Gemcitabine
Gemcitabine Prescribing Information
Warnings and Precautions, Hemolytic Uremic Syndrome (
Hemolytic uremic syndrome (HUS), including fatalities from renal failure or the requirement for dialysis, can occur with gemcitabine. In clinical trials, HUS occurred in 0.25% of 2429 patients. Most fatal cases of renal failure were due to HUS
Assess renal function prior to initiation of Gemcitabine Injection and periodically during treatment. Consider the diagnosis of HUS in patients who develop anemia with evidence of microangiopathic hemolysis; increased bilirubin or LDH; reticulocytosis; severe thrombocytopenia; or evidence of renal failure (increased serum creatinine or BUN)
Gemcitabine Injection is a nucleoside metabolic inhibitor indicated:
- in combination with carboplatin, for the treatment of advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy. ()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.
- in combination with paclitaxel, for first-line treatment of metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated. ()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.
- in combination with cisplatin for the treatment of non-small cell lung cancer. ()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).
- as a single agent for the treatment of pancreatic cancer. ()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.
Gemcitabine Injection is for intravenous use only.
- Ovarian Cancer: 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21 -day cycle. ()2.1 Ovarian CancerRecommended Dose and Schedule
The recommended dosage of Gemcitabine Injection is 1000 mg/m2intravenously 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 ModificationsRecommended 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 dayAbsolute Neutrophil Count (x 106/L)Platelet Count(x 106/L)Dosage ModificationDay 1 Greater than or equal to
1500And 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
1500And 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 OccurrenceMyelosuppression During Treatment CycleDosage ModificationInitial 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
● Cycle delay of more than one week due to toxicityPermanently reduce Gemcitabine
Injection to 800 mg/m2on Days 1 and 8Subsequent
OccurrenceIf any of the above toxicities occur after the initial dose reduction Permanently reduce Gemcitabine
Injection dose to 800 mg/m2on Day 1 only - Breast Cancer: 1250 mg/m2 over 30 minutes on Days 1 and 8 of each 21 -day cycle. ()2.2 Breast CancerRecommended Dose and Schedule
The recommended dosage of Gemcitabine Injection is 1250 mg/m2intravenously over 30 minutes on Days 1 and 8 of each 21-day cycle in combination with paclitaxel 175 mg/m2administered as a 3-hour intravenous infusion on Day 1 before Gemcitabine Injection administration. Refer to paclitaxel prescribing information for additional information.
Dosage ModificationsRecommended 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 DayAbsolute Neutrophil Count (x 106/L)Platelet Count(x 106/L)Dosage ModificationDay 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 - Non-Small Cell Lung Cancer: 1000 mg/m2 over 30 minutes on Days 1, 8, and 15 of each 28-day cycle or 1250 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle. ()2.3 Non-Small Cell Lung CancerRecommended Dose and Schedule28-day schedule
The recommended dosage of Gemcitabine Injection is 1000 mg/m2intravenously over 30 minutes on Days 1, 8, and 15 of each 28-day cycle in combination with cisplatin 100 mg/m2administered intravenously on Day 1 after Gemcitabine Injection administration.
21-day scheduleThe recommended dosage of Gemcitabine Injection is 1250 mg/m2intravenously over 30 minutes on Days 1 and 8 of each 21-day cycle in combination with cisplatin 100 mg/m2administered intravenously on Day 1 after Gemcitabine Injection administration.
Refer to cisplatin prescribing information for additional information.
Dosage ModificationsRecommended dosage modifications for Gemcitabine Injection myelosuppression are described in Table 4
[see Warnings and Precautions (5.2)]. Refer to the recommended dosage modifications for non-hematologic adverse reactions[see Dosage and Administration (2.5)]. - Pancreatic Cancer: 1000 mg/m2 over 30 minutes once weekly for the first 7 weeks, then one-week rest, then once weekly for 3 weeks of each 28-day cycle. ()2.4 Pancreatic CancerRecommended Dose and Schedule
The recommended dosage of Gemcitabine Injection is 1000 mg/m2intravenously over 30 minutes. The recommended treatment schedule is as follows:
- Weeks 1 to 8: weekly dosing for the first 7 weeks followed by one-week rest.
- After week 8: weekly dosing on Days 1, 8, and 15 of each 28-day cycle.
Dosage ModificationsRecommended dosage modifications for Gemcitabine Injection for myelosuppression are described in Table 4
[see Warnings and Precautions (5.2)].Refer to the recommended dosage modifications for non-hematologic adverse reactions[see Dosage and Administration (2.5)].Table 4: Recommended Dosage Modifications for Gemcitabine Injection for Myelosuppression in Pancreatic Cancer and Non-Small Cell Lung Cancer Absolute Neutrophil Count (x 106/L)Platelet count (x 106/L)Dosage ModificationGreater than or equal to 1000 And Greater than or equal to 100,000 None 500 to 999 Or 50,000 to 99,999 75% of full dose Less than 500 Or Less than 50,000 Hold
Injection: 200 mg/5.26 mL (38 mg/mL), 1 g/26.3 mL (38 mg/mL), and 2 g/52.6 mL (38 mg/mL) as a clear and colorless to light straw-colored solution in a single-dose vial.
Lactation: Advise not to breastfeed.
There is no information regarding the presence of gemcitabine or its metabolites in human milk, or their effects on the breastfed infant or on milk production. Due to the potential for serious adverse reactions in breastfed infants, advise women not to breastfeed during treatment with Gemcitabine Injection and for at least one week following the last dose.
Gemcitabine Injection is contraindicated in patients with a known hypersensitivity to gemcitabine.
Reactions include anaphylaxis
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in the clinical practice.