Gemcitabine

GEMCITABINE- gemcitabine hydrochloride injection, solution
Hospira, Inc.

1 INDICATIONS AND USAGE

1.1 Ovarian Cancer

Gemcitabine Injection 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 Injection 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 Injection 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 Injection 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 Injection 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 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

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