1000

  And/or

  <75,000

  Hold

  In general, for severe (Grade 3 or 4) non-hematological toxicity, except nausea/vomiting, therapy with Gemcitabine Injection should be held or decreased by 50% depending on the judgment of the treating physician. For carboplatin dosage adjustment, see manufacturer’s prescribing information.

  Dose adjustment for Gemcitabine Injection in combination with carboplatin for subsequent cycles is based upon observed toxicity. The dose of Gemcitabine Injection in subsequent cycles should be reduced to 800 mg/m2 on Days 1 and 8 in case of any of the following hematologic toxicities:

  Absolute granulocyte count <500 x 106/L for more than 5 days Absolute granulocyte count <100 x 106/L for more than 3 days Febrile neutropenia Platelets <25,000 x 106/L Cycle delay of more than one week due to toxicity

  If any of the above toxicities recur after the initial dose reduction, for the subsequent cycle, Gemcitabine Injection should be given on Day 1 only at 800 mg/m2.

  2.2 Breast Cancer

  Gemcitabine Injection should be administered intravenously at a dose of 1250 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle. Paclitaxel should be administered at 175 mg/m2 on Day 1 as a 3-hour intravenous infusion before Gemcitabine Injection administration. Patients should be monitored prior to each dose with a complete blood count, including differential counts. Patients should have an absolute granulocyte count ≥1500 x 106/L and a platelet count ≥100,000 x 106/L prior to each cycle.

  Dose Modifications

  Gemcitabine Injection dosage adjustment for hematological toxicity is based on the granulocyte and platelet counts taken on Day 8 of therapy. If marrow suppression is detected, Gemcitabine Injection dosage should be modified according to the guidelines in Table 2.

  Table 2: Day 8 Dosage Reduction Guidelines for Gemcitabine Injection in Combination with Paclitaxel

  Absolute granulocyte count

  (x 106/L)

   

  Platelet count

  (x 106/L)

  % of full dose

  ≥1200

  And

  >75,000

  100

  1000-1199

  Or

  50,000-75,000

  75

  700-999

  And

  ≥50,000

  50

  <700

  Or

  <50,000

  Hold

  In general, for severe (Grade 3 or 4) non-hematological toxicity, except alopecia and nausea/vomiting, therapy with Gemcitabine Injection should be held or decreased by 50% depending on the judgment of the treating physician. For paclitaxel dosage adjustment, see manufacturer’s prescribing information.

  2.3 Non-Small Cell Lung Cancer

  Two schedules have been investigated and the optimum schedule has not been determined [see Clinical Studies (14.3)]. With the 4-week schedule, Gemcitabine Injection should be administered intravenously at 1000 mg/m2 over 30 minutes on Days 1, 8, and 15 of each 28-day cycle. Cisplatin should be administered intravenously at 100 mg/m2 on Day 1 after the infusion of Gemcitabine Injection. With the 3-week schedule, Gemcitabine Injection should be administered intravenously at 1250 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle. Cisplatin at a dose of 100 mg/m2 should be administered intravenously after the infusion of Gemcitabine Injection on Day 1. See prescribing information for cisplatin administration and hydration guidelines.

  Dose Modifications

  Dosage adjustments for hematologic toxicity may be required for Gemcitabine Injection and for cisplatin. Gemcitabine Injection dosage adjustment for hematological toxicity is based on the granulocyte and platelet counts taken on the day of therapy. Patients receiving Gemcitabine Injection should be monitored prior to each dose with a complete blood count (CBC), including differential and platelet counts. If marrow suppression is detected, therapy should be modified or suspended according to the guidelines in Table 3. For cisplatin dosage adjustment, see manufacturer’s prescribing information.

  In general, for severe (Grade 3 or 4) non-hematological toxicity, except alopecia and nausea/vomiting, therapy with Gemcitabine Injection plus cisplatin should be held or decreased by 50% depending on the judgment of the treating physician. During combination therapy with cisplatin, serum creatinine, serum potassium, serum calcium, and serum magnesium should be carefully monitored (Grade 3/4 serum creatinine toxicity for Gemcitabine Injection plus cisplatin was 5% versus 2% for cisplatin alone).

