Usual Adult Dose for Breast Cancer

FIRST-LINE MAINTENANCE TREATMENT OF BRCA-MUTATED ADVANCED OVARIAN CANCER:
300 mg orally 2 times a day until disease progression, unacceptable toxicity, or completion of 2 years of therapy; patients with a complete response (no radiological evidence of disease) at 2 years should stop; patients with evidence of disease at 2 years, who in the opinion of the treating healthcare provider can derive further benefit from therapy, can be treated beyond 2 years

FIRST-LINE MAINTENANCE TREATMENT OF HRD-POSITIVE ADVANCED OVARIAN CANCER IN COMBINATION WITH BEVACIZUMAB:
300 mg orally 2 times a day until disease progression, unacceptable toxicity, or completion of 2 years of therapy; patients with a complete response (no radiological evidence of disease) at 2 years should stop; patients with evidence of disease at 2 years, who in the opinion of the treating healthcare provider can derive further benefit from therapy, can be treated beyond 2 years

• When used with this drug, the recommended dose of bevacizumab is 15 mg/kg every 3 weeks for a total of 15 months including the period given with chemotherapy and given as maintenance.

ADJUVANT TREATMENT OF GERMLINE BRCA-MUTATED HER2-NEGATIVE HIGH RISK EARLY BREAST CANCER:
300 mg orally 2 times a day until disease recurrence, unacceptable toxicity, or completion of 1 years of therapy; patients should continue concurrent treatment with endocrine therapy as per current clinical practice guidelines

RECURRENT OVARIAN CANCER; GERMLINE BRCA-MUTATED ADVANCED OVARIAN CANCER; HER2-NEGATIVE METASTATIC BREAST CANCER; METASTATIC PANCREATIC ADENOCARCINOMA; HRR GENE-MUTATED METASTATIC CASTRATION RESISTANT PROSTATE CANCER; BRCAm METASTATIC CASTRATION-RESISTANT PROSTATE CANCER IN COMBINATION WITH ABIRATERONE AND PREDNISONE OR PREDNISOLONE:
300 mg orally 2 times a day until disease progression or unacceptable toxicity

Comments:

• Patients should start therapy no later than 8 weeks after completion of their final dose of the platinum-containing regimen.
• Patients should be selected based on the presence of deleterious or suspected deleterious HRR gene mutations, including BRCA mutations, or genomic instability based on the indication, biomarker, and sample type.
• Refer to the prescribing Information for bevacizumab when used in combination

with this drug for more information.

Uses:

• BRCA-MUTATED ADVANCED OVARIAN CANCER: For maintenance therapy of patients with deleterious or suspected deleterious germline or somatic BRCA-mutated advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy
• FIRST-LINE MAINTENANCE TREATMENT OF HRD-POSITIVE ADVANCED OVARIAN CANCER IN COMBINATION WITH BEVACIZUMAB: In combination with bevacizumab for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD)-positive status defined by either a deleterious or suspected deleterious BRCA mutation AND/OR genomic instability
• MAINTENANCE TREATMENT OF RECURRENT OVARIAN CANCER: For the maintenance treatment of patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in complete or partial response to platinum-based chemotherapy
• ADJUVANT TREATMENT OF GERMLINE BRCA-MUTATED HER2-NEGATIVE HIGH RISK EARLY BREAST CANCER: For the adjuvant treatment of adult patients with deleterious or suspected deleterious gBRCAm human epidermal growth factor receptor 2 (HER2)-negative high risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy
• GERMLINE BRCA-MUTATED HER2-NEGATIVE METASTATIC BREAST CANCER: For the treatment of patients with deleterious or suspected deleterious gBRCAm, HER2-negative metastatic breast cancer, who have been treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic setting; patients with hormone receptor (HR)-positive breast cancer should have been treated with a prior endocrine therapy or be considered inappropriate for endocrine therapy
• FIRST-LINE MAINTENANCE TREATMENT OF GERMLINE BRCA-MUTATED METASTATIC PANCREATIC ADENOCARCINOMA: For maintenance treatment of patients with deleterious or suspected deleterious gBRCAm metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen
• GENE-MUTATED METASTATIC CASTRATION-RESISTANT PROSTATE CANCER: For treatment of patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC) who have progressed following prior treatment with enzalutamide or abiraterone
• BRCA-MUTATED METASTATIC CASTRATION-RESISTANT PROSTATE CANCER IN COMBINATION WITH ABIRATERONE AND PREDNISONE OR PREDNISOLONE: For treatment of adult patients with deleterious or suspected deleterious BRCA-mutated metastatic castration resistant prostate cancer

