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TALZENNA Highlights (talazoparib)

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

Dosage and Administration, Dose Modifications for Patients with Renal Impairment (2.4)3/2020

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)
  • For patients with severe renal impairment (Clcr 15 – 29 mL/min), the recommended dose of TALZENNA is 0.5 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)
  • Severe Renal Impairment: Reduce TALZENNA dose and monitor for potential increased adverse reactions as appropriate. (8.6, 12.3)

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Revised: 3/2020

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