Gemcitabine Dosage

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Usual Adult Dose for:

Additional dosage information:

Usual Adult Dose for Pancreatic Cancer

For the first-line treatment of patients with locally advanced (nonresectable Stage II or Stage III) or metastatic (Stage IV) adenocarcinoma of the pancreas. (Gemcitabine is indicated for patients previously treated with 5-FU.)

1000 mg/m² intravenously one time over 30 minutes. May repeat at weekly intervals for up to 7 weeks, followed by one week of rest. If toxicity occurs, a dose should be held. Subsequent cycles should consist of weekly cycles for 3 consecutive weeks, out of every 4 weeks.

Dosage Modifications, Decreases: Doses may need to be adjusted, based upon the degree of hematologic toxicity experienced by the patient. If marrow suppression is detected, therapy should be modified or suspended according to the following guidelines: Absolute granulocyte count 500,000,000-999,000,000/L or Platelet count 50,000,000,000-99,000,000,000 give 75% of the full dose. Absolute granulocyte count < 500,000,000 or Platelet count < 50,000,000,000, then hold the dose.

Dosage Modifications, Increases: Patients who complete an entire seven week initial cycle of therapy or subsequent three week cycle at a dose of 1000 mg/m² may have the dose for subsequent cycles increased by 25%, provided that the absolute granulocyte count (AGC) > 1,500,000,000/L, platelet nadirs > 1,000,000,000,000 and nonhematologic toxicity has not been > WHO Grade 1. If patients tolerate the subsequent course of gemcitabine at the increased dose, the dose for the next cycle can be further increased by 20%, provided again that the AGC and platelet nadirs exceed 1500,000,000/L and 100,000,000,000/L, respectively, and that nonhematologic toxicity has not been greater than WHO grade 1.

Usual Adult Dose for Non-Small Cell Lung Cancer

In combination with cisplatin for the first-line treatment of patients with inoperable, locally advanced (Stage IIIA or IIIB) or metastatic (Stage IV) non-small cell lung cancer:

Two schedules have been investigated and the optimum schedule has not been determined. With the 4 week schedule, gemcitabine should be administered intravenously at 1000 mg/m2 over 30 minutes on days 1, 8, and 15 of each 28 day cycle. With the 3 week schedule, gemcitabine should be administered intravenously at 1250 mg/m2 over 30 minutes on days 1 and 8 of each 21 day cycle.

Dose Modifications: Dosage adjustments for hematologic toxicity may be required for gemcitabine and for cisplatin. Gemcitabine dosage adjustment for hematological toxicity is based on the granulocyte and platelet counts taken on the day of therapy. Patients receiving gemcitabine should be monitored prior to each dose with a complete blood count (CBC), including differential and platelet counts. If marrow suppression is detected, therapy should be modified or suspended according to the guidelines below:

Dosage Modifications, Decreases: Doses may need to be adjusted, based upon the degree of hematologic toxicity experienced by the patient. If marrow suppression is detected, therapy should be modified or suspended according to the following guidelines: Absolute granulocyte count 500,000,000-999,000,000/L or Platelet count 50,000,000,000-99,000,000,000/L give 75% of the full dose. Absolute granulocyte count < 500,000,000 or Platelet count < 50,000,000,000/L, then hold the dose.

In general, for severe (grade 3 or 4) nonhematologic toxicity, except alopecia and nausea/vomiting, therapy with gemcitabine plus cisplatin should be held or decreased by 50% depending on the judgment of the treating physician. During combination therapy with cisplatin, serum creatinine, serum potassium, serum calcium, and serum magnesium should be carefully monitored.

Usual Adult Dose for Breast Cancer

In combination with paclitaxel as first-line therapy in the treatment of patients with metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy (unless anthracyclines were clinically contraindicated):

Gemcitabine 1250 mg/m2 intravenously over 30 minutes on days 1 and 8 of each 21 day cycle. Gemcitabine is given in combination with paclitaxel. Paclitaxel should be administered at 175 mg/m2 on day 1 as a 3 hour intravenous infusion before gemcitabine administration.

