Gemcitabine Actavis

Gemcitabine Actavis



Teva Pharma


Concise Prescribing Info
Gemcitabine HCl
1st-line treatment of patients w/ locally advanced or metastatic non-small cell lung carcinoma as monotherapy or in combination w/ cisplatin. Locally advanced or metastatic adenocarcinoma of the pancreas. Inoperable or metastatic bladder carcinoma. Treatment of patients w/ inoperable, locally recurrent or metastatic breast cancer who have relapsed following adjuvant/neoadjuvant chemotherapy in combination w/ paclitaxel. Treatment of patients w/ recurrent epithelial ovarian carcinoma who have relapsed after >6 mth following a therapy containing platina in combination w/ carboplatin.
Dosage/Direction for Use
Adult Non-small cell lung carcinoma 1,000 mg/m2 IV infusion over 30 min as single agent. Repeat once wkly for 3 wk, followed by 1 wk rest period. In combination w/ cisplatin: 1,250 mg/m2 or 1,000 mg/m2 IV infusion over 30 min on day 1 & 8 of a 21-day or 1, 8 & 15 of a 28-day cycle, respectively. Pancreatic carcinoma 1,000 mg/m2 IV infusion over 30 min. Repeat once wkly for up to 7 wk followed by a wk of rest. Subsequent cycles should consist of administration once wkly for 3 consecutive wk followed by a week of rest. Inoperable or metastatic bladder carcinoma Gemcitabine 1,000 mg/m2 slow infusion over 30 min followed by cisplatin 70 mg/m2 on day 1. Postpone cisplatin dose on day 2. Repeat recommended dose of gemcitabine on days 8 & 15 on a 28-day cycle. Inoperable, locally recurrent or metastatic breast carcinoma Administer paclitaxel 175 mg/m2 IV infusion over approx 3 hr on day 1 followed by gemcitabine 1,250 mg/m2 IV infusion over 30 min on days 1 & 8 of each 21-day cycle. Recurrent epithelial ovarian carcinoma 1,000 mg/m2 IV infusion over 30 min on days 1 & 8 of each 21-day cycle. On day 1, carboplatin is given after administration of gemcitabine.
Hypersensitivity. Moderate & severe impaired hepatic function or severe impaired renal function (GFR <30 mL/min). Pregnancy & lactation.
Special Precautions
Impaired bone marrow function. Concurrent liver metastases or preexisting medical history of hepatitis, alcoholism or liver cirrhosis. Impaired renal function. Check thrombocyte, leucocyte & granulocyte counts before each dose. Discontinue use if micro-angiopathic haemolytic anaemia occurs. Do not father a child during or up to 6 mth after treatment. Patients w/ lung cancer or metastases. May impair ability to drive or operate machinery. Childn.
Adverse Reactions
Leucopenia, thrombocytopenia, anaemia, neutropenia, bone marrow suppression; somnolence; dyspnoea; nausea, vomiting; mild proteinuria, haematuria; allergic skin rash; oedema/peripheral oedema, influenza-like symptoms, fever, headache, back pain, shivering, muscle pain, asthenia, malaise & anorexia, cough, rhinitis, perspiration & sleeping difficulties; increased liver transaminases (AST & ALT) & alkaline phosphatase. Febrile neutropenia; pain; diarrhoea, constipation, stomatitis; alopecia, erythema; anorexia; chills; increased bilirubin.
Drug Interactions
ATC Classification
L01BC05 - gemcitabine ; Belongs to the class of antimetabolites, pyrimidine analogues. Used in the treatment of cancer.
Gemcitabine Actavis infusion (lyo) 1 g
Gemcitabine Actavis infusion (lyo) 200 mg
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