Generic Name and Formulations:
Olaparib 50mg; caps.
Indications for LYNPARZA:
Treatment of patients with deleterious or suspected deleterious germline BRCA-mutated (as detected by an FDA-approved test) advanced ovarian cancer who have been treated with ≥3 prior lines of chemotherapy.
Swallow whole. 400mg twice daily; max 800mg daily. Continue until disease progression or unacceptable toxicity. Dose adjustments for adverse reactions: reduce to 200mg twice daily; may further reduce to 100mg twice daily. Concomitant strong or moderate CYP3A inhibitors: avoid; if co-admin unavoidable, reduce olaparib dose to 150mg twice daily (with strong inhibitors) or 200mg twice daily (with moderate inhibitors). Moderate renal impairment (CrCl 31–50mL/min): reduce to 300mg twice daily; max 600mg daily.
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. Moderate or severe hepatic impairment, severe renal impairment or ESRD (CrCl ≤30mL/min): not studied. Embryo-fetal toxicity. Pregnancy; exclude status prior to initiating therapy. Females of reproductive potential should use effective contraception during therapy 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. Nursing mothers: not recommended (during and for 1 month after last dose).
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.
Poly (ADP-ribose) polymerase (PARP) inhibitor.
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.
Caps—112; Tabs—60, 120