Breast cancer:
Indications for TALZENNA:
Treatment of deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), HER2-negative locally advanced or metastatic breast cancer, as detected by an FDA-approved test.
Adult:
Swallow whole. 1mg once daily. Continue until disease progression or unacceptable toxicity. Dose reductions for adverse reactions (1st reduction): 0.75mg once daily; (2nd reduction): 0.5mg once daily; (3rd reduction): 0.25mg once daily. Discontinue if >3 dose reductions are required. Dose modifications for hematologic/non-hematologic 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.
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. 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: if toxicity occurs, modify/manage dose (see full labeling). Moderate or severe renal impairment (see Adults); if severe, monitor for adverse reactions and adjust dosing accordingly. Hemodialysis: not studied. Moderate or severe hepatic impairment: 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).
Pharmacologic Class:
Poly (ADP-ribose) polymerase (PARP) inhibitor.
Interactions:
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.
Adverse Reactions:
Fatigue, anemia, nausea, neutropenia, headache, thrombocytopenia, vomiting, alopecia, diarrhea, decreased appetite, lab abnormalities (see full labeling); MDS/AML.
Elimination:
Renal (major), fecal.
Generic Availability:
NO
How Supplied:
Caps—30