  2.4 Pancreatic Cancer

  Gemcitabine Injection should be administered by intravenous infusion at a dose of 1000 mg/m2 over 30 minutes once weekly for up to 7 weeks (or until toxicity necessitates reducing or holding a dose), followed by a week of rest from treatment. Subsequent cycles should consist of infusions once weekly for 3 consecutive weeks out of every 4 weeks.

  Dose Modifications

  Dosage adjustment is based upon the degree of hematologic toxicity experienced by the patient [see Warnings and Precautions (5.2)]. Clearance in women and the elderly is reduced and women were somewhat less able to progress to subsequent cycles [see Warnings and Precautions (5.2) and Clinical Pharmacology (12.3)].

  Patients receiving Gemcitabine Injection should be monitored prior to each dose with a complete blood count (CBC), including differential and platelet count. If marrow suppression is detected, therapy should be modified or suspended according to the guidelines in Table 3.

  Table 3: Dosage Reduction Guidelines

  Absolute granulocyte count

  (x 106/L)

   

  Platelet count

  (x 106/L)

  % of full dose

  ≥1000

  And

  ≥100,000

  100

  500-999

  Or

  50,000-99,999

  75

  <500

  Or

  <50,000

  Hold

  Laboratory evaluation of renal and hepatic function, including transaminases and serum creatinine, should be performed prior to initiation of therapy and periodically thereafter. Gemcitabine Injection should be administered with caution in patients with evidence of significant renal or hepatic impairment as there is insufficient information from clinical studies to allow clear dose recommendation for these patient populations.

  Patients treated with Gemcitabine Injection who complete an entire cycle of therapy may have the dose for subsequent cycles increased by 25%, provided that the absolute granulocyte count (AGC) and platelet nadirs exceed 1500 x 106/L and 100,000 x 106/L, respectively, and if non-hematologic toxicity has not been greater than WHO Grade 1. If patients tolerate the subsequent course of Gemcitabine Injection at the increased dose, the dose for the next cycle can be further increased by 20%, provided again that the AGC and platelet nadirs exceed 1500 x 106/L and 100,000 x 106/L, respectively, and that non-hematologic toxicity has not been greater than WHO Grade 1.

  2.5 Dose Modifications for Non-Hematologic Adverse Reactions

  Permanently discontinue Gemcitabine for any of the following  

  Unexplained dyspnea or other evidence of severe pulmonary toxicity   Severe hepatic toxicity   Hemolytic-Uremic Syndrome   Capillary Leak Syndrome   Posterior reversible encephalopathy syndrome  

  Withhold Gemcitabine or reduce dose by 50% for other severe (Grade 3 or 4) non-hematological toxicity until resolved. No dose modifications are recommended for alopecia, nausea, or vomiting. 

  2.6 Preparation and Administration Precautions

  Caution should be exercised in handling and preparing Gemcitabine Injection and diluted solution. The use of gloves is recommended. If Gemcitabine Injection and diluted solution contacts the skin or mucosa, immediately wash the skin thoroughly with soap and water or rinse the mucosa with copious amounts of water. Although acute dermal irritation has not been observed in animal studies, 2 of 3 rabbits exhibited drug-related systemic toxicities (death, hypoactivity, nasal discharge, shallow breathing) due to dermal absorption.

  Procedures for proper handling and disposal of anti-cancer drugs should be considered. Several guidelines on this subject have been published [see References (15)].

  2.7 Preparation for Intravenous Infusion Administration

  Each vial contains a gemcitabine concentration of 38 mg/mL. Hence, withdrawing 5.26 mL, 26.3 mL, or 52.6 mL of the vial contents will provide 200 mg, 1 g, or 2 g of gemcitabine, respectively. The appropriate amount of drug should be further diluted with 0.9% Sodium Chloride Injection to concentrations as low as 0.1 mg/mL.

