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); for breast cancer: if unavoidable, reduce dose (see Adults); for mCRPC: not studied, monitor and adjust dose as needed. 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; also in combination with enzalutamide: fractures, dysgeusia; lab abnormalities (see full labeling).
Drug Elimination:
- Renal (68.7%), fecal (19.7%).
- Half-life: 90 hours.
- Apparent oral clearance: 6.45 L/h.
Generic Drug Availability:
NO
How Supplied:
Caps—30
Prostate and other male cancers:
Indications for: TALZENNA
In combination with enzalutamide for adults with homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC).
Adult Dosage:
Select patients based on the presence of HRR gene mutations. Swallow whole. 0.5mg once daily in combination with enzalutamide. Continue until disease progression or unacceptable toxicity. Dose modifications for adverse reactions: see full labeling. Renal impairment (moderate [CrCl 30–59mL/min]): 0.35mg once daily in combination with enzalutamide; (severe [CrCl 15–29mL/min]): 0.25mg once daily in combination with enzalutamide.
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); for breast cancer: if unavoidable, reduce dose (see Adults); for mCRPC: not studied, monitor and adjust dose as needed. 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; also in combination with enzalutamide: fractures, dysgeusia; lab abnormalities (see full labeling).
Drug Elimination:
- Renal (68.7%), fecal (19.7%).
- Half-life: 90 hours.
- Apparent oral clearance: 6.45 L/h.
Generic Drug Availability:
NO
How Supplied:
Caps—30
