Gemcitabine Actavis

Gemcitabine HCl

Monotherapy or in combination w/ cisplatin as 1st-line treatment in patients w/ locally advanced or metastatic non-small cell lung carcinoma. Locally advanced or metastatic adenocarcinoma of pancreas; inoperable or metastatic bladder carcinoma; biliary tract cancer; primary treatment of patients w/ locally advanced cervical cancer. In combination w/ paclitaxel for patients w/ inoperable, locally recurrent or metastatic breast cancer who have relapsed following adjuvant/neoadjuvant chemotherapy. In combination w/ carboplatin for patients w/ recurrent epithelial ovarian carcinoma who have relapsed after >6 mth following therapy containing platina.

Adult NSCLC 1,000 mg/m² by IV infusion over 30 min as single agent. Repeat once wkly for 3 wk, followed by 1 wk rest period. Combination w/ cisplatin: Gemcitabine 1,250 mg/m² on day 1 & 8 of 21-day cycle, or 1,000 mg/m² by IV infusion over 30 min on day 1, 8 & 15 of 28-day cycle. Pancreatic carcinoma 1,000 mg/m² by IV infusion over 30 min. Repeat once wkly for up to 7 wk, followed by wk of rest. Subsequently, once wkly for 3 consecutive wk, followed by wk of rest. Inoperable or metastatic bladder carcinoma Combination w/ cisplatin: Gemcitabine 1,000 mg/m² by slow infusion over 30 min, followed by cisplatin 70 mg/m² on day 1. Postpone cisplatin dose on day 2. Repeat Gemcitabine 1,000 mg/m² on days 8 & 15 on 28-day cycle. Biliary tract cancer 1,000 mg/m² by IV infusion over 30 min as single agent. Repeat once wkly for 3 wk, followed by 1 wk rest period. Combination w/ cisplatin: Cisplatin 70 mg/m² by IV infusion on day 1, followed by Gemcitabine 1,250 mg/m² by IV infusion over 30 min on days 1 & 8 of each 21-day cycle. Cervical cancer Combination therapy w/ radiation: Cisplatin 40 mg/m² followed by Gemcitabine 125 mg/m² by IV infusion once wkly for 6 wk on days 1, 8, 15, 22 & 36, 1-2 hr before concurrent pelvic RT. Inoperable, locally recurrent or metastatic breast carcinoma Administer Paclitaxel 175 mg/m² by IV infusion over approx 3 hr on day 1, followed by Gemcitabine 1,250 mg/m² by IV infusion over 30 min on days 1 & 8 of each 21-day cycle. Recurrent epithelial ovarian carcinoma Gemcitabine 1,000 mg/m² by IV infusion over 30 min on days 1 & 8 of each 21-day cycle. Administer Carboplatin on day 1 after Gemcitabine administration.

Hypersensitivity. Moderate & severe impaired hepatic function or severe impaired renal function (GFR <30 mL/min). Pregnancy & lactation.

Discontinue use at 1st signs of micro-angiopathic haemolytic anaemia; interstitial pneumonitis w/ pulmonary infiltrates occur. Patients w/ impaired bone marrow function; lung cancer or metastases; concurrent liver metastases or preexisting medical history of hepatitis, alcoholism or liver cirrhosis. Renal failure including haemolytic uraemic syndrome. Pulmonary oedema, interstitial pneumonitis & acute resp distress syndrome. Check thrombocyte, leucocyte & granulocyte counts before each dose. May affect ability to drive & use machines. Moderate & severe hepatic impairment. Severe renal impairment. Men should not father a child during & up to 6 mth after treatment. Women should not be pregnant during & 3 mth after treatment. Avoid during pregnancy & lactation. Childn.

Leucopenia, thrombocytopenia, anaemia, neutropenia, bone marrow suppression; somnolence; dyspnoea; nausea, vomiting; mild proteinuria, haematuria; allergic skin rash; oedema/peripheral oedema, flu-like symptoms, fever, headache, back pain, shivering, muscle pain, asthenia, malaise & anorexia, cough, rhinitis, perspiration & sleeping difficulties; elevated liver transaminases (AST & ALT) & alkaline phosphatase. Febrile neutropenia; pain; diarrhoea, constipation, stomatitis; alopecia, erythema; anorexia; chills; increased bilirubin.

RT.

Cytotoxic Chemotherapy

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

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