Patients should be monitored prior to each dose with a complete blood count, including differential counts. Patients should have an absolute granulocyte count greater than or equal to 1,500,000,000/L and a platelet count greater than or equal to 100,000,000,000/L prior to each cycle.

Dosage adjustments for hematologic toxicity are based on the granulocyte and platelet counts taken on day 8 of therapy. If marrow suppression is detected, the dosage of gemcitabine should be modified as follows:

If the absolute granulocyte count is greater than or equal to 1,200,000,000/L and the platelet count is greater than 75,000,000,000/L, than give 100% of the full dose.

If the absolute granulocyte count is between 1,000,000,000/L and 1,199,000,000/L or the platelet count is between 50,000,000,000/L and 75,000,000,000/L, than give 75% of the full dose.

If the absolute granulocyte count is between 700,000,000/L and 999,000,000/L and the platelet count is greater than or equal to 50,000,000,000/L, than give 50% of the full dose.

If the absolute granulocyte count is less than 700,000,000/L or the platelet count is less than 50,000,000,000/L, than the dose should be held.

In general, for severe (grade 3 or 4) nonhematologic toxicity, except alopecia and nausea/vomiting, therapy with gemcitabine plus cisplatin should be held or decreased by 50% depending on the judgment of the treating physician.

Usual Adult Dose for Ovarian Cancer

In combination with carboplatin for the treatment of patients with advanced ovarian cancer that has relapsed at least six months after completion of platinum-based therapy:

1000 mg/m2 intravenously over 30 minutes on days 1 and 8 of each 21 day cycle. Carboplatin should be administered intravenously on day 1 after gemcitabine administration. Patients should be monitored prior to each dose with a complete blood count, including differential counts. Patients should have an absolute granulocyte count greater than or equal to 1,500,000,000/L and a platelet count greater than or equal to 100,000,000,000/L prior to each cycle.

Dose Modifications: Gemcitabine dosage adjustments for hematologic toxicity within a cycle of treatment is based on the granulocyte and platelet counts taken on day 8 of therapy.

If marrow suppression is detected, gemcitabine dosage should be modified according to guidelines below.

Dosage Reduction Guidelines for Gemcitabine in Combination with Carboplatin:

If the absolute granulocyte count is greater than or equal to 1,500,000,000/L and the platelet count is greater than 100,000,000,000/L, than give 100% of the full dose.

If the absolute granulocyte count is between 1,000,000,000/L and 1,499,000,000/L and/or the platelet count is between 75,000,000,000/L and 99,999,000,000/L, than give 50% of the full dose.

If the absolute granulocyte count is less than 1,000,000,000/L and/or the platelet count is less than 75,000,000,000/L, than the dose should be held.

In general, for severe (Grade 3 or 4) nonhematologic toxicity, except nausea/vomiting, therapy with gemcitabine should be held or decreased by 50% depending on the judgment of the treating physician.

Dose adjustment for gemcitabine in combination with carboplatin for subsequent cycles is based upon observed toxicity. The dose of gemcitabine in subsequent cycles should be reduced to 800 mg/m2 on days 1 and 8 in case of any of the following hematologic toxicities:
Absolute granulocyte count less than 500,000,000/L for more than five days
Absolute granulocyte count less than 100,000,000/L for more than three days
Febrile neutropenia
Platelets less than 25,000,000,000/L
Cycle delay of more than one week due to toxicity

If any of the above toxicities recur after the initial dose reduction, for the subsequent cycle, gemcitabine should be given on day 1 only at 800 mg/m2.

Gemcitabine may be administered on an outpatient basis.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Dose Adjustments

Doses may depend upon the specific indication for use. Reference to specific protocols is recommended.

Precautions

Patients should be monitored prior to each dose with a complete blood count including differential and platelet count.

Gemcitabine should be used with caution in patients with significant renal or hepatic impairment as there is insufficient information from clinical studies to allow clear dose recommendations for these patient populations.

Safety and effectiveness have not been established in pediatric patients (less than 18 years of age).

Dialysis

Data not available

Other Comments

Gemcitabine is for intravenous use only.

Laboratory evaluation of renal and hepatic function, including transaminases and serum creatinine should be performed prior to initiation of therapy and periodically during therapy.

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