- Breast cancer
- Gynecologic cancers
- Pancreatic, thyroid, and other endocrine cancers
- Prostate and other male cancers
Breast cancer:
Indications for: LYNPARZA
Adjuvant treatment of deleterious or suspected deleterious germline BRCA-mutated, HER2-negative (as detected by an FDA-approved test) high risk early breast cancer in adults who have been treated with neoadjuvant or adjuvant chemotherapy. Treatment of deleterious or suspected deleterious germline BRCA-mutated, HER2-negative (as detected by an FDA-approved test) metastatic breast cancer in adults who have been treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic setting (patients with HR-positive breast cancer should have been treated with prior endocrine therapy or be considered inappropriate for endocrine therapy).
Adult Dosage:
Swallow whole. 300mg twice daily. Early breast cancer: continue for a total of 1yr, or until disease recurrence or unacceptable toxicity. Metastatic breast cancer: continue until disease progression or unacceptable toxicity. Dose adjustments for adverse reactions: reduce to 250mg twice daily; may further reduce to 200mg twice daily. Concomitant strong or moderate CYP3A inhibitors (if unavoidable): reduce olaparib dose to 100mg twice daily (with strong inhibitors) or 150mg twice daily (with moderate inhibitors). Moderate renal impairment (CrCl 31–50mL/min): reduce to 200mg twice daily.
Children Dosage:
Not established.
LYNPARZA Warnings/Precautions:
Do not start therapy until recovery from hematological toxicity due to previous chemotherapy (CTCAE Grade ≤1). Monitor CBC for cytopenia at baseline and monthly thereafter during therapy or weekly until recovery (for prolonged hematological toxicities). Discontinue if myelodysplastic syndrome/acute myeloid leukemia (MDS/AML) is confirmed. Interrupt therapy and evaluate if new or worsening respiratory symptoms occur; discontinue and treat if pneumonitis is confirmed. Monitor for venous thrombosis, pulmonary embolism; treat appropriately. Mild renal impairment: monitor closely. Severe hepatic or severe renal impairment or ESRD (CrCl ≤30mL/min): not studied. Embryo-fetal toxicity. Advise females of reproductive potential to use effective contraception during and for 6 months after the last dose. Males (w. female partners) should use effective contraception and do not donate sperm during and for 3 months after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 1 month after the last dose).
LYNPARZA Classification:
Poly (ADP-ribose) polymerase (PARP) inhibitor.
LYNPARZA Interactions:
Increased myelosuppressive toxicity with concomitant other myelosuppressive anticancer agents, including DNA damaging agents. Avoid concomitant strong CYP3A inhibitors (eg, itraconazole) and moderate CYP3A inhibitors (eg, fluconazole); if unavoidable, reduce dose (see Adults). Avoid grapefruit, grapefruit juice, Seville oranges, and Seville orange juice. Avoid concomitant strong CYP3A inducers (eg, rifampicin) and moderate CYP3A inducers (eg, efavirenz); if unavoidable, be aware of potential for decreased efficacy.
Adverse Reactions:
Nausea, fatigue, asthenia, anemia, vomiting, diarrhea, decreased appetite, headache, neutropenia, dysgeusia, cough, dyspnea, dizziness, dyspepsia, leukopenia, thrombocytopenia, upper abdominal pain. In combination with bevacizumab or abiraterone and prednisone or prednisolone: also lymphopenia, UTI.
Drug Elimination:
- Renal (44%), fecal (42%). Half-life: 14.9 ± 8.2 hours.
Generic Drug Availability:
NO
How Supplied:
Tabs—60, 120
Gynecologic cancers:
Indications for: LYNPARZA
First-line maintenance treatment of deleterious or suspected deleterious germline or somatic BRCA-mutated (as detected by an FDA-approved test) advanced epithelial ovarian, fallopian tube or primary peritoneal cancer, in adults who are in complete or partial response to first-line platinum-based chemotherapy. In combination with bevacizumab for the first-line maintenance treatment of advanced epithelial ovarian, fallopian tube or primary peritoneal cancer, in adults 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 (as detected by an FDA-approved test). Maintenance treatment of recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, in adults who are in complete or partial response to platinum-based chemotherapy. Treatment of deleterious or suspected deleterious germline BRCA-mutated (as detected by an FDA-approved test) advanced ovarian cancer in adults who have been treated with ≥3 prior lines of chemotherapy.
