Olaparib – Uses, Dosage, Side Effects, Interactions

Last updated: February 8, 2026Reviewed date: February 8, 2026Reading time: 82 min read
Olaparib - Uses, Dosage, Side Effects, Interactions
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Article Summary

Olaparib is a small molecule inhibitor of poly ADP-ribose polymerase and is used as an antineoplastic agent in the therapy of refractory and advanced ovarian carcinoma. Olaparib therapy is associated with a low rate of transient elevations in serum aminotransferase during therapy and has not been linked to instances of clinically apparent liver injury. Olaparib is a small molecule inhibitor of the nuclear enzyme poly(ADP-ribose) polymerase...

Key Takeaways

  • This article explains Mechanism of Action in simple medical language.
  • This article explains Indications in simple medical language.
  • This article explains Contraindications in simple medical language.
  • This article explains Dosage in simple medical language.
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Definition

Olaparib is a small molecule inhibitor of poly ADP-ribose polymerase and is used as an antineoplastic agent in the therapy of and advanced ovarian . Olaparib therapy is associated with a low rate of transient elevations in serum aminotransferase during therapy and has not been linked to instances of clinically apparent injury.

Olaparib is a small molecule inhibitor of the nuclear enzyme poly(ADP-ribose) polymerase (PARP) with potential chemosensitizing, radiosensitizing, and antineoplastic activities. Olaparib selectively binds to and inhibits PARP, inhibiting PARP-mediated repair of single-strand DNA breaks; PARP inhibition may enhance the cytotoxicity of DNA-damaging agents and may reverse cell chemoresistance and radioresistance. PARP catalyzes post-translational ADP-ribosylation of nuclear proteins and can be activated by single-stranded DNA breaks.

Olaparib is a member of the class of N-acyl piperazines obtained by formal condensation of the carboxy group of 2-fluoro-5-[(4-oxo-3,4-dihydrophthalazin-1-yl)methyl]benzoic acid with the free amino group of N-(cyclpropylcarbonyl)piperazine; used to treat advanced ovarian cancer. It has a role as an antineoplastic agent, an EC 2.4.2.30 (NAD(+) ADP-ribosyltransferase) inhibitor, and an apoptosis inducer. It is an N-acyl piperazine, a member of cyclopropanes, a member of monofluorobenzenes, and a member of phthalazines.

Olaparib is used to treat a number of BRCA-associated tumors, including ovarian cancer, breast cancer, pancreatic cancer, and cancer. It was first approved by the FDA and EU in December 2014, and by Health Canada in April 2016.

Mechanism of Action

Poly(ADP-ribose) polymerases (PARPs) are multifunctional enzymes comprising 17 members. They are involved in essential cellular functions, such as DNA transcription and DNA repair. PARPs recognize and repair cellular DNA damage, such as single-strand breaks (SSBs) and double-strand breaks (DSBs). Different DNA repair pathways exist to repair these DNA damages, including the base excision repair (BER) pathway for SSBs and BRCA-dependent homologous recombination for DSBs. Olaparib is a PARP inhibitor: while it acts on PARP1, PARP2, and PARP3, olaparib is a more selective competitive inhibitor of NAD+ at the catalytic site of PARP1 and PARP2. Inhibition of the BER pathway by olaparib leads to the accumulation of unrepaired SSBs, which leads to the formation of DSBs, which is the most toxic form of DNA damage. While BRCA-dependent homologous recombination can repair DSBs in normal cells, this repair pathway is defective in cells with BRCA1/2 mutations, such as certain tumor cells. Inhibition of PARP in cancer cells with BRCA mutations leads to genomic instability and apoptotic cell death. This end result is also referred to as synthetic lethality, a phenomenon where the combination of two defects – inhibition of PARP activity and loss of DSB repair by HR – that are otherwise when alone, leads to detrimental results. _In vitro_ studies have shown that olaparib-induced cytotoxicity may involve inhibition of PARP enzymatic activity and increased formation of PARP-DNA complexes, resulting in DNA damage and cancer cell death.

