HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use TALZENNA safely and effectively. See full prescribing information for TALZENNA.
TALZENNA® (talazoparib) capsules, for oral use
Initial U.S. Approval: 2018
RECENT MAJOR CHANGES
INDICATIONS AND USAGE
TALZENNA is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated 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. (1)
DOSAGE AND ADMINISTRATION
DOSAGE FORMS AND STRENGTHS
Capsules: 0.25 mg, 1 mg (3)
WARNINGS AND PRECAUTIONS
To report SUSPECTED ADVERSE REACTIONS, contact Pfizer, Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
USE IN SPECIFIC POPULATIONS
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.