Indications for: TALZENNA
In adults with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), HER2-negative locally advanced or metastatic breast cancer, as detected by an FDA-approved test.
Swallow whole. 1mg once daily. Continue until disease progression or unacceptable toxicity. Dose modifications for adverse reactions: see full labeling. Renal impairment (moderate [CrCl 30–59mL/min]): 0.75mg once daily; (severe [CrCl 15–29mL/min]): 0.5mg once daily. Concomitant certain P-gp inhibitors (if unavoidable): reduce to 0.75mg once daily; increase to previous dose once inhibitor is discontinued.
Monitor CBCs for cytopenia at baseline and monthly thereafter. Do not start therapy until recovery from hematological toxicity due to previous chemotherapy. Prolonged hematological toxicities: interrupt and monitor blood counts weekly until recovery; if levels not recovered after 4 weeks, consult hematologist. Discontinue if myelodysplastic syndrome/acute myeloid leukemia (MDS/AML) is confirmed. Myelosuppression. Moderate or severe renal impairment (see Adult dose); if severe, monitor and adjust dosing accordingly. Hemodialysis: not studied. Embryo-fetal toxicity. Advise females of reproductive potential to use effective contraception during and for ≥7 months after last dose. Advise males (w. female partners) to use effective contraception during and for ≥4 months after last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for ≥1 month after last dose).
Poly (ADP-ribose) polymerase (PARP) inhibitor.
May be potentiated by P-gp inhibitors (eg, amiodarone, carvedilol, clarithromycin, itraconazole, verapamil); if unavoidable, reduce dose (see Adults). May be potentiated by BCRP inhibitors; if unavoidable, monitor for increased adverse reactions.
Fatigue, anemia, nausea, neutropenia, headache, thrombocytopenia, vomiting, alopecia, diarrhea, decreased appetite, lab abnormalities (see full labeling).
Generic Drug Availability: