Citagem Dosage/Direction for Use

Gemcitabine is for intravenous (IV) use only. Reconstituted and diluted solutions of gemcitabine are generally infused over a period of 30 minutes; any unused portion after preparation of the appropriate dose should be discarded.
Infusion time should not exceed 60 minutes and not more frequent than once a week (see Precautions). (See Table 1.)

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Dosage Adjustments: Patients receiving gemcitabine should be monitored prior to each dose for platelet, leukocyte and granulocyte counts and, if necessary, the dose of gemcitabine may be either reduced or withheld in the presence of hematological toxicity.
For the detection of nonhematologic toxicity, periodic physical examination and checks of renal and hepatic function should be made.
Ovarian Cancer: The dose of gemcitabine within a cycle of treatment should be adjusted according to the granulocyte and platelet counts obtained on day 8 of therapy: See Table 2.

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Generally, for severe (grade 3/4) nonhematologic toxicity other than nausea and vomiting, gemcitabine should be withheld or reduced to 50% depending on the judgment of the treating physician. For carboplatin dosage adjustment, see respective product label for complete prescribing information.
Dose adjustment for gemcitabine in combination with carboplatin in subsequent cycles should be adjusted according to observed toxicity. The dose should be reduced to 800 mg/m² on days 1 and 8 if any of the following hematologic toxicities occur: Absolute granulocyte counts <500 x 10⁶/L for more than 5 days.
Absolute granulocyte counts <100 x 10⁶/L for more than 3 days.
Febrile neutropenia.
Platelet counts <25,000 x 10⁶/L.
Cycle delay of more than 1 week due to toxicity.
If any of these toxicities recur after the initial dosage reduction, gemcitabine should be administered on day 1 only at a dose of 800 mg/m² for the subsequent cycle.
Breast Cancer: The dose of gemcitabine should be adjusted according to the granulocyte and platelet counts obtained on day 8 of therapy: See Table 3.

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Generally, for severe (grade 3/4) nonhematologic toxicity other than alopecia and nausea/vomiting, gemcitabine should be withheld or reduced to 50% depending on the judgment of the treating physician. For paclitaxel dosage adjustment, see respective product label for complete prescribing information.
NSCLC/Pancreatic Cancer/Bladder Cancer: The dose of gemcitabine should be adjusted according to the granulocyte and platelet counts obtained on the day of therapy: See Table 4.

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Generally, in patients receiving gemcitabine in combination with cisplatin who develop grade 3/4 nonhematologic toxicity other than alopecia or nausea and vomiting, gemcitabine and cisplatin doses should be withheld or reduced by 50%.