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Ovarian cancer maintenance therapy

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    Distribution Tablet: ± L; Capsule: ± L. Metabolism Primarily hepatic via CYP3A; the majority of metabolism is through oxidation with some metabolites undergoing subsequent glucuronide or sulfate conjugation.

    Clearance: Tablet: 7.

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    Time to Peak Tablet: 1. Half-Life Elimination Tablet: Use: Labeled Indications Breast cancer, metastatic BRCA-mutated, HER2-negative : Tablets: Treatment of deleterious or suspected deleterious germline BRCA-mutated gBRCAmHER2-negative metastatic breast cancer in adults who have been treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic setting; patients with hormone receptor-positive disease should have received a prior endocrine therapy or be considered inappropriate for endocrine therapy select patients for therapy based on an approved olaparib companion diagnostic test for gBRCA1m or gBRCA2m in blood specimen.

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    Ovarian cancer, advanced BRCA-mutated : Tablets, capsules: Treatment of deleterious or suspected deleterious gBRCAm advanced ovarian cancer in adults who have been treated with 3 or more prior lines of chemotherapy select patients for therapy based on an approved olaparib companion diagnostic test for gBRCA1m or gBRCA2m in blood specimen.

    Ovarian cancer, advanced BRCA-mutatedfirst-line maintenance therapy: Tablets: First-line maintenance treatment as monotherapy of deleterious or suspected deleterious germline or somatic BRCA-mutated advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer in adults who are in complete or partial response to first-line, platinum-based chemotherapy select patients for therapy based on an approved olaparib companion diagnostic test for BRCA1m or BRCA2m ovarian cancer maintenance therapy tumor or blood specimen.

    Ovarian cancer, recurrent maintenance therapy : Tablets: Maintenance treatment of recurrent epithelial ovarian, ovarian cancer maintenance therapy tube, or primary peritoneal cancer in adults who are in complete or partial response to ovarian cancer maintenance therapy chemotherapy.

    Pancreatic cancer, metastatic BRCA-mutatedfirst-line maintenance therapy: Tablets: First-line maintenance treatment of deleterious or suspected deleterious gBRCAm metastatic pancreatic adenocarcinoma in adults whose disease has not progressed on at least 16 weeks of a first-line, platinum-based chemotherapy regimen select patients for therapy based on an approved olaparib companion diagnostic test for gBRCA1m or gBRCA2m in blood specimen.

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    Contraindications There are no contraindications listed in the manufacturer's US labeling. Canadian labeling: Hypersensitivity to olaparib or any component of the formulation.

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    Ovarian cancer maintenance therapy Adult Note: Olaparib is available in tablets and in some regions capsules. Due to differences in dosing and bioavailability, do not substitute capsules for tablets or vice versa on a mg-per-mg basis. Select patients for therapy based on an approved olaparib companion diagnostic test for detection of genetic mutations for all indications except ovarian cancer, recurrent maintenance therapy.

    Ovarian cancer, advanced, gBRCAm: Oral: Tablets: mg twice daily until disease progression or unacceptable toxicity.

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    Capsules: mg twice daily until disease progression or unacceptable toxicity Domchek Ovarian cancer, advanced, germline or somatic BRCA-mutated, first-line maintenance therapy monotherapy : Oral: Tablets: mg twice daily until disease progression or unacceptable toxicity or completion of 2 years of therapy. Patients with a complete ovarian cancer maintenance therapy no radiologic evidence of disease at 2 paraziti rari should discontinue olaparib; patients with evidence of disease at 2 years may continue treatment beyond 2 years if further olaparib treatment may provide benefit Moore Ovarian cancer, advanced homologous recombination deficient-positivefirst-line maintenance therapy combination therapy : Oral: Tablets: mg twice daily in combination tratamentul colitei de vierme bevacizumab until disease progression or tip trichocefalos toxicity or completion of 2 years of therapy Ray-Coquard Patients with a complete response no radiologic evidence of disease at 2 years should discontinue olaparib; patients with evidence of disease at 2 years may continue treatment beyond 2 years if further olaparib treatment may provide benefit.

    Inclusion of other subtypes should first be discussed with the Medical Monitor. Patients must not have received bevacizumab during this course of treatment. Bevacizumab use as part of an earlier line of chemotherapy is permitted Patients must not have received any investigational agent during this course of treatment Patients must be randomised within 8 weeks of their last dose of chemotherapy last dose is the day of the last infusion - Patients must have normal organ and bone marrow function measured within 28 days of randomization.

    Bevacizumab duration is for a total of 15 months including when administered with chemotherapy as well as maintenance. Ovarian cancer, recurrent, maintenance therapy: Oral: Tablets: mg twice daily until disease progression or unacceptable toxicity Pujade-Lauraine Pancreatic cancer, metastatic, gBRCAm, first-line maintenance therapy: Oral: Tablets: mg twice daily until disease progression or unacceptable toxicity Golan Prostate cancer, metastatic, castration-resistant homologous recombination repair gene-mutated : Oral: Tablets: mg twice daily until disease progression or unacceptable toxicity de Bono Patients should also receive a gonadotropin-releasing hormone analog or have had bilateral orchiectomy.

    Consult Drug Interactions database for more information.

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    Missed doses: If a dose is missed, administer the next dose at its scheduled time. Consult drug interactions database for more information.