Gemita

Gemcitabine HCl

In combination w/ cisplatin for 1st-line treatment of patients w/ inoperable, locally advanced (Stage IIIA or IIIB) or metastatic (Stage IV) NSCLC. 1st-line treatment for locally advanced (nonresectable Stage II or Stage III) or metastatic (Stage IV) pancreatic adenocarcinoma & in patients previously treated w/ 5-fluorouracil. In combination w/ paclitaxel for 1st-line treatment of patients w/ metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy. In combination w/ cisplatin for bladder cancer. Monotherapy or in combination w/ carboplatin for patients w/ recurrent epithelial ovarian carcinoma who have relapsed following platinum-based therapy. Biliary tract cancer. In combination therapy w/ radiation & cisplatin for locally advanced cervical cancer.

IV Adult Administer as 30-min infusion. NSCLC Monotherapy: 1,000 mg/m² repeated once wkly for 3 wk, followed by 1 wk rest period. This 4-wk cycle is then repeated. Combination w/ cisplatin: 3-wk schedule: 1,250 mg/m² on days 1 & 8 of each 21-day cycle; or 4-wk schedule: 1,000 mg/m² on days 1, 8, 15 of each 28-day cycle. Pancreatic cancer 1,000 mg/m² repeated once wkly for up to 7 wk, followed by 1 wk rest period. Subsequent cycles: Once wkly inj for 3 consecutive wk out of every 4 wk. Breast cancer Combination w/ paclitaxel: Paclitaxel 175 mg/m² on day 1 over approx 3-hr IV infusion, followed by gemcitabine 1,250 mg/m² on days 1 & 8 of each 21-day cycle. Bladder cancer Combination w/ cisplatin: Gemcitabine 1,000 mg/m² on days 1, 8 & 15 of each 28-day cycle, combined w/ cisplatin 70 mg/m² on day 1 following gemcitabine or day 2 of each 28-day cycle. This 4-wk cycle is then repeated. Ovarian cancer Monotherapy: 800-1,250 mg/m² on days 1, 8 & 15 of each 28-day cycle. This 4-wk cycle is then repeated. Combination w/ carboplatin: Gemcitabine 1,000 mg/m² on days 1 & 8 of each 21-day cycle, combined w/ carboplatin following gemcitabine on day 1 consistent w/ AUC 4 mg/mL/min. Biliary tract cancer Monotherapy: 1,000 mg/m² repeated 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 on day 1, followed by gemcitabine 1,250 mg/m² on days 1 & 8 of each 21-day cycle. This 3-wk cycle is then repeated. Cervical cancer Combination w/ radiation & cisplatin: Cisplatin 40 mg/m² followed immediately by gemcitabine 125 mg/m² once wkly for 6 wk on days 1, 8, 15, 22, 29 & 36 at 1-2 hr before concurrent pelvic RT of 50.4 Gγ in 28 fractions (ie, 1.8 Gγ/day) 5 days/wk over 6 wk of chemotherapy, followed by 2 adjuvant 21-day cycles of gemcitabine 1,000 mg/m² on days 1 & 8 plus cisplatin 50 mg/m² on day 1 of each cycle.

Hypersensitivity.

Discontinue immediately in case of severe lung toxicity. Suspend or modify therapy if bone marrow suppression is detected. Reduce or withhold dose in the presence of haematological toxicty. Increased toxicity w/ prolonged infusion time (>60 min) & frequency >wkly dosing. Bone marrow suppression; hemolytic uremic syndrome, renal failure; pulmonary toxicity; serious hepatotoxicity including liver failure; tissue injury w/ concurrent RT. Concurrent liver metastases or preexisting medical history of hepatitis, alcoholism, or liver cirrhosis. Absolute granulocyte count of at least 1,500 x 10⁶/L prior to initiation of gemcitabine + paclitaxel combination. Monitor CBC including differential, platelet, leucocyte & granulocyte count prior to each dose. Monitor for myelosuppression during therapy. Perform lab evaluation & physical exam of renal & hepatic function prior to initiation of therapy & periodically thereafter. Preexisting renal or hepatic impairment. Women especially older women. Pregnancy & lactation. Paed patients.

Myelosuppression; anemia, leucopenia or thrombocytopenia, petechiae or mild blood loss (hemorrhage); nausea, vomiting, diarrhea, stomatitis; transient elevation of serum transaminases; mild proteinuria & hematuria; fever; rash, pruritus; dyspnea, pulmonary toxicity; edema, peripheral & generalized edema; asthenia, anorexia, headache, cough, chills, myalgia; infections; alopecia; mild paresthesias; inj-site related events; bronchospasm; MI, CVA, arrhythmia, hypotension.

Cytotoxic Chemotherapy

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

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