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Gemcitabine HCl

Recurrent epithelial ovarian carcinoma in patients who have relapsed at least 6 mth following platinum-based therapy in combination w/ carboplatin. 1st-line treatment in unresectable, locally recurrent or metastatic breast cancer who have relapsed following adjuvant/neoadjuvant chemotherapy in combination w/ paclitaxel; inoperable, locally advanced (stage IIIA or IIIB) or metastatic (stage IV) non-small cell lung cancer (NSCLC) alone or in combination w/ cisplatin; locally advanced or (nonresectable stage II or III) or metastatic (stage IV) adenocarcinoma of the pancreas. 1st-line or 2nd line therapy in 5-FU refractory pancreatic cancer. Advanced transitional cell bladder cancer in combination w/ cisplatin.

IV infusion Adult Ovarian cancer Combination therapy: Gemcitabine 1,000 mg/m² on days 1 & 8 of each 21-day cycle; carboplatin administered on day 1 consistent w/ a target AUC of 4 mg/mL/min. Breast cancer Combination therapy: 1,250 mg/m² on days 1 & 8 of each 21-day cycle; paclitaxel 175 mg/m² administered on day 1 over approx 3 hr as an IV infusion before administration of gemcitabine. NSCLC Monotherapy: 1,000 mg/m² repeated once a wk for 3 wk, followed by a 1-wk rest period. The 4-wk cycle is then repeated. Combination therapy: 3-wk schedule: Gemcitabine 1,250 mg/m² on days 1 & 8 of each 21-day cycle; cisplatin 100 mg/m² IV administered on day 1 after gemcitabine infusion. 4-wk schedule: Gemcitabine 1,000 mg/m² on days 1, 8 & 15 of each 21-day cycle; cisplatin 100 mg/m² IV administered on day 1 after gemcitabine infusion. Pancreatic cancer Monotherapy: 1,000 mg/m² repeated once a wk for up to 7 wk, followed by a 1-wk rest period. Subsequent cycles should consist of inj once a wk for 3 consecutive wk out of every 4 wk. Bladder cancer Monotherapy: 1,250 mg/m² on days 1, 8 & 15 of each 28-day cycle. This 4-wk cycle is then repeated. Combination therapy: Gemcitabine 1,000 mg/m² on days 1, 8 & 15 of each 28-day cycle; cisplatin 70 mg/m² administered on day 1 following gemcitabine or day 2 of each 28-day cycle. This 4-wk cycle is then repeated.

Hypersensitivity. Lactation.

Monitor for myelosuppression. Discontinue if severe lung toxicity; anemia w/ evidence of microangiopathic hemolysis; elevation of serum bilirubin or LDH; reticulocytosis &/or severe thrombocytopenia w/ or w/o evidence of renal failure occurs. Hemolytic-uremic syndrome &/or renal failure, serious hepatotoxicity. Perform CBC including differential & platelet count; laboratory evaluation of renal & hepatic function prior to each dose. Preexisting renal impairment or hepatic insufficiency, or significant renal or hepatic impairment; current liver metastases or history of hepatitis, alcoholism or cirrhosis. Women. May impair ability to drive or operate machinery. Childn <17 yr. Elderly.

Myelosuppression; nausea, vomiting, diarrhea, stomatitis; hepatic, genitourinary, dermatological, resp, neurological & CV effects; fever & flu-like symptoms; rash, pruritus; pulmonary edema, interstitial pneumonitis, pulmonary fibrosis, adult resp distress syndrome; edema, infection, extravasation, hypersensitivity effects; radiation toxicity & radiation recall reactions.

Risk of radiation toxicity or radiation recall reactions w/ radiation therapy; systemic & possibly fatal disease (particularly in immunosuppressed patients) w/ yellow fever & other live attenuated vaccines.

Cytotoxic Chemotherapy

L01BC05 - gemcitabine ; Belongs to the class of antimetabolites, pyrimidine analogues. Used in the treatment of cancer.

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