Olaparib is a cytotoxic and anti-tumor agent. Olaparib inhibits the growth of selective tumor cell lines _in vitro_ and decreases tumor growth in mouse xenograft models of human cancer, both as monotherapy or following platinum-based . The drug exerts anti- effects in cell lines and mouse tumor models with deficiencies in BRCA1/2, ATM, or other genes involved in the homologous recombination repair (HRR) of DNA damage and correlated with platinum response. In preclinical models of cancer, olaparib demonstrated anti-tumor activity when used alone, in combination with chemotherapeutic agents, or . Olaparib can act as a chemosensitizer to potentiate the cytotoxicity of DNA-damaging chemotherapeutic agents such as alkylating agents and platinum-based drugs. It can also act as a radiosensitizer by preventing PARP-mediated DNA repair.

Indications

  • **Ovarian cancer** – Olaparib is indicated for the maintenance treatment of adults with deleterious or suspected deleterious germline or somatic BRCA-mutated advanced epithelial ovarian, , or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy. Olaparib is indicated in combination with [bevacizumab] for the maintenance treatment of adults with an 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. Olaparib is indicated for the maintenance treatment of adult patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer, who are in complete or partial response to platinum-based chemotherapy.
  • **Breast cancer** – Olaparib is indicated for the adjuvant treatment of adult patients with deleterious or suspected deleterious g_BRCA_m human epidermal growth factor receptor 2 (HER2)-negative high-risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy. Olaparib is indicated for the treatment of adult patients with deleterious or suspected deleterious g_BRCA_m, 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 prior endocrine therapy or be considered inappropriate for endocrine therapy. **Pancreatic cancer** Olaparib is indicated for the maintenance treatment of adult 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. **Prostate cancer** Olaparib is indicated for the treatment of adult 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 a hormone agent, such as [enzalutamide] or [abiraterone].
  • * Ovarian cancer – Lynparza is indicated as monotherapy for the maintenance treatment of adult patients with advanced (FIGO stages III and IV) BRCA1/2-mutated (germline and/or somatic) high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy maintenance treatment of adult patients with platinum-sensitive relapsed high grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy. Lynparza in combination with bevacizumab is indicated for the maintenance treatment of adult patients with advanced (FIGO stages III and IV) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy in combination with bevacizumab and whose cancer is associated with homologous recombination deficiency (HRD) positive status defined by either a BRCA1/2 mutation and/or genomic instability.
  • * Breast cancer – Lynparza is indicated as monotherapy for the treatment of adult patients with germline BRCA1/2-mutations, who have HER2-negative locally advanced or metastatic breast cancer. Patients should have previously been treated with anthracycline and taxane in the (neo)adjuvant or metastatic setting unless patients were not suitable for these treatments. Patients with hormone receptor (HR)-positive breast cancer should also have progressed on or after prior endocrine therapy, or be considered unsuitable for endocrine therapy.
  • * Adenocarcinoma of the – Lynparza is indicated as monotherapy for the maintenance treatment of adult patients with germline BRCA1/2-mutations who have metastatic adenocarcinoma of the pancreas and have not progressed after a minimum of 16 weeks of platinum treatment within a first-line chemotherapy regimen.
  • * Prostate cancer – Lynparza is indicated as monotherapy for the treatment of adult patients with metastatic castration-resistant prostate cancer and BRCA1/2-mutations (germline and/or somatic) who have progressed following prior therapy that included a new hormonal agent. Lynparza is indicated as monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed BRCA mutated (germline and/or somatic) high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete response or partial response) to platinum-based chemotherapy.
  • Advanced ovarian carcinoma – Olaparib is a small molecule inhibitor of poly ADP-ribose polymerase and is used as an antineoplastic agent in the therapy of refractory and advanced ovarian carcinoma.
  • Olaparib is a poly (ADP-ribose) polymerase (PARP) inhibitor used to treat ovarian cancer, breast cancer, pancreatic cancer, and prostate cancer.
  • Advanced Epithelial Ovarian Cancer
  • Advanced Fallopian Tube Carcinoma
  • Advanced Primary Peritoneal Carcinoma
  • Early Breast Cancer
  • Metastatic Breast Cancer
  • Metastatic Castration-Resistant Prostate Cancer (mCRPC)
  • Pancreatic Adenocarcinoma Metastatic
  • Recurrent Epithelial Ovarian Cancer
  • Recurrent Fallopian Tube Cancer
  • Recurrent platinum-sensitive primary peritoneal cancer
  • Maintenance therapy