  After dilution with 0.9% Sodium Chloride Injection the solution should be inspected visually for particulate matter and discoloration, prior to administration, whenever solution or container permits. If particulate matter or discoloration is found, do not administer.

  When prepared as directed, diluted gemcitabine solutions are stable for 24 hours at controlled room temperature 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Discard unused portion.

  The compatibility of Gemcitabine Injection with other drugs has not been studied. No incompatibilities have been observed with infusion bottles or polyvinyl chloride bags and administration sets.

  Close
  No Recall

  More Info
• Dr. Reddy’s Laboratories Limited
  

  ×

  Gemcitabine | Dr. Reddy's Laboratories Limited

  

  ---

  Gemcitabine for injection is for intravenous use only. Gemcitabine for injection may be administered on an outpatient basis.

  2.1 Ovarian Cancer

  Recommended Dose and Schedule

  The recommended dose of gemcitabine for injection is 1000 mg/m2 as an intravenous infusion over 30 minutes on Days 1 and 8 of each 21-day cycle, in combination with carboplatin AUC 4 intravenously after gemcitabine for injection administration on Day 1 of each 21-day cycle. Refer to carboplatin prescribing information for additional information.  

  Dose Modifications

  Recommended gemcitabine for injection dose modifications for myelosuppression are described Table 1 and Table 2 [see Warnings and Precautions (5.2)]. Refer to Dosage and Administration (2.5) for recommendations for non-hematologic adverse reactions.

  Table 1: Dosage Reduction Guidelines for Gemcitabine For Injection for Myelosuppression on Day of Treatment in Ovarian Cancer

  Treatment Day Absolute granulocyte count (x 106/L)   Platelet count (x 106/L) % of full dose Day 1 ≥1500 and ≥100,000 100%   <1500 or <100,000 Delay Treatment Cycle Day 8 ≥1500 and ≥100,000 100   1000 to 1499 or 75,000 to 99,999 50   <1000 or <75,000 Hold

  Table 2: Gemcitabine For Injection Dose Modification for Myelosuppression in Previous Cycle In Ovarian Cancer

  Occurrence Myelosuppression During Treatment Cycle Dose Modification Initial Occurrence Absolute granulocyte count less than 500 x 106/L for more than 5 days
  Absolute granulocyte count less than 100 x 106/L for more than 3 days
  Febrile neutropenia Platelets less than 25,000x106/L
  Cycle delay of more than one week due to toxicity Permanently reduce gemcitabine for injection to 800 mg/m2 on Days 1 and 8 Subsequent Occurrence If any of the above toxicities occur after the initial dose reduction Permanently reduce gemcitabine for injection dose to 800 mg/m2on Day 1 only  2.2 Breast Cancer

  Recommended Dose and Schedule

  The recommended dose of gemcitabine for injection is 1250 mg/m2 intravenously over 30 minutes on Days 1 and 8 of each 21-day cycle that includes paclitaxel. Paclitaxel should be administered at 175 mg/m2 on Day 1 as a 3 hour intravenous infusion before gemcitabine for injection administration.

  Dose Modifications Recommended dose modifications for gemcitabine for injection for myelosuppression are described in Table 3 [see Warnings and Precautions (5.2)]. Refer to Dosage and Administration (2.5) for recommendations for non-hematologic adverse reactions. 

  Table 3: Recommended Dose Reductions for Gemcitabine For Injection for Myelosuppression on Day of Treatment in Breast Cancer

  Treatment Day Absolute granulocyte count (x 106/L)    Platelet count(x 106/L)  % of full dose Day 1 ≥1500 and ≥ 100,000 100%   less than1500 or less than 100,000 Hold Day 8 ≥ 1200 and > 75,000 100%   1000 to 1199 or 50,000 to 75,000 75% 700 to 999 and ≥ 50,000 50%   < 700 or < 50,000 Hold 2.3 Non-Small Cell Lung Cancer

  Recommended Dose and Schedule

  Every 4-week schedule The recommended dose of gemcitabine for injection is 1000 mg/m2 intravenously over 30 minutes on Days 1, 8, and 15 in combination with cisplatin therapy. Administer cisplatin intravenously at 100 mg/m2 on Day 1 after the infusion of gemcitabine for injection.

