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  • Imatinib Taro
    / Taro International Ltd


    Active Ingredient
    Imatinib 100 mg, 400 mg

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Film Coated Tablets

    60 X 100 mg

    full basket chart

    Film Coated Tablets

    30 X 400 mg

    full basket chart

    Related information


    Dosage

    Therapy should be initiated by a physician experienced in the treatment of patients with hematological malignancies and malignant sarcomas, as appropriate. See prescribing information for full details.


    Indications

    -Treatment of adult patients and children 3 years of age and above with Ph+ chronic myeloid leukaemia (Ph + – CML) in chronic phase, accelerated phase or blast crisis.
    -Treatment of adult patients with Kit (CD117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumors (GIST).
    -Adjuvant treatment of adult patients following complete gross resection of Kit (CD117) positive GIST.
    -Treatment of adult patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia (Ph + ALL) integrated with chemotherapy.
    -Treatment of adult patients with relapsed or refractory Ph+ ALL as monotherapy.
    -Treatment of adult patients with unresectable dermatofibrosarcoma protuberans (DFSP) and adult patients with recurrent and/or metastatic DFSP who are not eligible for surgery.
    -Treatment of adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with PDGFR (platelet-derived growth factor receptor) gene re-arrangements.
    -Treatment of adult patients with hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL) who have the FIP1L1-PDGFRα fusion kinase (mutational analysis or FISH demonstration of CHIC2 allele deletion) and for patients with HES and/or CEL who are FIP1L1- PDGFRα fusion kinase negative.
    -Treatment of adult patients with aggressive systemic mastocytosis (ASM) without the D816V c-kit mutation.


    Contra-Indications

    Hypersensitivity to the active substance or to any of the excipients.


    Special Precautions

    Caution should be used when taking Imatinib with protease inhibitors, azole antifungals, certain macrolides, CYP3A4 substrates with a narrow therapeutic window (e.g. cyclosporine,pimozide, tacrolimus, sirolimus, ergotamine, diergotamine, fentanyl, alfentanil, terfenadine, bortezomib, docetaxel, quinidine) or warfarin and other coumarin derivatives.
    Concomitant use of strong CYP3A4 inducers (e.g. dexamethasone, phenytoin, carbamazepine, rifampicin, phenobarbital or Hypericum perforatum, also known as St. John’s Wort) and Imatinib should be avoided.
    Thyroid stimulating hormone (TSH) levels should be closely monitored during treatment with Imatinib.
    Hepatic function should be carefully monitored in circumstances where Imatinib is combined with chemotherapy regimens also known to be associated with hepatic dysfunction
    Caution should be exercised in patients with cardiac dysfunction.
    Patients with cardiac disease, risk factors for cardiac failure or history of renal failure should be monitored carefully, and any patient with signs or symptoms consistent with cardiac or renal failure should be evaluated and treated.
    Correction of clinically significant dehydration and treatment of high uric acid levels are recommended prior to initiation of Imatinib.
    Patients should be tested for HBV infection before initiating treatment with Imatinib. Carriers of HBV who require treatment with Imatinib should be closely monitored for signs and symptoms of active HBV infection throughout therapy and for several months following termination of therapy
    Exposure to direct sunlight should be avoided or minimised due to the risk of phototoxicity associated with Imatinib treatment. Patients should be instructed to use measures such as protective clothing and sunscreen with high sun protection factor (SPF).
    If laboratory or clinical findings associated with thrombotic microangiopathy (TMA) occur in a patient receiving Imatinib, treatment should be discontinued and thorough evaluation for TMA, including ADAMTS13 activity and anti-ADAMTS13-antibody determination, should be completed. If anti-ADAMTS13-antibody is elevated in conjunction with low ADAMTS13 activity, treatment with Imatinib should not be resumed.
    Complete blood counts and liver function must be performed regularly during therapy with Imatinib.
    Patients with renal impairment should be given the minimum starting dose. Patients with severe renal impairment should be treated with caution. The dose can be reduced if not tolerated.
    Close monitoring of growth in children under Imatinib treatment is recommended.


    Side Effects

    Miscellaneous adverse reactions such as pleural effusion, ascites, pulmonary oedema and rapid weight gain with or without superficial oedema that may be collectively described as “fluid retention”.
    When Imatinib was combined with high dose chemotherapy in Ph + ALL patients, transient liver toxicity in the form of transaminase elevation and hyperbilirubinaemia were observed.
    Patients with advanced stages of malignancies may have numerous confounding medical conditions that make causality of adverse reactions difficult to assess due to the variety of symptoms related to the underlying disease, its progression, and the co-administration of numerous medicinal products.
    See prescribing information for full details.


    Drug interactions

    Active substances that may increase Imatinib plasma concentrations
    Substances that inhibit the cytochrome P450 isoenzyme CYP3A4 activity (e.g. protease inhibitors such as indinavir, lopinavir/ritonavir, ritonavir, saquinavir, telaprevir, nelfinavir, boceprevir; azole antifungals including ketoconazole, itraconazole, posaconazole, voriconazole; certain macrolides such as erythromycin, clarithromycin and telithromycin) could decrease metabolism and increase Imatinib concentrations.

    Active substances that may decrease Imatinib plasma concentrations
    Substances that are inducers of CYP3A4 activity (e.g. dexamethasone, phenytoin, carbamazepine, rifampicin, phenobarbital, fosphenytoin, primidone or Hypericum perforatum, also known as St. John’s Wort) may significantly reduce exposure to Imatinib , potentially increasing the risk of therapeutic failure
    Active substances that may have their plasma concentration altered by Imatinib
    Caution is recommended when administering Imatinib with CYP3A4 substrates with a narrow therapeutic window (e.g. cyclosporine, pimozide, tacrolimus, sirolimus, ergotamine, diergotamine, fentanyl, alfentanil, terfenadine, bortezomib, docetaxel and quinidine). Imatinib may increase plasma concentration of other CYP3A4 metabolised drugs (e.g. triazolo-benzodiazepines, dihydropyridine calcium channel blockers, certain HMG-CoA reductase inhibitors, i.e. statins, etc.).
    Patients who require anticoagulation should receive low-molecular-weight or standard heparin, instead of coumarin derivatives such as warfarin.
    Caution should be exercised when using high doses of Imatinib and paracetamol concomitantly.
    In thyroidectomy patients receiving levothyroxine, the plasma exposure to levothyroxine may be decreased when Imatinib is co-administered.


    Pregnancy and Lactation

    Women of childbearing potential
    Women of childbearing potential must be advised to use effective contraception during treatment and for at least 15 days after stopping treatment with Imatinib.
    Pregnancy
    There are limited data on the use of Imatinib in pregnant women. There have been post-marketing reports of spontaneous abortions and infant congenital anomalies from women who have taken Imatinib. Studies in animals have however shown reproductive toxicity and the potential risk for the foetus is unknown. Imatinib should not be used during pregnancy unless clearly necessary. If it is used during pregnancy, the patient must be informed of the potential risk to the foetus.

    Breast-feeding
    There is limited information on Imatinib distribution on human milk. Since the effects of low-dose exposure of the infant to Imatinib are unknown, women should not breast-feed during treatment and for at least 15 days after stopping treatment with Imatinib.
    Fertility
    Studies on patients receiving Imatinib and its effect on fertility and gametogenesis have not been performed. Patients concerned about their fertility on Imatinib treatment should consult with their physician.


    Overdose

    Experience with doses higher than the recommended therapeutic dose is limited.
    In the event of overdose, the patient should be observed and appropriate supportive treatment given.


    Manufacturer
    SUN Pharmaceutical Industries LTD., India
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