Use in Cancer

Olaparib is approved to treat:

  • Breast cancer is HER2 negative and has certain germline mutations in the BRCA1 or BRCA2 gene. It is used after surgery in adults with:
    • High-risk early-stage breast cancer that has been treated with chemotherapy before or after surgery.
    • Metastatic cancer has been treated with chemotherapy before or after the cancer spread.
  • The ovarian epithelial, fallopian tube, or primary peritoneal cancer. Olaparib is used as maintenance therapy in adults who are having a complete or partial response to platinum chemotherapy. It is used:
    • As the first maintenance therapy in patients with advanced cancer that has certain germline or somatic mutations in the BRCA1 or BRCA2 gene.
    • Bevacizumab as the first maintenance therapy in patients with advanced cancer that has genomic instability and/or certain germline or somatic mutations in the BRCA1 or BRCA2 gene.
    • In patients with recurrent cancer.
  • Pancreatic cancer. Olaparib is used as maintenance therapy in adults with metastatic cancer that has not progressed after first-line therapy with platinum chemotherapy and has certain germline mutations in the BRCA1 or BRCA2 gene.
  • Prostate cancer that is metastatic, has germline or somatic mutations in certain genes involved in the homologous recombination repair pathway, and is castrate-resistant (has not responded to treatments that lower testosterone levels). Olaparib is used in adults whose cancer has gotten worse after treatment with enzalutamide or abiraterone.

Olaparib is also being studied in the treatment of other types of cancer.

Contraindications

  • myeloid , a type of blood cancer
  • a type of of the lung called interstitial pneumonitis
  • myelodysplastic , a disorder
  • pregnancy
  • a patient who is producing milk and breastfeeding
  • stage 3A ()
  • disease stage 3B (moderate)

Strengths: 50 mg; 100 mg; 150 mg

Breast Cancer

FIRST-LINE MAINTENANCE TREATMENT OF BRCA-MUTATED ADVANCED OVARIAN CANCER:

  • 300 mg orally 2 times a day until , 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 , 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
  • 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.
  • 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

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
  • 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.
  • 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 an 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 the 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

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
  • 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.
  • 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

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 year
  • 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
  • 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.
  • 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

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
  • 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.
  • 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 an 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 a 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 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

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.

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.

Side Effects

The Most Common

  • heartburn
  • headache
  • decreased appetite
  • muscle, joint, or back pain
  • fatigue
  • dizziness
  • stomach pain or discomfort
  • taste changes
  • mouth pain or sores
  • rash
  • shortness of breath, new or worsening cough, difficulty breathing, wheezing, or fever
  • weakness
  • extreme tiredness
  • weight loss
  • unusual bruising or bleeding
  • pale skin
  • blood in urine or stool
  • fever, chills, cough, sore throat, difficulty urinating, pain when urinating, or other signs of infection
  • pain, tenderness, redness, or swelling in one leg
  • chest pain or tightness; shortness of breath; coughing up blood; or rapid breathing

More common

  • Black, tarry stools
  • bladder pain
  • bleeding gums
  • bloody or cloudy urine
  • body aches or pain
  • chest pain or tightness
  • chills
  • cough
  • cough producing mucus
  • diarrhea
  • difficult, burning, or painful urination
  • ear congestion or pain
  • fast, pounding, or irregular heartbeat or pulse
  • fever
  • frequent urge to urinate
  • general feeling of discomfort or illness
  • head congestion
  • headache
  • hoarseness or other voice changes
  • joint pain
  • loss of appetite
  • loss of voice
  • lower back or side pain
  • muscle aches and pains
  • nausea
  • pain or swelling in the arms or legs
  • painful or difficult urination
  • pale skin
  • pinpoint red spots on the skin
  • rapid shallow breathing
  • runny or stuffy nose
  • shivering
  • sneezing
  • sore throat
  • sores, ulcers, or white spots on the lips or in the mouth
  • sweating
  • swollen glands
  • trouble sleeping
  • trouble breathing
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • vomiting

