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  • Lenalidomide Teva
    / Abic


    Active Ingredient
    Lenalidomide 5, 10, 15, 25 mg

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Hard Capsules

    21 X 5 mg

    not in the basket chart 45712

    Hard Capsules

    21 X 10 mg

    not in the basket chart 45709

    Hard Capsules

    21 X 15 mg

    not in the basket chart 45710

    Hard Capsules

    21 X 25 mg

    not in the basket chart 45711

    Dosage

    Newly Diagnosed Multiple Myeloma (NDMM)
    Lenalidomide maintenance in patients who have undergone autologous stem cell transplantation (ASCT): Lenalidomide maintenance should be initiated after adequate haematologic recovery following ASCT in patients without evidence of progression. Lenalidomide must not be started if the Absolute Neutrophil Count (ANC) is < 1.0 x 10^9/L, and/or platelet counts are < 75 x 10^9/L.
    Recommended dose: The recommended starting dose is lenalidomide 10 mg orally once daily continuously (on days 1 to 28 of repeated 28-day cycles) given until disease progression or intolerance. After 3 cycles of lenalidomide maintenance, the dose can be increased to 15 mg orally once daily if tolerated.
    Lenalidomide in combination with dexamethasone until disease progression in patients who are not eligible for transplant: Lenalidomide treatment must not be started if the ANC is < 1.0 x 10^9/L, and/or platelet counts are < 50 x 10^9/L.
    Recommended dose: The recommended starting dose of lenalidomide is 25 mg orally once daily on days 1-21 of repeated 28-day cycles. The recommended dose of dexamethasone is 40 mg orally once daily on days 1, 8, 15 and 22 of repeated 28-day cycles. Patients may continue lenalidomide and dexamethasone therapy until disease progression or intolerance.
    Dosing is continued or modified based upon clinical and laboratory findings. For patients ≥75 years of age, the starting dose of dexamethasone is 20 mg/day on days 1, 8, 15 and 22 of each 28-day treatment cycle. The recommended dose of lenalidomide for patients suffering from moderate renal impairment is 10 mg once daily.
    Recommended dose adjustments during treatment and restart of treatment: Dose adjustments, as summarised below, are recommended to manage grade 3 or 4 thrombocytopenia, neutropenia, or other grade 3 or 4 toxicity judged to be related to lenalidomide.
    Lenalidomide in combination with melphalan and prednisone followed by maintenance monotherapy in patients who are not eligible for transplant: Lenalidomide treatment must not be started if the ANC is < 1.5 x 10^9/L, and/or platelet counts are < 75 x 10^9/L.
    Recommended dose: The recommended starting dose is lenalidomide 10 mg/day orally on days 1-21 of repeated 28-day cycles for up to 9 cycles, melphalan 0.18 mg/kg orally on days 1-4 of repeated 28 day cycles, prednisone 2 mg/kg orally on days 1-4 of repeated 28-day cycles. Patients who complete 9 cycles or who are unable to complete the combination therapy due to intolerance are treated with lenalidomide alone,10 mg/day orally on days 1-21 of repeated 28-day cycles given until disease progression. Dosing is continued or modified based upon clinical and laboratory findings.
    Recommended dose adjustments during treatment and restart of treatment: Dose adjustments, as summarised below, are recommended to manage grade 3 or 4 thrombocytopenia, neutropenia, or other grade 3 or 4 toxicity judged to be related to lenalidomide.
    Multiple Myeloma with at least one prior therapy: The recommended starting dose of Lenalidomide  is 25 mg once daily on days 1-21 of repeated 28-day cycles. The recommended dose of dexamethasone is 40 mg once daily on days 1-4, 9-12, and 17-20 of each 28-day cycle for the first 4 cycles of therapy and then 40 mg once daily orally on days 1-4 every 28 days. Treatment is continued or modified based upon clinical and laboratory findings.
    Prescribing physicians should carefully evaluate which dose of dexamethasone to use, taking into account the condition and disease status of the patient.
    Lenalidomide treatment must not be started if the ANC < 1,000/mcL, and/or platelet counts < 75,000/ mcL or, dependent on bone marrow infiltration by plasma cells, platelet counts < 30,000/mcL.
    Dose Adjustments for Hematologic Toxicities during Multiple Myeloma Treatment: Dose modification guidelines, as summarized below, are recommended to manage Grade 3 or 4 neutropenia or thrombocytopenia or other Grade 3 or 4 toxicity judged to be related  this drug.
    Myelodysplastic Syndromes: The recommended starting dose of Lenalidomide is 10 mg daily. Treatment is continued or modified based upon clinical and laboratory findings.
    Please refer to the license holder for further details.


    Indications

    Previously untreated multiple myeloma (MM)  in adult patients who are not eligible for transplant.
    In combination with dexamethasone treatment of multiple myeloma patient who have received at least one prior therapy.
    Patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q abnormality with or without additional cytogenetic abnormalities.
    The treatment of adults patients with relapsed and/or refractory mantle cell lymphoma (MCL).


    Contra-Indications

    Hypersensitivity to active substance or to any of its excipients.
    Blood donation is contraindicated during the therapy with Lenalidomide and for 4 weeks after discontinuations of the therapy.
    Women of child bearing potential (WOCBP): two reliable forms of contraception are necessary during the treatment of this drug. WOCBP should postpone the planning of the pregnancy by 4 weeks after discontinuation of Lenalidomide therapy.
    Breastfeeding should be discontinued for 4 weeks after discontinuation of   Lenalidomide therapy.
    Males: Donation of the semen while taking Lenalidomide, during therapy and short discontinuations is contraindicated. The donation is allowed 4 weeks after discontinuation of Lenalidomide therapy. Male patients should use a reliable contraception during the therapy in every sexual intercourse.


    Special Precautions

    Because of potential toxicity and to avoid fetal exposure, Lenalidomide Teva is only available under a special controlled distribution program called “Lenalidomide Teva Risk Minimization Plan- Pregnancy Prevention Program (RMP-PPP)”. Prescribers and pharmacists registered with the program can prescribe and dispense the product to patients who are registered and meet all the conditions of the Lenalidomide Teva RMP-PPP. Please see the following information for prescribers, female patients, and male patients about this controlled distribution program: http://lp6.me/1IJR1


    Side Effects

    See prescribing information for full details.


    Manufacturer
    Teva Pharmaceutical Industries Ltd, Israel
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