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Gemcitabine Dosage

Applies to the following strength(s): 200 mg ; 1 g ; 2 g ; 38 mg/mL

The information at Drugs.com is not a substitute for medical advice. ALWAYS consult your doctor or pharmacist.

Usual Adult Dose for:

Additional dosage information:

Usual Adult Dose for Pancreatic Cancer

1000 mg/m2 IV one time over 30 minutes.
-Weeks 1 through 8: Weekly dosing for the first 7 weeks, followed by one week of rest. If toxicity occurs, a dose should be held.
-After week 8: Weekly dosing on Days 1, 8, and 15 of 28 day cycles

Comments:
-Patients should be monitored prior to each dose with a complete blood count (CBC), including differential and platelet count.
-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.
-Dose modifications due to hematological toxicity in subsequent cycles, for all indications:
The gemcitabine dose should be reduced to 75% of the original cycle initiation dose, in the case of the following hematological toxicities:
1) Absolute granulocyte count less than 500,000,000/L for more than 5 days
2) Absolute granulocyte count less than 100,000,000/L more than 3 days
3) Febrile neutropenia
4) Platelets less than 25,000,000,000/L
5) Cycle delay of more than 1 week due to toxicity
-Withhold therapy or reduce dose by 50% for other severe (Grade 3 or 4) nonhematological toxicity until resolved. No dose modifications are recommended for alopecia, nausea, or vomiting.

Use: Pancreatic cancer (as first-line treatment for patients with locally advanced (nonresectable Stage II or Stage III) or metastatic (Stage IV) adenocarcinoma of the pancreas. This drug is indicated for patients previously treated with 5-FU).

Usual Adult Dose for Non-Small Cell Lung Cancer

Four week schedule: 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in combination with cisplatin therapy
Three week schedule: 1250 mg/m2 IV over 30 minutes on days 1 and 8 in combination with cisplatin therapy

Comments:
-Patients should be monitored prior to each dose with a complete blood count (CBC), including differential and platelet count.
-Dose modifications due to hematological toxicity in subsequent cycles, for all indications:
The gemcitabine dose should be reduced to 75% of the original cycle initiation dose, in the case of the following hematological toxicities:
1) Absolute granulocyte count less than 500,000,000/L for more than 5 days
2) Absolute granulocyte count less than 100,000,000/L more than 3 days
3) Febrile neutropenia
4) Platelets less than 25,000,000,000/L
5) Cycle delay of more than 1 week due to toxicity
-Withhold therapy or reduce dose by 50% for other severe (Grade 3 or 4) non-hematological toxicity until resolved. No dose modifications are recommended for alopecia, nausea, or vomiting.

Use: 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.

Usual Adult Dose for Breast Cancer

1250 mg/m2 IV over 30 minutes on days 1 and 8 of each 21 day cycle that includes paclitaxel. Paclitaxel should be administered at 175 mg/m2 IV on day 1 as a 3 hour IV infusion before gemcitabine administration
Dose reduction with each cycle or within a cycle may be applied based upon the grade of toxicity experienced by the patient. Patients should have an absolute granulocyte count of at least 1,500,000,000/L prior to initiation of gemcitabine plus paclitaxel combination.

Comments:
-Patients should be monitored prior to each dose with a complete blood count (CBC), including differential and platelet count.
-Doses may need to be adjusted, based upon the degree of hematologic toxicity experienced by the patient. -Dose Modifications for Non-Hematologic Adverse Reactions
Permanently discontinue therapy for any of the following:
1) Unexplained dyspnea or other evidence of severe pulmonary toxicity
2) Severe hepatic toxicity
3) Hemolytic-Uremic Syndrome
4) Capillary Leak Syndrome
5) Posterior reversible encephalopathy syndrome
-Withhold therapy or reduce dose by 50% for other severe (Grade 3 or 4) non-hematological toxicity until resolved. No dose modifications are recommended for alopecia, nausea, or vomiting.

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

Usual Adult Dose for Ovarian Cancer

1000 mg/m2 IV over 30 minutes on days 1 and 8 of each 21 day cycle. Carboplatin should be administered IV on day 1 of each 21 day cycle after gemcitabine administration.

Comments:
-Patients should be monitored prior to each dose with a complete blood count, including differential counts.
-Guidelines for dose modification vary in different regions. Consult the manufacturer

Use: 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.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Dose Adjustments

Specific dosage reduction guidelines for all conditions vary in different regions and for different products. The manufacturer product information or local protocol should be consulted for guidance in dosing patients with myelosuppression.

Nonhematologic Toxicity:
-Check renal and hepatic function and perform periodic physical examination.
-For severe (Grade 3 or 4) nonhematologic toxicity, except nausea/vomiting, therapy with this drug should be withheld or decreased based on the judgment of the treating physician.
-Doses should be withheld until toxicity has resolved in the opinion of the physician.

Precautions

-Safety and efficacy have not been established in patients younger than 18 years.

-Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

General:
-Gemcitabine is for intravenous use only.

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

Reconstitution/preparation techniques:
-Refer to manufacturer product information.

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