Adult Dosage:
Swallow whole. 300mg twice daily. First-line maintenance of BRCA-mutated or HRD-positive advanced ovarian: continue until disease progression, unacceptable toxicity, or completion of 2yrs of treatment. Discontinue if complete response at 2yrs; may treat beyond 2yrs in those with evidence of disease if provider can derive further benefit from continuous treatment. Others: continue until disease progression or unacceptable toxicity. In combination with bevacizumab: give bevacizumab (15mg/kg every 3 weeks) for total of 15 months (refer to respective product labeling for details). Dose adjustments for adverse reactions: reduce to 250mg twice daily; may further reduce to 200mg twice daily. Concomitant strong or moderate CYP3A inhibitors (if unavoidable): reduce olaparib dose to 100mg twice daily (with strong inhibitors) or 150mg twice daily (with moderate inhibitors). Moderate renal impairment (CrCl 31–50mL/min): reduce to 200mg twice daily.
Children Dosage:
Not established.
LYNPARZA Warnings/Precautions:
Do not start therapy until recovery from hematological toxicity due to previous chemotherapy (CTCAE Grade ≤1). Monitor CBC for cytopenia at baseline and monthly thereafter during therapy or weekly until recovery (for prolonged hematological toxicities). Discontinue if myelodysplastic syndrome/acute myeloid leukemia (MDS/AML) is confirmed. Interrupt therapy and evaluate if new or worsening respiratory symptoms occur; discontinue and treat if pneumonitis is confirmed. Monitor for venous thrombosis, pulmonary embolism; treat appropriately. Mild renal impairment: monitor closely. Severe hepatic or severe renal impairment or ESRD (CrCl ≤30mL/min): not studied. Embryo-fetal toxicity. Advise females of reproductive potential to use effective contraception during and for 6 months after the last dose. Males (w. female partners) should use effective contraception and do not donate sperm during and for 3 months after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 1 month after the last dose).
See Also:
LYNPARZA Classification:
Poly (ADP-ribose) polymerase (PARP) inhibitor.
LYNPARZA Interactions:
Increased myelosuppressive toxicity with concomitant other myelosuppressive anticancer agents, including DNA damaging agents. Avoid concomitant strong CYP3A inhibitors (eg, itraconazole) and moderate CYP3A inhibitors (eg, fluconazole); if unavoidable, reduce dose (see Adults). Avoid grapefruit, grapefruit juice, Seville oranges, and Seville orange juice. Avoid concomitant strong CYP3A inducers (eg, rifampicin) and moderate CYP3A inducers (eg, efavirenz); if unavoidable, be aware of potential for decreased efficacy.
Adverse Reactions:
Nausea, fatigue, asthenia, anemia, vomiting, diarrhea, decreased appetite, headache, neutropenia, dysgeusia, cough, dyspnea, dizziness, dyspepsia, leukopenia, thrombocytopenia, upper abdominal pain. In combination with bevacizumab or abiraterone and prednisone or prednisolone: also lymphopenia, UTI.
Drug Elimination:
- Renal (44%), fecal (42%). Half-life: 14.9 ± 8.2 hours.
Generic Drug Availability:
NO
How Supplied:
Tabs—60, 120
Pancreatic, thyroid, and other endocrine cancers:
Indications for: LYNPARZA
First-line maintenance treatment of deleterious or suspected deleterious germline BRCA-mutated (as detected by an FDA-approved test) metastatic pancreatic adenocarcinoma in adults whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen.
Adult Dosage:
Swallow whole. 300mg twice daily. Continue until disease progression or unacceptable toxicity. Dose adjustments for adverse reactions: reduce to 250mg twice daily; may further reduce to 200mg twice daily. Concomitant strong or moderate CYP3A inhibitors (if unavoidable): reduce olaparib dose to 100mg twice daily (with strong inhibitors) or 150mg twice daily (with moderate inhibitors). Moderate renal impairment (CrCl 31–50mL/min): reduce to 200mg twice daily.
Children Dosage:
Not established.
LYNPARZA Warnings/Precautions:
Do not start therapy until recovery from hematological toxicity due to previous chemotherapy (CTCAE Grade ≤1). Monitor CBC for cytopenia at baseline and monthly thereafter during therapy or weekly until recovery (for prolonged hematological toxicities). Discontinue if myelodysplastic syndrome/acute myeloid leukemia (MDS/AML) is confirmed. Interrupt therapy and evaluate if new or worsening respiratory symptoms occur; discontinue and treat if pneumonitis is confirmed. Monitor for venous thrombosis, pulmonary embolism; treat appropriately. Mild renal impairment: monitor closely. Severe hepatic or severe renal impairment or ESRD (CrCl ≤30mL/min): not studied. Embryo-fetal toxicity. Advise females of reproductive potential to use effective contraception during and for 6 months after the last dose. Males (w. female partners) should use effective contraception and do not donate sperm during and for 3 months after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 1 month after the last dose).