  Every 3-week schedule

  The recommended dose of gemcitabine for injection is 1250 mg/m2 intravenously over 30 minutes on Days 1 and 8 in combination with cisplatin therapy. Administer cisplatin intravenously at 100 mg/m2 on Day 1 after the infusion of gemcitabine for injection.

  Dose Modifications

  Recommended dose modifications for gemcitabine for injection myelosuppression are described in Table 4 [see Warnings and Precautions (5.2)]. Refer to Dosage and Administration (2.5) for gemcitabine for injection recommendations for non-hematologic adverse reactions. 

  2.4 Pancreatic Cancer

  Recommended Dose and Schedule

  The recommended dose of gemcitabine for injection is 1000 mg/m2 over 30 minutes intravenously. The recommended treatment schedule

  • Weeks 1 to 8: weekly dosing for the first 7 weeks followed by one week rest.

  • After week 8: weekly dosing on Days 1, 8, and 15 of 28-day cycles.

  Dose Modifications

  Recommended dose modifications for gemcitabine for injection for myelosuppression are described in Table 4 [see Warnings and Precautions (5.2)]. Refer to Dosage and Administration (2.5) for recommendations for non-hematologic adverse reactions.

  Patients receiving gemcitabine for injection should be monitored prior to each dose with a complete blood count (CBC), including differential and platelet count. If marrow suppression is detected, therapy should be modified or suspended according to the guidelines in Table 4. 

  Table 4: Recommended Dose Reductions for Gemcitabine For Injection for Myelosuppression in Pancreatic Cancer and Non-Small Cell Lung Cancer

  Absolute granulocyte count (x 106/L)   Platelet count(x 106/L) % of full dose ≥1000 And ≥100,000 100 500 to 999 Or 50,000 to 99,999 75 <500 Or <50,000 Hold

  2.5 Dose Modifications for Non-Hematologic Adverse Reactions

  Permanently discontinue gemcitabine for injection for any of the following

  Unexplained dyspnea or other evidence of severe pulmonary toxicity Severe hepatic toxicity Hemolytic-Uremic Syndrome Capillary Leak Syndrome Posterior reversible encephalopathy syndrome

  Withhold gemcitabine for injection or reduce dose by 50% for other severe (Grade 3 or 4) non-hematological toxicity until resolved. No dose modifications are recommended for alopecia, nausea, or vomiting. 

  2.6 Preparation and Administration Precautions

  Exercise caution and wear gloves when preparing gemcitabine for injection solutions. Immediately wash the skin thoroughly or rinse the mucosa with copious amounts of water if gemcitabine for injection contacts the skin or mucus membranes. Death has occurred in animal studies due to dermal absorption. For further guidance on handling gemcitabine for injection go to “OSHA Hazardous Drugs” (refer to antineoplastic weblinks including OSHA Technical Manual) at OSHA. http://www.osha.gov/SLTC/hazardousdrugs/index.html

  2.7 Preparation for Intravenous Infusion Administration

  Reconstitute the vials with 0.9% Sodium Chloride Injection without preservatives. Add 5 mL to the 200 mg vial or 25 mL to the 1 g vial. These dilutions each yield a gemcitabine for injection concentration of 38 mg/mL. Complete withdrawal of the vial contents will provide 200 mg or 1 g of gemcitabine for injection. Prior to administration the appropriate amount of drug must be diluted with 0.9% Sodium Chloride Injection. Final concentrations may be as low as 0.1 mg/mL.