Usual Adult Dose for Prostate Cancer

FIRST-LINE MAINTENANCE TREATMENT OF BRCA-MUTATED ADVANCED OVARIAN CANCER:
300 mg orally 2 times a day until disease progression, unacceptable toxicity, or completion of 2 years of therapy; patients with a complete response (no radiological evidence of disease) at 2 years should stop; patients with evidence of disease at 2 years, who in the opinion of the treating healthcare provider can derive further benefit from therapy, can be treated beyond 2 years

FIRST-LINE MAINTENANCE TREATMENT OF HRD-POSITIVE ADVANCED OVARIAN CANCER IN COMBINATION WITH BEVACIZUMAB:
300 mg orally 2 times a day until disease progression, unacceptable toxicity, or completion of 2 years of therapy; patients with a complete response (no radiological evidence of disease) at 2 years should stop; patients with evidence of disease at 2 years, who in the opinion of the treating healthcare provider can derive further benefit from therapy, can be treated beyond 2 years

• When used with this drug, the recommended dose of bevacizumab is 15 mg/kg every 3 weeks for a total of 15 months including the period given with chemotherapy and given as maintenance.

ADJUVANT TREATMENT OF GERMLINE BRCA-MUTATED HER2-NEGATIVE HIGH RISK EARLY BREAST CANCER:
300 mg orally 2 times a day until disease recurrence, unacceptable toxicity, or completion of 1 years of therapy; patients should continue concurrent treatment with endocrine therapy as per current clinical practice guidelines

RECURRENT OVARIAN CANCER; GERMLINE BRCA-MUTATED ADVANCED OVARIAN CANCER; HER2-NEGATIVE METASTATIC BREAST CANCER; METASTATIC PANCREATIC ADENOCARCINOMA; HRR GENE-MUTATED METASTATIC CASTRATION RESISTANT PROSTATE CANCER; BRCAm METASTATIC CASTRATION-RESISTANT PROSTATE CANCER IN COMBINATION WITH ABIRATERONE AND PREDNISONE OR PREDNISOLONE:
300 mg orally 2 times a day until disease progression or unacceptable toxicity

Comments:

• Patients should start therapy no later than 8 weeks after completion of their final dose of the platinum-containing regimen.
• Patients should be selected based on the presence of deleterious or suspected deleterious HRR gene mutations, including BRCA mutations, or genomic instability based on the indication, biomarker, and sample type.
• Refer to the prescribing Information for bevacizumab when used in combination

with this drug for more information.

Uses:

