TALZENNA
Generic Name/API: talazoparib
Manufacturer: Pfizer
Dosage Forms & Strength & Pack Size:
Capsules: 0.1 mg, 0.25 mg, 0.35 mg, 0.5 mg, 0.75 mg, and 1 mg
Storage:
Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F).
INDICATIONS AND USAGE
TALZENNA is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated for:
Breast Cancer
As a single agent, for the treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) HER2-negative locally advanced or metastatic breast cancer. Select patients for therapy based on an FDA-approved companion diagnostic for TALZENNA.
HRR Gene-mutated mCRPC
In combination with enzalutamide for the treatment of adult patients with HRR gene mutated metastatic castration-resistant prostate cancer (mCRPC).
CONTRAINDICATIONS
WARNINGS AND PRECAUTIONS
Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML): MDS/AML occurred in patients exposed to TALZENNA, and some cases were fatal. Monitor patients for
hematological toxicity and discontinue if MDS/AML is confirmed. (5.1) Myelosuppression: TALZENNA may affect hematopoiesis and can cause anemia, neutropenia, and/or thrombocytopenia. (5.2) Embryo-Fetal Toxicity: TALZENNA can cause fetal harm. Advise of the potential risk to the fetus and to use effective contraception. (5.3, 8.1, 8.3)
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