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. Moderate renal impairment (CrCl 30–59mL/min): 0.75mg 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). Severe renal impairment or hemodialysis: not studied. Moderate or severe hepatic impairment: not studied. Embryo-fetal toxicity. Females of reproductive potential should use effective contraception during and for ≥7 months after last dose. Males (w. female partners) should 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.

Generic Availability:

NO

How Supplied:

Caps—30