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GEMCITABINE - SOLUTION Dosage and Administration (gemcitabine injection)

2 DOSAGE AND ADMINISTRATION

2.1 Ovarian Cancer

Recommended Dose and Schedule

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

Dosage Modifications

Recommended dosage modifications for Gemcitabine Injection for myelosuppression are described in Tables 1 and 2 [see Warnings and Precautions (5.2)]. Refer to the recommended dosage modifications for non-hematologic adverse reactions [see Dosage and Administration (2.5)].

Table 1: Recommended Dosage Modifications for Gemcitabine Injection for Myelosuppression on Day of Treatment in Ovarian Cancer
Treatment Day Absolute Neutrophil Count
(× 106/L)
Platelet Count
(× 106/L)
Dosage Modification
Day 1 Greater than or equal to 1500 And Greater than or equal to 100,000 None
Less than 1500 Or Less than 100,000 Delay Treatment Cycle
Day 8 Greater than or equal to 1500 And Greater than or equal to 100,000 None
1000 to 1499 Or 75,000 to 99,999 50% of full dose
Less than 1000 Or Less than 75,000 Hold
Table 2: Recommended Dosage Modifications for Gemcitabine Injection for Myelosuppression in Previous Cycle in Ovarian Cancer
Occurrence Myelosuppression During Treatment Cycle Dosage Modification
Initial Occurrence
  • Absolute neutrophil count less than 500 × 106/L for more than 5 days or
  • Absolute neutrophil count less than 100 × 106/L for more than 3 days or
  • Febrile neutropenia or
  • Platelets less than 25,000 × 106/L
  • Cycle delay for more than one week due to toxicity
Permanently reduce Gemcitabine 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 Injection dose to 800 mg/m2 on Day 1 only

2.2 Breast Cancer

Recommended Dose and Schedule

The recommended dosage of Gemcitabine Injection is 1250 mg/m2 intravenously over 30 minutes on Days 1 and 8 of each 21-day cycle in combination with paclitaxel 175 mg/m2 administered as a 3-hour intravenous infusion on Day 1 before Gemcitabine Injection administration. Refer to paclitaxel prescribing information for additional information.

Dosage Modifications

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

Table 3: Recommended Dosage Modifications for Gemcitabine Injection for Myelosuppression on Day of Treatment in Breast Cancer
Treatment Day Absolute Neutrophil Count
(× 106/L)
Platelet Count
(× 106/L)
Dosage Modification
Day 1 Greater than or equal to 1500 And Greater than or equal to 100,000 None
Less than 1500 Or Less than 100,000 Hold
Day 8 Greater than or equal to 1200 And Greater than 75,000 None
1000 to 1199 Or 50,000 to 75,000 75% of full dose
700 to 999 And Greater than or equal to 50,000 50% of full dose
Less than 700 Or Less than 50,000 Hold

2.3 Non-Small Cell Lung Cancer

Recommended Dose and Schedule

28-day schedule

The recommended dosage of Gemcitabine Injection is 1000 mg/m2 intravenously over 30 minutes on Days 1, 8, and 15 of each 28-day cycle in combination with cisplatin 100 mg/m2 administered intravenously on Day 1 after Gemcitabine Injection administration.

21-day schedule

The recommended dosage of Gemcitabine Injection is 1250 mg/m2 intravenously over 30 minutes on Days 1 and 8 of each 21-day cycle in combination with cisplatin 100 mg/m2 administered intravenously on Day 1 after Gemcitabine Injection administration.

Refer to cisplatin prescribing information for additional information.

Dosage Modifications

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

2.4 Pancreatic Cancer

Recommended Dose and Schedule

The recommended dosage of Gemcitabine Injection is 1000 mg/m2 intravenously over 30 minutes. 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 each 28-day cycle.

Dosage Modifications

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

Table 4: Recommended Dosage Modifications for Gemcitabine Injection for Myelosuppression in Pancreatic Cancer and Non-Small Cell Lung Cancer
Absolute Neutrophil Count
(× 106/L)
Platelet Count
(× 106/L)
Dosage Modification
Greater than or equal to 1000 And Greater than or equal to 100,000 None
500 to 999 Or 50,000 to 99,999 75% of full dose
Less than 500 Or Less than 50,000 Hold

2.5 Dosage Modifications for Non-Hematologic Adverse Reactions

Permanently discontinue Gemcitabine Injection for any of the following:

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

2.6 Preparation

Gemcitabine Injection is a cytotoxic drug. Follow applicable special handling and disposal procedures.1

Exercise caution and wear gloves when preparing Gemcitabine Injection solutions. Immediately wash the skin thoroughly or rinse the mucosa with copious amounts of water if Gemcitabine Injection contacts the skin or mucus membranes. Death has occurred in animal studies due to dermal absorption.

Preparation for Intravenous Infusion Administration

  • Withdraw the calculated dose from the vial and discard any unused portion.
  • Prior to administration, dilute the appropriate amount of drug with 0.9% Sodium Chloride Injection to a minimum final concentration of at least 0.1 mg/mL.
  • Store diluted Gemcitabine Injection solution for no more than 24 hours at controlled room temperature of 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Discard if not used within 24 hours after dilution.
  • Visually inspect for particulate matter or discoloration prior to administration and discard if particulate matter or discoloration is observed.
  • No incompatibilities have been observed with infusion bottles or polyvinyl chloride bags and administration sets.
 
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