Olaparib Dosage
Medically reviewed by Drugs.com. Last updated on Nov 23, 2020.
Applies to the following strengths: 50 mg; 100 mg; 150 mg
Usual Adult Dose for:
Additional dosage information:
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.
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:
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 have confirmation of a breast cancer susceptibility gene (BRCA) mutation (either germline or tumor) before initiation of therapy.
-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
-ADVANCED GERMLINE BRCA-MUTATED OVARIAN CANCER AFTER 3 OR MORE LINES OF CHEMOTHERAPY: For the treatment of patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) advanced ovarian cancer who have been treated with 3 or more prior lines of 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
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.
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:
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 have confirmation of a breast cancer susceptibility gene (BRCA) mutation (either germline or tumor) before initiation of therapy.
-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
-ADVANCED GERMLINE BRCA-MUTATED OVARIAN CANCER AFTER 3 OR MORE LINES OF CHEMOTHERAPY: For the treatment of patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) advanced ovarian cancer who have been treated with 3 or more prior lines of 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
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.
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:
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 have confirmation of a breast cancer susceptibility gene (BRCA) mutation (either germline or tumor) before initiation of therapy.
-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
-ADVANCED GERMLINE BRCA-MUTATED OVARIAN CANCER AFTER 3 OR MORE LINES OF CHEMOTHERAPY: For the treatment of patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) advanced ovarian cancer who have been treated with 3 or more prior lines of 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
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.
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:
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 have confirmation of a breast cancer susceptibility gene (BRCA) mutation (either germline or tumor) before initiation of therapy.
-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
-ADVANCED GERMLINE BRCA-MUTATED OVARIAN CANCER AFTER 3 OR MORE LINES OF CHEMOTHERAPY: For the treatment of patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) advanced ovarian cancer who have been treated with 3 or more prior lines of 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
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.
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:
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 have confirmation of a breast cancer susceptibility gene (BRCA) mutation (either germline or tumor) before initiation of therapy.
-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
-ADVANCED GERMLINE BRCA-MUTATED OVARIAN CANCER AFTER 3 OR MORE LINES OF CHEMOTHERAPY: For the treatment of patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) advanced ovarian cancer who have been treated with 3 or more prior lines of 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
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.
Monitoring:
-Monitor complete blood count testing at baseline and monthly thereafter.
-For prolonged hematological toxicities, monitor blood counts weekly and interrupt therapy until recovery.
Frequently asked questions
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