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Gemcitabine Package Insert

gemcitabine package insert

Usual Adult Dose for Pancreatic Cancer

1000 mg/m2 IV one time over 30 minutes. Weeks 1 through 8: Weekly dosing for the first 7 weeks, followed by one week of rest. If toxicity occurs, a dose should be held. After week 8: Weekly dosing on Days 1, 8, and 15 of 28 day cycles

Usual Adult Dose for Breast Cancer

1250 mg/m2 IV over 30 minutes on days 1 and 8 of each 21 day cycle that includes paclitaxel. Paclitaxel should be administered at 175 mg/m2 IV on day 1 as a 3 hour IV infusion before gemcitabine administration Dose reduction with each cycle or within a cycle may be applied based upon the grade of toxicity experienced by the patient. Patients should have an absolute granulocyte count of at least 1,500,000,000/L prior to initiation of gemcitabine plus paclitaxel combination.

Usual Adult Dose for Ovarian Cancer

1000 mg/m2 IV over 30 minutes on days 1 and 8 of each 21 day cycle. Carboplatin should be administered IV on day 1 of each 21 day cycle after gemcitabine administration. Patients should be monitored prior to each dose with a complete blood count, including differential counts. Guidelines for dose modification vary in different regions. Consult the manufacturer In combination with carboplatin for the treatment of patients with advanced ovarian cancer that has relapsed at least six months after completion of platinum-based therapy.

Dose Adjustments

Specific dosage reduction guidelines for all conditions vary in different regions and for different products. The manufacturer product information or local protocol should be consulted for guidance in dosing patients with myelosuppression.          Check renal and hepatic function and perform periodic physical examination. For severe (Grade 3 or 4) nonhematologic toxicity, except nausea/vomiting, therapy with this drug should be withheld or decreased based on the judgment of the treating physician. Doses should be withheld until toxicity has resolved in the opinion of the physician.

Overview

Gemzar, 200 mg, 1000 mg, powder for solution for infusion, is a pyrimidine antagonist and is given in the management of solid tumours. It is indicated in bladder cancer, advanced non-small cell lung cancer, advanced pancreatic cancer, breast cancer and ovarian cancer. On 8 June 2007, the European Commission presented to the EMEA a referral under Article 30 of Directive 2001/83/EC, as amended, in order to harmonise the nationally authorised Summaries of Product Characteristics (SPC), Labelling and Package Leaflet including quality aspects of the medicinal product Gemzar. The basis for referral was that there were divergences in the Summaries of Product Characteristics (SPC) including quality aspects of Gemzar approved across EU Member States, mainly with respect to the approved indications, the posology, the contra-indications and the warnings.

Warnings

Capillary leak syndrome reported with severe consequences; discontinue if symptoms occur Pulmonary toxicity, including interstitial pneumonitis, pulmonary fibrosis, pulmonary edema, and ARDS reported; onset of pulmonary symptoms may occur up to 2 weeks after last dose; discontinue treatment in patients who develop unexplained dyspnea, with or without bronchospasm, or have any evidence of pulmonary toxicity Hemolytic uremic syndrome reported, including fatalities; permanently discontinue therapy in patients with HUS or severe renal impairment; renal failure may not be reversible even with discontinuation of therapy.

Drug-induced liver injury reported, including liver failure and death; assess hepatic function prior to initiation of therapy and periodically during treatment; discontinue drug in patients that develop severe liver injury Infusions longer than 60 minutes or more frequently than qWk increase the incidence of clinically significant hypotension, severe flu-like symptoms, myelosuppression, and asthenia; gemcitabine half-life is influenced by the length of the infusion Posterior reversible encephalopathy syndrome (PRES) reported; PRES can present with headache, seizure, lethargy, hypertension, confusion, blindness, and other visual and neurologic disturbances; discontinue if PRES develops.

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