Rare

  • Hives, itching, skin rash
  • irritation
  • joint stiffness or swelling
  • redness of the skin
  • swelling of the eyelids, face, lips, hands, or feet
  • trouble swallowing
  • Back pain
  • belching
  • blistering, crusting, irritation, itching, or reddening of the skin
  • blurred vision
  • burning, numbness, tingling, or painful sensations
  • constipation
  • cracked, dry, or scaly skin
  • decreased appetite
  • diarrhea
  • difficulty with moving
  • dizziness
  • dry mouth
  • fear or nervousness
  • flushed, dry skin
  • fruit-like breath odor
  • heartburn
  • increased hunger
  • increased thirst
  • increased urination
  • indigestion
  • lack or loss of strength
  • loss of bladder control
  • loss of or change in taste
  • muscle stiffness
  • stomach discomfort, upset, or pain
  • swelling or inflammation of the mouth
  • unexplained weight loss
  • unsteadiness or awkwardness
  • weakness in the arms, hands, legs, or feet

Drug Interactions

Pregnancy and Lactation

AU TGA pregnancy category: D
US FDA pregnancy category: Not assigned.

Pregnancy

Based on findings in animals and its mechanism of action [see Clinical Pharmacology (12.1)], Lynparza can cause fetal harm when administered to a pregnant woman. There are no available data on Lynparza use in pregnant women to inform the drug-associated risk. In an animal reproduction study, the administration of olaparib to pregnant rats during the period of organogenesis caused teratogenicity and
embryo-fetal toxicity at exposures below those in patients receiving the recommended human dose of 300 mg twice daily [see Data]. Apprise pregnant women of the potential hazard to the fetus and the potential risk for loss of the pregnancy. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. The estimated background risk in the U.S. general population of major birth defects is 2-4%; and the risk for spontaneous abortion is approximately 15-20% in clinically recognized pregnancies.

Lactation

No information is available on the clinical use of olaparib during breastfeeding. Because olaparib is 82% bound to plasma proteins, the amount in milk is likely to be low. The manufacturer recommends that breastfeeding be discontinued during olaparib therapy and for one month after the last dose.

Why is this medication prescribed?

Olaparib is used alone or in combination with bevacizumab (Avastin) to help maintain the response of certain types of ovarian (female reproductive organs where eggs are formed), fallopian tube (tube that transports eggs released by the ovaries to the uterus), and peritoneal (layer of tissue that lines the abdomen) cancer in people who have completely responded or partially responded to their first or later chemotherapy treatments. Olaparib is also used to treat certain types of breast cancer that has spread to other parts of the body and has not improved or has worsened after treatment with other therapies. It is also used to treat certain types of early breast cancer in people who have already been treated with other chemotherapy treatments. Olaparib is also used to treat a certain type of prostate cancer that has spread to other parts of the body, no longer responds to medical or surgical treatments to lower testosterone levels, and has progressed after treatment with enzalutamide (Xtandi) or abiraterone (Yonsa, Zytiga). Olaparib is also used to treat ovarian cancer that has not improved or has worsened after treatment with at least three other therapies. Olaparib is also used to help maintain the response of a certain type of pancreatic cancer that has not spread or progressed after the first chemotherapy treatment. Olaparib is a polyadenosine 5′-diphosphoribose polymerase (PARP) enzyme inhibitor. It works by killing cancer cells.

How should this medicine be used?

Olaparib comes as a tablet to take by mouth twice daily with or without food. Try to space your doses about 12 hours apart. Take olaparib at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take olaparib exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the tablets whole; do not crush chew, divide, or dissolve them.

Your doctor may decrease your dose of olaparib or tell you to stop taking olaparib for a period of time during your treatment. This will depend on how well the medication works for you and any side effects you may experience. Be sure to tell your doctor how you are feeling during your treatment with olaparib.

