Gemzar

GEMZAR- gemcitabine hydrochloride injection, powder, lyophilized, for solution
Eli Lilly and Company

1 INDICATIONS AND USAGE

1.1 Ovarian Cancer

GEMZAR® 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

GEMZAR 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

GEMZAR 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

GEMZAR 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. GEMZAR is indicated for patients previously treated with fluorouracil.

2 DOSAGE AND ADMINISTRATION

2.1 Ovarian Cancer

Recommended Dose and Schedule

The recommended dosage of GEMZAR 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 GEMZAR administration. Refer to carboplatin prescribing information for additional information.

Dosage Modifications

Recommended GEMZAR 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 GEMZAR 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 GEMZAR 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 25,000×106 /L or
  • Cycle delay for more than one week due to toxicity
Permanently reduce GEMZAR 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 GEMZAR to 800 mg/m2 on Day 1 only

2.2 Breast Cancer

Recommended Dose and Schedule

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

Dosage Modifications

Recommended GEMZAR 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 GEMZAR 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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