  Reconstituted gemcitabine for injection is a clear, colorless to light straw-colored solution. Inspect visually prior to administration and discard for particulate matter or discoloration. Gemcitabine for injection solutions are stable for 24 hours at controlled room temperature of 20° to 25°C (68° to 77°F). Do not refrigerate as crystallization can occur.

  No incompatibilities have been observed with infusion bottles or polyvinyl chloride bags and administration sets.

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  Gemcitabine | Bedford Laboratories

  

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  Gemcitabine for injection is for intravenous use only. Gemcitabine for injection may be administered on an outpatient basis.

  2.1 Ovarian Cancer

  Recommended Dose and Schedule

  The recommended dose of gemcitabine for injection is 1000 mg/m2 as an intravenous infusion over 30 minutes on Days 1 and 8 of each 21-day cycle, in combination with carboplatin AUC 4 intravenously after gemcitabine for injection administration on Day 1 of each 21-day cycle. Refer to carboplatin prescribing information for additional information.  

  Dose Modifications

  Recommended gemcitabine for injection dose modifications for myelosuppression are described Table 1 and Table 2 [see Warnings and Precautions (5.2)]. Refer to Dosage and Administration (2.5) for recommendations for non-hematologic adverse reactions.

  Table 1: Dosage Reduction Guidelines for Gemcitabine For Injection for Myelosuppression on Day of Treatment in Ovarian Cancer

  Treatment Day Absolute granulocyte count (x 106/L)   Platelet count (x 106/L) % of full dose Day 1 ≥1500 and ≥100,000 100%   <1500 or <100,000 Delay Treatment Cycle Day 8 ≥1500 and ≥100,000 100   1000 to 1499 or 75,000 to 99,999 50   <1000 or <75,000 Hold

  Table 2: Gemcitabine For Injection Dose Modification for Myelosuppression in Previous Cycle In Ovarian Cancer

  Occurrence Myelosuppression During Treatment Cycle Dose Modification Initial Occurrence Absolute granulocyte count less than 500 x 106/L for more than 5 days
  Absolute granulocyte count less than 100 x 106/L for more than 3 days
  Febrile neutropenia Platelets less than 25,000x106/L
  Cycle delay of more than one week due to toxicity Permanently reduce gemcitabine for injection to 800 mg/m2 on Days 1 and 8 Subsequent Occurrence If any of the above toxicities occur after the initial dose reduction Permanently reduce gemcitabine for injection dose to 800 mg/m2on Day 1 only  2.2 Breast Cancer

  Recommended Dose and Schedule

  The recommended dose of gemcitabine for injection is 1250 mg/m2 intravenously over 30 minutes on Days 1 and 8 of each 21-day cycle that includes paclitaxel. Paclitaxel should be administered at 175 mg/m2 on Day 1 as a 3 hour intravenous infusion before gemcitabine for injection administration.

  Dose Modifications Recommended dose modifications for gemcitabine for injection for myelosuppression are described in Table 3 [see Warnings and Precautions (5.2)]. Refer to Dosage and Administration (2.5) for recommendations for non-hematologic adverse reactions. 

  Table 3: Recommended Dose Reductions for Gemcitabine For Injection for Myelosuppression on Day of Treatment in Breast Cancer

  Treatment Day Absolute granulocyte count (x 106/L)    Platelet count(x 106/L)  % of full dose Day 1 ≥1500 and ≥ 100,000 100%   less than1500 or less than 100,000 Hold Day 8 ≥ 1200 and > 75,000 100%   1000 to 1199 or 50,000 to 75,000 75% 700 to 999 and ≥ 50,000 50%   < 700 or < 50,000 Hold 2.3 Non-Small Cell Lung Cancer

  Recommended Dose and Schedule

  Every 4-week schedule The recommended dose of gemcitabine for injection is 1000 mg/m2 intravenously over 30 minutes on Days 1, 8, and 15 in combination with cisplatin therapy. Administer cisplatin intravenously at 100 mg/m2 on Day 1 after the infusion of gemcitabine for injection.

