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:

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:

Not established.

Warnings/Precautions:

Monitor CBC for cytopenia at baseline and monthly thereafter; do not start therapy until recovery from hematological toxicity due to previous chemotherapy (CTCAE Grade ≤1). 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. 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 last dose. Males (w. female partners) should use effective contraception and do not donate sperm during and for 3 months after last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 1 month after last dose).

Pharmacologic Class:

Poly (ADP-ribose) polymerase (PARP) inhibitor.

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, vomiting, abdominal pain, anemia, diarrhea, dizziness, neutropenia, leukopenia, nasopharyngitis/upper respiratory tract infection/influenza, respiratory tract infection, arthralgia/myalgia, dysgeusia, headache, dyspepsia, decreased appetite, constipation, stomatitis, dyspnea, thrombocytopenia, lab abnormalities (see full labeling); MDS/AML, pneumonitis.

Generic Availability:

NO

How Supplied:

Tabs—60, 120

Pricing for LYNPARZA

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

Gynecologic cancers:

Indications for LYNPARZA:

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. 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:

Swallow whole. 300mg twice daily. First-line maintenance of BRCA-mutated 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. 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:

Not established.

Warnings/Precautions:

Monitor CBC for cytopenia at baseline and monthly thereafter; do not start therapy until recovery from hematological toxicity due to previous chemotherapy (CTCAE Grade ≤1). 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. 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 last dose. Males (w. female partners) should use effective contraception and do not donate sperm during and for 3 months after last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 1 month after last dose).

See Also:

    Pharmacologic Class:

    Poly (ADP-ribose) polymerase (PARP) inhibitor.

    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, vomiting, abdominal pain, anemia, diarrhea, dizziness, neutropenia, leukopenia, nasopharyngitis/upper respiratory tract infection/influenza, respiratory tract infection, arthralgia/myalgia, dysgeusia, headache, dyspepsia, decreased appetite, constipation, stomatitis, dyspnea, thrombocytopenia, lab abnormalities (see full labeling); MDS/AML, pneumonitis.

    Generic Availability:

    NO

    How Supplied:

    Tabs—60, 120

    Pricing for LYNPARZA

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

    Pancreatic, thyroid, and other endocrine cancers:

    Indications for LYNPARZA:

    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:

    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:

    Not established.

    Warnings/Precautions:

    Monitor CBC for cytopenia at baseline and monthly thereafter; do not start therapy until recovery from hematological toxicity due to previous chemotherapy (CTCAE Grade ≤1). 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. 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 last dose. Males (w. female partners) should use effective contraception and do not donate sperm during and for 3 months after last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 1 month after last dose).

    Pharmacologic Class:

    Poly (ADP-ribose) polymerase (PARP) inhibitor.

    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, vomiting, abdominal pain, anemia, diarrhea, dizziness, neutropenia, leukopenia, nasopharyngitis/upper respiratory tract infection/influenza, respiratory tract infection, arthralgia/myalgia, dysgeusia, headache, dyspepsia, decreased appetite, constipation, stomatitis, dyspnea, thrombocytopenia, lab abnormalities (see full labeling); MDS/AML, pneumonitis.

    Generic Availability:

    NO

    How Supplied:

    Tabs—60, 120

    Pricing for LYNPARZA

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