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
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
The recommended dose of TALZENNA is 1 mg taken as a single oral daily dose, with or without food. (2.2)
Patients should be treated until disease progression or unacceptable toxicity occurs. (2.2)
For adverse reactions, consider dosing interruption or dose reduction. (2.3)
For patients with moderate renal impairment (CLcr 30 – 59 mL/min), the recommended dose of TALZENNA is 0.75 mg once daily. (2.4)
DOSAGE FORMS AND STRENGTHS
Capsules: 0.25 mg, 1 mg (3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML): MDS/AML has been reported in 2 out of 584 (0.3%) solid tumor patients treated with TALZENNA in clinical studies. Monitor patients for hematological toxicity at baseline and monthly thereafter. 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)
ADVERSE REACTIONS
Most common (≥20%) adverse reactions of any grade were: Fatigue, anemia, nausea, neutropenia, headache, thrombocytopenia, vomiting, alopecia, diarrhea, decreased appetite. (6.1)
Most common laboratory abnormalities (≥25%) were: Decreases in hemoglobin, platelets, neutrophils, lymphocytes, leukocytes, and calcium. Increases in glucose, alanine aminotransferase, aspartate aminotransferase, and alkaline phosphatase. (6.1)

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.
DRUG INTERACTIONS
P-gp Inhibitors: Reduce TALZENNA dose for certain P-gp inhibitors, and monitor for potential increased adverse reactions as appropriate. (2.5, 7.1, 12.3)
BCRP Inhibitors: Monitor for potential increased adverse reactions. (7.1)
USE IN SPECIFIC POPULATIONS
Lactation: Advise women not to breastfeed. (8.2)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 10/2018
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Patient Selection
2.2 Recommended Dosing
2.3 Dose Modifications for Adverse Reactions
2.4 Dose Modifications for Patients with Renal Impairment
2.5 Dose Modifications for Use with P-glycoprotein (P-gp) Inhibitors
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Myelodysplastic Syndrome/Acute Myeloid Leukemia
5.2 Myelosuppression
5.3 Embryo-Fetal Toxicity
6 ADVERSE REACTIONS
6.1 Clinical Trials Expe