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  • Tarceva
    / Roche


    Active Ingredient
    Erlotinib 100 mg, 150 mg

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Film Coated Tablets

    30 x 100 mg

    partial basket chart 13839 20725

    Film Coated Tablets

    30 x 150 mg

    partial basket chart 69596 20726

    Related information


    Dosage

    Non-small cell lung cancer: 150 mg daily without food. Treatment should continue until disease progression or unacceptable toxicity occurs. There is no evidence that treatment beyond progression is beneficial.
    Pancreatic cancer: 100 mg daily without food, in combination with gemcitabine. See prescribing information for full details.


    Indications

    Non-Small Cell Lung Cancer (NSCLC): Tarceva is indicated for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR activating mutations.Indicated for the maintenance treatment of patients with locally advanced or metastatic non-small cell lung cancer whose disease has not progressed after four cycles of platinum-based first-line chemotherapy.Tarceva is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of at least one prior chemotherapy regimen.
    Pancreatic cancer: Tarceva is indicated in combination with gemcitabine for the first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer.


    Contra-Indications

    Hypersensitivity to erlotinib or to any of the excipients.


    Special Precautions

    There have been infrequent reports of serious Interstitial Lung Disease (ILD), including fatalities, in patients receiving Tarceva for treatment of NSCLC or other advanced solid tumors. Symptoms started from 5 days to more than 9 months (median 47 days) after initiating therapy. Most of the cases were associated with confounding or contributing factors such as concomitant/prior chemotherapy, prior radiotherapy, pre-existing parenchymal lung disease, metastatic lung disease, or pulmonary infections.Periodic liver function testing (transaminases, bilirubin, and alkaline phosphatase) should be considered. Dose reduction or interruption should be considered if changes in liver function are severe. Erlotinib exposure may be increased in patients with hepatic dysfunction. Elevated international normalized ratio and potential bleeding. Patients taking Warfarin or other coumarin-derivative anticoagulants should be monitored regularly for changes in prothrombin time or INR. The safety and effectiveness in pediatric patients have not been studied. No dosage adjustments are recommended in elderly patients. In patients who develop an acute onset of new or progressive pulmonary symptoms, such as dyspnea, cough or fever, treatment should be interrupted pending diagnostic evaluation.Diarrhea can usually be managed with loperamide. Patients with severe diarrhea who are unresponsive to loperamide or who become dehydrated may require dose reduction or temporary interruption of therapy. Patients with severe skin reactions may also require dose reduction or temporary interruption of therapy. When dose reduction is necessary, the dose should be reduced in 50 mg decrements.In patients who are being concomitantly treated with a strong CYP3A4 inhibitor such as atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, troleandomycin (TAO), or voriconazole, a dose reduction should be considered should severe adverse reactions occur. Pre-treatment with the CYP3A4 inducer rifampicin decreased erlotinib AUC by about 2/3. Alternate treatments lacking CYP3A4 inducing activity should be considered. If an alternative treatment is unavailable, a Tarceva dose greater than 150 mg should be considered. Erlotinib is eliminated by hepatic metabolism and biliary excretion. Therefore, caution should be used when treating patients with hepatic impairment. Dose reduction or interruption should be considered should severe adverse reactions occur.
    For full details see prescribing information.


    Side Effects

    Rash, diarrhea, anorexia, fatigue, dyspnea, cough. Nausea, infection, vomiting, stomatitis, pruritis, dry skin, conjunctivitis, keratoconjuntivitis sicca, abdominal pain. Liver function test abnormalities. Serious adverse events reported were G.I. disorders, infections and infestations.


    Drug interactions

    Co-treatment with the potent CYP3A4 inhibitor ketoconazole and other strong CYP3A4 inhibitors such as atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, troleandomycin (TAO), voriconazole. Co-treatment with CYP3A4 inducers such as rifabutin, rifapentin, phenytoin, carbamazepine, phenobarbital and St. John’s Wort.
    For full details see prescribing information.


    Pregnancy and Lactation

    Pregnancy: There are no adequate data for the use of erlotinib in pregnant women. Studies in animals have shown no evidence of teratogenicity or abnormal parturition. However, an adverse effect on the pregnancy can not be excluded as rat and rabbit studies have shown increased embryo/foetal lethality. The potential risk for humans is unknown.
    Women of childbearing potential: Women of childbearing potential must be advised to avoid pregnancy while on Tarceva. Adequate contraceptive methods should be used during therapy, and for at least 2 weeks after completing therapy. Treatment should only be continued in pregnant women if the potential benefit to the mother outweighs the risk to the foetus.
    Breast-feeding It is not known whether erlotinib is excreted in human milk. Because of the potential harm to the infant, mothers should be advised against breast-feeding while receiving Tarceva.
    Fertility: Studies in animals have shown no evidence of impaired fertility. However, an adverse effect on the fertility can not be excluded as animal studies have shown effects on reproductive parameters.The potential risk for humans is unknown.


    Overdose

    Symptoms: Single oral doses of Tarceva up to 1000 mg erlotinib in healthy subjects and up to 1600 mg in cancer patients have been tolerated. Repeated twice daily doses of 200 mg in healthy subjects were poorly tolerated after only a few days of dosing. Based on the data from these studies, severe adverse reactions such as diarrhoea, rash and possibly increased activity of liver aminotransferases may occur above the recommended dose.
    Management: In case of suspected overdose, Tarceva should be withheld and symptomatic treatment initiated.


    Manufacturer
    F. Hoffmann - La Roche Ltd.
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