GEMCITABINE HYDROCHLORIDE

GEMCITABINE HYDROCHLORIDE- gemcitabine hydrochloride injection, powder, lyophilized, for solution
Mylan Institutional LLC

1 INDICATIONS AND USAGE

1.1 Ovarian Cancer

Gemcitabine 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 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 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 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 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 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 administration. Refer to carboplatin prescribing information for additional information.

Dosage Modifications

Recommended gemcitabine for injection 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)].

Table 1: Recommended Dosage Modifications for Gemcitabine for Injection for Myelosuppression on Day of Treatment in Ovarian Cancer

Treatment Day

Absolute Neutrophil Count

(x 106 /L)

Platelet Count

(x 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 for Injection for Myelosuppression in Previous Cycle in Ovarian Cancer

Occurrence

Myelosuppression During Treatment Cycle

Dosage Modification

Initial Occurrence

Absolute neutrophil count less than 500 x 106 /L for more than 5 days or
Absolute neutrophil count less than 100 x 106 /L for more than 3 days or
Febrile neutropenia or
Platelets less than 25,000 x 106 /L or
Cycle delay for more than one week due to toxicity

Permanently reduce gemcitabine for 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 for injection to 800 mg/m2 on Day 1 only

2.2 Breast Cancer

Recommended Dose and Schedule

The recommended dosage of gemcitabine for 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 for injection administration. Refer to paclitaxel prescribing information for additional information.

Dosage Modifications

Recommended gemcitabine for injection 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)].

Table 3: Recommended Dosage Modifications for Gemcitabine for Injection for Myelosuppression on Day of Treatment in Breast Cancer

Treatment Day

Absolute Neutrophil Count

(x 106 /L)

Platelet Count

(x 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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