Breast cancer:
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.
Adult Dosage:
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.
Children Dosage:
Not established.
TALZENNA Warnings/Precautions:
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).
TALZENNA Classification:
Poly (ADP-ribose) polymerase (PARP) inhibitor.
TALZENNA 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).
Generic Drug Availability:
NO
How Supplied:
Caps—30
