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See related Gemzar infusion information |
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Manufacturer |
Eli Lilly |
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Distributor |
DKSH |
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Contents |
Gemcitabine HCl |
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Indications |
Locally advanced or metastatic adenocarcinoma of the pancreas. Patients w/ 5-FU refractory pancreatic cancer. Locally advanced or metastatic non-small cell lung cancer. Bladder, biliary tract, breast, ovarian & cervical cancer. |
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Dosage |
Adult Pancreatic cancer 1,000 mg/m2 as 30-min IV infusion once wkly for up to 7 wk, followed by a wk of rest. Subsequent cycles should be once wkly for 3 consecutive wk out of every 4 wk. Non-small cell lung cancer Single agent use: 1,000 mg/m2 as 30-min IV infusion once wkly for 3 wk followed by 1 wk rest period. This 4-wk cycle is then repeated. Combination w/ cisplatin: 1,250 mg/m2 as 30-min IV infusion on day 1 & 8 of each 21-day cycle. Or 1,000 mg/m2 as 30-min IV infusion on day 1, 8 & 15 of each 28-day cycle. Combination w/ carboplatin: 1,000 or 1,200 mg/m2 as 30-min IV infusion on day 1 & 8 of each 21-day cycle. Give carboplatin after gemcitabine on day 1 w/ a target AUC of 5 mg/mL/min. Bladder cancer Combination w/ cisplatin: 1,000 mg/m2 as 30-min IV infusion on day 1, 8 & 15 of each 28-day cycle, cisplatin 70 mg/m2 on day 1 or 2. This 4-wk cycle is then repeated. Breast cancer Single agent use: 1,000-1,200 mg/m2 as 30-min IV infusion on day 1, 8 & 15 of each 28-day cycle. This 4-wk cycle is then repeated. Combination w/ paclitaxel: Paclitaxel 175 mg/m2 on day 1 over approx 3 hr as IV infusion, followed by gemcitabine 1,250 mg/m2 as 30-min IV infusion on day 1 & 8 of each 21-day cycle. Ovarian cancer Single agent use: 800-1,250 mg/m2 as 30-min IV infusion on day 1, 8 & 15 of each 28-day cycle. This 4-wk cycle is then repeated. Combination w/ carboplatin: 1,000 mg/m2 as 30-min IV infusion on day 1 & 8 of each 21-day cycle. After gemcitabine, give carboplatin on day 1 consistent w/ a target AUC of 4 mg/mL/min. Biliary tract cancer Single agent use: 1,000 mg/m2 as 30-min IV infusion. Repeat once wkly for 3 wk followed by 1 wk rest period. This 4-wk cycle is then repeated. Combination w/ cisplatin: Cisplatin 70 mg/m2 as IV infusion on day 1 then gemcitabine 1,250 mg/m2 as 30-min IV infusion on day 1 & 8 of each 21-day cycle. This 3-wk cycle is then repeated. Cervical cancer Combination therapy using radiation: In combination w/ cisplatin 40 mg/m2 followed immediately by gemcitabine 125 mg/m2 IV infusion once wkly for 6 wk (day 1, 8, 15, 22, 29 & 36) 1-2 hr before concurrent pelvic radiation therapy of 50.4 Gy external beam radiation delivered to the entire field of radiation in 28 fractions, 1.8 Gy/day, 5 days/wk over the 6 wk of chemotherapy, followed by 2 adjuvant 21-day cycles of gemcitabine (1,000 mg/m2 on day 1 & 8) plus cisplatin (50 mg/m2 on day 1). |
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Special Precautions |
Monitor platelet, leukocyte & granulocyte counts. Pregnancy, lactation, childn, impaired renal function or hepatic insufficiency. May impair ability to drive or operate machinery. |
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Adverse Drug Reactions |
Anaemia, leucopenia, thrombocytopenia, nausea & vomiting, diarrhoea, stomatitis, mild proteinuria & haematuria, rash, bronchospasm, dyspnoea, oedema/peripheral oedema, alopecia, somnolence, oral toxicity, constipation.
View ADR Monitoring Form |
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Pregnancy Category (US FDA) |
Category D: There is positive evidence of human foetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective). |
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Presentation/Packing |
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Form |
Packing |
Photo |
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Gemzar infusion |
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Gemzar 1 g x 1's |
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Gemzar 200 mg x 1's |
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Manufacturer: |
Eli Lilly |
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Distributor: |
DKSH
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