Gemita RTU

Gemcitabine

1st-line treatment for patients w/ locally advanced (non-resectable stage II or III) or metastatic (stage IV) pancreas adenocarcinoma. Alone or in combination w/ carboplatin for patients w/ recurrent epithelial ovarian carcinoma who have relapsed following platinum-based therapy. In combination w/ cisplatin for 1st-line treatment of patients w/ inoperable, locally advanced (stage IIIA or IIIB) or metastatic (Stage IV) NSCLC; bladder cancer. In combination w/ paclitaxel for 1st-line treatment of patients w/ metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy unless anthracyclines were clinically contraindicated. In combination w/ radiation & cisplatin in patients w/ locally advanced cervical cancer. Biliary tract cancer.

IV infusion Adult NSCLC Monotherapy: 1,000 mg/m² for 30 min, repeated once wkly for 3 wk, followed by 1 wk rest period. 4-wk cycle is then repeated. Combination use w/ cisplatin: 3-wk schedule: 1,250 mg/m² for 30 min on days 1 & 8 of each 21-day cycle; 4-wk schedule: 1,000 mg/m² for 30 min on days 1, 8, 15 of each 28 days cycle. Pancreatic cancer 1,000 mg/m² for 30 min, repeated once wkly for up to 7 wk, followed by wk of rest. Subsequent cycles should consist of inj once wkly for 3 consecutive wk out of every 4 wk. Breast cancer In combination w/ paclitaxel: Paclitaxel (175 mg/m²) on Day 1 over approx 3 hr as IV infusion, followed by gemcitabine (1,250 mg/m²) for 30-min on Days 1 & 8 of each 21-day cycle. Patients should have an absolute granulocyte count of at least 1,500 (x 10⁶/L) prior initiation of gemcitabine + paclitaxel. Bladder cancer In combination w/ cisplatin: 1,000 mg/m² for 30 min on Days 1, 8 & 15 of each 28-day cycle. Cisplatin 70 mg/m² on Day 1 following gemcitabine or Day 2 of each 28-day cycle. 4-wk cycle is then repeated. Ovarian cancer Monotherapy: 800-1,250 mg/m² for 30 min on Days 1, 8 & 15 of each 28-day cycle. 4-wk cycle is then repeated. Combination use w/ carboplatin: 1,000 mg/m² for 30 min on Days 1 & 8 of each 21-day cycle. Carboplatin given on Day 1 after gemcitabine, consistent w/ target AUC 4 mg/mL·min. Biliary tract cancer Monotherapy: 1,000 mg/m² for 30 min. Repeated once wkly for 3 wk, followed by 1-wk rest period. 4-wk cycle is then repeated. Combination use w/ cisplatin: Cisplatin 70 mg/m² on Day 1 as IV infusion, followed by gemcitabine 1,250 mg/m² for 30 min on Days 1 & 8 of each 21-day cycle. 3-wk cycle is then repeated. Cervical cancer Combination therapy using radiation & cisplatin: 40 mg/m² followed immediately by gemcitabine 125 mg/m² once wkly for 6 wk (days 1, 8, 15, 22, 29 & 36), 1-2 hr before concurrent pelvic RT. RT should be 50.4 Gy external beam radiation delivered to entire field of radiation in 28 fractions, ie, 1.8 Gy/day, 5 days/wk over 6 wk chemotherapy, followed by 2 adjuvant 21-day cycles of gemcitabine (1,000 mg/m² on day 1 & 8) + cisplatin (50 mg/m² on day 1 of each cycle).

Hypersensitivity.

Not indicated for use in combination w/ RT. Permanently discontinue in patients who develop unexplained dyspnea, w/ or w/o bronchospasm or evidence of severe pulmonary toxicity, hemolytic uremic syndrome (HUS) or severe renal impairment. Discontinue in patients if severe liver injury; capillary leak syndrome; posterior reversible encephalopathy syndrome (PRES) develops during therapy. Increased incidence of clinically significant hypotension, severe flu-like symptoms, myelosuppression during asthenia by prolongation of infusion time beyond 60 min or more frequent than wkly dosing. Increased risk of myelosuppression manifested by neutropenia, thrombocytopenia & anemia when combined w/ other cytotoxics. Pulmonary toxicity including interstitial pneumonitis, adult resp distress syndrome, pulmonary fibrosis & edema. Serious cases of thrombotic microangiopathy other than HUS. Exacerbation of underlying hepatic insufficiency in patients w/ concurrent liver metastases or pre-existing medical history or hepatitis, alcoholism or liver cirrhosis. Life-threatening mucositis, especially esophagitis & pneumonitis w/ concurrent treatment & RT (given together or ≤7 days apart). Drug-induced liver injury, including liver failure & death in patients receiving alone or in combination w/ other potentially hepatotoxic drugs. Assess renal & hepatic function prior to initiation & periodically during treatment. Patients w/ preexisting renal &/or hepatic impairment. May impair fertility in men of reproductive potential. Verify pregnancy status in females of reproductive potential prior to treatment initiation. Men & women of reproductive potential should use effective contraception during treatment, & for 3 mth (men) & 6 mth (women) following final dose. May cause fetal harm during pregnancy. Pregnancy & lactation. Lower clearance in women resulting in high conc of drug. Ped patients.

Monotherapy: Nausea/vomiting, anemia, increased ALT, AST & alkaline phosphatase, neutropenia, proteinuria, fever, hematuria, rash, thrombocytopenia, dyspnea, edema. Monotherapy & in combination w/ other cytotoxic agents: PRES; allergic skin rash frequently associated w/ pruritus & alopecia, TEN, SJS; radiation recall reactions & toxicity; stomatitis & ulceration.

Cytotoxic Chemotherapy

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

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