Select therapeutic use:

Breast cancer:

Indications for LYNPARZA:

Treatment of deleterious or suspected deleterious germline BRCA-mutated, HER2-negative (as detected by an FDA-approved test) metastatic breast cancer in patients 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. 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: avoid; if co-admin 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 and 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

Pricing for LYNPARZA

120 tablets of 150mg bottle (Qty: 1)
Appx. price $14287
GoodRx

Gynecologic Cancers:

Pricing for LYNPARZA

120 tablets of 150mg bottle (Qty: 1)
Appx. price $14287
GoodRx

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: avoid; if co-admin 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 and 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

Pricing for LYNPARZA

120 tablets of 150mg bottle (Qty: 1)
Appx. price $14287
GoodRx

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. Dose adjustments for adverse reactions: reduce to 250mg twice daily; may further reduce to 200mg twice daily. Concomitant strong or moderate CYP3A inhibitors: avoid; if co-admin 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 and 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

Pricing for LYNPARZA

120 tablets of 150mg bottle (Qty: 1)
Appx. price $14287
GoodRx