• BRCA-MUTATED ADVANCED OVARIAN CANCER: For maintenance therapy of patients with deleterious or suspected deleterious germline or somatic BRCA-mutated advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy
• FIRST-LINE MAINTENANCE TREATMENT OF HRD-POSITIVE ADVANCED OVARIAN CANCER IN COMBINATION WITH BEVACIZUMAB: In combination with bevacizumab for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD)-positive status defined by either a deleterious or suspected deleterious BRCA mutation AND/OR genomic instability
• MAINTENANCE TREATMENT OF RECURRENT OVARIAN CANCER: For the maintenance treatment of patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in complete or partial response to platinum-based chemotherapy
• ADJUVANT TREATMENT OF GERMLINE BRCA-MUTATED HER2-NEGATIVE HIGH RISK EARLY BREAST CANCER: For the adjuvant treatment of adult patients with deleterious or suspected deleterious gBRCAm human epidermal growth factor receptor 2 (HER2)-negative high risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy
• GERMLINE BRCA-MUTATED HER2-NEGATIVE METASTATIC BREAST CANCER: For the treatment of patients with deleterious or suspected deleterious gBRCAm, HER2-negative metastatic breast cancer, who have been treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic setting; patients with hormone receptor (HR)-positive breast cancer should have been treated with a prior endocrine therapy or be considered inappropriate for endocrine therapy
• FIRST-LINE MAINTENANCE TREATMENT OF GERMLINE BRCA-MUTATED METASTATIC PANCREATIC ADENOCARCINOMA: For maintenance treatment of patients with deleterious or suspected deleterious gBRCAm metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen
• GENE-MUTATED METASTATIC CASTRATION-RESISTANT PROSTATE CANCER: For treatment of patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC) who have progressed following prior treatment with enzalutamide or abiraterone
• BRCA-MUTATED METASTATIC CASTRATION-RESISTANT PROSTATE CANCER IN COMBINATION WITH ABIRATERONE AND PREDNISONE OR PREDNISOLONE: For treatment of adult patients with deleterious or suspected deleterious BRCA-mutated metastatic castration resistant prostate cancer

Usual Adult Dose for Ovarian Cancer

FIRST-LINE MAINTENANCE TREATMENT OF BRCA-MUTATED ADVANCED OVARIAN CANCER:
300 mg orally 2 times a day until disease progression, unacceptable toxicity, or completion of 2 years of therapy; patients with a complete response (no radiological evidence of disease) at 2 years should stop; patients with evidence of disease at 2 years, who in the opinion of the treating healthcare provider can derive further benefit from therapy, can be treated beyond 2 years

FIRST-LINE MAINTENANCE TREATMENT OF HRD-POSITIVE ADVANCED OVARIAN CANCER IN COMBINATION WITH BEVACIZUMAB:
300 mg orally 2 times a day until disease progression, unacceptable toxicity, or completion of 2 years of therapy; patients with a complete response (no radiological evidence of disease) at 2 years should stop; patients with evidence of disease at 2 years, who in the opinion of the treating healthcare provider can derive further benefit from therapy, can be treated beyond 2 years

• When used with this drug, the recommended dose of bevacizumab is 15 mg/kg every 3 weeks for a total of 15 months including the period given with chemotherapy and given as maintenance.

ADJUVANT TREATMENT OF GERMLINE BRCA-MUTATED HER2-NEGATIVE HIGH RISK EARLY BREAST CANCER:
300 mg orally 2 times a day until disease recurrence, unacceptable toxicity, or completion of 1 years of therapy; patients should continue concurrent treatment with endocrine therapy as per current clinical practice guidelines

RECURRENT OVARIAN CANCER; GERMLINE BRCA-MUTATED ADVANCED OVARIAN CANCER; HER2-NEGATIVE METASTATIC BREAST CANCER; METASTATIC PANCREATIC ADENOCARCINOMA; HRR GENE-MUTATED METASTATIC CASTRATION RESISTANT PROSTATE CANCER; BRCAm METASTATIC CASTRATION-RESISTANT PROSTATE CANCER IN COMBINATION WITH ABIRATERONE AND PREDNISONE OR PREDNISOLONE:
300 mg orally 2 times a day until disease progression or unacceptable toxicity

Comments:

• Patients should start therapy no later than 8 weeks after completion of their final dose of the platinum-containing regimen.
• Patients should be selected based on the presence of deleterious or suspected deleterious HRR gene mutations, including BRCA mutations, or genomic instability based on the indication, biomarker, and sample type.
• Refer to the prescribing Information for bevacizumab when used in combination

with this drug for more information.

