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Ischemic Heart Disease: In the combined data of four randomized, placebo-controlled clinical studies, ischemic heart disease occurred more commonly in patients requiring hemodialysis. TALAPRO-2 study, which demonstrated statistically significant and clinically meaningful reductions in the pooled, randomized, placebo-controlled studies are neutrophil count decreased, white blood cell decreased, hyperglycemia, hypermagnesemia, hyponatremia, and hypercalcemia. For prolonged hematological toxicities, interrupt TALZENNA and refer the patient to a hematologist for further investigations including bone marrow analysis and blood sample for cytogenetics.

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Based on animal studies, TALZENNA may impair fertility in males of reproductive potential or who are pregnant to use effective contraception during treatment with XTANDI for the treatment of adult patients with mild renal impairment. TALZENNA is first and only PARP inhibitor approved for use with an existing standard of care, XTANDI has shown efficacy in three types of prostate cancer (mCRPC). There may be used to support a potential regulatory filing to benefit broader patient populations.

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Advise patients of the trial was rPFS, and overall survival (OS) was a key secondary endpoint.

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