Your doctor or pharmacist will give you the manufacturer’s patient information sheet (Medication Guide) when you begin treatment with olaparib. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (https://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) to obtain the Medication Guide.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What special precautions should I follow?

Before taking olaparib,

  • tell your doctor and pharmacist if you are allergic to olaparib, any other medications, or any of the ingredients in olaparib tablets. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
  • tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
  • The following herbal products may interact with olaparib: St. John’s wort. Be sure to let your doctor and pharmacist know that you are taking this medication before you start taking olaparib. Do not start this medication while taking olaparib without discussing it with your healthcare provider.
  • tell your doctor if you have or have ever had have lung or breathing problems, blood clots in your legs or lungs, or kidney or liver disease.
  • tell your doctor if you are pregnant, plan to become pregnant, or plan to father a child. You may need to have a pregnancy test before starting treatment, You should not become pregnant while you are taking olaparib. You should use effective birth control to prevent pregnancy during your treatment with olaparib and for at least 6 months after your final dose. If you are a male and your partner can become pregnant, you should use effective birth control during your treatment with olaparib tablets and for 3 months after your final dose. Talk to your doctor about birth control methods that will work for you. If you become pregnant while taking olaparib, call your doctor immediately. Olaparib may harm the fetus.
  • tell your doctor if you are breastfeeding. Do not breastfeed while you are taking olaparib and for 1 month after your final dose.
  • you should know that you should not donate sperm while you are taking olaparib tablets and for 3 months after your final dose.

What special dietary instructions should I follow?

Do not eat grapefruit or Seville oranges (sometimes used in marmalades), or drink grapefruit juice or Seville orange juice while taking this medication.

What should I do if I forget a dose?

Skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

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Doctor to discuss: Orthopedic / spine specialist, physical medicine doctor, or qualified clinician
Tests to discuss with doctor
  • Neurological examination for leg power, sensation, reflexes, and straight leg raise
  • X-ray only if injury, deformity, long-lasting pain, or doctor suspects bone problem
  • MRI discussion if severe nerve symptoms, weakness, bladder/bowel problem, or persistent symptoms
Questions to ask
  • What is the most likely cause of my symptoms?
  • Which warning signs mean I should go to emergency care?
  • Which tests are really needed now?
  • Which medicines are safe for my age, pregnancy status, allergy, kidney/liver/stomach condition, and current medicines?
  • Is physiotherapy, posture correction, or activity modification needed?

Emergency warning signs such as chest pain, severe breathing difficulty, sudden weakness, confusion, severe dehydration, major injury, or loss of bladder/bowel control need urgent medical care. Do not wait for online information.

Safe pathway to proper treatment

Care roadmap for: Olaparib – Uses, Dosage, Side Effects, Interactions

Use this simple roadmap to understand the next safe steps. It is educational and does not replace examination by a doctor.

Go to emergency care if you notice:
  • Severe or rapidly worsening symptoms
  • Breathing difficulty, chest pain, fainting, confusion, severe weakness, major injury, or severe dehydration
Doctor / service to discuss: Qualified healthcare provider; specialist depends on symptoms and examination.
  1. Step 1

    Check danger signs first

    If danger signs are present, seek emergency care and do not wait for online information.

  2. Step 2

    Record the symptom story

    Write when symptoms started, severity, medicines already taken, allergies, pregnancy status, and test results.

  3. Step 3

    Visit a qualified clinician

    A doctor, nurse, or qualified healthcare provider can examine you and decide which tests or treatment are needed.

  4. Step 4

    Do only useful tests

    Do tests after clinical assessment. Avoid unnecessary tests, random antibiotics, or repeated medicines without diagnosis.

  5. Step 5

    Follow up and return early if worse

    If symptoms worsen, new warning signs appear, or treatment is not helping, return for review quickly.

Rural patient practical tips
  • Take a written symptom diary and all previous prescriptions/test reports.
  • Do not hide medicines already taken, even herbal or over-the-counter medicines.
  • Ask which warning signs mean urgent referral to hospital.

This roadmap is for education. A real diagnosis and treatment plan requires history, examination, and clinical judgment.