Uses:

• BRCA-MUTATED ADVANCED OVARIAN CANCER: For maintenance therapy of patients with deleterious or suspected deleterious germline or somatic BRCA-mutated advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy
• FIRST-LINE MAINTENANCE TREATMENT OF HRD-POSITIVE ADVANCED OVARIAN CANCER IN COMBINATION WITH BEVACIZUMAB: In combination with bevacizumab for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD)-positive status defined by either a deleterious or suspected deleterious BRCA mutation AND/OR genomic instability
• MAINTENANCE TREATMENT OF RECURRENT OVARIAN CANCER: For the maintenance treatment of patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in complete or partial response to platinum-based chemotherapy
• ADJUVANT TREATMENT OF GERMLINE BRCA-MUTATED HER2-NEGATIVE HIGH RISK EARLY BREAST CANCER: For the adjuvant treatment of adult patients with deleterious or suspected deleterious gBRCAm human epidermal growth factor receptor 2 (HER2)-negative high risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy
• GERMLINE BRCA-MUTATED HER2-NEGATIVE METASTATIC BREAST CANCER: For the treatment of patients with deleterious or suspected deleterious gBRCAm, HER2-negative metastatic breast cancer, who have been treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic setting; patients with hormone receptor (HR)-positive breast cancer should have been treated with a prior endocrine therapy or be considered inappropriate for endocrine therapy
• FIRST-LINE MAINTENANCE TREATMENT OF GERMLINE BRCA-MUTATED METASTATIC PANCREATIC ADENOCARCINOMA: For maintenance treatment of patients with deleterious or suspected deleterious gBRCAm metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen
• GENE-MUTATED METASTATIC CASTRATION-RESISTANT PROSTATE CANCER: For treatment of patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC) who have progressed following prior treatment with enzalutamide or abiraterone
• BRCA-MUTATED METASTATIC CASTRATION-RESISTANT PROSTATE CANCER IN COMBINATION WITH ABIRATERONE AND PREDNISONE OR PREDNISOLONE: For treatment of adult patients with deleterious or suspected deleterious BRCA-mutated metastatic castration resistant prostate cancer

Usual Adult Dose for Pancreatic Cancer

FIRST-LINE MAINTENANCE TREATMENT OF BRCA-MUTATED ADVANCED OVARIAN CANCER:
300 mg orally 2 times a day until disease progression, unacceptable toxicity, or completion of 2 years of therapy; patients with a complete response (no radiological evidence of disease) at 2 years should stop; patients with evidence of disease at 2 years, who in the opinion of the treating healthcare provider can derive further benefit from therapy, can be treated beyond 2 years

FIRST-LINE MAINTENANCE TREATMENT OF HRD-POSITIVE ADVANCED OVARIAN CANCER IN COMBINATION WITH BEVACIZUMAB:
300 mg orally 2 times a day until disease progression, unacceptable toxicity, or completion of 2 years of therapy; patients with a complete response (no radiological evidence of disease) at 2 years should stop; patients with evidence of disease at 2 years, who in the opinion of the treating healthcare provider can derive further benefit from therapy, can be treated beyond 2 years

• When used with this drug, the recommended dose of bevacizumab is 15 mg/kg every 3 weeks for a total of 15 months including the period given with chemotherapy and given as maintenance.

ADJUVANT TREATMENT OF GERMLINE BRCA-MUTATED HER2-NEGATIVE HIGH RISK EARLY BREAST CANCER:
300 mg orally 2 times a day until disease recurrence, unacceptable toxicity, or completion of 1 years of therapy; patients should continue concurrent treatment with endocrine therapy as per current clinical practice guidelines

RECURRENT OVARIAN CANCER; GERMLINE BRCA-MUTATED ADVANCED OVARIAN CANCER; HER2-NEGATIVE METASTATIC BREAST CANCER; METASTATIC PANCREATIC ADENOCARCINOMA; HRR GENE-MUTATED METASTATIC CASTRATION RESISTANT PROSTATE CANCER; BRCAm METASTATIC CASTRATION-RESISTANT PROSTATE CANCER IN COMBINATION WITH ABIRATERONE AND PREDNISONE OR PREDNISOLONE:
300 mg orally 2 times a day until disease progression or unacceptable toxicity

