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)].
| 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 |
| Occurrence | Myelosuppression During Treatment Cycle | Dosage Modification |
|---|---|---|
| Initial Occurrence |
| 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)].
| 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)].
| 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:
- Unexplained dyspnea or evidence of severe pulmonary toxicity [see Warnings and Precautions (5.3)]
- Hemolytic uremic syndrome (HUS) or severe renal impairment [see Warnings and Precautions (5.4)]
- Severe hepatic toxicity [see Warnings and Precautions (5.5)]
- Capillary leak syndrome (CLS) [see Warnings and Precautions (5.8)]
- Posterior reversible encephalopathy syndrome (PRES) [see Warnings and Precautions (5.9)]
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.