Gemcitabine
GEMCITABINE- gemcitabine hydrochloride injection, powder, lyophilized, for solution
Sagent Pharmaceuticals
1 INDICATIONS AND USAGE
1.1 Ovarian Cancer
Gemcitabine for Injection, USP in combination with carboplatin is indicated for the treatment of patients with advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy.
1.2 Breast Cancer
Gemcitabine for Injection, USP in combination with paclitaxel is indicated for the first-line treatment of patients with metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated.
1.3 Non-Small Cell Lung Cancer
Gemcitabine for Injection, USP in combination with cisplatin is indicated for the first-line treatment of patients with inoperable, locally advanced (Stage IIIA or IIIB) or metastatic (Stage IV) non-small cell lung cancer (NSCLC).
1.4 Pancreatic Cancer
Gemcitabine for Injection, USP is indicated as first-line treatment for patients with locally advanced (nonresectable Stage II or Stage III) or metastatic (Stage IV) adenocarcinoma of the pancreas. Gemcitabine for Injection, USP is indicated for patients previously treated with fluorouracil.
2 DOSAGE AND ADMINISTRATION
2.1 Ovarian Cancer
Recommended Dose and Schedule
The recommended dosage of Gemcitabine for Injection, USP 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 for Injection, USP administration. Refer to carboplatin prescribing information for additional information.
Dosage Modifications
Recommended Gemcitabine for Injection, USP 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 (x 10 6 /L) | Platelet Count (x 10 6 /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 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 to 800 mg/m2 on Day 1 only |
2.2 Breast Cancer
Recommended Dose and Schedule
The recommended dosage of Gemcitabine for Injection, USP 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 for Injection, USP administration. Refer to paclitaxel prescribing information for additional information.
Dosage Modifications
Recommended Gemcitabine for Injection, USP 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 (x 10 6 /L) | Platelet Count (x 10 6 /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 |
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