| Cycle length: 8 weeks for first cycle, then 4 weeks. |
| Drug | Dose and route | Administration | Given on days |
| Gemcitabine* | 1000 mg/m2 IV | Dilute in 250 mL normal saline (concentration no greater than 40 mg/mL) and administer over 30 to 60 minutes. | Weekly for seven weeks followed by one week of rest in the first cycle, then weekly for three weeks followed by one week of rest in all subsequent cycles |
| Pretreatment considerations: |
| Emesis risk | - LOW.
- Refer to UpToDate topics on prevention of chemotherapy-induced nausea and vomiting in adults.
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| Infection prophylaxis | - Primary prophylaxis with granulocyte colony stimulating factors not indicated (incidence of neutropenic fever <1%[1-4]).
- Refer to UpToDate topics on use of granulocyte colony stimulating factors in adult patients with chemotherapy-induced neutropenia and conditions other than acute leukemia, myelodysplastic syndrome, and hematopoietic cell transplantation.
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| Dose adjustment for baseline liver or kidney dysfunction | - A lower starting dose may be needed for patients with liver impairment.
- Refer to UpToDate topics on chemotherapy hepatotoxicity and dose modification in patients with liver disease, conventional cytotoxic agents and chemotherapy hepatotoxicity and dose modification in patients with liver disease, molecularly targeted agents.
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| Monitoring parameters: |
- CBC with differential and platelet count weekly during treatment.
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- Assess basic metabolic panel (including serum creatinine) and liver function tests prior to each cycle and otherwise as indicated during treatment.
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| Suggested dose modifications for toxicity: |
| Myelotoxicity | - This regimen should not be initiated unless the white blood cell count is >3500 cells/microL and platelets are ≥100,000/microL.[1] During therapy, the dose of gemcitabine should be decreased by 25% if the absolute neutrophil count decreases to <1000 cells/microL but ≥500 cells/microL, or the platelets decrease to <100,000/microL and ≥50,000/microL.[5] The United States Prescribing Information recommends holding gemcitabine for an absolute neutrophil count <500 cells/microL or platelets <50,000/microL.[5]
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| Hepatotoxicity | - Gemcitabine is commonly associated with a transient rise in serum transaminases, but these are seldom of clinical significance. There is insufficient information from clinical studies to allow clear dose recommendations in these patients.
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| Thrombotic microangiopathy | - Thrombotic microangiopathy (TMA, also sometimes called thrombotic thrombocytopenic purpura [TTP] or hemolytic uremic syndrome [HUS]) has been associated with gemcitabine, in individuals who have received a large or small cumulative dose.[5] Consider the possibility of TMA if the patient develops Coombs-negative hemolysis, thrombocytopenia, kidney failure, and/or neurologic findings. Management consists of drug discontinuation and supportive care, without plasma exchange, as long as there is high confidence in a drug-induced etiology rather than TTP.
- Refer to UpToDate topics on drug-induced thrombotic microangiopathy.
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| Pulmonary toxicity | - A variety of manifestations of pulmonary toxicity have been reported. Discontinue gemcitabine immediately and permanently.
- Refer to UpToDate topics on pulmonary toxicity associated with antineoplastic therapy, cytotoxic agents.
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| If there is a change in body weight of at least 10%, doses should be recalculated. |
