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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     Platelet count   % of full dose     (x 106/L)     (x 106/L)    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 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 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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