Medication Guide
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Prescribing Information
Dosage and Administration
Recommended Dose and Schedule
The recommended dosage of gemcitabine is 1,000 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 administration. Refer to carboplatin prescribing information for additional information.
Dosage Modifications
Recommended gemcitabine dosage modifications 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 1,500 | And | Greater than or equal to 100,000 | None |
Less than 1,500 | Or | Less than 100,000 | Delay Treatment Cycle | |
Day 8 | Greater than or equal to 1,500 | And | Greater than or equal to 100,000 | None |
1,000 to 1,499 | Or | 75,000 to 99,999 | 50% of full dose | |
Less than 1,000 | Or | Less than 75,000 | Hold |
| Occurrence | Myelosuppression During Treatment Cycle | Dosage Modification |
|---|---|---|
Initial Occurrence |
| 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 to 800 mg/m2 on Day 1 only |
Recommended Dose and Schedule
The recommended dosage of gemcitabine is 1,250 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 administration. Refer to paclitaxel prescribing information for additional information.
Dosage Modifications
Recommended gemcitabine dosage modifications 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 1,500 | And | Greater than or equal to 100,000 | None |
Less than 1,500 | Or | Less than 100,000 | Hold | |
Day 8 | Greater than or equal to 1,200 | And | Greater than 75,000 | None |
1,000 to 1,199 | 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 |
Recommended Dose and Schedule
28-day schedule
The recommended dosage of gemcitabine is 1,000 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 administration.
21-day schedule
The recommended dosage of gemcitabine is 1,250 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 administration.
Refer to cisplatin prescribing information for additional information.
Dosage Modifications
Recommended dosage modifications for gemcitabine 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)].
Recommended Dose and Schedule
The recommended dosage of gemcitabine is 1,000 mg/m2 intravenously over 30 minutes. The recommended treatment schedule is as follows:
Dosage Modifications
Recommended dosage modifications for gemcitabine 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 1,000 | 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 |
Permanently discontinue gemcitabine for any of the following:
Withhold gemcitabine 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.
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