GEMCITABINE

GEMCITABINE- gemcitabine hydrochloride injection, solution
BluePoint Laboratories

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 is indicated in combination with cisplatin 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/m 2 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 the carboplatin prescribing information for additional information.

Dose Modifications

Recommended Gemcitabine Injection dose modifications for myelosuppression are described in Table 1 and Table 2 [see Warnings and Precautions ( 5.2)]. Refer to the dose modification recommendations 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 (x 106 /L)

Platelet count (x 106 /L)

Dose modification

Day 1

Greater than or equal to 1500

Less than 1500

and

or

Greater than or equal to 100,000 Less than 100,000

None

Delay Treatment Cycle

Day 8

Greater than or equal to 1500

1000-1499 Less than 1000

and

or or

Greater than or equal to 100,000 75,000-99,999 Less than 75,000

None

50% of full dose Hold

Table 2: Recommended Dosage Modifications for Gemcitabine Injection for Myelosuppression in Previous Cycle in Ovarian Cancer

Occurrence

Myelosuppression During Treatment Cycle

Dose Modification

Initial Occurrence

Absolute neutrophil count less than500 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 25,000×106 /L Cycle delay of more than one week due to toxicity

Permanently reduce Gemcitabine Injection dose 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 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/m 2 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 the paclitaxel prescribing information for additional information.

Dosage Modifications

Recommended Gemcitabine Injection dose 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 Injection for Myelosuppression on Day of Treatment in Breast Cancer

Treatment Day

Absolute neutrophil count (x 106 /L)

Platelet count (x 10 6 /L)

Dose 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

1000-1199

or

50,000-75,000

75% of full dose

700-999

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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