Gemibine-200/Gemibine-1000

Gemcitabine HCl

Treatment of locally advanced or metastatic bladder cancer in combination w/ cisplatin; locally advanced or metastatic adenocarcinoma of the pancreas; 1st-line treatment of patients w/ locally advanced or metastatic non-small cell lung cancer (NSCLC) in combination w/ cisplatin; locally advanced or metastatic epithelial ovarian carcinoma in combination w/ carboplatin in patients w/ relapsed disease following a recurrence-free interval of at least 6 mth after platinum-based, 1st-line therapy; unresectable, locally recurrent or metastatic breast cancer who have relapsed following adjuvant/neoadjuvant chemotherapy in combination w/ paclitaxel (prior chemotherapy should have included an anthracycline).

Bladder cancer Combination therapy: 1,000 mg/m² by 30-min infusion on Days 1, 8 & 15 of each 28-day cycle, in combination w/ cisplatin 70 mg/m² on Day 1 following gemcitabine on day 2 of each 28-day cycle. This 4-wk cycle is then repeated. Pancreatic cancer 1,000 mg/m² by 30-min IV infusion. Repeat once wkly for up to 7 wk followed by a wk of rest. Subsequent cycles should consist of inj once wkly for 3 consecutive wk out of every 4 wk. NSCLC Monotherapy: 1,000 mg/m² by 30-min IV infusion. Repeat once wkly for 3 wk followed by a 1-wk rest period. This 4-wk cycle is then repeated. Combination therapy: 1,250 mg/m² as 30-min IV infusion on Days 1 & 8 of the treatment cycle (21 days), in combination w/ cisplatin 75-100 mg/m² once every 3 wk. Breast cancer Combination therapy: In combination w/ paclitaxel 175 mg/m² administered on Day 1 over approx 3-hr as IV infusion, followed by gemcitabine 1,250 mg/m² as a 30-min IV infusion on Days 1 & 8 of each 21-day cycle. Ovarian cancer Combination therapy: 1,000 mg/m² administered on Days 1 & 8 of each 21-day cycle as 30-min IV infusion. After gemcitabine, carboplatin will be given on Day 1 consistent w/ a target AUC of 4 mg/mL·min.

Hypersensitivity. Lactation.

Increased toxicity w/ prolongation of the infusion time & increased dosing frequency. May suppress bone marrow function; monitor prior to each dose for platelet, leucocyte & granulocyte counts. Patients w/ impaired bone marrow function. Risk of cumulative bone-marrow suppression when treatment is given together w/ other chemotherapy. Concurrent liver metastases or pre-existing medical history of hepatitis, alcoholism or liver cirrhosis. Concomitant radiotherapy (given together or ≤7 days apart). Not recommended w/ Yellow fever vaccine & other live attenuated vaccines. History of CV events. Pulmonary effects eg, pulmonary oedema, interstitial pneumonitis or adult respiratory distress syndrome (ARDS). Discontinue at the 1st signs of microangiopathic haemolytic anaemia eg, rapidly falling Hb w/ concomitant thrombocytopaenia, elevation of serum bilirubin, serum creatinine, BUN or LDH. Patients on controlled Na diet. Hepatic insufficiency or impaired renal function. May affect ability to drive or operate machinery. Men under treatment are advised not to father a child during & up to 6 mth after treatment. Pregnancy. Childn <18 yr.

Leucopaenia; bone-marrow suppression; granulocyte count; thrombocytopaenia; anaemia; dyspnoea; vomiting, nausea; elevation of liver transaminases (AST & ALT) & alkaline phosphatase; allergic skin rash frequently associated w/ pruritus, alopecia; haematuria, mild proteinuria; flu-like symptoms, oedema/peripheral oedema including facial oedema. Febrile neutropaenia; anorexia; headache, insomnia, somnolence; cough, rhinitis; diarrhoea, stomatitis & ulceration of the mouth, constipation; increased bilirubin; itching, sweating, back pain, myalgia; fever, asthenia, chills. Radiation toxicity.

Enhanced toxicity when administered >7 days before or after radiation other than radiation recall. Risk of systemic, possibly fatal, disease w/ Yellow fever & other live attenuated vaccines (particularly in immunosuppressed patients).

Cytotoxic Chemotherapy

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

Rx