LYNPARZA Classification:
Poly (ADP-ribose) polymerase (PARP) inhibitor.
LYNPARZA Interactions:
Increased myelosuppressive toxicity with concomitant other myelosuppressive anticancer agents, including DNA damaging agents. Avoid concomitant strong CYP3A inhibitors (eg, itraconazole) and moderate CYP3A inhibitors (eg, fluconazole); if unavoidable, reduce dose (see Adults). Avoid grapefruit, grapefruit juice, Seville oranges, and Seville orange juice. Avoid concomitant strong CYP3A inducers (eg, rifampicin) and moderate CYP3A inducers (eg, efavirenz); if unavoidable, be aware of potential for decreased efficacy.
Adverse Reactions:
Nausea, fatigue, asthenia, anemia, vomiting, diarrhea, decreased appetite, headache, neutropenia, dysgeusia, cough, dyspnea, dizziness, dyspepsia, leukopenia, thrombocytopenia, upper abdominal pain. In combination with bevacizumab or abiraterone and prednisone or prednisolone: also lymphopenia, UTI.
Drug Elimination:
- Renal (44%), fecal (42%). Half-life: 14.9 ± 8.2 hours.
Generic Drug Availability:
NO
How Supplied:
Tabs—60, 120
Prostate and other male cancers:
Indications for: LYNPARZA
Treatment of deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated (as detected by an FDA-approved test) metastatic castration-resistant prostate cancer in adults who have progressed following prior treatment with enzalutamide or abiraterone. In combination with abiraterone and prednisone or prednisolone for the treatment of deleterious or suspected deleterious BRCA-mutated (BRCAm) (as detected by an FDA-approved test) mCRPC in adults.
Adult Dosage:
Swallow whole. 300mg twice daily. Continue until disease progression or unacceptable toxicity. Should also give a GnRH analog concurrently or should have had bilateral orchiectomy. For BRCAm mCRPC: give abiraterone 1000mg once daily with prednisone or prednisolone 5mg twice daily. Dose adjustments for adverse reactions: reduce to 250mg twice daily; may further reduce to 200mg twice daily. Concomitant strong or moderate CYP3A inhibitors (if unavoidable): reduce olaparib dose to 100mg twice daily (with strong inhibitors) or 150mg twice daily (with moderate inhibitors). Moderate renal impairment (CrCl 31–50mL/min): reduce to 200mg twice daily.
Children Dosage:
Not established.
LYNPARZA Warnings/Precautions:
Do not start therapy until recovery from hematological toxicity due to previous chemotherapy (CTCAE Grade ≤1). Monitor CBC for cytopenia at baseline and monthly thereafter during therapy or weekly until recovery (for prolonged hematological toxicities). Discontinue if myelodysplastic syndrome/acute myeloid leukemia (MDS/AML) is confirmed. Interrupt therapy and evaluate if new or worsening respiratory symptoms occur; discontinue and treat if pneumonitis is confirmed. Monitor for venous thrombosis, pulmonary embolism; treat appropriately. Mild renal impairment: monitor closely. Severe hepatic or severe renal impairment or ESRD (CrCl ≤30mL/min): not studied. Embryo-fetal toxicity. Advise females of reproductive potential to use effective contraception during and for 6 months after the last dose. Males (w. female partners) should use effective contraception and do not donate sperm during and for 3 months after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 1 month after the last dose).
LYNPARZA Classification:
Poly (ADP-ribose) polymerase (PARP) inhibitor.
LYNPARZA Interactions:
Increased myelosuppressive toxicity with concomitant other myelosuppressive anticancer agents, including DNA damaging agents. Avoid concomitant strong CYP3A inhibitors (eg, itraconazole) and moderate CYP3A inhibitors (eg, fluconazole); if unavoidable, reduce dose (see Adults). Avoid grapefruit, grapefruit juice, Seville oranges, and Seville orange juice. Avoid concomitant strong CYP3A inducers (eg, rifampicin) and moderate CYP3A inducers (eg, efavirenz); if unavoidable, be aware of potential for decreased efficacy.
Adverse Reactions:
Nausea, fatigue, asthenia, anemia, vomiting, diarrhea, decreased appetite, headache, neutropenia, dysgeusia, cough, dyspnea, dizziness, dyspepsia, leukopenia, thrombocytopenia, upper abdominal pain. In combination with bevacizumab or abiraterone and prednisone or prednisolone: also lymphopenia, UTI.
Drug Elimination:
- Renal (44%), fecal (42%). Half-life: 14.9 ± 8.2 hours.
Generic Drug Availability:
NO
How Supplied:
Tabs—60, 120
