DBL Gemcitabine

Gemcitabine HCl

Locally advanced or metastatic non-small cell lung cancer (NSCLC) & pancreatic adenocarcinoma; fluorouracil refractory pancreatic cancer. Alone or in combination w/ cisplatin for bladder cancer. Combination w/ paclitaxel for unresectable, locally recurrent or metastatic breast cancer relapse following adjuvant/neoadjuvant chemotherapy. Combination w/ carboplatin for recurrent epithelial ovarian carcinoma relapse >6 mth following platinum-based therapy.

Adult Bladder cancer Combination therapy: 1,000 mg/m² given as 30-min IV infusion on days 1, 8 & 15 of each 28-day cycle in combination w/ cisplatin 70 mg/m² on day 1 or 2 of each 28-day cycle. Pancreatic cancer 1,000 mg/m² given as 30-min IV infusion. Repeated once wkly for up to 7 wk, followed by 1-wk rest period. NSCLC Monotherapy: 1,000 mg/m² given as 30-min IV infusion. Repeated once wkly for 3 wk, followed by 1-wk rest period. This 4-wk cycle is then repeated. Combination therapy: 1,250 mg/m² given as 30-min IV infusion on days 1 & 8 of each 21-day cycle in combination w/ cisplatin 75-100 mg/m² once every 3 wk. Ovarian cancer Combination therapy: 1,000 mg/m² given as 30 min IV infusion on days 1 & 8 of each 21-day cycle followed by carboplatin on day 1 to attain target AUC of 4 mg/mL/min. Breast cancer Combination therapy: Paclitaxel 175 mg/m² given as 3-hr IV infusion on day 1, followed by gemcitabine 1,250 mg/m² given as 30-min IV infusion on days 1 & 8 of each 21-day cycle.

Hypersensitivity.

Discontinue use if severe rarely fatal pulmonary effects occur eg, pulmonary oedema, interstitial pneumonitis & acute resp distress syndrome occur. Bone marrow suppression, leucopenia, thrombocytopenia, anaemia, myelosuppression. Monitor platelet, leukocyte & granulocyte counts. Concurrent liver metastases, or preexisting medical history of hepatitis, alcoholism or liver cirrhosis. Haemolytic uraemic syndrome. Prolonged & high-dose use. May affect ability to drive or operate machinery. Renal & hepatic impairment. Women of childbearing potential. Not to be used during pregnancy. Avoid use during lactation. Not recommended in childn <18 yr.

Leucopenia, thrombocytopenia, anaemia; dyspnoea; nausea, vomiting; AST, ALT & alkaline phosphatase elevation; allergic skin rash, pruritus; mild proteinuria, haematuria; oedema/peripheral oedema, influenza-like symptoms, cough, rhinitis, perspiration, malaise, sleeping difficulties. Febrile neutropenia; somnolence; diarrhoea, constipation; increased bilirubin; alopecia, mouth ulceration, itching; fever, asthenia.

Concurrent use w/ large vol of radiotherapy.

Cytotoxic Chemotherapy

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

B