Gemcitabine is a nucleoside metabolic inhibitor indicated:

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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)

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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)

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in combination with cisplatin, for the treatment of non-small cell lung cancer. (1.3)

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as a single agent for the treatment of pancreatic cancer. (1.4)

Gemcitabine for injection, USP is for intravenous use only.

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Ovarian Cancer: 1,000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle. (2.1)

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Breast Cancer: 1,250 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle. (2.2)

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Non-Small Cell Lung Cancer: 1,000 mg/m2 over 30 minutes on Days 1, 8, and 15 of each 28-day cycle or 1,250 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle. (2.3)

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Pancreatic Cancer: 1,000 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)

For injection: 2 gram lyophilized powder in single-dose vials for reconstitution. (3)

Patients with a known hypersensitivity to gemcitabine. (4)

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Schedule-Dependent Toxicity: Increased toxicity with infusion time greater than 60 minutes or dosing more frequently than once weekly. (5.1)

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Myelosuppression: Monitor for myelosuppression prior to each cycle and reduce or withhold dose for severe myelosuppression. (5.2, 5.8)

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Severe Cutaneous Adverse Reactions (SCARs): Permanently discontinue gemcitabine injection if SCARs occur. (5.3)

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Pulmonary Toxicity and Respiratory Failure: Discontinue gemcitabine for injection for unexplained dyspnea or other evidence of severe pulmonary toxicity. (5.4)

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Hemolytic Uremic Syndrome (HUS): Monitor renal function prior to initiation and during treatment. Discontinue gemcitabine for injection for HUS or severe renal impairment. (5.5)

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Hepatic Toxicity: Monitor hepatic function prior to initiation and during treatment. Discontinue gemcitabine for injection for severe hepatic toxicity. (5.6)

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Embryo-Fetal Toxicity: Can cause fetal harm. Advise females and males of reproductive potential to use effective contraception. (5.7, 8.1)

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Exacerbation of Radiation Therapy Toxicity: May cause severe and life-threatening toxicity when administered during or within 7 days of radiation therapy. (5.8)

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Capillary Leak Syndrome: Discontinue gemcitabine for injection. (5.9)

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Posterior Reversible Encephalopathy Syndrome (PRES): Discontinue gemcitabine for injection. (5.10)

The most common adverse reactions for the single agent (≥20%) are nausea/vomiting, anemia, increased aspartate aminotransferase (AST), increased alanine aminotransferase (ALT), neutropenia, increased alkaline phosphatase, proteinuria, fever, hematuria, rash, thrombocytopenia, dyspnea, and edema. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Hospira, Inc. at 1-800-441-4100, or FDA at 1-800-FDA-1088 or https://www.fda.gov/medwatch.

Lactation: Advise not to breastfeed. (8.2)