Gemcitabine

DEA Class; Rx

Common Brand Names; Gemzar, Infugem

Deoxycytidine antimetabolite nucleoside inhibitor
Used for breast cancer, non-small cell lung cancer (NSCLC), ovarian cancer, and pancreatic cancer
Increased toxicities occur with infusion times longer than 60 minutes or with dosing more than once weekly

Hypersensitivity

• N/V (69%)
• Anemia (65%)
• Elev LFTs (68%)
• Neutropenia (63%)
• Leukopenia (62%)
• Pain (48%)
• Proteinuria (45%)
• Fever (41%)
• Hematuria (35%)
• Rash (30%)
• Thrombocytopenia (24%)
• Dyspnea (23%)
• Constipation (23%)
• Diarrhea (19%)
• Flu-like syndrome (19%)
• Hemorrhage (17%)
• BUN increased (16%)
• Infection (16%)
• Alopecia (15%)
• Edema (13%)
• Elev bilirubin (13%)

Serious cases of thrombotic microangiopathy reported

In combination with carboplatin or paclitaxel: patients should have ANC >1.5 x 10^6/mL and platelet count >10^8/mL prior to each cycle

Capillary leak syndrome reported with severe consequences; discontinue if symptoms occur

Pulmonary toxicity, including interstitial pneumonitis, pulmonary fibrosis, pulmonary edema, and ARDS reported; onset of pulmonary symptoms may occur up to 2 weeks after last dose; discontinue treatment in patients who develop unexplained dyspnea, with or without bronchospasm, or have any evidence of pulmonary toxicity

Assess renal function prior to initiation of therapy and periodically during treatment; hemolytic uremic syndrome reported, including fatalities; permanently discontinue therapy in patients with HUS or severe renal impairment; renal failure may not be reversible even with discontinuation of therapy

Drug-induced liver injury reported, including liver failure and death; assess hepatic function prior to initiation of therapy and periodically during treatment; discontinue drug in patients that develop severe liver injury

Not indicated for use with radiation therapy; know to exacerbate radiation toxicity, including life-threatening mucositis, especially esophagitis and pneumonitis; excessive toxicity not observed when treatment is administered more than 7 days before or after radiation; radiation recall has been reported in patients who received drug after prior radiation

Infusions longer than 60 minutes or more frequently than qWk increase the incidence of clinically significant hypotension, severe flu-like symptoms, myelosuppression, and asthenia; gemcitabine half-life is influenced by the length of the infusion

Based on animal data and its mechanism of action, therapy can cause fetal harm when administered to a pregnant woman

There are no data on presence of drug in human milk, or effects of gemcitabine on breastfed infant or milk production