Transcription of Lynparza Prescribing Information
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Lynparza Prescribing Information
US-54700. HIGHLIGHTS OF Prescribing Information Prostate cancer These highlights do not include all the Information needed to use Lynparza safely for the treatment of adult patients with deleterious or suspected deleterious germline and effectively. See full Prescribing Information for Lynparza . or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC) who have progressed following prior Lynparza (olaparib) tablets, for oral use treatment with enzalutamide or abiraterone. Select patients for therapy based on an Initial Approval: 2014 FDA-approved companion diagnostic for Lynparza . ( , ). --------------------------------- DOSAGE AND ADMINISTRATION -------------------------------- ------------------------------------ RECENT MAJOR CHANGES ----------------------------------- Indications and Usage (1) 5/2020 Recommended dosage is 300 mg taken orally twice daily with or without food.
• Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML): Occurred in approximately 1.5% of patients exposed to Lynparza monotherapy and the majority of events had a fatal outcome. Monitor patients for hematological toxicity at baseline and monthly thereafter. Discontinue if MDS/AML is confirmed. (5.1)
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