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    DEA Class; Rx

    Common Brand Names; Gemzar, Infugem

    • Antineoplastics, Antimetabolite

    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

    Indicated as a single-agent for pancreatic cancer

    Various regimens exist including monotherapy and in combination with other chemotherapy agents (eg, erlotinib, paclitaxel protein bound, capecitabine)

    Indicated in combination with cisplatin for non-small cell lung cancer

    Indicated 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

    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


    • 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

    The suggested maximum tolerated dose (MTD) for gemcitabine is dependent on performance status, other chemotherapy agents or radiation given in combination, and disease state. Therefore, dosing may vary from protocol to protocol. If questions arise, clinicians should consult the appropriate references to verify the dose.


    1,250 mg/m2 IV once weekly; number of weekly doses and length of cycle is indication-specific.


    1,250 mg/m2 IV once weekly; number of weekly doses and length of cycle is indication-specific.


    Safety and efficacy have not been established.


    Safety and efficacy have not been established.


    injection, lyophilized powder for reconstitution

    • 200mg/single-use vial (Gemzar, generics)
    • 1g/single-use vial (Gemzar, generics)

    solution for injection (generics)

    • 200mg/2mL (100mg/mL)
    • 200mg/5.26mL (38mg/mL)
    • 1g/10mL (100mg/mL)
    • 1g/26.3mL (38mg/mL)
    • 1.5g/15mL (100mg/mL)
    • 2g/20mL (100mg/mL)
    • 2g/52.6mL (38mg/mL)

    injection, single-dose premixed infusion bag (Infugem)

    • 10mg/mL (contains gemcitabine in 0.9% NaCl) concentration in following sizes:
      • 1200mg/120mL
      • 1300mg/130mL
      • 1400mg/140mL
      • 1500mg/150mL
      • 1600mg/160mL
      • 1700mg/170mL
      • 1800mg/180mL
      • 1900mg/190mL
      • 2000mg/200mL
      • 2200mg/220mL