Gemcitabine

GEMCITABINE- gemcitabine hydrochloride injection, solution
Meitheal Pharmaceuticals 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 1,000 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 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 (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
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 x 10 6 /L for more than 5 days or
  • Absolute neutrophil count less than 100 x 10 6 /L for more than 3 days or
  • Febrile neutropenia or
  • Platelets less than 25,000 x 10 6 /L
  • Cycle delay for more than one week due to toxicity
Permanently reduce gemcitabine injection to 800 mg/m 2 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/m 2 on Day 1 only

2.2 Breast Cancer

Recommended Dose and Schedule

The recommended dosage of gemcitabine injection is 1,250 mg/m 2 intravenously over 30 minutes on Days 1 and 8 of each 21-day cycle in combination with paclitaxel 175 mg/m 2 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 (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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