Comments:

• Patients should start therapy no later than 8 weeks after completion of their final dose of the platinum-containing regimen.
• Patients should be selected based on the presence of deleterious or suspected deleterious HRR gene mutations, including BRCA mutations, or genomic instability based on the indication, biomarker, and sample type.
• Refer to the prescribing Information for bevacizumab when used in combination

with this drug for more information.

Uses:

• BRCA-MUTATED ADVANCED OVARIAN CANCER: For maintenance therapy of patients with deleterious or suspected deleterious germline or somatic BRCA-mutated advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy
• FIRST-LINE MAINTENANCE TREATMENT OF HRD-POSITIVE ADVANCED OVARIAN CANCER IN COMBINATION WITH BEVACIZUMAB: In combination with bevacizumab for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD)-positive status defined by either a deleterious or suspected deleterious BRCA mutation AND/OR genomic instability
• MAINTENANCE TREATMENT OF RECURRENT OVARIAN CANCER: For the maintenance treatment of patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in complete or partial response to platinum-based chemotherapy
• ADJUVANT TREATMENT OF GERMLINE BRCA-MUTATED HER2-NEGATIVE HIGH RISK EARLY BREAST CANCER: For the adjuvant treatment of adult patients with deleterious or suspected deleterious gBRCAm human epidermal growth factor receptor 2 (HER2)-negative high risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy
• GERMLINE BRCA-MUTATED HER2-NEGATIVE METASTATIC BREAST CANCER: For the treatment of patients with deleterious or suspected deleterious gBRCAm, HER2-negative metastatic breast cancer, who have been treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic setting; patients with hormone receptor (HR)-positive breast cancer should have been treated with a prior endocrine therapy or be considered inappropriate for endocrine therapy
• FIRST-LINE MAINTENANCE TREATMENT OF GERMLINE BRCA-MUTATED METASTATIC PANCREATIC ADENOCARCINOMA: For maintenance treatment of patients with deleterious or suspected deleterious gBRCAm metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen
• GENE-MUTATED METASTATIC CASTRATION-RESISTANT PROSTATE CANCER: For treatment of patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC) who have progressed following prior treatment with enzalutamide or abiraterone
• BRCA-MUTATED METASTATIC CASTRATION-RESISTANT PROSTATE CANCER IN COMBINATION WITH ABIRATERONE AND PREDNISONE OR PREDNISOLONE: For treatment of adult patients with deleterious or suspected deleterious BRCA-mutated metastatic castration resistant prostate cancer

Usual Adult Dose for Fallopian Tube Cancer

FIRST-LINE MAINTENANCE TREATMENT OF BRCA-MUTATED ADVANCED OVARIAN CANCER:
300 mg orally 2 times a day until disease progression, unacceptable toxicity, or completion of 2 years of therapy; patients with a complete response (no radiological evidence of disease) at 2 years should stop; patients with evidence of disease at 2 years, who in the opinion of the treating healthcare provider can derive further benefit from therapy, can be treated beyond 2 years

FIRST-LINE MAINTENANCE TREATMENT OF HRD-POSITIVE ADVANCED OVARIAN CANCER IN COMBINATION WITH BEVACIZUMAB:
300 mg orally 2 times a day until disease progression, unacceptable toxicity, or completion of 2 years of therapy; patients with a complete response (no radiological evidence of disease) at 2 years should stop; patients with evidence of disease at 2 years, who in the opinion of the treating healthcare provider can derive further benefit from therapy, can be treated beyond 2 years

• When used with this drug, the recommended dose of bevacizumab is 15 mg/kg every 3 weeks for a total of 15 months including the period given with chemotherapy and given as maintenance.

