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  • Gemcitabine Teva Concentrate
    / Abic


    Active Ingredient
    Gemcitabine (as HCl) 40 mg/ml

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Vial

    1 X 200 mg / 5 ml

    partial basket chart 53730 7916

    Vial

    1 X 1000 mg / 25 ml

    partial basket chart 53731 7917

    Vial

    1 X 2000 mg / 50 ml

    partial basket chart 53732 7918

    Dosage

    Bladder cancer-Combination use: The recommended dose for gemcitabine is 1000 mg/m², given by 30-minute infusion. The dose should be given on Days 1, 8 and 15 of each 28-day cycle in combination with cisplatin. Cisplatin is given at a recommended dose of 70 mg/m2 on Day 1 following gemcitabine or day 2 of each 28-day cycle. This 4-week cycle is then repeated. Dosage reduction with each cycle or within a cycle may be applied based upon the grade of toxicity experienced by the patient.
    Pancreatic cancer: The recommended dose of gemcitabine is 1000 mg/m², given by 30-minute intravenous infusion. This should be repeated once weekly for up to 7 weeks followed by a week of rest. Subsequent cycles should consist of injections once weekly for 3 consecutive weeks out of every 4 weeks. Dosage reduction with each cycle or within a cycle may be applied based upon the grade of toxicity experienced by the patient. Not to be used in children under 18 years of age.
    Non small Cell lung cancer -Monotherapy: The recommended dose of gemcitabine is 1000 mg/m², given by 30-minute intravenous infusion. This should be repeated once weekly for 3 weeks, followed by a 1-week rest period. This 4-week cycle is then repeated. Dosage reduction with each cycle or within a cycle may be applied based upon the grade of toxicity experienced by the patient.
    Combination use: The recommended dose for gemcitabine is 1250 mg/m² body surface area given as a 30 -minute intravenous infusion on Day 1 and 8 of the treatment cycle (21 days). Dosage reduction with each cycle or within a cycle may be applied based upon the grade of toxicity experienced by the patient. Cisplatin has been used at doses between 75-100 mg/m2 once every 3 weeks.
    Breast cancer-Combination use: Gemcitabine in combination with paclitaxel is recommended using paclitaxel (175 mg/m²) administered on Day 1 over approximately 3-hours as an intravenous infusion, followed by gemcitabine (1250 mg/m²) as a 30-minute intravenous infusion on Days 1 and 8 of each 21-day cycle. 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 (x 10^6/l) prior to initiation of gemcitabine + paclitaxel combination.
    Ovarian cancer-Combination use: Gemcitabine in combination with carboplatin is recommended using gemcitabine 1000 mg/m² administered on Days 1 and 8 of each 21-day cycle as a 30-minute intravenous infusion. After gemcitabine, carboplatin will be given on Day 1 consistent with a target Area under curve (AUC) of 4.0 mg/ml·min. Dosage reduction with each cycle or within a cycle may be applied based upon the grade of toxicity experienced by the patient.
    Monitoring for toxicity and dose modification due to toxicity: See prescribing information for full details.
    Patients with renal or hepatic impairment: Gemcitabine should be used with caution in patients with hepatic or renal insufficiency as there is insufficient information from clinical studies to allow for clear dose recommendations for these patient populations.Laboratory evaluation of renal and hepatic function (including virological tests) should be performed periodically.
    Elderly population (> 65 years): Gemcitabine has been well tolerated in patients over the age of 65. There is no evidence to suggest that dose adjustments, other than those already recommended for all patients, are necessary in the elderly.
    Paediatric population (<18 years): Gemcitabine is not recommended for use in children under 18 years of age.
    See prescribing information for full details.


    Indications

    Non-small cell lung cancer: Palliative treatment of adult patients with locally advanced or metastatic non-small cell lung cancer.
    Breast cancer: In combination with paclitaxel, is indicated for the treatment of patients with unresectable, locally recurrent or metastatic breast cancer who have relapsed following adjuvant/neoadjuvant chemotherapy. Prior chemotherapy should have included an anthracycline unless clinically contraindicated.
    Pancreatic cancer: Palliative treatment of adult patients with locally advanced or metastatic adenocarcinoma of the pancreas and for patients with 5-FU refractory pancreatic cancer.
    Ovarian cancer: In combination with carboplatin, is indicated for the treatment of patients with recurrent epithelial ovarian carcinoma who have relapsed at least 6 months after platinum-based therapy.


    Contra-Indications

    Hypersensitivity, breastfeeding.


    Special Precautions

    Prolongation of the infusion time and increased dosing frequency have been shown to increase toxicity.
    Haematological toxicity: Gemcitabine can suppress bone marrow function as manifested by leucopaenia, thrombocytopaenia and anaemia. Patients receiving gemcitabine should be monitored prior to each dose for platelet, leucocyte and granulocyte counts. Suspension or modification of therapy should be considered when drug-induced bone marrow depression is detected. However, myelosuppression is short lived and usually does not result in dose reduction and rarely in discontinuation. Peripheral blood counts may continue to deteriorate after gemcitabine administration has been stopped. In patients with impaired bone marrow function, the treatment should be started with caution. As with other cytotoxic treatments, the risk of cumulative bone-marrow suppression must be considered when gemcitabine treatment is given together with other chemotherapy.
    Hepatic insufficiency: Administration of gemcitabine in patients with concurrent liver metastases or a pre-existing medical history of hepatitis, alcoholism or liver cirrhosis may lead to exacerbation of the underlying hepatic insufficiency. Laboratory evaluation of renal and hepatic function (including virological tests) should be performed periodically.
    Concomitant radiotherapy: Concomitant radiotherapy (given together or ≤ 7 days apart): Toxicity has been reported.  Yellow fever vaccine and other live attenuated vaccines are not recommended in patients treated with gemcitabine.
    Cardiovascular: Due to the risk of cardiac and/or vascular disorders with gemcitabine, particular caution must be exercised with patients presenting a history of cardiovascular events.
    Pulmonary: Pulmonary effects, sometimes severe (such as pulmonary oedema, interstitial pneumonitis or adult respiratory distress syndrome (ARDS)) have been reported in association with gemcitabine therapy. The aetiology of these effects is unknown. If such effects develop, consideration should be made to discontinuing gemcitabine therapy. Early use of supportive care measure may help ameliorate the condition.
    See prescribing information for full details.   


    Side Effects

    Anemia, leucopenia and thrombocytopenia can occur. Thrombocythemia, nausea, vomiting, rash, edema/peripheral edema, alopecia, somnolence, diarrhea.
    See prescribing information for full details. 


    Drug interactions

    Yellow fever and other live attenuated vaccines are not recommended due to the risk of systemic, possibly fatal, disease, particularly in immunosuppressed patients. The amount of alcohol in this medicinal product may alter the effects of other medicines.
    See prescribing information for full details.


    Pregnancy and Lactation

    Pregnancy: Women should be advised not to become pregnant during treatment with gemcitabine and to warn their attending physician immediately, should this occur after all.
    Lactation: It’s contraindicated to breastfeed during treatment with this drug.


    Overdose

    There is no known antidote for overdose of gemcitabine. Doses as high as 5700 mg/m2 have been administered by intravenous infusion over 30-minutes every 2 weeks with clinically acceptable toxicity. In the event of suspected overdose, the patient should be monitored with appropriate blood counts and receive supportive therapy, as necessary.


    Manufacturer
    Actavis, Italy S.P.S
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