- 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: also lymphopenia, UTI.
Generic Drug Availability:
NO
How Supplied:
Tabs—60, 120
Gynecologic Cancers:
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: also lymphopenia, UTI.
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.
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. 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: also lymphopenia, UTI.
Generic Drug Availability:
NO
How Supplied:
Tabs—60, 120