ADJUVANT TREATMENT OF GERMLINE BRCA-MUTATED HER2-NEGATIVE HIGH RISK EARLY BREAST CANCER:
300 mg orally 2 times a day until disease recurrence, unacceptable toxicity, or completion of 1 years of therapy; patients should continue concurrent treatment with endocrine therapy as per current clinical practice guidelines

RECURRENT OVARIAN CANCER; GERMLINE BRCA-MUTATED ADVANCED OVARIAN CANCER; HER2-NEGATIVE METASTATIC BREAST CANCER; METASTATIC PANCREATIC ADENOCARCINOMA; HRR GENE-MUTATED METASTATIC CASTRATION RESISTANT PROSTATE CANCER; BRCAm METASTATIC CASTRATION-RESISTANT PROSTATE CANCER IN COMBINATION WITH ABIRATERONE AND PREDNISONE OR PREDNISOLONE:
300 mg orally 2 times a day until disease progression or unacceptable toxicity

Comments:

• Patients should start therapy no later than 8 weeks after completion of their final dose of the platinum-containing regimen.
• Patients should be selected based on the presence of deleterious or suspected deleterious HRR gene mutations, including BRCA mutations, or genomic instability based on the indication, biomarker, and sample type.
• Refer to the prescribing Information for bevacizumab when used in combination

with this drug for more information.

Uses:

• BRCA-MUTATED ADVANCED OVARIAN CANCER: For maintenance therapy of patients with deleterious or suspected deleterious germline or somatic BRCA-mutated advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy
• FIRST-LINE MAINTENANCE TREATMENT OF HRD-POSITIVE ADVANCED OVARIAN CANCER IN COMBINATION WITH BEVACIZUMAB: In combination with bevacizumab for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD)-positive status defined by either a deleterious or suspected deleterious BRCA mutation AND/OR genomic instability
• MAINTENANCE TREATMENT OF RECURRENT OVARIAN CANCER: For the maintenance treatment of patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in complete or partial response to platinum-based chemotherapy
• ADJUVANT TREATMENT OF GERMLINE BRCA-MUTATED HER2-NEGATIVE HIGH RISK EARLY BREAST CANCER: For the adjuvant treatment of adult patients with deleterious or suspected deleterious gBRCAm human epidermal growth factor receptor 2 (HER2)-negative high risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy
• GERMLINE BRCA-MUTATED HER2-NEGATIVE METASTATIC BREAST CANCER: For the treatment of patients with deleterious or suspected deleterious gBRCAm, HER2-negative metastatic breast cancer, who have been treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic setting; patients with hormone receptor (HR)-positive breast cancer should have been treated with a prior endocrine therapy or be considered inappropriate for endocrine therapy
• FIRST-LINE MAINTENANCE TREATMENT OF GERMLINE BRCA-MUTATED METASTATIC PANCREATIC ADENOCARCINOMA: For maintenance treatment of patients with deleterious or suspected deleterious gBRCAm metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen
• GENE-MUTATED METASTATIC CASTRATION-RESISTANT PROSTATE CANCER: For treatment of patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC) who have progressed following prior treatment with enzalutamide or abiraterone
• BRCA-MUTATED METASTATIC CASTRATION-RESISTANT PROSTATE CANCER IN COMBINATION WITH ABIRATERONE AND PREDNISONE OR PREDNISOLONE: For treatment of adult patients with deleterious or suspected deleterious BRCA-mutated metastatic castration resistant prostate cancer

Usual Adult Dose for Peritoneal Cancer

FIRST-LINE MAINTENANCE TREATMENT OF BRCA-MUTATED ADVANCED OVARIAN CANCER:
300 mg orally 2 times a day until disease progression, unacceptable toxicity, or completion of 2 years of therapy; patients with a complete response (no radiological evidence of disease) at 2 years should stop; patients with evidence of disease at 2 years, who in the opinion of the treating healthcare provider can derive further benefit from therapy, can be treated beyond 2 years

