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

Indications and Usage (1)

6/2023

Dosage and Administration (2)

2/2024

Warnings and Precautions (5)

6/2023

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. (1.1)

HRR Gene-mutated mCRPC

•
In combination with enzalutamide for the treatment of adult patients with HRR gene-mutated metastatic castration-resistant prostate cancer (mCRPC). (1.2)

DOSAGE AND ADMINISTRATION

•
Take TALZENNA with or without food. (2.4)

Breast Cancer

•
The recommended dosage of TALZENNA is 1 mg taken orally once daily until disease progression or unacceptable toxicity. (2.2)
•
For adverse reactions, consider dosing interruption or dose reduction. (2.5)

HRR Gene-Mutated mCRPC

•
The recommended dosage of TALZENNA is 0.5 mg taken orally once daily in combination with enzalutamide until disease progression or unacceptable toxicity. (2.3)
•
Patients should also receive a gonadotropic-releasing hormone (GnRH) analog concurrently or should have had bilateral orchiectomy. (2.3)

DOSAGE FORMS AND STRENGTHS

Capsules: 0.1 mg, 0.25 mg, 0.35 mg, 0.5 mg, 0.75 mg, and 1 mg (3)

CONTRAINDICATIONS

None. (4)

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)

ADVERSE REACTIONS

Most common adverse reactions (≥20%) as a single agent, including laboratory abnormalities, are:

•
Hemoglobin decreased, neutrophils decreased, lymphocytes decreased, platelets decreased, fatigue, glucose increased, aspartate aminotransferase increased, alkaline phosphatase increased, alanine aminotransferase increased, calcium decreased, nausea, headache, vomiting, alopecia, diarrhea, and decreased appetite. (6.1)

Most common adverse reactions (≥10%) in combination with enzalutamide, including laboratory abnormalities, are:

•
Hemoglobin decreased, neutrophils decreased, lymphocytes decreased, fatigue, platelets decreased, calcium decreased, nausea, decreased appetite, sodium decreased, phosphate decreased, fractures, magnesium decreased, dizziness, bilirubin increased, potassium decreased, and dysgeusia. (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 the dose when coadministered with certain P-gp inhibitors. Monitor for increased adverse reactions. (2.7, 7.1)
•
BCRP Inhibitors: Monitor for potential increased adverse reactions. (7.1)

USE IN SPECIFIC POPULATIONS

•
Lactation: Advise women not to breastfeed. (8.2)
•
Renal Impairment: Reduce the dose and monitor for increased adverse reactions for patients with moderate or severe renal impairment. (2.6, 8.7)

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

Revised: 2/2024

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Highlights

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 (1)

6/2023

Dosage and Administration (2)

2/2024

Warnings and Precautions (5)

6/2023

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. (1.1)

HRR Gene-mutated mCRPC

•
In combination with enzalutamide for the treatment of adult patients with HRR gene-mutated metastatic castration-resistant prostate cancer (mCRPC). (1.2)

DOSAGE AND ADMINISTRATION

•
Take TALZENNA with or without food. (2.4)

Breast Cancer

•
The recommended dosage of TALZENNA is 1 mg taken orally once daily until disease progression or unacceptable toxicity. (2.2)
•
For adverse reactions, consider dosing interruption or dose reduction. (2.5)

HRR Gene-Mutated mCRPC

•
The recommended dosage of TALZENNA is 0.5 mg taken orally once daily in combination with enzalutamide until disease progression or unacceptable toxicity. (2.3)
•
Patients should also receive a gonadotropic-releasing hormone (GnRH) analog concurrently or should have had bilateral orchiectomy. (2.3)

DOSAGE FORMS AND STRENGTHS

Capsules: 0.1 mg, 0.25 mg, 0.35 mg, 0.5 mg, 0.75 mg, and 1 mg (3)

CONTRAINDICATIONS

None. (4)

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)

ADVERSE REACTIONS

Most common adverse reactions (≥20%) as a single agent, including laboratory abnormalities, are:

•
Hemoglobin decreased, neutrophils decreased, lymphocytes decreased, platelets decreased, fatigue, glucose increased, aspartate aminotransferase increased, alkaline phosphatase increased, alanine aminotransferase increased, calcium decreased, nausea, headache, vomiting, alopecia, diarrhea, and decreased appetite. (6.1)

Most common adverse reactions (≥10%) in combination with enzalutamide, including laboratory abnormalities, are:

•
Hemoglobin decreased, neutrophils decreased, lymphocytes decreased, fatigue, platelets decreased, calcium decreased, nausea, decreased appetite, sodium decreased, phosphate decreased, fractures, magnesium decreased, dizziness, bilirubin increased, potassium decreased, and dysgeusia. (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 the dose when coadministered with certain P-gp inhibitors. Monitor for increased adverse reactions. (2.7, 7.1)
•
BCRP Inhibitors: Monitor for potential increased adverse reactions. (7.1)

USE IN SPECIFIC POPULATIONS

•
Lactation: Advise women not to breastfeed. (8.2)
•
Renal Impairment: Reduce the dose and monitor for increased adverse reactions for patients with moderate or severe renal impairment. (2.6, 8.7)

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

Revised: 2/2024
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