LYNPARZA TABLETS Rx

Select the drug indication to add to your list

LYNPARZA TABLETS

Breast cancer
Gynecologic cancers
Only 4 drugs may be compared at once

Generic Name and Formulations:

Olaparib 100mg, 150mg.

Select therapeutic use:

Indications for LYNPARZA TABLETS:

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; max 600mg 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; max 400mg daily.

Children:

Not established.

Warnings/Precautions:

Caps and tabs are not interchangeable on a mg-to-mg basis. 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. Females of reproductive potential should 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).

Pharmacological 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, telithromycin, clarithromycin, ketoconazole, voriconazole, nefazodone, posaconazole, ritonavir, lopinavir/ritonavir, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) and moderate CYP3A inhibitors (eg, amprenavir, aprepitant, atazanavir, ciprofloxacin, crizotinib, darunavir/ritonavir, diltiazem, erythromycin, fluconazole, fosamprenavir, imatinib, verapamil); if unavoidable, reduce dose (see Adults). Avoid grapefruit, grapefruit juice, Seville oranges, and Seville orange juice. Avoid concomitant strong CYP3A inducers (eg, phenytoin, rifampicin, carbamazepine, St. John’s Wort) and moderate CYP3A inducers (eg, bosentan, efavirenz, etravirine, modafinil, nafcillin); if unavoidable, be aware of potential for decreased efficacy.

Adverse Reactions:

Anemia, nausea, fatigue, asthenia, vomiting, neutropenia, leukopenia, nasopharyngitis/URI/influenza, diarrhea, arthralgia, myalgia, dysgeusia, headache, dyspepsia, decreased appetite, constipation, stomatitis, lab abnormalities (see full labeling); MDS/AML, pneumonitis.

Generic Availability:

NO

How Supplied:

Caps—112; Tabs—60, 120

Indications for LYNPARZA TABLETS:

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; max 600mg 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; max 400mg daily.

Children:

Not established.

Warnings/Precautions:

Caps and tabs are not interchangeable on a mg-to-mg basis. 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. Females of reproductive potential should 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:

LYNPARZA

Pharmacological 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, telithromycin, clarithromycin, ketoconazole, voriconazole, nefazodone, posaconazole, ritonavir, lopinavir/ritonavir, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) and moderate CYP3A inhibitors (eg, amprenavir, aprepitant, atazanavir, ciprofloxacin, crizotinib, darunavir/ritonavir, diltiazem, erythromycin, fluconazole, fosamprenavir, imatinib, verapamil); if unavoidable, reduce dose (see Adults). Avoid grapefruit, grapefruit juice, Seville oranges, and Seville orange juice. Avoid concomitant strong CYP3A inducers (eg, phenytoin, rifampicin, carbamazepine, St. John’s Wort) and moderate CYP3A inducers (eg, bosentan, efavirenz, etravirine, modafinil, nafcillin); if unavoidable, be aware of potential for decreased efficacy.

Adverse Reactions:

Anemia, nausea, fatigue, asthenia, vomiting, neutropenia, leukopenia, nasopharyngitis/URI/influenza, diarrhea, arthralgia, myalgia, dysgeusia, headache, dyspepsia, decreased appetite, constipation, stomatitis, lab abnormalities (see full labeling); MDS/AML, pneumonitis.

Generic Availability:

NO

How Supplied:

Caps—112; Tabs—60, 120