FIRST-LINE MAINTENANCE TREATMENT OF HRD-POSITIVE ADVANCED OVARIAN CANCER IN COMBINATION WITH BEVACIZUMAB:
300 mg orally 2 times a day until disease progression, unacceptable toxicity, or completion of 2 years of therapy; patients with a complete response (no radiological evidence of disease) at 2 years should stop; patients with evidence of disease at 2 years, who in the opinion of the treating healthcare provider can derive further benefit from therapy, can be treated beyond 2 years

• When used with this drug, the recommended dose of bevacizumab is 15 mg/kg every 3 weeks for a total of 15 months including the period given with chemotherapy and given as maintenance.

ADJUVANT TREATMENT OF GERMLINE BRCA-MUTATED HER2-NEGATIVE HIGH RISK EARLY BREAST CANCER:
300 mg orally 2 times a day until disease recurrence, unacceptable toxicity, or completion of 1 years of therapy; patients should continue concurrent treatment with endocrine therapy as per current clinical practice guidelines

RECURRENT OVARIAN CANCER; GERMLINE BRCA-MUTATED ADVANCED OVARIAN CANCER; HER2-NEGATIVE METASTATIC BREAST CANCER; METASTATIC PANCREATIC ADENOCARCINOMA; HRR GENE-MUTATED METASTATIC CASTRATION RESISTANT PROSTATE CANCER; BRCAm METASTATIC CASTRATION-RESISTANT PROSTATE CANCER IN COMBINATION WITH ABIRATERONE AND PREDNISONE OR PREDNISOLONE:
300 mg orally 2 times a day until disease progression or unacceptable toxicity

Comments:

• Patients should start therapy no later than 8 weeks after completion of their final dose of the platinum-containing regimen.
• Patients should be selected based on the presence of deleterious or suspected deleterious HRR gene mutations, including BRCA mutations, or genomic instability based on the indication, biomarker, and sample type.
• Refer to the prescribing Information for bevacizumab when used in combination

with this drug for more information.

Uses:

• BRCA-MUTATED ADVANCED OVARIAN CANCER: For maintenance therapy of patients with deleterious or suspected deleterious germline or somatic BRCA-mutated advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy
• FIRST-LINE MAINTENANCE TREATMENT OF HRD-POSITIVE ADVANCED OVARIAN CANCER IN COMBINATION WITH BEVACIZUMAB: In combination with bevacizumab for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD)-positive status defined by either a deleterious or suspected deleterious BRCA mutation AND/OR genomic instability
• MAINTENANCE TREATMENT OF RECURRENT OVARIAN CANCER: For the maintenance treatment of patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in complete or partial response to platinum-based chemotherapy
• ADJUVANT TREATMENT OF GERMLINE BRCA-MUTATED HER2-NEGATIVE HIGH RISK EARLY BREAST CANCER: For the adjuvant treatment of adult patients with deleterious or suspected deleterious gBRCAm human epidermal growth factor receptor 2 (HER2)-negative high risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy
• GERMLINE BRCA-MUTATED HER2-NEGATIVE METASTATIC BREAST CANCER: For the treatment of patients with deleterious or suspected deleterious gBRCAm, HER2-negative metastatic breast cancer, who have been treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic setting; patients with hormone receptor (HR)-positive breast cancer should have been treated with a prior endocrine therapy or be considered inappropriate for endocrine therapy
• FIRST-LINE MAINTENANCE TREATMENT OF GERMLINE BRCA-MUTATED METASTATIC PANCREATIC ADENOCARCINOMA: For maintenance treatment of patients with deleterious or suspected deleterious gBRCAm metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen
• GENE-MUTATED METASTATIC CASTRATION-RESISTANT PROSTATE CANCER: For treatment of patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC) who have progressed following prior treatment with enzalutamide or abiraterone
• BRCA-MUTATED METASTATIC CASTRATION-RESISTANT PROSTATE CANCER IN COMBINATION WITH ABIRATERONE AND PREDNISONE OR PREDNISOLONE: For treatment of adult patients with deleterious or suspected deleterious BRCA-mutated metastatic castration resistant prostate cancer

