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    NUBEQA® Publications

    ARAMIS Preview

    ARAMIS Trial

     

    Darolutamide in Nonmetastatic, Castration-Resistant Prostate Cancer

    Fizazi K, Shore N, Tammela TL, Ulys A, Vjaters E, Polyakov S, et al. Darolutamide in nonmetastatic, castration-resistant prostate cancer. N Engl J Med. 2019;380(13):1235-1246.

     

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    ARASENS Preview

    ARASENS Trial

     

    Darolutamide and Survival in Metastatic, Hormone-Sensitive Prostate Cancer

    Smith MR, Hussain M, Saad F, Fizazi K, Sternberg CN, Crawford ED, et al. Darolutamide and survival in metastatic, hormone-sensitive prostate cancer. N Engl J Med. 2022;386(12):1132-1142.

     

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    ARANOTE Preview

    ARANOTE Trial

     

    Darolutamide in Combination With Androgen-Deprivation Therapy in Patients With Metastatic Hormone-Sensitive Prostate Cancer From the Phase III ARANOTE Trial

    Saad F, Vjaters E, Shore N, Olmos D, Xing N, de Santana Gomes AJP, et al. Darolutamide in combination with androgen-deprivation therapy in patients with metastatic hormone-sensitive prostate cancer from the phase III ARANOTE trial. J Clin Oncol. 2024;42(36):4271-4281. doi:10.1200/JCO-24-01798.

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    Click here for additional safety information and for a link to the product monograph

     

    NUBEQA (darolutamide) is indicated for the treatment of:
    •    patients with non-metastatic castration resistant prostate cancer (nmCRPC). NUBEQA has not been studied in patients with nmCRPC at low risk of developing metastases. The benefit and risk profile in these patients is unknown.
    •    patients with metastatic castration-sensitive prostate cancer (mCSPC).
    •    patients with metastatic castration-sensitive prostate cancer (mCSPC) in combination with docetaxel.
     

    See the Product Monograph

    here
    for important information about:
    •    Relevant warnings and precautions regarding monitoring for signs and symptoms of ischemic heart disease, drug-induced liver injury with increases in ALT and AST, risk of seizure, harm to developing fetus or loss of pregnancy, use of effective contraception, impaired fertility, monitoring for disease progression and PSA.
    •    Conditions of clinical use, adverse reactions, drug interactions and dosing instructions.

     

    The Product Monograph is also available by calling Bayer Medical Information at 1-800-265-7382.
     

    PP-NUB-CA-0687-2