Company: Actavis Ireland Ltd.
Legal category: Hospital. Sport permitted.
Active ingredient: Gemcitabine (as HCl) 200mg, 1g.
Description: Concentrate for solution for infusion.
Presentation: 2ml or 5ml vial; prices available on request.
Indications: Locally advanced or metastatic bladder cancer in combination with cisplatin. Locally advanced or metastatic adenocarcinoma of the pancreas. In combination with cisplatin, first line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC). Monotherapy can be considered in elderly patients or those with performance status 2. Locally advanced or metastatic epithelial ovarian carcinoma, in combination with carboplatin, in patients with relapsed disease following a recurrence-free interval of at least 6 months after platinum-based, first-line therapy. In combination with paclitaxel, for unresectable, locally recurrent or metastatic breast cancer in patients who have relapsed following adjuvant/neoadjuvant chemotherapy including an anthracycline.
Pharmacology: Gemcitabine, which is a pyrimidine antimetabolite, is metabolised intracellularly by nucleoside kinase to the active diphosphate and triphosphate nucleosides. The cytotoxic effect of gemcitabine is due to inhibition of DNA synthesis by two mechanisms of action by both active nuclosides.
Dosage: Adult: Bladder cancer: 1000mg/m2 by IV infusion over 30 minutes on days 1,8,15 of each 28 day cycle and cisplatin 70mg/m2 on day 1 following gemcitabine or on day 2. Pancreatic cancer: 1000mg/m2 by IV infusion over 30 minutes once weekly for 7 weeks followed by a week of rest. Subsequent cycles, once per week for 3 out of every 4 weeks. NSCLC: Single agent use: 1000mg/m2 by IV infusion over 30 minutes once weekly for 3 weeks followed by a week of rest. Repeat cycle. Combination use: Gemcitabine 1250mg/m2 given by IV infusion over 30 minutes on days 1 and 8 of each 21 day cycle. Cisplatin dose range: 75-100mg/m2 once every 3 weeks. Breast cancer: Paclitaxel 175mg/m2 on day 1 over approx. 3 hours as IV infusion, followed by gemcitabine 1250mg/m2 as 30 minutes IV infusion on days 1 and 8 of each 21 day cycle. Ovarian cancer: 1000mg/m2 on days 1 and 8 of each 21-day cycle as 30 minutes IV infusion. After gemcitabine, administer carboplatin on day 1, with target AUC of 4mg/ml/min. Adjust dose according to blood counts (see SPC). Elderly: As per adults. Children: Under 18 years, not recommended.
Contraindications: Hypersensitivity to the active substance or to any of the excipients. Lactation. Pregnancy (unless clearly necessary).
Special precautions: Prolongation of the infusion time and increased dosing frequency increase toxicity. Monitor prior to each dose for platelet, leucocyte and granulocyte counts. Hepatic or renal insufficiency, history of cardiovascular events. Pulmonary effects, haemolytic uraemic syndrome reported. Possibility of male infertility. Male contraception advised up to 6 months after treatment. Contains sodium.
Drug interactions: Avoid live attenuated vaccines, radiotherapy.
Adverse drug reactions: Myelosuppression (anaemia, leucopenia and thrombocytopenia), febrile neutropenia; suspend or modify therapy if occurs. Raised liver transaminases (AST/ALT) and alkaline phosphatase, proteinuria and hematuria, allergic skin rashes. GI disorders, dyspnoea, anorexia, headache, somnolence, insomnia, cough, rhinitis, alopecia, itching, sweating, back pain, myalgia, flu-like symptoms, oedema.
Full prescribing information and references available from Actavis Ireland Ltd. Telephone: (021) 4619040. Fax: (021) 4619049. E-mail: firstname.lastname@example.org