Renal Dose Adjustments

Mild renal impairment (CrCl 51 to 80 mL/min): No adjustment recommended.
Moderate renal impairment (CrCl 31 to 50 mL/min): 200 mg orally 2 times a day for a total daily dose of 400 mg
Severe renal impairment (CrCl less than 30 mL/min) or end stage renal disease: Data not available

Liver Dose Adjustments

Mild (Child-Pugh A) to moderate (Child-Pugh B) hepatic impairment: No adjustment recommended.
Severe (Child-Pugh C) hepatic impairment: Data not available

Dose Adjustments

FIRST DOSE REDUCTION: 250 mg orally 2 times a day
SECOND DOSE REDUCTION: 200 mg orally 2 times a day

CYP450 3A inhibitors:
Avoid concomitant use of this drug with CYP450 3A inhibitors and consider alternative agents. If concomitant use cannot be avoided:

• Reduce dose to 150 mg orally 2 times a day when used with moderate CYP450 3A inhibitor.
• Reduce dose to 100 mg orally 2 times a day when used with strong CYP450 3A inhibitor.

Precautions

CONTRAINDICATIONS:

• None

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• This drug may be taken with or without food.
• The 100-mg tablet is available for dose reduction.
• Swallow tablets whole; do not chew, crush, dissolve, or divide.
• Advise patients to avoid grapefruit, grapefruit juice, and Seville oranges during treatment as they may increase the level of this drug in the blood.
• If a patient misses a dose, instruct them to take their next dose at its scheduled time.

Storage:

• Store at 20C to 25C (68F to 77F), excursions permitted to 15C to 30C (59F to 86F).
• Store in original bottle.

Monitoring:

• Monitor complete blood count testing at baseline and monthly thereafter.
• For prolonged hematological toxicities, monitor blood counts weekly and interrupt therapy until recovery.

Patient Advice:

• If patients experience weakness, fatigue, fever, weight loss, frequent infections, bruising, easy bleeding, breathlessness, blood in urine or stool, or low blood cell counts, they should contact their healthcare provider. These symptoms could indicate hematological toxicity or a rare bone marrow condition known as myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML), which have been observed in patients using this drug.
• Instruct patients to reach out to their healthcare provider if they encounter any new or worsening respiratory symptoms such as breathlessness, fever, cough, or wheezing.
• Patients should promptly inform their healthcare provider about any indications or symptoms of thromboembolism, including limb pain or swelling, breathlessness, chest pain, rapid breathing, and rapid heartbeat.
• Inform pregnant women about the potential risks to the fetus and the possibility of pregnancy loss. Advise females to notify their healthcare provider if they are aware of or suspect pregnancy.
• Recommend that women capable of reproduction utilize reliable contraception while undergoing this treatment and for six months following the final dose.
• Advise male patients who have female partners capable of reproduction or who are pregnant to use reliable contraception throughout the treatment period and for three months after the final dose of this drug. Instruct male patients not to donate sperm during therapy and for three months after the last dose of this drug.
• Instruct patients to refrain from breastfeeding while using this drug and for a duration of one month after the final dose.
• Advise patients and caregivers to notify their healthcare provider about all medications they are taking, including prescriptions, over-the-counter drugs, vitamins, and herbal products. Also, inform patients to avoid consuming grapefruit, grapefruit juice, Seville oranges, and Seville orange juice while using this drug.
• Inform patients that experiencing mild to moderate nausea and/or vomiting is frequently observed in those undergoing this treatment. Advise them to consult their healthcare provider, who can suggest various antiemetic treatments that are available.

Frequently asked questions

• How long does it take Lynparza (olaparib) to work?
• How effective is Lynparza (olaparib)?
• Does Lynparza (olaparib) cause hair loss?