Gemcitabine

1 INDICATIONS AND USAGE Gemcitabine for 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 ) • 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 ) • in combination with cisplatin, for the treatment of non-small cell lung cancer. ( 1.3 ) • as a single agent for the treatment of pancreatic cancer.

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: • Hypersensitivity [see Contraindications ( 4 )] • Schedule-Dependent Toxicity [see Warnings and Precautions ( 5.1 )] • Myelosuppression [see Warnings and Precautions ( 5.2 )] • Pulmonary Toxicity and Respiratory Failure [see Warnings and Precautions ( 5.3 )] • Hemolytic Uremic Syndrome [see Warnings and Precautions ( 5.4 )] • Hepatic Toxicity [see Warnings and Precautions ( 5.5 )] • Exacerbation of Radiation Therapy Toxicity [see Warnings and Precautions ( 5.7 )] • Capillary Leak Syndrome [see Warnings and Precautions ( 5.8 )] • Posterior Reversible Encephalopathy Syndrome [see Warnings and Precautions ( 5.9 )] The most common adverse reactions for the single agent (≥20%) ar...

8.1 Pregnancy Risk Summary Based on animal data and its mechanism of action, gemcitabine can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology ( 12.1 )] . There are no available data on the use of gemcitabine in pregnant women. In animal reproduction studies, gemcitabine was teratogenic, embryotoxic, and fetotoxic in mice and rabbits (see Data ) . Advise pregnant women of the potential risk to a fetus [see Use in Special Populations ( 8.3 )] . In the U.S.

5 WARNINGS AND PRECAUTIONS • Schedule-Dependent Toxicity: Increased toxicity with infusion time greater than 60 minutes or dosing more frequently than once weekly. ( 5.1 ) • Myelosuppression: Monitor for myelosuppression prior to each cycle and reduce or withhold dose for severe myelosuppression. ( 5.2 , 5.7 ) • Pulmonary Toxicity and Respiratory Failure: Discontinue gemcitabine for unexplained dyspnea or other evidence of severe pulmonary toxicity. ( 5.3 ) • Hemolytic Uremic Syndrome (HUS): Monitor renal function prior to initiation and during treatment. Discontinue gemcitabine for HUS or severe renal impairment. ( 5.4 ) • Hepatic Toxicity: Monitor hepatic function prior to initiation and during treatment. Discontinue gemcitabine for severe hepatic toxicity. 4 CONTRAINDICATIONS Gemcitabine for Injection is contraindicated in patients with a known hypersensitivity to gemcitabine. Reactions include anaphylaxis [see Adverse Reactions ( 6.1 )]. Patients with a known hypersensitivity to gemcitabine. ( 4 )