  Every 3-week schedule

  The recommended dose of gemcitabine for injection is 1250 mg/m2 intravenously over 30 minutes on Days 1 and 8 in combination with cisplatin therapy. Administer cisplatin intravenously at 100 mg/m2 on Day 1 after the infusion of gemcitabine for injection.

  Dose Modifications

  Recommended dose modifications for gemcitabine for injection myelosuppression are described in Table 4 [see Warnings and Precautions (5.2)]. Refer to Dosage and Administration (2.5) for gemcitabine for injection recommendations for non-hematologic adverse reactions. 

  2.4 Pancreatic Cancer

  Recommended Dose and Schedule

  The recommended dose of gemcitabine for injection is 1000 mg/m2 over 30 minutes intravenously. The recommended treatment schedule

  • Weeks 1 to 8: weekly dosing for the first 7 weeks followed by one week rest.

  • After week 8: weekly dosing on Days 1, 8, and 15 of 28-day cycles.

  Dose Modifications

  Recommended dose modifications for gemcitabine for injection for myelosuppression are described in Table 4 [see Warnings and Precautions (5.2)]. Refer to Dosage and Administration (2.5) for recommendations for non-hematologic adverse reactions.

  Patients receiving gemcitabine for injection should be monitored prior to each dose with a complete blood count (CBC), including differential and platelet count. If marrow suppression is detected, therapy should be modified or suspended according to the guidelines in Table 4. 

  Table 4: Recommended Dose Reductions for Gemcitabine For Injection for Myelosuppression in Pancreatic Cancer and Non-Small Cell Lung Cancer

  Absolute granulocyte count (x 106/L)   Platelet count(x 106/L) % of full dose ≥1000 And ≥100,000 100 500 to 999 Or 50,000 to 99,999 75 <500 Or <50,000 Hold

  2.5 Dose Modifications for Non-Hematologic Adverse Reactions

  Permanently discontinue gemcitabine for injection for any of the following

  Unexplained dyspnea or other evidence of severe pulmonary toxicity Severe hepatic toxicity Hemolytic-Uremic Syndrome Capillary Leak Syndrome Posterior reversible encephalopathy syndrome

  Withhold gemcitabine for injection or reduce dose by 50% for other severe (Grade 3 or 4) non-hematological toxicity until resolved. No dose modifications are recommended for alopecia, nausea, or vomiting. 

  2.6 Preparation and Administration Precautions

  Exercise caution and wear gloves when preparing gemcitabine for injection solutions. Immediately wash the skin thoroughly or rinse the mucosa with copious amounts of water if gemcitabine for injection contacts the skin or mucus membranes. Death has occurred in animal studies due to dermal absorption. For further guidance on handling gemcitabine for injection go to “OSHA Hazardous Drugs” (refer to antineoplastic weblinks including OSHA Technical Manual) at OSHA. http://www.osha.gov/SLTC/hazardousdrugs/index.html

  2.7 Preparation for Intravenous Infusion Administration

  Reconstitute the vials with 0.9% Sodium Chloride Injection without preservatives. Add 5 mL to the 200 mg vial or 25 mL to the 1 g vial. These dilutions each yield a gemcitabine for injection concentration of 38 mg/mL. Complete withdrawal of the vial contents will provide 200 mg or 1 g of gemcitabine for injection. Prior to administration the appropriate amount of drug must be diluted with 0.9% Sodium Chloride Injection. Final concentrations may be as low as 0.1 mg/mL.

  Reconstituted gemcitabine for injection is a clear, colorless to light straw-colored solution. Inspect visually prior to administration and discard for particulate matter or discoloration. Gemcitabine for injection solutions are stable for 24 hours at controlled room temperature of 20° to 25°C (68° to 77°F). Do not refrigerate as crystallization can occur.

  No incompatibilities have been observed with infusion bottles or polyvinyl chloride bags and administration sets.

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